Chronic fatigue syndrome (CFS)

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https://www.zeit.de/karriere/beruf/2014-06/wichtigste-fragen-burn-out

Vergleich: Siehe: Gemütsverfassungen + Krankheiten + Fatigue/Erschöpfung/Burn-out + Araliacae

[Jenny Tree]

Dr. Jadin, working in South Africa, reviewed 3,400 cases of Chronic Fatigue syndrome, fibromyalgia, rheumatoid arthritis, depression and multiple sclerosis, and felt that

after an initial flu-like state, the cases had become sub-acute or chronic, and shared the symptoms of Rickettsia, which we also know as Typhus, Rocky Mountain Spotted Fever, Kew Gardens Fever, Mediterranean Fever, Irish Fever, Siberia Fever, and North Queensland tick typhus, amongst many others. The geography of the names shows

the worldwide extent of the disease. I am not suggesting that typhus is at the root of all eating disorders, but when the eating disorder has its start in a fever, after which the patient fails to thrive, loses appetite, refuses to eat, it is possible to look here. In homeopathy we know the remedy as Typhus nosode. Quelle: Remedia pharmacy in Austria sells as Fleckfieber nosode.

[Saul Wayne]

https://ir.dut.ac.za/bitstream/10321/44/16/Saul_2005.pdf

Chronic fatigue syndrome (CFS) is a sporadic illness (Straus, 2004:1234). It is characterized by debilitating symptoms of unexplained fatigue of at least 6 months + several other symptoms. The latter may include unrefreshing sleep, sore throat, tender lymph nodes, muscle +/o. joint pain, +/o. headaches. CFS patients experience significant functional impairment that is not resolved by rest (Skinner, 2004:28). They may also report difficulty in everyday physical and mental tasks, reflected in terms of painful muscle exertion and painful cognitive processing (Wessely, Hotopf & Sharpe, 1999:417).

Despite much research, the cause of CFS remains unknown. Pathophysiological abnormalities have been noted across many domains, suggesting that CFS is a heterogeneous condition of multifactorial aetiology (Afari & Buchwald, 2003:223).

According to Gray (2001:8) CFS is a complex illness pointing to physiological, environmental and psychological influences on its aetiopathogenesis.

As no biological marker has been found (Mostert, 1999:81), there are no tests to confirm or refute a diagnosis of CFS. Careful history and examination of the patient is needed to exclude an underlying organic cause, or severe psychiatric disorder (Cleare & Wessely, 1997:102,106). Diagnosis made on the basis of symptoms using a clinical case definition (Afari, van der Meer, Bleijenberg & Buchwald, 2005:351).

Much professional and public non-acceptance surrounds the diagnosis of CFS (Welch, 1999:1). According to the likes of Gray (2001:2) and Tucker (2004:164), many physicians do not believe that CFS exists, despite its official recognition.

Further problematic, is that nosological debate continues with unresolve, on whether CFS is a somatic or psychological based illness (Hyland, 2001:273).

CFS is hence conceded, in point, a diagnostic and management challenge for healthcare providers (Mostert, 1999:72; Solomon & Reeves, 2004:2241).

Whilst pharmacological approaches have failed to resolve CFS, two strategies have emerged beneficial to many sufferers: that is cognitive-behavioural therapy and graded exercise (Straus, 2004:1234). However, these modalities do not render patients symptom free (Wessely, Hotopf & Sharpe, 1999:416).

The prognosis for all CFS sufferers is variable as no treatment has yet been significantly effective (Rutherford, 2003). Although not associated with mortality, CFS renders considerable morbidity to its sufferers and complete recovery is rare (Mostert, 1999:92).

Whilst biomedical confirmation remains crucial to legitimising the care and support needed by CFS sufferers (Featherstone, 1998:105), the interactional approaches offered

by mind-body medicine and cognate, homoeopathy, may provide importance to illness management in CFS (Hyland, 2001; Featherstone, 1998).

Homoeopathy is a natural pharmaceutical system that utilizes microdoses of substances, from plant, mineral or animal kingdoms, in order to stimulate the innate healing response of the human being. It is a system disposed to strengthening the organism’s immune and defense capacity so as to establish health and prevent disease. This is achieved without producing the side effects common to other conventional drug treatments (Ullman, 1991:xxiii - xxix).

Reports of homoeopathy’s effectiveness for CFS have been conflicting (Wessely, Hotopf & Sharpe, 199:387; Bailey, 1995:189): A research study coordinated by Awdry (1996) was deemed inconclusive due to inadequate statistical analysis (Afari & Buchwald, 2003:228).

Another, more recent randomised controlled study, conducted in the UK, found equivocal evidence for the effectiveness of homoeopathic treatment for CFS (Weatherley-Jones Nicholl, Thomas, Parry, McKendrick, Green, Stanley & Lynch, 2004). From both accounts, and of evidence hitherto available, the question of effectiveness lies unresolved and further research was therefore warranted.

OBJECTIVES

1^st Objective

To determine the effectiveness of homoeopathic similimum treatment in the management of chronic fatigue syndrome (CFS), in terms of the symptoms of CFS, by use

of a self-report CFS questionnaire.

2^nd Objective

To determine the effectiveness of homoeopathic similimum treatment in the management of chronic fatigue syndrome (CFS), in terms of the levels of fatigue experienced,

by use of a fatigue visual analogue scale (VAS).

3^rd Objective

To determine the effectiveness of placebo treatment in the management of chronic fatigue syndrome (CFS), in terms of the symptoms of CFS, by use of a self-report CFS

questionnaire.

4^th Objective

To determine the effectiveness of placebo treatment in the management of chronic fatigue syndrome (CFS), in terms of the levels of fatigue experienced, by use of a fatigue visual analogue scale (VAS).

1^st Hypothesis

It is hypothesised that the homoeopathic similimum treatment will not be effective in reducing the symptoms of chronic fatigue syndrome, as measured by the CFS questionnaire scores.

2^nd Hypothesis

It is hypothesised that the homoeopathic similimum treatment will not be effective in reducing levels of fatigue, as measured by fatigue visual analogue scale (VAS) scores.

3^rd Hypothesis

It is hypothesised that there will be no difference in effect between the homoeopathic similimum and placebo in reducing symptoms of chronic fatigue syndrome, as measured by the CFS questionnaire scores.

4^th Hypothesis

It is hypothesised that there will be no difference in effect between the homoeopathic similimum and placebo in reducing levels of fatigue, as measured by fatigue visual analogue scale (VAS) scores.

DEFINITION OF FATIGUE

Sharpe & Wilks (2002:480) define fatigue as “a subjective symptom of malaise and aversion to activity, or to objectively impaired performance.” Fatigue in the corporeal sense, means “inability to sustain force”, and alludes to dysfunction in the neuraxis or neuromuscular apparatus, whether physiologic (following strenuous exercise) or pathologic (Lane, 2000:416).

Fatigue is a poorly defined feeling of tiredness or exhaustion, and is by definition distinct from lack of energy, loss of motivation, or sleepiness; the latter being cause for enquiry into other specific diagnoses (Sharpe & Wilks, 2002:480).

Fatigue is a commonly experienced symptom in the community, with up to half of the general population reporting fatigue in large surveys. It is also reported by at least 20% of patients seeking medical care (Afari & Buchwald, 2003:221).

„Feeling tired’, as is often synonymous with fatigue, is so common that it may be considered normal. However, there is no simple way of separating normal from abnormal fatigue, as it cannot be objectively measured. Many variables are attributable to this distinction. These include the duration of the fatigue, its severity and associated disability, and the presence of other symptoms.

Hence, the concept of fatigue is multidimensional (Wessely, Hotopf & Sharpe, 1999:27). Normal fatigue is thought to be transient, selflimiting and explainable by prevailing circumstances (Afari & Buchwald, 2003:221). Furthermore, rest permits recovery (Lane, 2000:416). According to Wessely, Hotopf & Sharpe (1999:27-28) fatigue may be viewed as illness when the sufferer regards it as a problem sufficient enough to seek help.

Fatigue is one of the most common presenting symptoms in primary care, being the main complaint of 5 - 10% of patients, and an important ancillary symptom in a further

5 - 10%. Fatigue may present in association with known medical and psychiatric conditions. However, for the majority of patients with fatigue, the symptom remains unexplained or idiopathic. Statistically, of all patients in primary care presenting with fatigue as a main complaint, 90% of cases are not due to a recognizable medical disease. This figure is found to be even lower in patients seen in secondary care (Sharpe & Wilks, 2002:480).

Without treatment, the prognosis of patients with idiopathic fatigue is poor, as half of those seen in general practice are still fatigued six months later (Sharpe & Wilks, 2002). In the context of clinical practice and research, fatigue seems elusive to both measurement and management (Straus, 2004:1234), and requires a multidimensional approach (Wessely, Hotopf & Sharpe (1999:19).

When persistent and debilitating fatigue cannot be explained by a medical condition, it may represent chronic fatigue syndrome (Afari & Buchwald, 2003:221).

A cross sectional British study conducted by Darbishire, Ridsdale & Seed (2003), indicated that only a third of those chronically fatigued had chronic fatigue syndrome.

General - Anaemia, chronic infection, autonomic disease, cancer

- Endocrine disease

- Diabetes, hypothyroidism, hypoadrenalism

- Sleep disorders

- Obstructive sleep apnoea and other sleep disorders

- Neuromuscular

- Myositis, multiple sclerosis

- Gastrointestinal

- Liver disease

- Cardiovascular

- Chronic heart disease

- Respiratory

- Chronic lung disease

Taken from Sharpe & Wilks, 2002:480

Common psychiatric conditions that may present with fatigue:

Psychiatric diagnoses commonly associated with fatigue

- Depression

- Anxiety and panic

- Eating disorders

- Substance misuse disorders

- Somatisation disorder

Taken from Sharpe & Wilks, 2002:481

CFS: FACTORS CONSIDERED CAUSATIVE

- Viral infection

- Infectious mononucleosis (EBV); viral hepatitis; viral meningitis

- Immune dysfunction

- Overactuation / deficiencies

- HPA

- axis and serotonin pathway abnormalities

– Hypocortisolism - Central 5-HT dysfunction

- Cerebral blood flow abnormalities

- Hypoperfusion problem

- Sympathetic Nervous System Dysfunction

- Sleep Disorder – difficulty falling asleep; unrefreshing sleep; daytime napping

- Genetic Factors – still to be identified

- Personality-Type

- A Behaviour pattern (TABP)

- Psychological disorders

- Depression; anxiety; Somatoform disorders

- Stress and life events

- Work; relationship; trauma

Adapted: Cleare & Wessely, 1997:104; Afari & Buchwald, 2003:222 - 226; Kirshner, 2005:32; Afari, et al. 2005:352

VIROLOGICAL / SEROLOGICAL EVIDENCE

Most CFS patients recall their illness to have started with an influenza-like episode (Gow, Simpson, Behan, Choudhuri, McKay & Behan, 2001:2080).

A posteriori, infectious mononucleosis, influenza and hepatitis have all been implicated as precursory to CFS. In many cases however, there is no convincing

evidence of viral infection, either from the history or antibody titres (Lloyd, 2001:1092). Furthermore, much of the general population may also test positive

for the same ubiquitous virus found in a CFS sufferer (Gordon, 1993:10).

Antithetically, White, Thomas, Sullivan & Buchwald (2004:499) were able to document a “postsystemic infection fatigue syndrome” in American primary care

patients. The results of their study support the existence of two discrete chronic fatigue syndromes following infectious mononucleosis. Their work however has

not been replicated, and it appears more research is needed to resolve the apparent ambiguities in the CFS-infection relationship.

IMMUNOLOGICAL DYSREGULATION

Non-specific immunologic abnormalities have been detected in people with CFS, raising the possibility of defects in general virus-handling mechanisms (Gow, et al. 2001:2080). Of the many described, the most consistently reported are depressed natural killer cell function and increased expression of T-lymphocyte activation

markers. The results of such findings have been inconsistent, non-specific and poorly correlative to the severity of symptoms in CFS sufferers (Wessely, Hotopf & Sharpe, 1999:207; Afari, et al. 2005:354). Nevertheless, subsequent support for the immune dysregulation hypothesis has given rise to the term chronic fatigue and immune dysfunction syndrome, or CFIDS (Gordon, 1993:10).

Confounding to current clinical evidence, researchers have recently developed a method for identifying potential biomarkers in CFS. The markers discovered comprise of

ten genes known to have functions in defence and immunity.

Notably, it supports the immune dysregulation pathogenesis in CFS. It was identified by means of a differential-display Polymerase chain reaction (PCR) of peripheral

blood mononuclear cells. Further studies will be required to determine the validity of these potential biomarkers (Method to identify biomarkers in chronic fatigue syndrome

developed, 2005:904)

2.2.5.3. Neuroendocrine Abnormalities

Hypothalamic-pituitary-adrenal Axis Abnormalities

Research has brought to light abnormalities of the hypothalamic-pituitary-adrenal (HPA) axis in CFS patients, suggested by mild hypocortisolism (Cleare & Wessely, 1997: 104

- 105). Subsequent studies have however concluded, that primary adrenal insufficiency is unlikely to play a significant role in the aetiology of CFS (Gaab, Huster, Peisen, Engert, Heitz, Schad, Schürmeyer & Ehlert, 2003:113). Instead, evidence suggests that the hypocortisolism may be the result of a central nervous system-serotonin problem (Demitrack, 1997:73-76).

Nevertheless, hypocortisolism has only been exhibited in about one-third of CFS patients (Parker, Wessely & Cleare, 2001:1331).

Abnormalities in Serotonin Neurotransmission

Some studies have demonstrated abnormalities of the central nervous system (CNS) serotonin physiology in CFS patients (Demitrack, 1997; Parker, Wessely & Cleare, 2001):

A significant increase in serum prolactin levels, relative to other non-CFS sufferers, followed administration of serotonin agonists. This suggests a CNS up-regulation of the serotonergic system, resulting in hypocortisolism (Cleare, Bearn, Allain, McGregor, Wessely, Murray & O’Kearn, 1995:283-289).

2.2.5.4.

Central Nervous Abnormalities

Several symptoms reported by CFS sufferers (impaired concentration, attention and memory, and headache) suggest central nervous system involvement in the pathogenesis

of CFS (Afari & Buchwald, 2003:223-224). Researchers have investigated this vinculum by use of structural and functional neuroimaging and neuropsychological evaluation (Afari, et al. 2005:354).

Cerebral Hypoperfusion Theory

A neuroimaging study of CFS, conducted in 1995, found numerous abnormalities including lowered blood perfusion of the brainstem (Costa, Tannock & Brostoff, 1995). A South African study conducted by Welch (1999), also found radiological evidence of lowered blood brain perfusion in CFS sufferers. Other studies have not been able to duplicate these findings due to technical difficulties (Cleare & Wessely, 1997:105).

Non-specific Neuroimaging Abnormalities

Magnetic resonance imaging (MRI) and single photon emission computed tomography (SPECT) studies have been generally consistent in demonstrating some abnormalities in CFS patients. “However, the functional significance and clinical utility of these findings remain uncertain and await further clarification.”

(Afari & Buchwald, 2003:224)

Neuropsychological Deficits

As many as 85% of CFS patients report impairments in attention, concentration, and memory abilities. However formal neuropsychological studies have failed to yield consistent results.

De facto, CFS sufferers appear to possess normal cognitive and global intellectual abilities (Afari & Buchwald, 2003:224).

Sympathetic Nervous System Dysfunction

Recent clinical evidence cited in a University of Alberta study, believes to have established a scientific basis for CFS. In a study of 112 people, Pazderka-Robinson, Morrison & Flor

- Henry (2004) found that patients with CFS had higher skin temperatures, and produced less sweat in response to stress, than either clinically depressed or healthy participants. These findings indicate that CFS patients exhibit a lower rate of stress reactivity, which is suggestive of sympathetic nervous system dysfunction. According to Pazderka-Robinson, Morrison & Flor-Henry (2004:178-180), the results indicate that CFS onset may be attributable to severe physical or mental stressor exposure. Furthermore, the outcome, as measured by electrodermal analysis, may be of potential benefit in the diagnosis of CFS. The authors are optimistic that their research will lead

to larger-scale work (Kirshner, 2005:32). For the interim however, this will stand as a finding pending further investigation and verification.

2.2.5.5.

GENETIC FACTORS

Recent evidence is supportive of a familial predisposition to CFS, but genetic loci have yet to be identified. Routine genetic testing is also unavailable (Afari, et al. 2005:354).

2.2.5.6.

SLEEP DISORDER

CFS patients experience more difficulty falling asleep, more interrupted sleep and more daytime napping than in healthy or chronically ill comparison subjects.

Yet the results of polysomnography in CFS have failed to reveal a consistent or diagnostic sleep disturbance. Nevertheless, sleep disturbance does not appear to correlate with fatigue severity per se. Moreover, if a severe sleep disorder was identified the diagnosis of CFS would be excluded (Afari & Buchwald, 2003:225).

2.2.5.7.

PSYCHOLOGICAL THEORIES

A psychogenic basis towards CFS has been proposed: some studies have shown that certain personality traits (Type A behaviour pattern - TABP) set-up premorbid psychogeneses to chronic fatigue syndrome (Mostert, 1999; Cleare & Wessely, 1997:104). TABP is characterized by perfectionism and over-achievement. It is thought that such a personality type induces high levels of psychological distress, which may preclude recovery from an otherwise self-limiting post-infectious fatigue (Cleare & Wessely, 1997:104). The fact that fatigue often accompanies excessive stress, anxiety, and depression is also well documented (Gordon, 1993:11).

Further, a significant proportion of the CFS population will also fulfil criteria for a psychiatric disorder, such as depression or somatization (Lane, 2000:416). A recent study found that lack of social support in CFS sufferers is yet another perpetuating factor of fatigue severity and functional impairment (Prins, Bos, Huibers, Servaes, van der Werf, van der Meer & Bleijenberg, 2004).

Chatham (1991) conducted a study to investigate the relationship between immunosuppressive emotional trauma and the onset of CFS. CFS sufferers were asked to describe their emotional state immediately preceding the onset of physical symptoms, whilst the control divulged their emotional state (as it was)

two years prior to the study. The results suggested a correlational relationship between pre-existent emotional trauma and subsequent development of CFS.

Although intriguing, authors Wessely, Hotopf & Sharpe (1999:233-339) warn that such studies are conducive to retrospective biasness of the CFS narrative.

Further, it is currently estimated that between 40% and 70% of children and adults in the general population will experience at least one major traumatic stressor in their lifetimes (Berliner & Briere, 1999:3); discordant to the estimated prevalence of CFS. Other studies have however concurred with Chatham (1991):

CFS being associated with severe stressors such as experiences of childhood abuse or combat related trauma (Heim, Bierl, Nisenbaum, Wagner & Reeves, 2004:672).

2.2.5.8.

AN INTERACTIVE MODEL: PSYCHONEUROIMMUNOLOGY

“This brings us to the subject of the relationship between viral infection, immune disorder, stress, and psychiatric disorder, exemplified by the term „psychoneuroimmunology’. This has many potentially important lessons for our understanding of CFS....” (Wessely, Hotopf & Sharpe, 1999:178)

It has been recognised in a local South African study, in which clinical hypnotherapy for CFS has shown encouraging results, that CFS falls into the realm of psychoneuroimmunology, or PNI (Welch, 1999).

PNI investigates the pathways connecting mind and body, and is a burgeoning field of research in its own right (Watkins, 1997:2). Anatomical, physiological and biochemical evidence all suggest that the body’s autonomic, endocrine and immune systems are not autonomous, but engage in an interactive dialogue with each other and with higher perceptual and emotional centres to maintain health and combat disease (Vollmer-Conna, 1994; Watkins, 1997:1). Hence, it is recognized that psychological factors, such as emotions, stress, or distress, play a role in odulating immunity and/or disease processes (Vollmer-Conner, 1994; Pitts & Phillips, 1998:61-65; Mate, 2003).

According to Hyland (2001:282) CFS should be viewed as neither psychological, nor physical, but considered as a „general dysregulation syndrome’ whereby communication within an extended self-regulatory brain-body network is compromised. Hence this would suggest that all mechanisms, as cited above, contain an element of truth, and that CFS is the final common pathway of some complex interaction between psychological, hypothalamic and immune mechanisms (Hyland, 2001).

CLINICAL PRESENTATION OF CFS

In terms of clinical features, fatigue is the hallmark symptom of CFS (Afari & Buchwald, 2003:222). Sufferers may show an incapacitating degree of physical malfunction and cognitive dysfunction (Welch, 1999:18). The spectrum of impairment may vary from being modest, in which the affected person retains the ability to carry out most normal activities, including work (provided it is paced and sufficient rest is allowed), through to the most severely affected, who are bed-bound and require total nursing care (Rutherford, 2003). Various clinical studies

have described CFS impairment as more severe than in persons with untreated hyperthyroidism, end-stage renal disease, heart disease, multiple sclerosis (Solomon & Reeves, 2004:2241) and cancer (Servaes, Prins, Verhagen & Bleijenberg, 2002).

Various symptoms, such as headaches, muscle pain and/or sore throats are typically known to coexist with the fatigue (Beers & Berkow, 1999:2482).

Additionally, patients may report fever (Pazderka-Robinson, Morrison & Flor-Henry, 2004:171), anorexia, nausea, night sweats, dizziness and multiple chemical sensitivities (Afari & Buchwald, 2003:222). The sleep pattern is also altered, with frequent waking or hypersomnia, and sufferers may present with various autonomic symptoms affecting the cardiovascular or gastrointestinal systems (Lloyd, 2001:1091). Depression is frequently noted as a coexisting disease (Lane, 2000:416; Frey, 2002:1838-1839). However in some patients, it is secondary to the debility of the fatigue itself (Demitrack, 1997:71). In terms of physical signs most reports do not confirm objectively assessed abnormalities on examination (Wessely, Hotopf & Sharpe, 1999:149).

Most CFS patients describe symptoms suggestive of marked cognitive disturbance. Questionnaire studies have confirmed these clinical observations, however many studies involving neuropsychological testing have failed to elucidate such impairments. It is thus conceded that neuropsychological deficits in CFS are minor, and disproportionate to the severity of the subjective complaints (Wessely, Hotopf & Sharpe, 1999:250-253).

2.2.7.

DIAGNOSIS AND CLASSIFICATION CRITERIA OF CFS

As no biological marker has yet been found, there are no tests to confirm or refute a diagnosis of CFS (Mostert, 1999:72). Diagnosis is made on the basis of symptoms and involves exclusion of a discernible cause (Afari & Buchwald, 2003:222). The latter of which involves a complete patient history, physical examination and normal screening laboratory tests (Katz, 2002:741) (Appendix F). Some conditions to be considered for exclusion include hypothyroidism, anaemia, sleep disorder, Addison’s Disease (Sharpe & Wessely, 1997:180),

brucellosis, myeloproliferative disorders (Lewith, 1996:43) and occult malignancy (Komaroff & Buchwald, 1998:3) (Appendix B).

Although a diagnostic model for CFS has been met, its use has been of more value to research than to clinical assessment (Rutherford, 2003). A few case definitions for CFS have been debatably recognized in various parts of the world.

These include the Centres for Disease Control (CDC) diagnostic criteria, Australian, American and UK criteria, and the „Oxford’ criteria for CFS (Wessely, Hotopf & Sharpe, 1999:141-144). However, major criticisms lie in these definitions of CFS:

1^st there exists considerable overlap between the criteria for CFS and those for neuropsychiatric syndromes, such as depression anxiety, and somatoform disorders(Fukuda, et al. 1994:953-954).

In a Zurich population survey, Angst, Dobler, Mikola & Binder (1984) found a consistent and linear relationship between the severity of depression and a number of somatic symptoms. These included gastrointestinal, respiratory and circulatory symptoms, as well as backache, headache and exhaustion. In another separate study, myalgia, muscle weakness and post

-exertional malaise did not differentiate CFS from severe depression (Manu, Lane & Matthews (1996).

2^nd according to Wessely, Hotopf & Sharpe (1999:142-144), most symptoms included in the definition of CFS are not specific to it, thus cannot differentiate CFS from other causes of chronic fatigue. Moreover, the case definition does not delineate a discrete condition that is identifiable by the same pathophysiology (Komaroff & Buchwald, 1998:4); hence it is not easily differentiated from other diagnostic entities (Fukuda, et al. 1994:953).

3^rd the requirement for the fatigue to be present for six months does not accommodate the possibility of an abrupt onset of the disorder. Hence some patients are unwillingly required to wait-it-out, before such time as a diagnosis can be made (Rutherford, 2003). In others whose CFS-like descriptions abate short of six months, they fail to acquire the CFS diagnosis (Pawlikowska, Chalder, Hirsch, Wallace, Wright & Wessely, 1994:746).

In terms of research however, the criteria are adequate in meeting the needs of studies (Rutherford, 2003). The most commonly utilized criteria in South Africa (Welch, 1999:6) and internationally are those revised by the CDC of Atlanta, Georgia, 1994. This definition requires at least six months of persistent fatigue that substantially reduces a person’s level of activity. Additionally four or more of the following symptoms must present concurrently within a six-month period: impaired memory or concentration, sore throat, tender lymph nodes, muscle +/o. multi-joint pain, new headaches, unrefreshing sleep, and post-exertional fatigue. Certain medical and psychiatric conditions are further exclusionary.

These are eating disorders, psychotic disorders, bipolar disorder, melancholic depression, and substance abuse within two years of fatigue onset Afari & Buchwald, 2003:222)

(refer to Appendix A). Those who do not meet the fatigue severity or symptom criteria have recourse to the diagnosis of „idiopathic chronic fatigue’ (Fukuda, et al. 1994:957/Afari & Buchwald, 2003:222).

CFS remains a medically unexplained syndrome. It seems for now, in the absence of any objective evidence, that CFS assumes a dualistic view to classification. According

to the current International Classification of Diseases (ICD-10) system, post-viral fatigue syndrome, or ME falls under neurology, whilst neurasthenia comes under psychiatry (David & Wessely, 1993:1247). CFS’s resultant straddling between the mutually exclusive medical and psychiatric classification systems has become problematic (Welch, 1999:6). According to the W.H.O., the classification is merely to enable both sides of the divide to record a diagnosis when faced with a chronically fatigued patient. It is recognized however, that the current classification for CFS stands inadequate and unresolved (Wessely, Hotopf & Sharpe, 1999:220-221).

It must be noted further, that neither CFS, nor its analogues are listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-4) (Welch, 1999:12).

2.2.8.

MANAGEMENT OF CFS

Cleare & Wessely (1997:102) consider the treatment of CFS to be far from satisfactory. They believe that, for many years, sufferers have received no advice nor help, but have been told,

“...to rest, „live within your limits’, and wait for the medical breakthrough.” Many sufferers are liable to stigmatisation from physician, family and friends, who doubt the veracity of their condition (Featherstone, 1998:98-105). In a South African thesis examining the illness narratives in CFS, Gray (2001:2-3) cited the following patient frustrations:

“My GP refuses to believe ME exists, never mind that I have it. Should I try to convince him or look for another doctor?”

“I used to get on okay with my family but since I’ve been ill my relationship with them has deteriorated. Not only are they unsupportive but some of them are actually cruel. Why have they become like this?”

Patients admit that such above experiences are common (Ware, 1992; Featherstone, 1998). For this reason, fundamental in the approach towards a

CFS patient, is to establish a positive working relationship (as shown in table 2.2.8). The doctor’s beliefs and attitudes are important in facilitating a therapeutic alliance (Wessely, Hotopf & Sharpe, 1999:352).

Table 2.2.8

lists the strategies a practitioner should take in order to aid the facilitation of a good working relationship with a CFS patient

CFS: Establishing a positive working relationship

- Take the patient’s physical complaints seriously

- Respect the patient’s illness beliefs (without necessarily agreeing with them)

- Empathize with experiences of being „disbelieved’ by others

- Empathize with effects of illness and express willingness to help

- Allow plenty of time, and allow the option of breaks/rest periods if needed

Taken from Wessely, Hotopf & Sharpe, 1999:352

The management of CFS patients must be based on the available evidence of what has been shown to be effective (Wessely, Hotopf & Sharpe, 1999:365).

Albeit, despite a multitude of claims, the only treatment modalities to have shown significant effect in randomised trials, and to be considered beneficial to CFS patients are cognitive-behavioural therapy (CBT) and graded exercise therapy (Straus, 2004:1234-1235/Lloyd, 2004:437). Least of all, patients require education about CFS and how to cope with it (Wessely, Hotopf & Sharpe, 1999:397).

Patients need to establish realistic goals for managing their lives and restructuring activities (Afari, et al. 2005:353-354). Moreover, the management of CFS should be multidimensional and tailored to the needs of each patient (Sharpe & Wessely, 1997:181/Afari & Buchwald, 2003:230).

2.2.9.

TREATMENT INTERVENTIONS FOR CFS

Treatment per se is symptom-based and includes pharmacological and behavioural strategies (Afari & Buchwald, 2003:230). However, no pharmacological agent has yet been shown to be convincingly helpful for CFS (Wessely, Hotopf & Sharpe, 1999:399; Straus, 2004:1235). Various treatment options are explored below.

2.2.9.1.

CONVENTIONAL MEDICAL TREATMENT

In terms of conventional medicine, drug therapies have included anti-depressants, anticholinergics, hormones (Afari & Buchwald, 2003:229) corticosteroids, anti-viral medications, as well as immunologically targeted drug treatments. Research has concluded that the aforementioned approaches have not been significantly effective (Wessely, Hotopf & Sharpe, 1999:374-388).

Due to the close association between depression and CFS, antidepressants are often the suggested drug of choice, for its potential benefits in pain reduction, sleep, increased energy and mood improvement. However, for unknown reasons, CFS patients are particularly sensitive to the side effects of antidepressant drugs. If given, these drugs should be started in the lowest possible dose and increased gradually to achieve compliance. It is recognized that its use is largely empirically based and is not clearly indicated in CFS (Wessely, Hotopf & Sharpe, 1999:399-400).

Other treatments are largely symptomatic (Lewith, 1996:45-49). Analgesics (non-steroidal anti-inflammatory drugs / NSAIDS) may be given for myalgia. However, many CFS sufferers have reported that this affords them little relief (Rutherford, 2003).

Multifarious pharmacologic agents have been assessed by means of randomised controlled trials (Afari & Buchwald, 2003:228). Whilst evidence is limited, most outcomes have been unconvincing to its cause (Reid, Chalder, Cleare, Hotopf & Wessely, 2000:292). Recently Blacker, Greenwood, Wesnes, Wilson, Woodward, Howe & Ali (2004) compared the efficacy and tolerability of galantamine hydrobromide in patients with CFS. The trial however, did not demonstrate any benefit of the drug over placebo.

2.2.9.2.

BEHAVIOURAL INTERVENTIONS

“By behavioural intervention is meant offering patients practical help to implement the advice they have been given about sleep, rest, and activity.” (Wessely, Hotopf & Sharpe, 1999:400)

Disturbed sleep patterns are commonly reported in CFS (Afari & Buchwald, 2003:225). There is sufficient circumstantial evidence to support regularization of sleep patterns. This is achieved by monitoring of „getting up times’ and avoidance of daytime napping. In terms of exercise, importance is given to implementing a stable continuum of rest and sustainable activity. Thereafter, gradual increases of activity can be planned (Wessely, Hotopf & Sharpe, 1999:400-401). Education regarding the benefits of exercise has been shown to be effective in increasing levels of activity in CFS (Powell, Bentall, Nye & Edwards, 2001).

2.2.9.3.

PSYCHOTHERAPY

Psychological interventions have been explored: Individual and group behaviour therapies have helped some patients (Beers & Berkow, 1999:2482). There is increasing evidence for the effectiveness of cognitive behavioural therapy (CBT) in CFS (Cairns & Hotopf, 2005:20; Rimes & Chalder, 2005:32). The amenity of this therapy is to helping patients achieve a more

constructive view of their illness, whilst adopting more effective coping strategies (Sharpe & Wessely, 1997:182). This approach in treating CFS patients is based on the premise that cognitive attributions and behavioural patterns act as perpetuating factors of the condition (Lloyd, 2004:437). Although CBT has been effective in reducing disability in CFS, it does not render patients symptom free (Wessely, Hotopf & Sharpe, 1999:416). One study revealed that counselling may be as useful as CBT for

treating CFS patients in primary care (Ridsdale, Godfrey, Chalder, Seed, King, Wallace & Wessely, 2001). Clinical hypnotherapy has also been utilized with some success (Welch, 1999).

2.2.9.4.

GRADED EXERCISE THERAPY

An increase in fatigue following exertion is a major symptom of CFS. Consequently, many sufferers reduce their physical activity to avoid exacerbations (Skinner, 2004:28). However, there is evidence to suggest that “graded” increases in physical activity are helpful in improving function and relieving symptoms of CFS (Sharpe & Wessely, 1997:182; Rimes & Chalder, 2005:33). Sufferers are thence advised to engage in graded exercise regimes that are sensitive to each of their particular circumstances (Rutherford, 2003).

Lloyd (2004:579-580) asserts caution to the boon of graded exercise, as severely ill CFS sufferers, unable to participate in exercise studies, are likely to be underrepresented

in published data. Likewise, Scroop & Burnet (2004:579) state that graded exercise studies, in CFS, have not provided compelling evidence of improvement in either physiological or clinical status of patients.

Nevertheless, it is recommended that those with CFS make exercise a regular part of their lifestyle (Skinner, 2004:29).

2.2.9.5.

DIETARY and VITAMIN SUPPLEMENTS

Other avenues of treatment have been directed at diet, vitamins and supplements (Beers & Berkow, 1999:2482). Vitamin B12 has long been used as a „treatment’ for fatigue and as a „goad’ to energy. NADH (nicotinamide adenine dinucleotide) has been given as an oral supplement. Carnitine and Co-enzyme Q10 (ubiquinone), obtained from health food stores have been advocated.

Results however have been disappointing (Rutherford, 2003). According to Wessely, Hotopf & Sharpe (1999:380-381), there seems little rationale for their use in the absence of clear dietary deficiency or malabsorption syndrome.

Hardy (2005:9) has also made mention of homoeopathy’s role in treating CFS patients. In a recent article, he cites a number of successfully treated cases from his practice.

Featherstone (1998) has reviewed (in the British Journal of Therapy and Rehabilitation) an informal study, in which 24 of 36 CFS patients found symptom relief using homoeopathy.

However, according to Walach (2004:210-211) homoeopathy is purportedly not always effective with chronic fatigue patients.

Wessely, Hotopf & Sharpe (1999:371) state that anecdotal reports and case series should only be considered as suggestive evidence, which should encourage further research. It is for this reason that this research study was undertaken. Such evidence needs to be substantiated by double-blind randomised study.

2.5.4.

HOMOEOPATHIC RESEARCH ON CFS

The London Homoeopathic Clinic, under the auspices of the London College of Classical Homoeopathy, conducted the first known study of utilising homoeopathic similimum against placebo in CFS. The randomised double-blind trial involved 64 participants, each of whom attended at least 12 clinic visits, over a 12-month period. The study outcome rested upon the results of two outcome measures: a daily (wellness) graph, and an end of trial self-assessment chart, both of which required completion by each participant. According to the trial co-ordinator, Awdry (1996:12-16), the results appeared encouraging, with outcomes revealing noticeable improvement in only the treatment group. However no statistical tests were performed.

Later, Wessely, Hotopf & Sharpe (1999:387) conducted a statistical analysis of the above study data, which indicated a 33% improvement in the treatment group compared

to 3% in the placebo group. However, these authors asserted scepticism over the study’s interpretation of results, stating that internal validity was questionable and insufficient to render reliable results.

Critical analyses by authors to follow, Afari & Buchwald (2003:228) and Rimes & Chalder (2005:34), considered Awdry’s study to be of poor quality and have conceded the outcome to be inconclusive.

A more recent study, reported in 2004, evaluated the efficacy of individualized homoeopathic treatment (similimum) for CFS. Weatherley-Jones, Nicholl, Thomas, Parry, McKendrick, Green, Stanley & Lynch (2004) conducted a carefully designed triple-blinded placebo-controlled trial. One hundred and three patients meeting the Oxford criteria for CFS were recruited to two specialist hospital outpatient departments in the UK, and attended monthly consultations with a professional homoeopath. Outcomes were made at six months using the Multidimensional Fatigue Inventory (MFI), Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP). 92 patients completed the trial (47 similimum treatment and 45 placebo) with 86 patients completing post-treatment outcome measures. Results revealed that 47% of patients in the treatment group showed a clinically significant improvement, compared to 28% of individuals in the placebo group (d=0.4). Although group differences were not statistically significant for most outcome measures, more people in the treatment group showed clinically significant improvement.

One author’s appraisal of the above study concluded the following: “The study certainly hasn’t conclusively answered the question of whether the effects are purely due to placebo or if there is a specific component in homoeopathic remedies.” (Walach, 2004:211) According to Weatherley-Jones, et al. (2004:190) the study reflected equivocal evidence that homoeopathic medicine was superior to placebo. The researchers believe further studies of this nature are needed to determine whether the differences noted would hold for larger samples.

2.6.1.

OUTCOME MEASURES IN CFS

Due to the descriptive nature of CFS, subjective outcome measures are currently conceded as the only means by which treatment responses can be evaluated by clinicians.

It is known that the feeling of fatigue cannot be objectively measured; it can however, be estimated by fatigue questionnaires (Naschitz, Rozenbaum, Shaviv, Fields, Enis, Babich, Manor, Yeshurun, Sabo, & Rosner, 2004:167-168).

According to Wessely, Hotopf & Sharpe (1999:371) the only outcomes that are likely to matter to patients are those that rely on self-reporting of symptoms and levels of activity - this entailing how they feel and how much they can do. In referring to measurement of exercise studies in CFS, Scroop & Burnet (2004:578) also state that outcomes should lie in self-reporting of symptom severity or functional status.

SUMMARY

While chronic fatigue is a common complaint for which individuals seek medical attention, chronic fatigue syndrome (CFS) is relatively rare (Ranjith, 2005:13). Notwithstanding, CFS poses a considerable worldwide public health problem (Rutherford, 2003).

Chronic fatigue syndrome (CFS) is, in the current state of knowledge, a descriptive term for a condition of unknown aetiology (Sharpe & Wilks, 2002:481). Disability and incapacity of such patients is paramount (Welch, 1999:18) and the costs to health services and society in terms of health resources used, and poor productivity is considerable (Wessely, Hotopf & Sharpe, 1999:149). Moreover, CFS is poorly managed and presents a considerable challenge to healthcare providers (Solomon & Reeves, 2004:2241).

Whilst biomedical confirmation remains crucial to legitimising the care and support needed by CFS sufferers (Feathersone, 1998:105), the interactional approaches offered

by mind-body medicine and cognate, homoeopathy, may provide importance to illness management in CFS (Hyland, 2001; Featherstone, 1998).

“CFS is an important reminder of the limitations of the narrow biomedical approach to illness, and the consequent limitations of medical thinking and practice.” (Wessely, Hotopf & Sharpe, 1999:419-420) 1M /

Prescribed remedies in the trial group.

Kalium carbonicum

Natrum muriaticum

Crocus sativus

Baptisia tinctoria

Ornithogalum umbellatum

Actaea spicata

Ranunculus sceleratus

Colchicum autumnale

Nux vomica

Viola odorata

Table 4.8.2 below, illustrates the similimum medicines dispensed to the placebo group in the post-trial period. The table shows that the most commonly prescribed medicine was Natrum muriaticum (3/15 = 20%), followed by an equal distribution of multifarious remedies (1/15 x 12 = 80%).

Medicines Dispensed in the Placebo Group

Ornithogalum umbellatum

Ferrum metallicum

Adamas

Lac equinum

Natrum muriaticum

Iodum

Clematis erecta

Niccolum metallicum

Sepia officinalis

Magnesium carbonicum

Gelsemium sempirvirens

Calcarea carbonica

Cannabis indica

Homoeopathic remedies are classified according to their source, and in the main, are obtained from mineral, plant and animal kingdoms (Sankaran, 1997a:229-233).

Figure 4.8 below provides a kingdom distribution for the various similimum prescriptions made in both treatment and placebo groups for the duration of the study.

As can be seen, 15 (50%) participants received a mineral remedy, 13 (43%), a plant remedy and 2 (7%), an animal-based remedy.

The most commonly prescribed medicines in the mineral and plant kingdoms were Natrum muriaticum (6/30 = 20%), and Ornithogalum umbellatum (2/30 = 7%)

respectively. Lac equinum and Sepia officinalis were the only two remedies of the animal kingdom, and both of which were placebo group prescriptions.

4.9.

DATA ANALYSIS: A REMEDY KINGDOM GROUP ANALYSIS

This section covers a data analysis for each of the remedy kingdoms (mineral, and plant), with subsequent evaluation of treatment responses. The animal kingdom was not analysed due to there being no treatment group for the study. The pre-existing data obtained from the fatigue visual analogue scale (VAS) was used for this analysis. The VAS was the outcome measure of choice, due to it being most sensitive to assessing the severity of fatigue for the study. Moreover, fatigue severity is the main parameter used in monitoring the effectiveness of therapeutic interventions in CFS (Naschitz, et al. 2004:167-168).

Mineral:

Figure 4.9.1 reveals that baseline values of fatigue was greater in the placebo

group than the treatment group. A marked reduction in levels of fatigue, from

baseline to FU2 was evident in the treatment group. No significant differences occurred between baseline and FU1, and FU1 and FU2 in this group. Whilst no

significant differences were noted in the placebo group, a favourable response appears observable.

Rhus-g.x

A condition characterised by persistent medically unexplained fatigue of at least 6 months (Parker, Wessely & Cleare, 2001:1331), and often + muscular pain,

along with various other symptoms. It overlaps with another descriptive term, fibromyalgia (a fatigue-related condition) that has often been used

when muscle pain is the predominating feature (Sharpe & Wilks, 2002:481). Fibromyalgia and CFS are regarded as separate diagnostic entities, differentiating

the two is often sought with difficulty (Demitrack, 1997:76). According to Wessely, Nimnuan & Sharpe (1999) both conditions could be viewed as the same;

subsumed under the umbrella term of functional somatic syndromes.

[Saul Wayne]

CFS, also known as myalgic encephalomyelitis (ME), has been previously, numerously dubbed neurasthenia, immune dysfunction syndrome and “yuppie flu”, amongst others (Mostert, 1999:71). It is a concerning health problem worldwide (Rutherford, 2003) with its prevalence being estimated at 0.5 to 1.5% of the population in primary care (Cleare & Wessely, 1997:102). It is said that there are about as many as 200 000 people with CFS in the UK alone (Rutherford, 2003), whilst the Centres for Disease Control and Prevention (2005) estimates that as many as 500 000 Americans may have is according to Gray (2001:5) no official epidemiological estimates have been provided for S. Africa, albeit its prevalence is reportedly on the incline (Schlebusch, 1990:79).

Contrary to the erroneously assumed stereotypical “yuppie flu” (Cleare & Wessely, 1997:102), CFS is found in all ages and socioeconomic groups, with highest rates found among women (Afari, van der Meer, Bleijenberg & Buchwald, 2005:351). According to Gallagher, Thomas, Hamilton & White (2004:575),

it is rare in children. However, new research suggests that sedentary children are at greater risk for developing CFS in later life (Viner & Hotopf, 2004:941).

According to Gordon (1993:9) most patients with CFS seem to be adults between the ages of 25 and 50.

In 1869 a New York neurologist, George Beard, was first to recognize the occurrence of fatigue as an illness in the absence of disease. He labelled the condition „neurasthenia’ (Wessely, Hotopf & Sharpe, 1999:13). Neurasthenia’s symptoms seemed analogous to today’s description of CFS.

”For several years in the late 1800s, Dr Beard’s new disease was the country’s most diagnosed malady, but the medical community eventually grew more sceptical, and the whole notion of neurasthenia fell into disrepute.” (Gordon, 1993:9) This was due to the dissent of and antipathy between differing interpretations of the condition.

Evidence could adduce no basis that neurasthenia was a physical illness; hence it constituted no legitimacy. Critics had to define it as psychological.

This insinuated that neurasthenia was unreal, imagined, or an illness of the malingering. No satisfactory answers were ever given to these dilemmas, and neurasthenia gradually „disappeared’ (Wessely, Hotopf & Sharpe, 1999:118-119).

The demised neurasthenia was later to resurface when reports emerged from various parts of the world, of syndromes similar in nature, all characterized by

chronic debilitating fatigue (Gordon, 1993:9). Two episodes that attracted the most attention took place at the Los Angeles County Hospital (LAC) in 1934, and

the Royal Free Hospital (RFH) in London, 1955. The symptoms of these epidemics remain unclear but were referable to the central nervous system. It was proposed as

an explanation for a series of outbreaks of a contagious condition. However, the laboratory tests available to the clinicians of the day, failed to provide objective evidence

of infection. Consequently, some critics attributed the epidemics to emotional distress or „mass hysteria’. The „mass hysteria’ hypothesis led to acrimonious debate,

which continues to this day. This did not deter initial authors however, from branding an organic aetiology to these

syndromes. The names neuromyasthenia and myalgic encephalomyelitis (ME) emerged (Wessely, Hotopf & Sharpe, 1999:127-130).

Epidemics of neuromyasthenia or ME gradually disappeared from the literature during the 1960s and 1970s (Wessely, Hotopf & Sharpe, 1999:131).

In the 1980s, chronic fatigue returned to prominence and drew the attention of the mass media. “Yuppie flu” was conceived by the lay press, since the majority

of patients at the time were accomplished individuals in their thirties. Patients were diagnosed as either suffering from chronic mononucleosis, or chronic

infection with the Epstein-Barr virus (EBV) (Mostert, 1999:71). These abstractions left the research and medical communities in a dilemma, which

resulted in a need for resolution of consensus. Discourse followed and resulted in the sanctioning of a new condition -chronic fatigue syndrome (CFS) (Wessely, Hotopf & Sharpe, 1999:134). This was first defined in 1988 by the Centres for Disease Control (CDC) and Prevention, in Atlanta. It delineated a symptom of chronic fatigue, of at least six months and associated with at least 50% reduction in the patient’s functional capacity. Included in the definition was the occurrence of other coexisting symptoms (Gordon, 1993:2).

The original CDC criteria were then revised in 1991 and again in 1994 (Fukuda, Straus, Hickie, Sharpe, Dobbins & Komaroff, 1994: 957).

See Diagnosis and Classification Criteria (pp. 27)

According to Wessely, Hotopf & Sharpe (1999:132) the link between neuromyasthenia (ME) and modern CFS is largely historical. Professional literature views them as largely synonymous, but the two conditions as they are described are very different. Chronic fatigue syndrome has subsequently become the focus of much research and debate (Wessely, Hotopf & Sharpe, 1999:13). Many question the credibility of the condition despite its official recognition (Gray, 001:2).

Despite more than a decade of research, CFS remains a heterogeneous condition, as no specific cause has yet been identified (Afari & Buchwald, 2003:222).

Studies have revealed possible factors implicated in triggering +/o. maintaining the disorder (see table 2.2.4). These include viral infections, neuroendocrine changes, pre-xisting psychological disorders (depression, anxiety), stress, and personality type (Type A behaviour pattern) (Cleare & Wessely, 1997:104).

New evidence beginning to emerge, suggests that CFS may also be familial. Pathophysiological abnormalities have thus been observed across many domains, suggesting that CFS is a condition of complex and multifactorial aetiology. (Afari & Buchwald, 2003:223).

Agreement has not yet been reached on whether CFS is a psychological or a physical illness (Mostert, 1999:80; Hyland, 2001:273). Patients with CFS generally attribute their illness to physical causes (Butler, Chalder & Wessely, 2001) but according to Mostert (1999:81) it is the absence of biological markers that favour a psychogenic aetiology. There exists considerable similarity between the symptoms of CFS and an affective disorder, consequently many psychiatrists

Recent clinical evidence cited in a University of Alberta study, believes to have established a biological basis for CFS. This research may provide independent verification for CFS sufferers (Pazderka-Robinson, Morrison & Flor-Henry, 2004). The lead author on the study, Pazderka-Robinson (Kirshner, 2005:32), is optimistic that her research will lead to larger - scale work.

See Sympathetic Nervous System Dysfunction (pp. 22) regard CFS as a variant of depression (Lloyd, 2001:1092). Moreover, the psychogenic model is supported by the frequency of psychiatric symptomatology in CFS (Hyland, 2001:274). Several lines of research however, suggest that CFS may be separate from psychiatric disorders (Demitrack, 1997:72; Komaroff & Buchwald, 1998:4).

Other researchers steer away from a primarily physical or psychological perspective, and provide an interactional model of conceptualising CFS, viewed

through the paradigm of psychoneuroimmunology (Welch, 1999; Hyland, 2001; Gray, 2001).

The pathogenesis of CFS is not clear. Investigations have documented diverse abnormalities, but none are reproducibly present in the majority of CFS patients.

Several theories have been proposed (Afari, et al. 2005:352 - 356) (refer to table 2.2.5. overleaf):

CFS: FACTORS CONSIDERED CAUSATIVE:

Viral infection: Infectious mononucleosis (EBV); viral hepatitis; viral meningitis

Immune dysfunction: Overactuation / deficiencies

HPA: axis and serotonin pathway abnormalities - Hypocortisolism

Central 5-HT dysfunction

Cerebral blood flow abnormalities - Hypoperfusion problem

Sympathetic Nervous System Dysfunction

Sleep Disorder: difficulty falling asleep; unrefreshing sleep; daytime napping

Genetic Factors: still to be identified

Personality: Type - A Behaviour pattern (TABP)

Psychological disorders: Depression; anxiety; Somatoform disorders

Stress and life events: Work; relationship; trauma

Adapted: Cleare & Wessely, 1997:104; Afari & Buchwald, 2003:222 - 226; Kirshner, 2005:32; Afari, et al. 2005:352

VIROLOGICAL / SEROLOGICAL EVIDENCE

Most CFS patients recall their illness to have started with an influenza.-like episode (Gow, Simpson, Behan, Choudhuri, McKay & Behan, 2001:2080).

Aposteriori, infectious mononucleosis., influenza and hepatitis. have all been implicated as precursory to CFS. In many cases however, there is no convincing

evidence of viral infection, either from the history or antibody titres (Lloyd, 2001:1092). Furthermore, much of the general population may also test positive

for the same ubiquitous virus found in a CFS sufferer (Gordon, 1993:10).

Antithetically, White, Thomas, Sullivan & Buchwald (2004:499) were able to document a “postsystemic infection fatigue syndrome” in American primary care

patients. The results of their study support the existence of two discrete chronic fatigue syndromes following infectious mononucleosis. Their work however has

not been replicated, and it appears more research is needed to resolve the apparent ambiguities in the CFS-infection relationship.

IMMUNOLOGICAL DYSREGULATION

Non-specific immunologic abnormalities have been detected in people with CFS, raising the possibility of defects in general virus-handling mechanisms

(Gow, et al. 2001:2080). Of the many described, the most consistently reported are depressed natural killer cell function and increased expression of

T-lymphocyte activation markers. However, the results of such findings have been inconsistent, non-specific and poorly correlative to the severity of symptoms in CFS

sufferers (Wessely, Hotopf & Sharpe, 1999:207; Afari, et al. 2005:354). Nevertheless, subsequent support for the immune dysregulation hypothesis has given rise to the

term chronic fatigue and immune dysfunction syndrome, or CFIDS (Gordon, 1993:10).

Confounding to current clinical evidence, researchers have recently developed a method for identifying potential biomarkers in CFS. The markers discovered

comprise of ten genes known to have functions in defence and immunity.

Notably, it supports the immune dysregulation pathogenesis in CFS. It was identified by means of a differential-display Polymerase chain reaction (PCR) of

peripheral blood mononuclear cells. Further studies will be required to determine the validity of these potential biomarkers (Method to identify biomarkers in

chronic fatigue syndrome developed, 2005:904).

NEUROENDOCRINE ABNORMALITIES

Hypothalamic-pituitary-adrenal Axis Abnormalities

Research has brought to light abnormalities of the hypothalamic-pituitary-adrenal (HPA) axis in CFS patients, suggested by mild hypocortisolism (Cleare &

Wessely, 1997: 104 - 105). Subsequent studies have however concluded, that primary adrenal insufficiency is unlikely to play a significant role in the aetiology

of CFS (Gaab, Huster, Peisen, Engert, Heitz, Schad, Schürmeyer & Ehlert, 2003:113). Instead, evidence suggests that the hypocortisolism may be the result

of a central nervous system-serotonin problem (Demitrack, 1997:73-76).

Nevertheless, hypocortisolism has only been exhibited in about one1/3 of CFS patients (Parker, Wessely & Cleare, 2001:1331).

The source publication was not officially available at the time this research study went to print.

Abnormalities in Serotonin Neurotransmission

Some studies have demonstrated abnormalities of the central nervous system (CNS) serotonin physiology in CFS patients (Demitrack, 1997; Parker, Wessely &

Cleare, 2001): A significant increase in serum prolactin levels, relative to other non-CFS sufferers, followed administration of serotonin agonists. This suggests a CNS up-regulation of the serotonergic system, resulting in hypocortisolism (Cleare, Bearn, Allain, McGregor, Wessely, Murray & O’Kearn, 1995:283-289).

CENTRAL NERVOUS SYSTEM ABNORMALITIES

Several symptoms reported by CFS sufferers (impaired concentration, attention and memory, and headache) suggest central nervous system involvement in the

pathogenesis of CFS (Afari & Buchwald, 2003:223-224). Researchers have investigated this vinculum by use of structural and functional neuroimaging and

neuropsychological evaluation (Afari, et al. 2005:354).

Cerebral Hypoperfusion Theory

A neuroimaging study of CFS, conducted in 1995, found numerous abnormalities incl. lowered blood perfusion of the brainstem (Costa, Tannock & Brostoff,

1995). A South African study conducted by Welch (1999), also found radiological evidence of lowered blood brain perfusion in CFS sufferers. Other studies have not been able to duplicate these findings due to technical difficulties (Cleare & Wessely, 1997:105).

Non-specific Neuroimaging Abnormalities

Magnetic resonance imaging (MRI) and single photon emission computertomography (SPECT) studies have been generally consistent in demonstrating some abnormalities in CFS patients. “However, the functional significance and clinical utility of these findings remain uncertain and await further clarification.”

(Afari & Buchwald, 2003:224)

Neuropsychological Deficits

As many as 85% of CFS patients report impairments in attention, concentration, and memory abilities. However formal neuropsychological studies have failed to yield consistent results. De facto, CFS sufferers appear to possess normal cognitive and global intellectual abilities (Afari & Buchwald, 2003:224).

Sympathetic Nervous System Dysfunction

Recent clinical evidence cited in a University of Alberta study, believes to have established a scientific basis for CFS. In a study of 112 people, Pazderka-

Robinson, Morrison & Flor-Henry (2004) found that patients with CFS had higher skin temperatures, and produced less sweat in response to stress, than either

clinically depressed or healthy participants. These findings indicate that CFS patients exhibit a lower rate of stress reactivity, which is suggestive of sympathetic nervous system dysfunction. According to Pazderka-Robinson, Morrison & Flor-Henry (2004:178-180), the results indicate that CFS onset may

be attributable to severe physical or mental stressor exposure. Furthermore, the outcome, as measured by electrodermal analysis, may be of potential benefit in

the diagnosis of CFS. The authors are optimistic that their research will lead to larger-scale work (Kirshner, 2005:32). For the interim however, this will stand as a finding pending further investigation and verification.

GENETIC FACTORS

Recent evidence is supportive of a familial predisposition to CFS, but genetic loci have yet to be identified. Routine genetic testing is also unavailable

(Afari, et al. 2005:354).

SLEEP DISORDER

CFS patients experience more difficulty falling asleep, more interrupted sleep and more daytime napping than in healthy or chronically ill comparison subjects.

Yet the results of polysomnography in CFS have failed to reveal a consistent or diagnostic sleep disturbance. Nevertheless, sleep disturbance does not appear

to correlate with fatigue severity per se. Moreover, if a severe sleep disorder was identified the diagnosis of CFS would be excluded (Afari & Buchwald, 2003:225).

PSYCHOLOGICAL THEORIES

A psychogenic basis towards CFS has been proposed: some studies have shown that certain personality traits (Type A behaviour pattern TABP) set-up premorbid psychogeneses to chronic fatigue syndrome (Mostert, 1999; Cleare & Wessely, 1997:104). TABP is characterized by perfectionism and over-

achievement. It is thought that such a personality type induces high levels of psychological distress, which may preclude recovery from an otherwise

self-limiting post-infectious fatigue (Cleare & Wessely, 1997:104). The fact that fatigue often accompanies excessive stress, anxiety, and depression is also well documented (Gordon, 1993:11).

Further, a significant proportion of the CFS population will also fulfil criteria for a psychiatric disorder, such as depression or somatization (Lane, 2000:416).

A recent study found that lack of social support in CFS sufferers is yet another perpetuating factor of fatigue severity and functional impairment (Prins, Bos, Huibers,

Servaes, van der Werf, van der Meer & Bleijenberg, 2004).

Chatham (1991) conducted a study to investigate the relationship between immunosuppressive emotional trauma and the onset of CFS. CFS sufferers were asked to

describe their emotional state immediately preceding the onset of physical symptoms, whilst the control divulged their emotional state (as it was)

two years prior to the study. The results suggested a correlational relationship between pre-existent emotional trauma and subsequent development of CFS.

Although intriguing, authors Wessely, Hotopf & Sharpe (1999:233-339) warn that such studies are conducive to retrospective biasness of the CFS narrative.

with severe stressors such as experiences of childhood abuse or combat related trauma (Heim, Bierl, Nisenbaum, Wagner & Reeves, 2004:672).

AN INTERACTIVE MODEL: PSYCHONEUROIMMUNOLOGY

PNI investigates the pathways connecting mind and body, and is a burgeoning field of research in its own right (Watkins, 1997:2). Anatomical, physiological and biochemical evidence all suggest that the body’s autonomic, endocrine and immune systems are not autonomous, but engage in a n interactive dialogue with each other and with higher perceptual and emotional centres to maintain health and combat disease (Vollmer-Conna, 1994; Watkins, 1997:1). Hence, it is recognized that psychological factors (emotions, stress, or distress) play a role in modulating immunity and/or disease processes (Vollmer-Conner, 1994; Pitts & Phillips, 1998:61-65; Mate, 2003).

According to Hyland (2001:282) CFS should be viewed as neither psychological, nor physical, but considered as a „general dysregulation syndrome’ whereby

communication within an extended self-regulatory brain-body network is compromised. Hence this would suggest that all mechanisms, as cited above, contain an element of truth, and that CFS is the final common pathway of some complex interaction between psychological, hypothalamic and immune mechanisms (Hyland, 2001).

See Mind-Body Medicine (pp. 38)

CLINICAL PRESENTATION OF CFS

In terms of clinical features, fatigue is the hallmark symptom of CFS (Afari & Buchwald, 2003:222). Sufferers may show an incapacitating degree of physical

malfunction and cognitive dysfunction (Welch, 1999:18). The spectrum of impairment may vary from being modest, in which the affected person retains the

ability to carry out most normal activities, including work (provided it is paced and sufficient rest is allowed), through to the most severely affected, who are bed-bound and require total nursing care (Rutherford, 2003). Various clinical studies have described CFS impairment as more severe than in persons with untreated hyperthyroidism, end-stage renal disease, heart disease, multiple sclerosis (Solomon & Reeves, 2004:2241) and cancer (Servaes, Prins, Verhagen & Bleijenberg, 2002).

Various symptoms, such as headaches, muscle pain and/or sore throats are typically known to coexist with the fatigue (Beers & Berkow, 1999:2482).

Additionally, patients may report fever (Pazderka-Robinson, Morrison & Flor-Henry, 2004:171), anorexia, nausea, night sweats, dizziness and multiple

chemical sensitivities (Afari & Buchwald, 2003:222). The sleep pattern is also altered, with frequent waking or hypersomnia, and sufferers may present with

various autonomic symptoms affecting the cardiovascular or gastrointestinal systems (Lloyd, 2001:1091). Depression is frequently noted as a coexisting

disease (Lane, 2000:416; Frey, 2002:1838-1839). However in some patients, it is secondary to the debility of the fatigue itself (Demitrack, 1997:71). In terms of

physical signs most reports do not confirm objectively assessed abnormalities on examination (Wessely, Hotopf & Sharpe, 1999:149).

DIAGNOSIS AND CLASSIFICATION CRITERIA OF CFS

As no biological marker has yet been found, there are no tests to confirm or refute a diagnosis of CFS (Mostert, 1999:72). Diagnosis is made on the basis of

symptoms and involves exclusion of a discernible cause (Afari & Buchwald, 2003:222). The latter of which involves a complete patient history, physical

examination and normal screening laboratory tests (Katz, 2002:741) (Appendix F). Some conditions to be considered for exclusion include hypothyroidism,

anaemia, sleep disorder, Addison’s Disease (Sharpe & Wessely, 1997:180), brucellosis, myeloproliferative disorders (Lewith, 1996:43) and occult malignancy

(Komaroff & Buchwald, 1998:3) (Appendix B).

Although a diagnostic model for CFS has been met, its use has been of more value to research than to clinical assessment (Rutherford, 2003). A few case

definitions for CFS have been debatably recognized in various parts of the world.

These include the Centres for Disease Control (CDC) diagnostic criteria, Australian, American and UK criteria, and the „Oxford’ criteria for CFS (Wessely,

Hotopf & Sharpe, 1999:141-144). However, major criticisms lie in these definitions of CFS: First, there exists considerable overlap between the criteria for CFS

and those for neuropsychiatric syndromes, such as depression anxiety, and somatoform disorders (Fukuda, et al. 1994:953-954).

In a Zurich population survey, Angst, Dobler, Mikola & Binder (1984) found a consistent and linear relationship between the severity of depression and a number

of somatic symptoms.

These included gastrointestinal, respiratory and circulatory symptoms, as well as backache, headache and exhaustion. In another separate study, myalgia, muscle

weakness and post-exertional malaise did not differentiate CFS from severe depression (Manu, Lane & Matthews (1996).

2^nd according to Wessely, Hotopf & Sharpe (1999:142-144), most symptoms included in the definition of CFS are not specific to it, thus cannot differentiate CFS

from other causes of chronic fatigue. Moreover, the case definition does not delineate a discrete condition that is identifiable by the same pathophysiology (Komaroff & Buchwald, 1998:4); hence it is not easily differentiated from other diagnostic entities (Fukuda, et al. 1994:953).

Third, the requirement for the fatigue to be present for six months does not accommodate the possibility of an abrupt onset of the disorder. Hence some patients are unwillingly required to wait-it-out, before such time as a diagnosis can be made (Rutherford, 2003). In others whose CFS-like descriptions abate short of six months,

they fail to acquire the CFS diagnosis (Pawlikowska, Chalder, Hirsch, Wallace, Wright & Wessely, 1994:746).

In terms of research however, the criteria are adequate in meeting the needs of studies (Rutherford, 2003). The most commonly utilized criteria in South Africa

(Welch, 1999:6) and internationally are those revised by the CDC of Atlanta, Georgia, 1994. This definition requires at least six months of persistent fatigue

that substantially reduces a person’s level of activity. Additionally four or more of the following symptoms must present concurrently within a six-month period: impaired memory or concentration, sore throat, tender lymph nodes, muscle +/o. multi-joint pain, new headaches, unrefreshing sleep, and post-exertional fatigue. Certain medical and psychiatric conditions are further exclusionary.

These are eating disorders, psychotic disorders, bipolar disorder, melancholic depression, and substance abuse within two years of fatigue onset Afari & Buchwald, 2003:222) (refer to Appendix A). Those who do not meet the fatigue severity or symptom criteria have recourse to the diagnosis of „idiopathic chronic fatigue’ (Fukuda, et al. 1994:957; Afari & Buchwald, 2003:222).

CFS remains a medically unexplained syndrome. It seems for now, in the absence of any objective evidence, that CFS assumes a dualistic view to

classification. According to the current International Classification of Diseases (ICD-10) system, post-viral fatigue syndrome, or ME falls under neurology, whilst neurasthenia comes under psychiatry (David & Wessely, 1993:1247). CFS’s resultant straddling between the mutually exclusive medical and psychiatric

classification systems has become problematic (Welch, 1999:6). According to the WHO, the classification is merely to enable both sides of the divide to record a diagnosis when faced with a chronically fatigued patient. It is recognized however, that the current classification for CFS stands inadequate and unresolved (Wessely, Hotopf & Sharpe, 1999:220-221).

It must be noted further, that neither CFS, nor its analogues are listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-4) (Welch, 1999:12).

MANAGEMENT OF CFS

Cleare & Wessely (1997:102) consider the treatment of CFS to be far from satisfactory. They believe that, for many years, sufferers have received no advice nor help, but have been told, “...to rest, „live within your limits’, and wait for the medical breakthrough.” Many sufferers are liable to stigmatisation from physician, family and friends, who doubt the veracity of their condition (Featherstone, 1998:98-105). In a South African thesis examining the illness narratives in CFS, Gray (2001:2-3) cited the following patient frustrations: “My GP refuses to believe ME exists, never mind that I have it. Should I try to convince him or look for another doctor?”

Patients admit that such above experiences are common (Ware, 1992; Featherstone, 1998). For this reason, fundamental in the approach towards a CFS patient, is to establish

a positive working relationship (as shown in table 2.2.8). The doctor’s beliefs and attitudes are important in facilitating a therapeutic

alliance (Wessely, Hotopf & Sharpe, 1999:352).

CFS: Establishing a positive working relationship

Take the patient’s physical complaints seriously

Respect the patient’s illness beliefs (without necessarily agreeing with them)

Empathize with experiences of being „disbelieved’ by others

Empathize with effects of illness and express willingness to help

Allow plenty of time, and allow the option of breaks/rest periods if needed

Taken from Wessely, Hotopf & Sharpe, 1999:352

The management of CFS patients must be based on the available evidence of what has been shown to be effective (Wessely, Hotopf & Sharpe, 1999:365).

Albeit, despite a multitude of claims, the only treatment modalities to have shown significant effect in randomised trials, and to be considered beneficial to CFS

patients are cognitive-behavioural therapy (CBT) and graded exercise therapy (Straus, 2004:1234-1235; Lloyd, 2004:437). Least of all, patients require education about CFS and how to cope with it (Wessely, Hotopf & Sharpe, 1999:397).

TREATMENT INTERVENTIONS FOR CFS

Various treatment options are explored below.

CONVENTIONAL MEDICAL TREATMENT

Due to the close association between depression and CFS, antidepressants are often the suggested drug of choice, for its potential benefits in pain reduction,

sleep, increased energy and mood improvement. However, for unknown reasons, CFS patients are particularly sensitive to the side effects of antidepressant drugs. Therefore, if given, these drugs should be started in the lowest possible dose and increased gradually to achieve compliance. It is recognized that its use is largely empirically based and is not clearly indicated in CFS (Wessely, Hotopf & Sharpe, 1999:399-400).

Other treatments are largely symptomatic (Lewith, 1996:45-49). Analgesics (non-steroidal anti-inflammatory drugs / NSAIDS) may be given for myalgia.

Many CFS sufferers have reported that this affords them little relief (Rutherford, 2003).

BEHAVIOURAL INTERVENTIONS

“By behavioural intervention is meant offering patients practical help to implement the advice they have been given about sleep, rest, and activity.”

(Wessely, Hotopf & Sharpe, 1999:400)

Disturbed sleep patterns are commonly reported in CFS (Afari & Buchwald, 2003:225). There is sufficient circumstantial evidence to support regularization of

sleep patterns. This is achieved by monitoring of „getting up times’ and avoidance of daytime napping. In terms of exercise, importance is given to implementing a stable continuum of rest and sustainable activity. Thereafter, gradual increases of activity can be planned (Wessely, Hotopf & Sharpe, 1999:400-

401). Education regarding the benefits of exercise has been shown to be effective in increasing levels of activity in CFS (Powell, Bentall, Nye & Edwards, 2001).

PSYCHOTHERAPY

Psychological interventions have been explored: Individual and group behaviour therapies have helped some patients (Beers & Berkow, 1999:2482). There is

increasing evidence for the effectiveness of cognitive behavioural therapy (CBT) in CFS (Cairns & Hotopf, 2005:20; Rimes & Chalder, 2005:32). The amenity of this therapy is to helping patients achieve a more constructive view of their illness, whilst adopting more effective coping strategies (Sharpe & Wessely,

1997:182). This approach in treating CFS patients is based on the premise that cognitive attributions and behavioural patterns act as perpetuating factors of the

condition (Lloyd, 2004:437). Although CBT has been effective in reducing disability in CFS, it does not render patients symptom free (Wessely, Hotopf &

Sharpe, 1999:416). One study revealed that counselling may be as useful as CBT for treating CFS patients in primary care (Ridsdale, Godfrey, Chalder, Seed,

King, Wallace & Wessely, 2001). Clinical hypnotherapy has also been utilized with some success (Welch, 1999).

GRADED EXERCISE THERAPY

An increase in fatigue following exertion is a major symptom of CFS.

Consequently, many sufferers reduce their physical activity to avoid exacerbations (Skinner, 2004:28). However, there is evidence to suggest that “graded” increases in physical activity are helpful in improving function and relieving symptoms of CFS (Sharpe & Wessely, 1997:182; Rimes & Chalder, 2005:33). Sufferers are thence

advised to engage in graded exercise regimes that are sensitive to each of their particular circumstances (Rutherford, 2003).

However, Lloyd (2004:579-580) asserts caution to the boon of graded exercise, as severely ill CFS sufferers, unable to participate in exercise studies, are likely

to be underrepresented in published data. Likewise, Scroop & Burnet (2004:579) state that graded exercise studies, in CFS, have not provided compelling

evidence of improvement in either physiological or clinical status of patients.

Nevertheless, it is recommended that those with CFS make exercise a regular part of their lifestyle (Skinner, 2004:29).

DIETARY AND VITAMIN SUPPLEMENTS

Other avenues of treatment have been directed at diet, vitamins and supplements (Beers & Berkow, 1999:2482). Vitamin B12 has long been used as a treatment for

fatigue and as a „goad’ to energy. NADH (nicotinamide adenine dinucleotide) has been given as an oral supplement. Carnitine and Co-enzyme Q10 (ubiquinone),

obtained from health food stores have been advocated.

Results however have been disappointing (Rutherford, 2003). According to Wessely, Hotopf & Sharpe (1999:380-381), there seems little rationale for their

use in the absence of clear dietary deficiency or malabsorption syndrome.

COMPLEMENTARY MEDICAL TREATMENT

A wide range of complementary therapies, appearing to have affinity for the immune system (in CFS) have included acupuncture, nutrition, intramuscular

magnesium, evening primrose oil and homoeopathy. The evidence to support them is limited and largely descriptive (Lewith, 1996:45-49). Clinical trials with

evening primrose oil and intramuscular magnesium have produced conflicting results (Rutherford, 2003).

According to Wessely, Hotopf & Sharpe (1999:387),

„Homeopathy’ as it is referred to here is complex homoeopathy. This adopts a different approach to classical (similimum) homoeopathy. The former utilizes mixtures

of herbal and homoeopathic remedies called „complexes’, targeted at the organs appearing to function least well. In CFS this is frequently the liver and colon

(Lewith, 1996:45-49). Many classical homoeopaths however, question the integrity of this approach in terms of its classification as a homoeopathic medicine

(Carlston, 2003:11,13).

More research needs to be conducted within the domain of complementary medicine.

PROGNOSIS OF CFS AND SOCIETAL IMPLICATIONS

The prognosis for CFS sufferers is variable as no treatment has yet been significantly effective (Rutherford, 2003). Unemployment is common, with loss of income and productivity in relatively young people being considerable (Lloyd & Pender, 1992; Bombardier & Buchwald, 1996). A recent study found that CFS costs the U.S. over $9 billion each year in lost productivity. This estimate is not inclusive of healthcare costs, which are likely to be considerable (Reynolds, Vernon, Bouchery & Reeves, 2004).

A literature search conducted by Cairns & Hotopf (2005) identified all studies describing the clinical follow-up of patients following a diagnosis of chronic

fatigue or CFS. The results showed that the median full recovery rate was 5%, and the median pro portion of patients who improved during a follow-up was

39,5%. Good outcomes were associated with a sense of control over symptoms and not attributing the illness to a physical cause. Return to work at follow

-up ranged from 8 to 30% in the three studies that considered this outcome.

Conclusions drawn from the study suggested that full recovery from untreated CFS is rare. The prognosis given for an improvement in symptoms is less poor

(Cairns & Hotopf, 2005:20).

If spontaneous recovery is going to occur, it usually takes place within the first few months (Lewith, 1996:43). Poor prognostic factors include older age, longer

illness duration, fatigue severity, comorbid psychiatric illness, and a physical attribution for CFS (Afari & Buchwald, 2003:230). Although not associated with

excess mortality, CFS renders considerable morbidity to its sufferers (Mostert, 1999:92).

Suicide resulting from disability has been reported (Lewith, 1996:43).

“Chronic Fatigue Syndrome has become a new challenge for health care professionals and needs increased attention in the diagnosis, assessment and treatment.”

(Mostert, 1999:72).

MIND - BODY MEDICINE

THE MIND - BODY DICHOTOMY

Cartesian mind-body dualism represents current biomedical models (and many psychological models) in health care that are functionally dualistic and

reductionistic, espousing the separate entities of psyche and soma. This results in healthcare that is not whole-person orientated and is bound to the value in

medical specialization and technological advancement (Schlebusch, 1990:3-5).

SYNOPSIS OF MIND-BODY MEDICINE

According to the likes of Schlebusch (1990:3-4), Benson and Friedman (1996:195) health sciences provide clear evidence of the limitations of assuming a narrow biomedical approach to health, disease and treatment. Consequently, modern healthcare is steering away from this Cartesian mind-body dualism in

adoption of a renewed approach, called mind-body medicine (Schlebusch, 1990:3).

Watkins (1997:1-2) defines mind-body medicine “as an approach to health that does not focus solely on the conscious mind and physical body, but incorporates unconscious emotional life and an individual’s spiritual dimension”.

The role of psychological factors and stress in the aetiology and maintenance of numerous medical and psychiatric disorders confirms this model. Conversely, the mind, being associated with chemical and electrical activity in the brain, is also a biological phenomenon (Schlebusch, 1990:5).

Current mind-body interventions cover a broad range of therapeutic practices, from counselling and cognitive behavioural therapy (CBT), to various alternative

medical practices such as homoeopathy. It has been suggested that homoeopathy may produce an effect through direct activation of mind-body

pathways (Watkins, 1997:2).

The mind-body approach is not new; rather it is a re-emergence of psychology’s relation to medicine of the past (Schlebusch, 1990:5).

PSYCHONEUROIMMUNOLOGY (PNI)

A substantial amount of research evidence suggests that mind and body intercommunicate by means of a multidirectional network of hormones, neuropeptides and cytokines (Adder, Cohen & Felten, 1995:100). Further, PNI research has adduced irrefutable evidence that virtually all of the body’s defense systems are

piloted by the central nervous system (CNS) (Watkins, 1997:3).

“Thus, every idea, thought and belief has a neurochemical consequence, and neuropeptides flow from the CNS, impinging on specific receptors on virtually all

leukocytes, regulating their function.” (Watkins, 1997:3)

The ability to inhibit or enhance immunity, under the directive of the CNS, is achieved through two major neuroimmunomodulatory pathways: neuroendocrine

and autonomic. These two pathways are thought to be critically important in maintaining health and opposing disease amidst immunological or psychological

threat (Berczi & Nagy, 1991:3-19).

According to Mostert (1999:137) and Welch (1999:248-249), the transactional model of psychoneuroimmunology, which suggests complex interactions

between multiple biological and psychological factors, should be an essential focus for the therapeutic intervention of CFS.

THE PLACEBO EFFECT

A placebo is a harmless treatment thought to have no measurable effect on the condition to which it is applied (Watkins, 1997:256), but which is used for its non

-specific psychological or psychophysiological effects (Bishop, 1994:432).

According to Benson and Friedman (1996:194-195) the placebo effect is “the aspect of treatment not attributable to specific pharmacologic or physiologic

properties”. They have proposed three determinants of the placebo effect: that is a positive belief and expectation on the part of the patient, a positive belief and

expectation on the part of the physician, and a good relationship existing between both the patient and physician.

Generally, the placebo effect can be defined as an effect that occurs following the administration of a therapeutically inactive substance. Placebo has been shown to be as effective as certain forms of surgery, and influence the action and effectiveness of medications (Watkins, 1997:234). Further, the effectiveness of placebo has been documented in a wide variety of conditions, including angina pectoris, asthma, congestive cardiac failure and mortality in coronary artery

disease. Herein, its efficacy has been shown to exceed 35% (Benson and Friedman, 1996:196). Controversy still resides over the relationship of alternative

medicine to placebo effects; it is still unclear to what extent the effects of an alternative therapy used, is the result of a placebo and to which is attributable to

specific effects (Donnelly, 2004:238-241).

In recent times, “placebo” has assumed derogatory connotations, possibly reducing the power of non-specific effects. This has been the result of conditioning, within the conceptual framework of medicine, by its focus on specific pharmacologic and surgical interventions (Benson & Friedman, 1996:195). Consequently, some authors have pressured for a “placebo” name change (Benson & Friedman, 1996:195; Basmajian, 1999:107-116).

Those conducting research on any treatment modality (i.e. pharmacotherapy or psychotherapy) must control for placebo effects. This is because the patient’s

expectancy of improvement and the attention received by the doctor could influence improvement rates. The treatment in question is usually considered effective if its

results show greater improvement than that produced by placebo (Sue, Sue & Sue, 2000:521).

Contrary to common belief, patients with CFS respond to placebos at a lower rate than people with many other illnesses. In a recent review and meta-analysis,

Cho, Hotopf & Wessely (2005) showed that 19,6% of CFS patients improved from placebo, compared to the widely accepted figure of about 30% for other

conditions.

A possible explanation given was that patients might have had low expectations due to the reality that CFS is difficult to treat and often persists for years.

The placebo effect seems to be the strongest in diseases with highly subjective symptoms. A priori, some researchers believed that its effect could be as high as 50% among CFS sufferers (Cho, Hotopf & Wessely, 2005:301-302).

HOMOEOPATHIC TREATMENT

Unfortunately, this bias against homoeopathy has been so unyielding that even positive evidence from well-conducted randomised controlled trials, has been ignored

(Carlston, 2003:4). In homoeopathy however, it is empirically recognized that the smaller the dose given, the greater the efficacy of the medicine (Ullman & Reichenberg - Ullman, 2000:47; Gray, 2000:12-13). Some scientific theories have been proposed to explain this miniscule-dose controversy (Carlston, 2003:4). According to Ullman (1991:12-13), small doses may work by means of a biological analogue to sound resonance:

“In explaining how small doses act, an analogy to music is helpful. It is commonly known that when one plays a „C’ note on a piano, other „C’ notes reverberate.

Even on another piano at the other end of a room, „C’ notes still have a hypersensitivity to the „C’ resonance.

In music theory (and physics), there is a basic principle that two things resonate if, and only if, they are „similar’.” (Ullman, 1991:12-13)

When the organism receives the resonant message of the medicine, its immune and defence systems may be catalysed into initiating a curative process (Ullman, 1991:11-22). Unlike medical orthodoxy, which prescribes medicines to oppose or obstruct a patient’s symptoms, homoeopathic medicine acts in concert with those symptoms

(Carlston, 2003:3).

The totality of symptoms (both physical and mental), crucial to the selection of the homoeopathic similimum, is underpinned by a particular mind state (Ullman, 1991:19-22). The mind state, representing a deeper level of disorder (Swayne, 1998:72), is rooted in biographical mental or emotional trauma. A corollary to the given mind state disturbance, is thence vulnerability to disease (Ullman & Reichenberg - Ullman, 2000:16-17). According to Chappell (1997:72-79) this biographical trauma prevents one’s flexible human intelligence from responding to appropriate reality thereafter, and represents an existential core „stuckness’.

He believes that the remedy frees the maladaptive state from the individual, thereby facilitating psychological and physical health.

Sankaran (1997b:11-15) likens this maladaptive state to, what he calls, “delusion”, to which a remedy is given. He proposes that the remedy corrects a psycho-neuro-

endocrine-immunological (P.N.E.I.) or central disturbance, facilitating improvement of the patient’s condition.

“Pathology grows on the central disturbance like a creeper on a stick. What we have to do is to remove the central disturbance.” (Sankaran, 1997b:8)

For this reason, the choice of remedy in terms of the homoeopathic similimum (particularly for chronic conditions) has rested predominantly upon the mental state or personality subtype of the patient (Ullman, 1991:19-22; Sankaran, 1997b:11-15). Further, according to Swayne (1998:71), it is the mind, personality and creativity

that define a person most completely.

A delusion is a false perception of reality. This is created by significant biographical events (in the life of an individual, or from previous generations) and may manifest

a disease state. The delusion forms part of the central or P.N.E.I. disturbance of an individual (Sankaran, 1997b:11-15).

In recent years however, Sankaran (2002:38-39) has proposed a newer model for understanding the mind-body connection and its amenability towards more effective similimum prescribing. It is his belief that a person’s “delusion” does not limit itself to the mind, but in fact expresses itself on the physical sphere as a manifestation of

a more deeper underlying state, called the “Vital Sensation” (central feeling). If the homoeopath can identify the specific “Vital Sensation” (psycho-sensory construct),

through focused case taking as it applies to homoeopathic materia medica, the better the chance for understanding the patient’s central disturbance (Sankaran, 2002:38-39)” (Appendix I).

As for example when a person says that he feels jealous or suspicious or expresses something mental and emotional then we might ask him for the experience behind that. He may feel he is being attacked and is frightened. In this way an emotional situation is perceived behind the mental symptom, which is good enough, but if you want to take it one step further you ask him how he experiences the attack. At this point you come to the intersection or cross point where the mind and body meet. Here they may have the feeling that something is breaking or burning or twisting. This is the common point between body and mind (The Vital Sensation) and here he will describe his emotional symptoms and physical symptoms in the same terms. This is a very deep level and if you reach this point there is a much better chance of success.” (Sankaran, 2002:38). “...mind and body both express the same phenomena, same disturbance, and the same vital problem.” (Sankaran 2002:48). In concurrence, Chappell (1997:79) states that most thoughts are feelings veiled in, or expressed through the medium of thoughts, and if one were to examine closely it would be seen that many thoughts are basic feelings.

“This „stuckness’ has thinking, feeling and physical components acting together synchronously and this perpetual reinforcement is what keeps the pattern alive. It becomes part of our posture, our cellular chemistry, our attitudes... our whole way of being in the world.” (Chappell 1997:79) Scholten (1999:17) also confirms that „feeling’ is energy, which is linked to and bound by a belief (“delusion”).

Mathur (1998:128), an homoeopathic physician, also alludes to the possibility that feeling is an underpinning factor of a mind state disturbance. His explanation exemplifies the approach.

“Each human being makes his own disease, better said, he forms a pathology both of his psychic personality and of his physical organism in accordance with an unconscious determinism originating from a dynamic miasmatic alteration of his vital force. That morbid determinism is contained in his biographical history, in his hereditary and particular antecedents, in his way of feeling, thinking and living and in all subjective symptoms that reveal his personality and make him a unique and personal case.” (Mathur, 1998:128)

According to Swayne (1998:1), and what is evident above, the homoeopathic approach involves an exceptionally complete and detailed description of the patient, the illness and its evolution. This is because the homoeopath inevitably seeks to select a single remedy out of a vast number of potential homoeopathic medicines (Carlston, 2003:2 - 3). Hitherto, there are over 3000 homoeopathic medicines with specific clinical indications and with a repertoire of multifarious symptomatology (Swayne, 1998:188).

In light of all the above, as pertaining to homoeopathic similimum treatment, it must be emphasized that there are various methods of prescribing for patients (Mathur, 1998:v). Regardless of the methodology used, the ultimate aim of the homoeopathic enquiry and analysis is to arrive at the similimum (Bloch, 2002:16).

HOMOEOPATHIC LITERATURE OF CFS TREATMENT

Brief mention has been made about the use of homoeopathy for CFS, but this is mostly anecdotal.

A cohort of well-known homoeopathic doctors have made reference to CFS’s amenability to homoeopathic similimum treatment.

According to De Schepper (2001:6-7) practitioners are not aware of the power of homoeopathy for CFS. He has claimed to have helped hundreds of patients with this condition.

“The results were a consistent restoration of the patient’s energy and overall health, such as they never experienced even with the best antiviral medications.”

Bailey (1995:189) has found homoeopathy to be greatly effective in treating CFS. He claims to have helped most of the CFS patients in his practice. He goes on further to state:

“It is the perfect sickness to catch if you are a workaholic and need to stop and feel your feelings.”

Hardy (2005:9) has also made mention of homoeopathy’s role in treating CFS patients. In a recent article, he cites a number of successfully treated cases from his practice.

Featherstone (1998) has reviewed (in the British Journal of Therapy and Rehabilitation) an informal study, in which 24 of 36 CFS patients found symptom relief using homoeopathy.

Walach (2004:210-211): homoeopathy is purportedly not always effective with chronic fatigue patients.

HOMOEOPATHIC RESEARCH ON CFS

The London Homoeopathic Clinic, under the auspices of the London College of Classical Homoeopathy, conducted the first known study of utilising homoeopathic similimum against placebo in CFS. The randomised double-blind trial involved 64 participants, each of whom attended at least 12 clinic visits, over a 12 month period. The study outcome rested upon the results of two outcome measures: a daily (wellness) graph, and an end of trial self-assessment chart, both of which required completion by each participant. According to the trial co-ordinator, Awdry (1996:12-16), the results appeared encouraging, with outcomes revealing noticeable improvement in only the treatment group. However no statistical tests were performed.

Later, authors Wessely, Hotopf & Sharpe (1999:387) conducted a statistical analysis of the above study data, which indicated a 33% improvement in the treatment group compared to 3% in the placebo group. However, these authors asserted scepticism over the study’s interpretation of results, stating that internal validity was questionable and insufficient to render reliable results.

Critical analyses by authors to follow, Afari & Buchwald (2003:228) and Rimes & Chalder (2005:34), considered Awdry’s study to be of poor quality and have conceded

the outcome to be inconclusive.

A more recent study, reported in 2004, evaluated the efficacy of individualized homoeopathic treatment (similimum) for CFS. Weatherley

- Jones, Nicholl, Thomas, Parry, McKendrick, Green, Stanley & Lynch (2004) conducted a carefully designed triple - blinded placebo

- controlled trial. 103 patients meeting the Oxford criteria for CFS were recruited to two specialist hospital outpatient departments in the UK, and attended monthly consultations with a professional homoeopath. Outcomes were made at six months using the Multidimensional Fatigue Inventory (MFI), Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP). 92 patients completed the trial (47

similimum treatment and 45 placebo) with 86 patients completing post-treatment outcome measures. Results revealed that 47% of patients in the treatment group showed a clinically significant improvement, compared to 28% of individuals in the placebo group (d=0.4). Although group differences were not statistically significant for most outcome measures, more people in the treatment group showed clinically significant improvement.

One author’s appraisal of the above study concluded the following: “The study certainly hasn’t conclusively answered the question of whether the effects are purely due to placebo or if there is a specific component in homoeopathic remedies.” (Walach, 2004:211) According to Weatherley - Jones, et al. (2004:190) the study reflected equivocal evidence that homoeopathic medicine was superior to placebo. The researchers believe further studies of this nature are needed to determine whether the differences noted would hold for larger samples.

OUTCOME MEASURES IN CFS

Due to the descriptive nature of CFS, subjective outcome measures are currently conceded as the only means by which treatment responses can be evaluated by clinicians. It is known that the feeling of fatigue cannot be objectively measured; it can however, be estimated by fatigue questionnaires (Naschitz, Rozenbaum, Shaviv, Fields, Enis, Babich, Manor, Yeshurun, Sabo, & Rosner, 2004:167-168).

According to Wessely, Hotopf & Sharpe (1999:371) the only outcomes that are likely to matter to patients are those that rely on self-reporting of symptoms and levels of activity-this entailing how they feel and how much they can do. In referring to measurement of exercise studies in CFS, Scroop & Burnet (2004:578) also state that outcomes should lie in self-reporting of symptom severity or functional status.

OUTCOME MEASURES UTILISED FOR THIS RESEARCH STUDY

Participants were given a self-report chronic fatigue syndrome (CFS) questionnaire (Appendix C1) and a single-item (100mm) fatigue visual analogue scale / VAS (Wessely, Hotopf & Sharpe, 1999:15; Appendix C2) to complete at each consultation.

THE SELF-REPORT CFS QUESTIONNAIRE

The self-report CFS questionnaire was adapted from various sources:

The fatigue scale of Chalder, Berelowitz, Pawlikowska, Watts, Wessely, Wright & Wallace (1993),

The Welch symptom checklist questionnaire (Welch, 1999:197, appendix G),

The CFS Emotional Symptom Scale (CFS-ESS) (Stoff & Pellingrino, 1992:169,170).

The adaptations made were for the following reasons:

First, the researcher was unable to find a definitively suitable questionnaire for effective assessment of CFS. According to Scroop & Burnet

(2004:578) subjective measurement of outcomes in intervention studies of CFS are vague but necessary.

Second, of each of the various scales and questionnaires found, none encapsulated all dimensions of the condition, i.e. cognitive, affective and physical, which would be appropriate for assessing outcomes of homoeopathic treatment. Adaptations were then made in order to amalgamate the multiaxial dimensions of recognised fatigue and CFS scales, into a single comprehensive questionnaire.

To exemplify the selected sources of the CFS questionnaire:

The checklist questionnaire of Welch (1999:197) covers a broad spectrum of malfunction for diagnostic purposes, and has the advantage of providing a baseline for monitoring results of therapeutic intervention. Welch (1999:8,11) recognized however, that the checklist was limited in its extent of covering cognitive dysfunction. Hence, the fatigue scale of Chalder, et al. (1993) was chosen for its separate physical and mental (cognitive) subscales. However, this scale is also restricted, but to mental and physical fatigue (Naschitz, et al. 2004:167-172). Finally, the researcher (Saul) located the CFS Emotional Symptom Scale (CFS-ESS) (Stoff & Pellingrino, 1992:169,170) to provide

assessment of the affective aspects of the condition.

THE FATIGUE VISUAL ANALOGUE SCALE (VAS)

Considering that fatigue is the main component of CFS, emphasis was made thereof, and a second separate scale, a 100mm fatigue visual analogue scale / VAS (Wessely, Hotopf & Sharpe, 1999:15; Appendix C2) was used to assess the degree of fatigue per se, contiguous to the other scale.

“In the management of patients with CFS, the severity of fatigue is the main parameter used in monitoring the patient’s course and evaluating the effectiveness of therapeutic interventions.” (Naschitz, et al. 2004:167-168).

These outcome measures were used to determine the effectiveness of homoeopathic similimum treatment in CFS, in terms of each articipant’s perception of the treatment.

SUMMARY

While chronic fatigue is a common complaint for which individuals seek medical attention, chronic fatigue syndrome (CFS) is relatively rare (Ranjith, 2005:13).

Notwithstanding, CFS poses a considerable worldwide public health problem (Rutherford, 2003).

Whilst biomedical confirmation remains crucial to legitimising the care and support needed by CFS sufferers (Feathersone, 1998:105), the interactional approaches offered by mind-body medicine and cognate, homoeopathy, may provide importance to illness management in CFS (Hyland, 2001; Featherstone, 1998).

STUDY DESIGN

A sample group of 30 participants were voluntarily selected for the study on the basis of inclusion and exclusion criteria. These participants were then randomly divided into 2 groups (15 patients for each of the treatment and placebo groups). Each participant had to attend a total of 3 consultations with the researcher, over a 3-month period, at the Durban Institute of Technology (DIT) Homoeopathic Day Clinic. Permission was granted by the clinic director, for the use of the facility over this period.

At the commencement of the first consultation each participant received the subject information letter (Appendix D) for perusal and the informed consent form (Appendix E) to sign. Following this, the researcher took a full, detailed case history (integrating both the medical and homoeopathic approach; Appendix F - G) and performed a physical examination (Appendix H) of each patient. At this point, if no significant clinical findings were noted in a previously diagnosed CFS patient, then that participant qualified for the study. In a patient previously undiagnosed with CFS, basic second line investigations were conducted (under the patient’s consent, and at own expense) to exclude other possible illnesses before accepting them into the research study.

Participants were required to complete a CFS questionnaire (Appendix C1) and a fatigue visual analogue scale (Wessely, Hotopf & Sharpe, 1999:15; Appendix C2) at the end of each of 3 consultations.

The Homoeopathic Day Clinic laboratory technician dispensed medication to the respective groups according to the randomisation sheet drawn up by the research supervisor. This followed the first and second consultations for each participant.

The treatment consisted of a total of 6 powders containing either an active ingredient (i.e. similimum) or matching placebo. Each participant received 3 powders (doses) following each of the first and second consultations and was directed on how to take them. Participants were asked to return for the second consultation 4 weeks following the first. At the second consultation the researcher reassessed the participant, in terms of the homoeopathic similimum approach before prescribing the next 3 powders. Hence, the second similimum prescription (homoeopathic remedy) could change from the first, depending on the individual (see chapter 2).

If improvement of a participant’s condition was noted at the second consultation the researcher would then suggest the participant only take the next 3 doses if again needed. This was done in accordance with the homoeopathic principle of minimum dose (Ullman, 1991:11-15).

The third and final consultation took place 3 months following the first, and involved the participant again completing the CFS questionnaire (Appendix C1) and fatigue visual analogue scale (Wessely, Hotopf & Sharpe).

The duration figure for this study (of 3 months) was derived from randomised controlled trials of Interferon-α, and evening primrose oil in CFS sufferers (Wessely, Hotopf & Sharpe, 1999:378,381).

The participant medicine profile, seen in tables 4.7.1 (treatment group) and 4.7.2 (placebo group), shows that the most commonly indicated similimum medicine for the study, was Natrum muriaticum (20%). This concurs with the anecdotal evidence presented by Bailey 1995:189): he has found Natrum muriaticum to be the most commonly prescribed homoeopathic remedy for CFS, in his practice. A brief description of a person requiring the remedy, Natrum muriaticum (Nat-m), is alluded to below.

The nature of the person is such that emotional pain is central to their existential core attachment (see chapter 2) - often originating in childhood when the unconditional love required as a child, was not freely given (Bailey, 1995:175-222). Consequently, the person develops an inner fear of being emotionally hurt or disappointed by others, to which he/she responds by reservedness or unapproachability (Sankaran, 1997a:144-145). According to Bailey (1995:220) this avoidance of feeling may also be achieved by retreating into the intellect,

resorting to humour and hilarity, keeping busy, caring for others, being a perfectionist, dramatizing emotions, or positive thinking.

Further, there may be inability of handling emotions. This may be expressed as an aversion to affection, difficulty in giving +/o. receiving, being aloof, or assuming a browbeater persona. They are one of the most predisposed to depression, resulting from suppressed sadness (Bailey, 1995:175 -222).

“It is difficult to get them to express their real feelings but when they „break’ a little, they can get sentimental and there may be a flood of grief.” (Sankaran, 1997a:144-145)

According to Scholten (1999:65-66) the central theme of Natrum muriaticum is that „there is no mother and no care’. This is confirmed by the repertory symptom “delusion his mother is dead”. It is the theme of being alone in the world, akin to the absence of nurturing. The standard situation is that of bereavement.

According to Bailey (1995:189) „Nat-m. illness’ (particularly chronic fatigue syndrome) is acquired as an unconscious means of emotional healing. That is their illness may only be resolved once the suppressed feelings are felt. This is seemingly in accord with a theory by Pert (1999:192). Pert states: “Since emotional expression is always tied to a specific flow of peptides in the body, the chronic suppression of emotions results in a massive disturbance of the psychosomatic network.”

In a study conducted by Dowsett (1990), it was reported that emotional lability, including depression, elation and frustration occurred in 98% of CFS patients.

Evident from the description above, Dowsett could also be describing an analogue to Nat-m. at a more superficial level. To exemplify, the following extract has been taken from Gibson’s materia medica on Nat-m: “There is a tendency to oscillate emotionally from one extreme to the other. Either the subject is very depressed, terrified and miserable, or else over-excited, very bright and gaily laughing.... The mere idea of one type of emotion arouses its opposite....” (Gibson, 2000:350-352).

Please refer to Appendix I, research case number s 3, 8 and 28, for case example

analysis themes, of the remedy Natrum muriaticum.

Of interest, according to Hardy (2005:9), one group of homoeopathic medicines particularly useful in chronic fatigue syndrome patients is the acids (Ph-ac., Pic-ac., etc). The researcher however found this not to be the case, with no research patient requiring an acid remedy for the study.

Demographics of Homoeopathic Prescriptions

As can be seen from the demographics of remedy kingdom analyses (Figure 4.7.2), 50% of participants received a mineral remedy, 43%, a plant remedy, and 7%, an animal-based remedy.

A patient requiring an acid remedy is involved in an intense struggle of effort, which is made in a particular direction in that person’s life. The specific direction of struggle depends on which acid the patient requires. The consequence of which is „collapse’ or fatigue (Hardy, 2005:9).

Data Analysis of Homoeopathic Prescriptions: A Kingdom Group

Analysis

According to homoeopaths Sankaran (2002:20) and Scholten (2002:813), kingdom classification and understanding is emerging as a beneficial tool for similimum selection. Hence, it was decided that data analysis should be further angled at differentiating treatment responses within kingdom groupings (i.e. mineral, plant, animal). However, the animal kingdom was unamenable to analysis as no prescriptions fell into the treatment group. Inter- and intra-group comparisons were made using the fatigue visual analogue scale (VA

S). The VAS was chosen due to it being most sensitive to assessing fatigue severity for the study. Moreover, fatigue severity is regarded as the main parameter for which the effectiveness of therapeutic interventions of CFS are generally evaluated (Naschitz, et al. 2004:167-168).

Intra-group analyses of the treatment group revealed significant improvements for both the mineral (p = 0.030) and plant (p = 0.016) kingdoms in the study period (see tables 4.9.1.1 and 4.9.2.1 respectively). In comparison, the placebogroup showed no significant intra-

group differences for either mineral (p = 0.124) or plant (p = 0.779) kingdoms. Inter-group analyses of each remedy kingdom,

revealed no statistically significant values for the study period (see tables 4.9.1.3 and 4.9.2.3).

It is worth noting however, that the strength of the study’s placebo response, as calculated by VAS means, resided mostly with the mineral kingdom, ranging from 23.5% to 45.6% (Figure 4.9.1). In comparison, the plant kingdom’s placebo response ranged from 1.3% to 6.7% (Figure 4.9.2). Both responses appear contrary to what is understood from current literature.

According to Sankaran (1997a:229 - 232) the central theme of the mineral-kingdom revolves around structure and organization. “Mineral” personalities are often revealed as organized, systematic and logical, with a predilection for facts and figures, and a need for fixity in way of thinking. One would expect then that such constitutions are more resistant to placebo effects.

The basic quality common to a remedy of the plant kingdom is sensitivity, as they are sensitive to changes in their external environment and are easily influenced (suggestible) by many things. “Plants” are generally disorganized and would be regarded as being more impressionable than the “Minerals” (Sankaran, 1997a:230-233).

Hence, the study’s placebo response was inversely proportional to a priori kingdom assumptions. One possible explanation is that these effects, labelled as placebo and perceived as non-specific, did not influence much of the study’s outcome. Instead, it is hypothesised that these effects were the result of entanglement between homoeopathy, the researcher’s therapeutic intent and a cognitive behavioural strategy. If the “Minerals” process their world and inner existence (themselves and their illness) on a more cognitive level, the case taking process may have excited renewed meaning to their illness experience.

This knowledge may have allowed them to further process causal attributions of their CFS (release the existential “stuckness”) and in turn facilitate a self-healing process. If this were to be true, then the study may have been comparing a cognitive behavioural strategy to homoeopathic similimum, with the former supplanting the placebo arm of the study. Nevertheless, this is solely conjectural.

DEMOGRAPHICS OF THE CFS TRIAL

The demographic data, although representing a small sample, is supportive of the current literature.

Most studies of gender differences report higher rates in women than in men (Ranjith, 2005:16). The distribution, illustrates that 8 (26.7%) men and 22 (73.3%) women participated in the trial, representing a ratio of 1 to 2.75 in favour of female reponderance.

Most people having received a diagnosis of CFS are between 30 and 40 years of age (Afari & Buchwald, 2003:222). Although the study age range was limited (18-60 years), the distribution varied. The greater portion of participants (36.7%) however, were between 45 and 53 years of age.

CONCLUSION

The study adds further to a limited body of evidence evaluating the effectiveness of individualised homoeopathic treatment of chronic fatigue syndrome. The findings of this study appear similar to that of Weatherley - Jones, et al. (2004).

Whilst both studies failed to yield statistically cogent results, outcomes have revealed significant intra-group differences, with the latter indicative of improvements in the treatment group.

This is promising considering that CFS is currently conceded as poorly treatable with any therapeutic intervention (Afari, et al. 2005:356 - 357).

On the matter of placebo effects, the trial has also concurred with that of Weatherley - Jones, et al. (2004): that there may be benefit for CFS patients in the non-specific effects of a homoeopathic consultation.

Despite the study’s encumbrances (methodological limitations and complexity of the placebo response) it is stated de facto that good homoeopathic research is not easy to conduct, and is often seemingly unamenable to scientific protocols (Carlston, 2003:97). However, with perseverance and experiential knowledge it is believed that these obstacles can be overcome (Ernst & Canter, 2005:67).

CONCLUSION

Chronic fatigue syndrome (CFS) is a concerning health problem worldwide (Rutherford, 2003). It is an illness characterized by profound disabling fatigue of at least 6 months and accompanied by numerous rheumatological, infectious, and neuropsychiatric symptoms (Afari & Buchwald, 2003:221).

The aim of treating patients with CFS is to reduce the suffering of their condition so that they are able to return to normal activity and lead fulfilled meaningful lives. This would be achieved through reduction of symptoms and annihilation of abnormal fatigue.

The purpose of this double - blind, placebo - controlled study was to determine the effectiveness of homoeopathic similimum treatment of CFS, in hope of homoeopathic inclusion into the therapeutic management of the condition.

Outcomes were assessed in terms of participant perception of the treatment, using a CFS questionnaire (Appendix C1), and a fatigue visual analogue scale (VAS) (Wessely, Hotopf & Sharpe, 1999:15; Appendix C2).

Intra-group analyses of the data showed significant improvements occurring in the treatment group, for both the CFS questionnaire total and VAS. The placebo group did not reveal any significant improvement for the same two outcome measures. At the end of the trial (follow

-up two), overall improvement in terms of levels of energy was 38.2% for the treatment group and 25.6% for the placebo group. This appears promising for a condition that is otherwise refractory to both pharmacologic and non-pharmacologic interventions (Straus, 004:1234

-1235), and typically resistant to placebo effects (Cho, Hotopf & Wessely, 2005:306-305).

Although homoeopathic similimum posed therapeutically beneficial for the treatment of chronic fatigue syndrome, the net outcome revealed that its effectiveness was not statistically significant. Bearing cognizance to the shortfalls of the study (chapter 5), it is suggested that more research be undertaken to establish the role of homoeopathy in the treatment of CFS.

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