Schlaf Anhang 2

[Ashnie Maharaj]

THE EFFICACY OF HOMOEOPATHIC SIMILLIMUM IN THE TREATMENT OF CHRONIC PRIMARY INSOMNIA

Mini dissertation submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homoeopathy, in the Faculty of Health Sciences at the Durban Institute of Technology

ABSTRACT The purpose of this double-blind placebo controlled study was to evaluate the efficacy of homoeopathic simillimum in the treatment of chronic primary insomnia. Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning (Diagnostic and Statistical Manual of Mental Disorders, 4th edition. Text revision. (DSM-IV TR), 2000: 599).

„Homoeopathy‟ comes from the words „Homoeo’, meaning „like‟ and „Pathos’, meaning „suffering‟. The underlying concept of homoeopathy is that, in all conditions of disease, the human body is fully capable of healing itself by means of the vital force. It is a therapeutic method which clinically applies the Law of Similars (similia similibus curentur) and which uses medicinal substances in weak or infinitesimal doses. The homoeopathic simillimum is that remedy which most closely corresponds to the totality of symptoms. Simillimum treatment is based on a full evaluation of the patient’s physical, emotional and mental characteristics (Swayne, 2000: 105).

Convenience sampling was utilized, whereby 30 participants were selected for the study on the basis of inclusion and exclusion criteria according to the DSM-IV TR (2000) diagnostic criteria for 307.42 primary insomnia. The participants were randomly divided between Treatment (14 participants) and Placebo Groups (16 in the Placebo Group). This study was conducted at the Homoeopathic Day Clinic at the Durban Institute of Technology.

The measurement tools utilized: a Sleep Diary , the Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993) .

The initial consultation consisted of an extensive homoeopathic interview and a full physical examination to exclude other disease conditions. There were 2 follow-up consultations at 2-week intervals. Homoeopathic medication was prescribed at the first and second consultations. The DBAS and SII were utilized at each consultation. The DBAS and SII used at the initial consult were baseline measurements. Each participant was instructed at the first consult to start a Sleep Diary. On completion of the trial the participants who received placebo were offered free treatment. Due to the small sample size, non-parametric tests were conducted. The data accumulated from the Sleep Diary, SII and DBAS was evaluated and analysed statistically using the SPSS software.

Intra-group analysis (within each group) of Sleep Diary readings indicated a significant difference in the total hours of sleep in the Treatment Group between baseline and weeks 2, 3 and 4, as well as between weeks 2 and 4.

There were no significant differences between any of the weeks in the Placebo Group. The total hours of sleep in the Treatment Group at baseline (week 1) were 35 hours. There was a significant increase in total hours of sleep to 45 hours at week 2. The total hours of sleep in week 3 were 43 hours and at week 4 it stood at 41. The overall gain in hours slept was therefore 6 hours per week (p = 0.002). There were no significant differences between any

of the weeks in the Placebo Group. Inter-group analysis (between the groups) of Sleep Diary readings indicates that the degree of sleeplessness was comparable between the two groups at baseline. When comparing the net gains

in hours slept and total hours of sleep per week between groups, it is noted that there were significant differences between the groups at all weeks. In the Treatment Group, total hours and net gains in hours slept were significantly different (higher) than those in the Placebo Group (p=0.036).

This positive trend was also reflected in the SII scores (both intra and inter-group analyses). Intra-group analysis of Sleep Impairment Index (SII) readings, comparing Follow-Up 1 and Follow-Up 2 as well as Follow-Up 2 and baseline, revealed significant differences in all questions. Inter-group analysis of SII readings resulted in significant differences, within the first week of treatment, in 8 of the 11 questions. At the end of the trial the significant differences had increased to 10 of the 11 questions. However DBAS scores did not reflect this trend. The results of this study lead to the conclusion that homoeopathic simillimum is more effective than placebo in the treatment

of chronic primary insomnia, in terms of the Sleep Diary and SII. The study showed that homoeopathy can offer significant relief for insomniacs, when the simillimum is prescribed.

An increase in severity of symptoms in response to external events, internal events such changes in body functioning or to the administration of a medicine or other therapeutic intervention (Swayne, 2000: 5). Allopathy = a term, loosely, and not always correctly, applied to the practice of mainstream (orthodox) medicine (Gaier, 1991: 30). Amnesia Lack (or loss) of memory. Inability to remember past experiences (Dorland’s Illustrated Medical Dictionary, 1994: 60). Anxiety is an unpleasant emotional state. It is often accompanied by physiological changes and behaviour similar to that caused by fear. As anxiety increases, performance efficiency increases proportionately, but only to an optimal level. Further increases in anxiety result in a decrease in performance efficiency (Beers and Berkow, 1999: 1512). Anxiolytic

Reduces anxiety and exerts a calming effect with little or no effect on motor or mental functions. Used in acute anxiety states for its sedative and minor tranquilising capabilities (Shargel, Mutnick, Souney, Swanson and Block, 1997: 276).

Avogradro’s number

Amedeo Avogadro (1776 - 1856) demonstrated that the number of molecules in one mole of any substance is 6.0255 x 1023. Avogadro’s number is of interest to homoeopathy because it specifies the potency at which a remedy does not contain any of the original material substance. (Swayne, 2000: 22).

Cataplexy

A condition in which there are abrupt attacks of muscular weakness and hypotonia triggered by an emotional stimulus such as mirth, anger, fear, or surprise. It is often associated with narcolepsy (Dorland’s Illustrated Medical Dictionary, 1994: 276). Centesimal potency A dilution in the proportion of 1 part in 100 (Swayne, 2000: 35).

Chronic primary insomnia Difficulty initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning (Diagnostic and Statistical Manual of Mental Disorders, 2000: 599). Circadian rhythm Innate, daily fluctuations of behavioural and physiological functions. It is generally tied to the 24 hour day-night cycle. Sometimes it is tied to a different periodicity (e.g. 23 hour or 25 hour) when light or dark and other time cues are removed (Kryger, Roth and Dement, 1998). Constitutional type Classification according to which a particular medicine suits a specific kind of patient (Gaier, 1991: 103).

Drug tolerance

Progressive diminution of susceptibility to the effects of a drug. This results from its continued administration (Dorland’s Illustrated Medical Dictionary, 1994: 1717). Dyspnoea

This is the subjective sensation of shortness of breath, often exacerbated by exertion. It may be due to cardiac, lung or anatomical pathologies (Longmore, Wilkinson and Rajagopalan, 2004: 70).

Dyssomnia

A category of sleep disorders consisting of disturbances in the quality, amount or timing of sleep (Dorland’s Illustrated Medical Dictionary, 1994: 519). Homoeopathy According to Gaier (1991:272), homoeopathy is a scientific system of medicinal therapy, founded by Samuel Hahnemann (1755-1843). It is based on the biological fact that a diseased organism can be restored to normal by specially-prepared medicinal stimuli. Homoeopathic medicines need only be administered in small doses, often in sub-physiological deconcentrations. This is due to an altered receptivity of tissue in disease to such stimuli, provided that

a) The medicinal agents chosen would produce symptoms and clinical features (like those of the disease) in healthy organisms

b) Obstacles to cure have been removed Homoeopathic drug preparation

Gaier (1991: 138): 3 processes of homoeopathic drug preparation are:

1. Serial dilution

2. Succussion and

3. Trituration

Dilution reduces the toxicity of the original crude drug by serialized deconcentrations. Serial dilution means that each is prepared from the dilution that immediately came before it. Succussion for soluble drugs, and trituration, for insoluble medicines, are the mechanical methods that impart the pharmacological message of the original substance (active principle) to the water molecules of the solvent or diluent respectively. Hypnagogic imagery

Vivid sensory images occurring at sleep onset. It is a feature of narcolepsy (Kryger, Roth and Dement, 1998). Hypnotic Produces drowsiness and encourages the onset and maintenance of a state of sleep. It is often used in the treatment of sleep disorders (Shargel, et al. 1997).

Iatrogenic

Any adverse condition in a patient occurring as the result of treatment by a physician or surgeon, especially to infections acquired by the patient during the course of treatment (Dorland’s Illustrated Medical Dictionary, 1994: 815).

Individualization Is to particularize medicine for any one patient (Gaier, 1991: 283). Infinitesimal dose

A dose of medicine whose source material has been diluted beyond Avogadro’s number. It is unlikely to contain any molecules of the original active ingredient (Swayne, 2000: 112). Insomnia Refers to the inability to sleep or the experience of abnormal wakefulness (Dorland’s Illustrated Medical Dictionary, 1994: 845). Insomniac An individual exhibiting insomnia (Dorland’s Illustrated Medical Dictionary, 1994: 845). LM Potency Potencies based on a dilution factor of 1/50 000, as compared with 1/10 (decimal potency) and 1/100 (centesimal potency) (Swayne, 2000: 127).

Materia medica

A systematic documentation based on the knowledge of medicines. In homoeopathy, it implies the description of the nature and therapeutic repertoire of homoeopathic medicines; of the pathology, the symptoms and signs, the modifying factors and the general characteristics of the patient associated with them (Swayne, 2000: 132).

Menopause

Menopause marks the end of the menstrual cycle and ovulation, occurring naturally at an average age of fifty to fifty one years. Menopause is established when menses has not occurred for one year (Davidson, 1999: 597).

Nightmare

A terrifying dream; an anxiety attack during dreaming, accompanied by mild autonomic reactions (Dorland’s Illustrated Medical Dictionary, 1994: 1138).

Pharmacology

The study of drugs - what they are, how they work and what they do. It is the study of the effect of chemical agents on living processes (Laurence and Carpenter, 1994: 166)

Pharmacopoeia

A book (especially one officially published) containing lists of drugs with standards of manufacture, purity, assay and directions for use (Laurence and Carpenter, 1994: 166).

Pharmacotherapy

The treatment of disease by medicines (Dorland’s Illustrated Medical Dictionary, 1994: 1272).

Phenomenological

Any remarkable appearance: any sign or objective symptom (Dorland’s Illustrated Medical Dictionary, 1994: 1275).

Placebo

Any dummy medical treatment; originally, a medicinal preparation having no specific pharmacological activity against the patient’s illness or complaint given solely for the psycho-physiological effects of the treatment.

Now also used in controlled studies to determine the efficacy of medicinal substances (Dorland’s Illustrated Medical Dictionary, 1994: 1298).

Polysomnograph

A bio-medical instrument used for the measurement of multiple physiological variables of sleep (Kryger, Roth and Dement, 1998). Potentization According to Gaier (1991), it is imparting (along serial dilutions) the pharmacological message of the original substance (i.e. creating a template of the active principle) by means of trituration or succussion. It describes the process of modification of medicines as invented by Hahnemann. It is characterized by the following features:

1. It is a purely mechanical and mathematico-physical process.

2. The procedure involves neither uncertain, unreliable nor immeasurable factors.

3. The resultant product is stable and can readily be maintained that way.

4. The process is theoretically illimitable, though it becomes laboriously time-consuming in the higher range of potencies.

Primary

It is the first in order or in time of development (Dorland’s Illustrated Medical Dictionary, 1994: 1351). Qualitative analysis The non-numerical examination and interpretation of observations for the purpose of discovering underlying meanings and patterns of relationships (Neuman, 1999: 418). Qualitative research paradigm It is a research approach, according to which research takes its departure point as the insider perspective on social action. Qualitative researchers attempt always to study human action from the insiders’ perspective. The goal of research is defined as describing and understanding rather than the explanation and prediction of human behaviour. The emphasis is on methods of observation and analysis which include unstructured interviewing, participant observation and the use of personal documents (Mouton, 2001). Quantitative analysis

The numerical representation and manipulation of observations, for the purpose of describing and explaining the phenomena that those observations reflect (Neuman, 1999: 418). Quantitative research paradigm The quantitative researcher believes that the best or only way of measuring the properties of phenomena (e.g. the attitudes of individuals towards certain topics) is through quantitative measurement, which involves assigning numbers to the perceived qualities of things. Emphasis is placed on variables in describing and analysing human behaviour. Quantitative research plays a central role in controlling sources of error in the research process. The nature of the

control is either through experimental control or through statistical controls (Mouton, 2001).

Simillimum Is the single homoeopathic medicine, the drug picture of which most nearly approaches the total symptom complex of the patient (Gaier, 1991: 509).

Sleep latency

This is the time measured from “lights out,” or bed time, to the beginning of sleep (Kryger, Roth and Dement, 1998).

Sleep spindle

Episodically appearing, spindle shaped aggregate of 12 -14 Hz waves with a duration of 0.5 - 1.5 seconds. It is a phenomena found on the electroencephalogram readings of non-REM stage 2 sleep (Kryger, Roth and Dement, 1998). Succussion The action of shaking up, or the condition of being shaken up, vigorously of a liquid dilution of a homoeopathic medicine in its vial or bottle, where each stroke ends with a jolt, usually pounding the hand engaged in

the shaking action against the other palm (Gaier, 1991: 352). Susceptibility Capacity, proneness or disposition to be affected (Gaier, 1991: 536).

Tachycardia

Rapid heart rate, usually defined by a pulse rate over 100 beats per minute (Kryger, Roth and Dement, 1998).

Thyrotoxicosis

A pathology of the thyroid gland where there are increased blood levels of triidothyronin (T3) and thyroxine (T4) accompanied by decreased levels of thyroid stimulating hormone (TSH). Some signs and symptoms include loss

of weight, an increase in appetite, psychosis, warm peripheries, goitre (a visibly enlarged thyroid gland seen as a mass in the neck) and bulging eyes (Longmore, Wilkinson and Rajagopalan, 2004: 304).

Trituration One of the processes of homoeopathic drug preparation. It is the act of prolonged grinding with a pestle in a mortar (or a similar mechanical procedure) to reduce a homoeopathic drug to a fine powder while amalgamating it thoroughly with saccharum lactis (sugar of milk) by rubbing the two together under the pestle in the motar (Gaier, 1991: 559).

INTRODUCTION Chronic primary insomnia is defined as difficulty initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress in areas of functioning (Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV TR), 2000: 599). According to Ancoli-Israel and Roth (1999), chronic insomnia is a prevalent and distressing problem, reported to affect approximately 9% -10% of

the population in the United States. Chronic insomnia, if untreated, can have social, economic and occupational impacts on the individual, as they are not functioning at their optimum (Morin, 1993: 9). There are many side

effects of allopathic drugs used to treat insomnia including nausea, vomiting, addiction and drowsiness (Beers and Berkow, 1999:1411-1412). Many people are becoming dissatisfied with allopathic medicine and are exploring alternative options. Therefore, questions about other treatment modalities should be examined (Roth, Roehrs, Costa e Silva and Chase, 1999).

Homoeopathy, based on the „law of similars’ is a system of medical therapeutics that subscribes to fundamental laws of nature. This allows homoeopathic remedies to utilise and enhance the body’s curative powers.

Homoeopathy is a curative system of medicine as it restores the patient to health and balance, both mentally and physically (Eizayaga, 1991: 11, 37). Homoeopathy is considerably cheaper than conventional medicine, making it a desirable alternative to allopathic medication (Ullman, 1991: 49).

PROBLEM STATEMENT The purpose of this double-blind placebo-controlled study was to evaluate the efficacy of a homoeopathic simillimum in the treatment of chronic primary insomnia in terms of the patient’s perception of the treatment using a Sleep Diary , the Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993: 201-204) . 1.3 ASSUMPTIONS Participants took

the medication as prescribed. Participants adhered to instructions to abstain from any other insomnia treatment for the duration of the study.

HYPOTHESES It is hypothesised that simillimum will have a significant impact on chronic primary insomnia in terms of the findings of the Sleep Diary , Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993: 201-204) . It is hypothesised that simillimum will have a more significant impact on chronic primary insomnia compared to placebo in terms of the three measurement tools completed during the study. For the above two hypotheses, the null hypothesis states that there is no significant differences between the relevant variables. The alternate hypothesis states that there will be a significant difference between the variables according to the three measurement tools.

INTRODUCTION Insomnia is the most commonly reported sleep problem in industrialized nations worldwide, leading to emotional distress, daytime fatigue and loss of productivity. The enormity of this problem indicates that routine clinical assessment and treatment of insomniacs may have important health consequences for the patient (Sateia, Doghramji, Hauri, and Morin, 2000). Insomnia is an epidemic of silent sufferers. Estimates of the economic costs of insomnia vary, illustrating the difficulty in assessing its consequences. With all of its associated health and quality-of-life issues, risk of accidents and morbidity, insomnia is justifiably considered an important public health problem (Christer and Markuu, 2002).

The purpose of this double-blind-placebo-controlled study was to evaluate the efficacy of homoeopathic simillimum in the treatment of chronic primary insomnia in terms of the patient’s perception of the treatment, using a Sleep Diary , the Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993: 201-204) . Consultations were conducted at the Homoeopathy Day Clinic, at the Durban Institute of Technology. Homoeopathy is an approach that utilizes medicines that stimulate the body’s own immune and defence systems to initiate the healing process. It is an approach that individualizes medicines according to the totality of the person’s physical, emotional and mental symptoms (Ullman, 1991: 3).

Sleep is defined as unconsciousness from which the person can be aroused by sensory or other stimuli (Guyton and Hall, 1997: 488). Sleep comprises two distinct physiological states: non-rapid eye movement (NREM) sleep and rapid eye movement (REM) sleep. These two states of sleep are characterised by varying brain wave activity. People normally cycle through four stages of NREM sleep, usually followed by a brief interval of REM sleep, 5 - 6x every night (Haslett, Chilvers, Hunter and Boon, 1999: 1093)

NREM sleep consists of four stages:

Stage 1: a decrease in brain wave activity, which is characteristic of relaxed wakefulness with the eyes closed. There is slow rolling of the eyes and the electromyogram (EMG) activity is low to moderate, which is comparable to a “drowsy” state. A transition from wakefulness to sleep and occupies about 5% of time spent asleep in healthy adults (Guyton and Hall, 1997: 489).

Stage 2: eye movements becomes rare and EMG is still low to moderate. Is considered to be the first true stage of sleep due to the presence of “sleep spindles.” This occupies about 50% of time spent asleep (Kryger, Roth and Dement, 1998: 16).

Stages 3 and 4 are known as „slow wave’ sleep because they are associated with low-frequency, synchronised waves on the electroencephalogram (EEG). This is the deepest level of sleep and occupies about 10% - 20% of sleep time. This sleep is exceedingly restful and is associated with a decrease in peripheral vascular tone. There is also a decrease in blood pressure, respiratory rate, and basal metabolic rate (Guyton and Hall, 1997: 489).

REM SLEEP Guyton and Hall (1997): REM sleep develops after progression through the various stages of NREM sleep. In a normal night of sleep, bouts of REM sleep, lasting 5 to 30 minutes, usually appear on the average every 90 minutes.

Characteristics: An association with active dreaming. Dreams during REM sleep are remembered, whereas those of slow wave sleep are usually not. The heart and respiration rates usually become irregular, which is characteristic of the dream state. A few irregular muscle movements which occur despite the inhibition of peripheral muscles. The brain is highly active in REM sleep, and the overall brain metabolism may be increased as much as 20%.

Sleep onset, under normal circumstances in healthy adults, is through NREM sleep. This fundamental principle reflects a highly reliable finding and is important in considering normal versus pathological sleep (Kryger, Roth and Dement, 1998: 17).

CLASSIFICATION OF SLEEP DISORDERS According to DSM-IV TR (2000: 597 - 630):

Primary sleep disorders: Primary sleep disorders are presumably due to an abnormality in sleep-wake generating or timing mechanisms. They are not due to another mental disorder, a general medical condition, or a substance.

Disorder related to a general medical condition,
Sleep disorder related to another mental disorder

Substance induced sleep disorder.

Primary sleep disorders are subdivided into:

Dyssomnias: characterized by abnormalities in the amount, quality or timing of sleep. They are primary disorders of initiating or maintaining sleep or of excessive sleepiness.

Including:

Primary insomnia The essential feature is a complaint of difficulty initiating or maintaining sleep or of nonrestorative sleep that lasts for at least 1 month and causes clinically significant

distress or impairment in social, occupational, or other important areas of functioning.

Primary hypersomnia The essential feature is excessive sleepiness for at least 1 month, where there are prolonged sleep episodes or daytime sleep episodes that occur almost daily.

Narcolepsy Breathing-related sleep disorder The essential features are repeated irresistible attacks of refreshing sleep, cataplexy (i.e., brief episodes of sudden bilateral loss of muscle tone, most often in association with intense emotion) and recurrent intrusions of REM sleep into the transition period between sleep and wakefulness. The individual’s sleepiness decreases after a sleep attack, only to return hours later. The sleep attacks must occur daily over a period of at least 3 months to make a diagnosis of narcolepsy. The essential feature is sleep disruption, leading to excessive sleepiness or insomnia that is due to a sleep-related breathing condition (e.g., obstructive or central sleep apnoea syndrome or central alveolar hypoventilation syndrome)

Circadian rhythm sleep disorder essential feature of circadian rhythm sleep disorder is a persistent or recurrent pattern of sleep disruption leading to excessive sleepiness or insomnia. Due to a mismatch between the sleep-wake schedule required by a person’s environment and his or her circadian sleep-wake pattern.

Dyssomnia not otherwise specified Parasomnias.

This section includes:

Nightmare disorder The essential feature of nightmare disorder is repeated awakenings from the major sleep periods or naps with detailed recall of extremely frightening dreams (usually involving threats to survival, security, or self-esteem). The awakenings generally occur during the second half of the sleep period. On awakening from the frightening dreams, the person rapidly becomes oriented and alert (in contrast to the confusion and disorientation seen in sleep terror disorder and some forms of epilepsy.)

Sleep terror disorder The essential feature is recurrent episodes of abrupt awakening from sleep, usually occurring during the first third of the major sleep episode, and beginning with a panicky scream.

There is intense fear and signs of autonomic arousal, such as tachycardia, rapid breathing, and sweating, during each episode.

Sleepwalking disorder The essential feature is repeated episodes of rising from bed during sleep and walking about, usually occurring during the first third of the major sleep episode. While sleepwalking,

the person has a blank, staring face, is relatively unresponsive to the efforts of others to communicate with him or her, and can be awakened only with great difficulty. On awakening (either from the sleepwalking episode or the next morning), the person has amnesia for the episode.

Parasomnia not otherwise specified category is for disturbances that are characterised by abnormal behavioural or physiological events during sleep or sleep-wake transitions, but that do not meet criteria for a more specific parasomnia.

Parasomnias are characterized by abnormal behavioural or physiological events occurring in association with sleep. Parasomnias represent the activation of physiological systems at inappropriate times during the sleep-wake cycle. These disorders involve activation of the autonomic nervous system, motor system, or cognitive processes during sleep or sleep-wake transitions. Individuals with parasomnias usually present with complaints of unusual behaviour during sleep, rather than complaints of insomnia or excessive daytime sleepiness.

SLEEP DISORDER RELATED TO ANOTHER MENTAL DISORDER This group of sleep disorders involves sleep disturbance resulting from a diagnosed mental disorder (often mood disorder or anxiety disorder). It is presumed that the pathophysiological mechanisms responsible for the mental disorder have an effect on sleep-wake regulation.

SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION This involves sleep disturbances resulting from the direct physiological effects of a general medical condition.

SUBSTANCE-INDUCED SLEEP DISORDER This involves sleep disturbances resulting from concurrent use of a substance (including medications). It may also be a result of recent discontinuation of use of a substance.

PATHOPHYSIOLOGY OF INSOMNIA Insomnia is defined as a complaint of perceived poor sleep quality, which results in the impairment of daytime function. It is a perception by patients that their sleep is inadequate or abnormal. Symptoms include difficulty initiating sleep, frequent awakenings from sleep, a short sleep time, and non-restorative sleep (Kryger, Roth and Dement, 1998: 483). The severity of insomnia often depends on the frequency and duration of the sleep problem. Virtually everyone encounters situational sleep disturbances, and as such would not necessarily be considered an insomniac. Sleep difficulties must be experienced three or more nights per week to be clinically significant (Morin, 1994). According to the International Classification of Sleep Disorders, insomnia lasting less than 1 month is considered transient, and it generally resolves itself after an adjustment to stressful events is made. Insomnia lasting between 1 and 6 months is considered sub acute, and when it persists for longer than 6 months it is classified as chronic (Morin, 1994).

According to Beers and Berkow (1999: 1410), Primary insomnia may be longstanding, with little relationship to immediate somatic or psychic events. Insomnia may be secondary to emotional problems, pain, physical disorders or use or withdrawal of drugs. According to Morin (1993: 3), insomnia encompasses a wide variety of complaints typically reflecting unsatisfactory duration, efficiency or quality of sleep. Presenting complaints include: problems with falling asleep at bedtime (sleep-onset insomnia), waking up in the middle of the night, with difficulty in going back to sleep (sleep-maintenance insomnia) , awakening too early in the morning (terminal insomnia)

These difficulties are not exclusive, as a person may present with one, two or all three problems. Sleep-onset insomnia requires that the latency to sleep onset after turning the lights out be greater than 30 minutes (Morin, 1993: 3). Sleep-maintenance insomnia involves either frequent and/or extended nocturnal awakening totalling more than 30 minutes of wakefulness after sleep onset, or premature awakening in the morning with less than 6.5 hours of sleep (Morin, 1993: 4).

Terminal insomnia involves a short time spent asleep resulting in non-restorative sleep. People suffering from terminal insomnia usually awaken too early in the morning. This may occur with or without sleep-onset insomnia and/or sleep maintenance insomnia. It is usually transient and can occur in individuals who in general sleep normally. Terminal insomnia may be related to the environment in which the individual sleeps or to the experience of psychological stress (Kryger, Roth, and Dement, 1998; 486). Sleep may be perceived as qualitatively deficient. Some people describe their phenomenological experience of a poor quality of sleep, as that of being in a “twilight zone” (half awake, half asleep) all night long. There is no major problem with initiating or maintaining sleep, however, its quality is described as non-restorative, with persistent thoughts preventing the natural progression to a deep sleep. This is associated with “alpha-delta” sleep, where there is frequent intrusion of alpha rhythms (wakefulness) into non-rapid-eye-movement sleep stages (Morin, 1993: 4). Because sleep patterns change as people age,

the elderly may think they have insomnia, when they do not. As people age, they tend to sleep less at night and nap during the day. Stage 4 sleep becomes shorter and eventually disappears (Beers, et al. 2003: 468).

DIAGNOSTIC CRITERIA OF PRIMARY INSOMNIA According to the DSM-IV TR (2000: 604), the diagnostic criteria for are:

A. The predominant complaint is difficulty initiating or maintaining sleep, or

B. Nonrestorative sleep, for at least 1 month.

C. The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.

D. The sleep disturbance does not occur exclusively during the course of narcolepsy, a breathing-related sleep disorder, circadian rhythm sleep disorder, or a parasomnia.

E. The disturbance does not occur exclusively during the course of another mental disorder (e.g. major depressive disorder, generalised anxiety disorder, a delirium).

F. The disturbance is not due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition.

AETIOLOGY OF PRIMARY INSOMNIA Many cases of insomnia have a fairly sudden onset at a time of psychological, social, or medical stress. Primary insomnia often persists long after the original causative factors resolve.

It is associated with increased physiological, cognitive, or emotional arousal during the night together with negative conditioning for sleep (Kryger, Roth and Dement, 1998: 483). Several predisposing factors to insomnia have

been hypothesized, including a familial component. Yves, Morin, Cervena, Carlander, Besset and Billiard (2003) found that more than one third of insomniacs had a familial history. Their study reported a dramatic increase of familial aggregation of insomnia, warranting further genetic studies in primary insomnia with early age onset. Many insomniacs have a history of easily disturbed sleep before the development of persistent sleep difficulties.

Other factors that may contribute include anxious over-concern with general health and increased sensitivity to the daytime consequences of sleep loss. Symptoms of anxiety or depression that do not meet criteria for a specific mental disorder may be present (Sateia, et al. 2000).

EPIDEMIOLOGY OF PRIMARY INSOMNIA Insomnia is a widespread problem affecting essentially everyone at one period or another. It is the most common of all sleep disorders, and perhaps the most frequent health complaint after pain. Insomnia is associated with demographic variables, including age, gender, occupational and socioeconomic status (Smith and Trinder, 2001). Complaints of insomnia are more prevalent with increasing age and among women. This may indicate an increased willingness among women to acknowledge this complaint. Insomnia is more common among homemakers, the unemployed, separated or widowed individuals, and those living alone. This is inversely related to educational and socioeconomic levels, though this finding is not consistent across surveys. Insomnia is certainly not restricted to people of lower socioeconomic levels. Many wealthy and highly successful individuals are insomniacs, although they may be less inclined to acknowledge it, for it may be perceived as a sign of weakness (Morin, 1993: 6). Primary insomnia typically begins in young adulthood or middle age and is rare in childhood or adolescence. Young adults complain of difficulty initiating sleep, whereas midlife and elderly adults are more likely to complain of difficulty maintaining sleep and early morning awakening (Smith and Trinder, 2001).

In clinics specializing in sleep disorders, approximately 15% - 25% of individuals are diagnosed with primary insomnia (DSM-IV TR, 2000: 601).

IMPACT OF CHRONIC INSOMNIA The extent to which psychological, social, and occupational functioning are affected by chronic insomnia is one of the most important criteria, when determining its clinical significance. Sleep disturbances can adversely affect a person’s life, causing significant psychosocial, occupational and health repercussions. Chronic insomnia may lead to decreased feelings of well being during the day. Prolonged sleep disturbances that characterize primary insomnia constitute a risk factor for the development of subsequent mood disorders and anxiety disorders (Morin, 1993: 9, 14). Analyses suggest that chronic insomnia is a “daytime” disorder as well as a “night-time” one (Grunstein, 2002). According to Moul, Nofzinger, Pilkonis, Houck, Miewald, and Buysse (2002), insomnia patients frequently report daytime symptoms. These include: decreased alertness being unrefreshed sleepiness inability to nap irritability tension hyperarousal depressed mood impaired memory functioning decreased memory and concentration social aversion anergia (extreme fatigue and lack of energy) disabilities in work and social life and pervasive malaise which affects many aspects of daytime functioning

Insomnia occurs with few physical signs, and is defined largely on the basis of the patient’s self report. Individuals with primary insomnia may appear fatigued or haggard, but show no other characteristic abnormalities on physical examination. There may be an increased incidence of stress-related psychophysiological problems such as tension headaches, increased muscle tension and gastric distress (Sateia, et al. 2000).

TREATMENT FOR PRIMARY INSOMNIA

Pharmacotherapy is the most frequently used method for treating insomnia; however, this may lead to iatrogenic insomnia. According to Morin (1993), chronic use of sleep medications undermines the development of self-management skills to cope with insomnia. Insomnia sufferers seek treatments for insomnia mainly because of perceived distress or impairment rather than how much sleep they get. The 1991 National Sleep Foundation survey found that 46% of patients with chronic insomnia discussed their sleep disturbances with a physician. The survey revealed that to promote sleep, 23% of people used over-the-counter medications; 28% used alcohol; and 21% used prescribed medications. Amongst the sleep-promoting agents, 61% received hypnotics, 27% anxiolytics and 11% antidepressants. People with primary insomnia sometimes use medications inappropriately: hypnotics or alcohol to help with night-time sleep, anxiolytics to combat tension or anxiety, and caffeine or other stimulants to combat excessive fatigue. Chronic insomnia may induce emotional distress and increase the risk of substance abuse or substance dependence (Christer and Markuu, 2002).

Intermittent use of hypnotics and anxiolytics is needed to prevent tolerance. However this intermittent schedule is powerful in creating and perpetuating a vicious cycle - insomnia, medication intake, tolerance, cessation of medication, rebound insomnia and resumption of medication (see Figure 2.3) (Morin, 1993: 164).

DEPENDENCE

RESUME USE OF MEDICATION

WITHDRAWAL: REBOUND INSOMNIA

ATTEMPT TO STOP MEDICATION

TOLERANCE

INCREASE SLEEP MEDICATION

TOLERANCE: DECREASED EFFECTIVENESS

SLEEP MEDICATION

INSOMNIA

Hypnotic drugs are often required for insomnia due to emotional disturbances (other than depression), especially if the patient’s sense of well-being is impaired. Patients are advised to use hypnotics for a short term (2 - 4 weeks) or episodically. Adverse effects of excessive hypnotics intake include tolerance, addiction, drowsiness, lethargy, hangover and amnesia. Often, skin eruptions and gastric-intestinal disturbances such as nausea and vomiting, are common side effects. In the elderly, any hypnotic can cause restlessness, excitement or exacerbations of delirium and dementia. Sudden withdrawal after prolonged use may lead to severe tremors or seizures (Beers and Berkow, 1999: 1411-1412). The benzodiazepines (BZDs) and benzodiazepine-like hypnotics are considered the drugs of choice for symptomatic relief of insomnia due to their safety and effectiveness. However, larger doses of benzodiazepines may induce serious respiratory depression. Even short acting BZDs may impair psychomotor performance and memory the next day. Some patients report an increase in daytime anxiety after repeated use or withdrawal (Beers and Berkow, 1999: 1413).

Antidepressants Tricyclic antidepressants are considered a better choice than benzodiazepines, especially among patients with a suicidal tendency. There is an increasing trend among physicians to prescribe anti-depressant medications for treating insomnia even in non-depressed people. Due to their sedative properties, some antidepressants are prescribed in sub therapeutic dosage. The potential for abuse and physical dependency is lower.

However, there is a higher potential for drug interaction (Morin, 1993: 159). According to Shargel, et al. 1997, tricyclic antidepressants can cause adverse effects including: Central nervous system effects such as drowsiness, dizziness, weakness, fatigue and confusion Cardiovascular effects, such as tachycardia and interference with the conduction system of the heart Gastro-intestinal effects, such as nausea, vomiting, diarrhoea and anorexia; and

Mania (in patients with manic-depressive illness)

Over-the-counter (OTC) sleep aids are probably used in greater proportions than prescribed hypnotics. Antihistamines (diphenhydramine or doxylamine) form the active ingredients in most of them, and, due to drowsiness

being a common side effect people use them to promote sleep. Diphenhydramine or doxylamine cause a paradoxical reaction in some, making people feel nervous, restless and agitated. Taking an OTC sleep aid for more than

7 - 10 days is not recommended because excessive intake of antihistamines cause constipation, urinary retention, dry mouth, blurred vision, decreased alertness and confusion (especially in the elderly) (Beers, Fletcher, Jones, Porter, Berkwits and Kaplan, 2003: 100).

Melatonin is a brain hormone that regulates the body’s sleep/wake cycles (circadian rhythm). It is available over-the-counter, and has become popular in recent years as a dietary supplement for promoting sleep. It has been suggested that changes in melatonin secretion may cause sleep disorders in people with certain nervous conditions. The disadvantage though, is that available preparations of melatonin are unregulated, therefore there is no assurance of its purity and content. The effects of long-term exposure to exogenous melatonin is unknown (Beers and Berkow, 1999: 1413).

5-hydroxytryptophan (5-HTP)

5-HTP is related to the amino acid tryptophan. The body uses 5-HTP to manufacture serotonin, which in turn is converted into melatonin in the brain. Thus a product that can be used to improve sleep patterns. (Bruni, Ferri, Miano and Verrillo, 2004).

Passionflower (Passiflora incarnata) has been reported to have sleep-promoting, muscle-relaxing, and pain-relieving properties. Active components may be harmala-type indole alkaloids, maltol and ethyl-maltol, and flavonoids (Miller and Murrey, 1998: 211-212). Herbalists recommend Passionflower for neuralgia (nerve pain), seizures, hysteria, and rapid heartbeat due to nervousness, asthma, and insomnia. Passionflower extracts have

been reported to reduce locomotor activity, prolong sleeping time, raise the pain threshold, and produce an anti-anxiety effect in laboratory animals (Soulimani, Younos, Jarmouni, Bousta, Misslin and Mortier, 1997).

In general, Passionflower is considered to be safe and non-toxic. However, there are isolated reports of adverse reactions associated with this herb (nausea/vomiting/drowsiness/a rapid heartbeat). Contraindicated during pregnancy and lactation. Due to their active ingredients, interactions with other herbs, supplements, or medication can be triggered (Brinker, 1998).

Valerian (Valeriana officinalis) is used as a calming, relaxing herb that soothes the nervous system under stress. Lindahl and Lindwall (1989) reported that Valerian helps improve sleep quality. Several active ingredients in the herb are believed to account for Valerian’s influence, including valepotriates, valeric acid, and pungent oils. These components have a sedative effect on the central nervous system, as well as a relaxing effect on the smooth muscles of the gastro-intestinal tract (Sakamoto, 1992). Valerian could be taken into consideration as an alternative to drugs in treating insomnia (Gutierrez, Ang-Lee, Walker and Zacny, 2004). Side effects may result which include mild headaches, nausea, nervousness, palpitations and morning drowsiness (Brinker, 1998).

According to Klepser and Klepser (1999), several cases of hepatotoxicity involving long-term use of single-ingredient Valerian preparations have been reported. There is insufficient data to determine the efficacy and safety of Valerian in children younger than 18 years of age and in pregnant women.

Hops (Humulus lupulus) is a popular sleep aid. Active ingredients in Hops include valerianic acid, oestrogenic substances, tannins, and flavonoids (Miller and Murrey, 1998: 211-212). Classified as a herb with hypnotic, antispasmodic, and topical antibiotic properties (Newall, Anderson and Phillipson, 1996: 162).Traditional uses of Hops include neuralgia, insomnia, excitability, topically for skin ulcerations, and primarily for restlessness associated with nervous tension. One study showed improvement of sleep disturbances with combinations of hops and other sedative herbs such as Valerian root and Passionflower (Bradley, 1992: 128 - 129). Human studies of the sedative action have generally combined Hops with one or more additional herbs. In laboratory studies, Hops have been reported to increase the sleeping time induced by pentobarbital (Lee, Jung, Song, Krauter and Kim, 1993).

NON-PHARMACOLOGICAL INTERVENTIONS

Acupuncture In traditional Chinese medicine, acupuncture is commonly employed for the treatment of insomnia. Montakab (1999), diagnosed 40 patients using Chinese traditional diagnosis. He then performed polysomnographic analyses of true acupuncture versus control needled patients. Objective as well as subjective significant differences in sleep quality were noted in the Treatment Group. Positive effects using scalp, body, and ear acupuncture points appeared almost immediately after treatment. Several auricular points were used in this study namely, Heart, Kidney, Adrenal, Sub-Cortex, Endocrine, San Chiao, and Shen Men. In addition to these standard 7 auricular points, Sympathetic, Occiput, and Gallbladder auricular points were added if reactive or tender (Montakab, 1999). The mechanisms by which acupuncture treatment modulates insomnia may be understood in terms of the general mechanism by which it produces analgesia. Sites in the central nervous system where acupuncture signals are integrated also participate in the regulation of sleep-wake cycles (Lin, 1995).

Behavioural Therapies Behavioural therapies seek to change maladaptive sleep habits, reduce autonomic arousal, and alter dysfunctional beliefs and attitudes that are presumed to maintain insomnia (Grunstein, 2002). Behavioural therapy aims at strengthening the association between sleep behaviours and such stimuli as the bed, bedtime and the bedroom surroundings. The rationale underlying its use is that sleep is a behaviour that is susceptible to conditioning processes. Environmental and temporal stimuli govern the occurrence of sleep at fairly regular intervals. When the stimuli normally conducive to sleep, lose their discriminative properties to do so, treatment must focus on altering these conditions. This is done so that the stimuli can regain their associative control with sleep (Soldatos, 2002 and Morin, 1993: 110). Behavioural treatment, either utilized in conjunction with pharmacological treatment or alone, is the recommended treatment of choice for patients with chronic primary insomnia (Langer, Mendelson and Richardson, 1999). According to Vincent and Lionberg (2001) patients prefer psychological treatment over pharmacological treatment for chronic insomnia.

Cognitive behavioural therapy (CBT) is a form of therapy that emphasizes observing and changing negative thoughts about sleep. It employs actions intended to change behaviour. A double-blind clinical trial done by Edinger, Wohlgemuth, Radtke, Marsh and Quillian (2001) tested the efficacy of cognitive behavioural therapy (CBT) compared with both muscle relaxation training and a placebo therapy for treating primary sleep-maintenance insomnia. Patients receiving CBT (a combination of sleep education, night time stimulus control, and time-in-bed restrictions) had a significant reduction (54%) in the amount of time spent awake after initially going to sleep and an overall improvement in the quality of sleep. CBT produced larger improvements across the majority of outcome measures than did muscle relaxation training or placebo treatment. This suggests that CBT represents a viable intervention for primary sleep-maintenance insomnia.

Sleep Hygiene Tips (Smith, Perlis, Park, Smith, Pennington, Giles and Buysse, 2002) Avoid excess caffeine, nicotine and alcohol Set aside „worry time’ in the evening (away from the bedroom) where you can go through current problems and the next days’ commitments Limit bed to sleep and sex - avoid reading, listening to the radio and watching television. Exercise in the early morning sunlight to strengthen normal sleep circadian rhythms Avoid strenuous exercise after 6pm Avoid napping during the day Plan for bedtime - eat a small snack or have a warm bath before bed Be sure that the mattress is not too soft or too firm, and that the pillow is at the right height and firmness Keep the clock face turned away, and do not find out what time it is when you wake up at night

HOMOEOPATHY AND THE SIMILLIMUM

„Homoeopathy’ is derived from the Greek words „Homoeo’, meaning „like’ and „Pathos’, meaning „suffering’. Homoeopathy is a system of medicine that uses preparations of substances whose effects, when given to healthy individuals corresponds to the manifestations of the disease (symptoms, clinical signs and pathological states) in the individual (Swayne, 2000: 105). A German physician, Dr. Samuel Hahnemann (1755-1843), founded this system of medicine. The foundation of Homoeopathy is “Like Cures Like”. This principle states that a substance which produces certain symptoms in healthy people can cure the same symptoms in the sick. The substance must be administered in minute doses (de Schepper, 2001: 26).

LAWS AND PRINCIPLES OF HOMOEOPATHY Homoeopathy as a system of medicine follows certain laws and principles. These include: Law of similars The minimum dose Single remedy prescription

In the Organon of the Art of Healing, Hahnemann laid out the laws and principles of homoeopathy, gathered over a period of 20 years. Briefly, he claimed and showed that:

1. A medical cure is brought about in accordance with certain laws of healing that are in nature.

2. Nobody can cure outside these laws.

3. There are no diseases as such, but only diseased individuals.

4. An illness is always dynamic by nature, so the remedy must also be in a dynamic state if it is to cure.

5. The patient needs only one particular remedy and no other at any given stage of the illness? Unless that certain remedy is found, he or she is not cured but at best the condition is only temporarily relieved (Vithoulkas, 2000: 6).

The statement “Similia similibus curentur” (“like cures like”) was first pronounced by Paracelsus and was later re-discovered by Hahnemann. This statement has been formalised in the law of similars. Hahnemann proceeded to build upon this fact his superstructure of scientific treatment by medicinal substances. Any substance, it may be of animal, vegetable or mineral origin, will produce certain reactions or symptoms, if given to the healthy individual for a long enough period (Shepherd, 1995: 6).

These reactions were collected by Hahnemann and his pupils with great diligence. It followed that these self-same symptoms, if found in a sick person, would be cured by the medicinal substance which produced them in the healthy individual. This was tested and proved by Hahnemann and his followers more than 150 years ago. Provings, as he called these experimental tests, were carried out on healthy human beings. A number of people were chosen and their peculiarities were noted. They received blank pills or powders for several days, then a medicinal substance was added without their knowledge, and any reactions or symptoms that were produced were noted, and a record was drawn up for each remedy proved. In that way nearly 106 medicinal substances were proved. Now homoeopaths possess a Materia Medica of approximately 2000 remedies from which to choose according to the law of similars the correct remedy for each case (Shepherd, 1995: 8 and Kayne, 1997: 25 - 28). The similarity between pathogenesis and treatment is therefore vital in understanding the law of similars. Figure 2.4 illustrates this similarity.

Law of Similars

The fundamental principle underlying homoeopathy is the law of similars. This law refers to a similarity existing between the toxicological action of a substance and its therapeutic action (Jouanny, 1993: 11). According to Jouanny (1993: 11-13), there are three components to this law:

1. All pharmacologically active substances cause a set of symptoms characteristic of the substance used when administered to healthy people.

2. All sick individuals display a set of symptoms characteristic of their disease (broader than the „diagnostic criteria’).

3. The cure may be achieved by prescribing the substance whose experimental symptoms in healthy people are most similar to the symptoms displayed by the ill patient. The substance must be administered in infinitesimal doses.

The Minimum Dose

Amedeo Avogadro (1776 - 1856) demonstrated that the number of molecules in one mole of any substance is 6.0255 x 1023. Avogadro’s number is of interest to homoeopathy because it specifies the potency at which a remedy does not contain any of the original material substance. (Swayne, 2000: 22). Avogadro’s number is exceeded at a potency of 12CH in concentrated pure chemical substances, including metals and between 7CH to 11CH in botanical or zoological materials (Kayne, 1997: 27). According to Shepherd (1995: 5), the Arndt’s Law helps to explain the phenomenon of potentization (as discussed in 2.10.8 later). The law was based on the following observations:

Small stimuli encourage living systems Medium stimuli impede living systems Strong stimuli destroy living systems

Thus, as solutions of homoeopathic remedies become weaker, they should be expected to encourage the healing process. According to Osawa (2001), the smallest dose will evoke the most gentle, rapid and permanent cure.

There is a homoeopathic Law of Cure associated with minute dose levels. It states;

“The quantity of action necessary to effect a change in nature is the least possible, and the decisive amount is always the minimum.” The minute dose was an empirical discovery, and it is taken to mean that not only should a minute dose be administered, but that the dose should not be repeated at frequent intervals (Kayne, 1997: 27). 2.10.2.3 Single Remedy Prescription This principle refers to the administering of only one dose of a single homoeopathic medicine, which is derived from one source material at any one time. This is the basis of unicist homoeopathy, often termed classical homoeopathy (Swayne, 2000: 195). According to Eizayaga (1991), there is usually only one remedy that covers the actual state of the patient and therefore only the most similar should be administered. When the symptoms change, it becomes, necessary to prescribe a new remedy according to the patient’s new state. If a combination of remedies is administered, the potential interactions that may occur between the components cannot be predicted. In addition any beneficial or adverse effects cannot be evaluated correctly, as there is no way to decide which one of the remedies of a combination has acted (Vithoulkas, 1998: 217).

VITAL FORCE An important concept of homoeopathy is that, in all conditions of ill health, the human body is fully capable of healing itself by means of the vital force. Ancient physicians were familiar with the natural power of an organism to control disease and they expressed it as “Vis Medicatrix Naturae” (healing power of nature). Hahnemann called this healing power the vital force. Disease is seen as a manifestation or reflection of the disturbed vital force (Sankaran, 1991: 2).

SIMILLIMUM The aim of the homeopathic consultation and analysis is to arrive at the simillimum. Simillimum treatment is based on a full evaluation of the patient’s physical, emotional and mental characteristics (Lockie and Geddes, 1995: 14). To do this, the homoeopath takes into consideration all symptoms that distinguish a person as an individual. There is an enquiry into the patient’s past and family history, his appetite, thirst, bowel habits, sleep and his temperament, amongst others (Sankaran, 1991: 2). Homoeopathic remedies are tailored not only to the patients’ symptoms but also to their personality types and the reason for their illness. With the vast number of remedies to choose from, homoeopaths reason that the simillimum will fit the patient on a dynamic plane, acting as a template by means of which the disordered vital force can readjust itself (de Schepper, 2001: 3 - 11 and

Weiner and Gross, 1989: 53). The selected remedy, in order to be the true simillimum, must match not only the patient’s symptoms but also the dynamic plane of the disease at the time the patient presents himself for treatment (Weiner and Gross, 1989: 58). According to Gaier (1991: 509), the simillimum remedy refers to that single, unique remedy, the drug picture of which most nearly approaches the total symptom complex of the patient. After the simillimum remedy has been given, not only are the symptoms alleviated but the patient should also have a sense of well-being (Eizayaga, 1991: 11, 37). This is because the vital force is strengthened and balanced resulting in restoration of the entire spiritual-mental-emotional-physical being (de Schepper, 2001: 3 - 11).

HOLISM AND HOMOEOPATHY Vital to developing the homoeopathic vision is to understand that disease is not merely something local, but it is a disturbance of the whole being. The mental state of the diseased individual often chiefly determines the prescription of the homoeopathic remedy (Sankaran, 1994: 11, 15). By 1813, Hahnemann concluded that the curative action of a drug lies in its dynamic effect, and not in its local organ effect. With present medical knowledge, we understand that the mind acts on the body through three systems, thus forming the Psyche-Neuro-Endocrine-Immunology (P-N-E-I) axis. These systems are intricately connected, such that changes in Psyche have an association with certain symptoms in the NEI-systems. This axis controls and regulates other systems. Homeopathic drugs cause a dynamic disturbance that must act through this axis (Sankaran, 1991: 36-37).

POTENCY Homoeopathic potency consists of medicinal matter raised to high rates of vibration, stimulating the vibratory rate of the vital force of the patient (Bernard, 1999). Dynamization (potentization) arouses the latent medicinal properties in natural substances during the processes of dilution and succussion. Succussion is the addition of kinetic energy to the remedy by virtue of vigorous shaking (Boericke, 1997: 19). The more a substance is succussed and diluted the greater the therapeutic effect while any toxic effect is simultaneously abolished (Vithoulkas, 1980). Homoeopathic dilutions are rendered by either the centesimal scale (1:100), denoted by “C”, or the decimal scale (1:10) to which resulting potencies are designated “X”. Thus in practice the first 1:100 dilution is termed a 1C and the thirtieth dilution 30C. The first 1:10 dilution is called a 1X and the thirtieth a 30X (Vithoulkas, 1980). Hahnemann spent the last decade of his life developing the fifty millesimal (LM) potencies. LM potencies are made by diluting the remedy in a ratio of 1: 50 000 (de Schepper, 2001).

POTENTISED MEDICINE Towsey and Hasan (1995) view the action of potentized homoeopathic medicines, as being biophysical and not biochemical. They suggest that such medicines probably consist of water crystals imprinted with specific distribution of isotopes. This distribution affects the frequencies at which water components within the medicine absorb and emit coherent radiation. These coherent emissions either enhance or inhibit enzyme action. They explain that modulated magnetic or electric fields are able to give water crystals a stable conformation. Subtle energies, they concluded, not only imprint molecular and crystalline structures but are able to have an effect on the supramolecular dynamic order of living things.

HOMOEOPATHIC TREATMENT OF INSOMNIA There is much literature about homoeopathic remedies used to treat insomnia. Unfortunately, there is paucity in controlled clinical trials based on the efficacy of homoeopathic treatment for chronic primary insomnia.

HOMOEOPATHIC SIMILLIMUM TREATMENT OF SECONDARY INSOMNIA IN PERI- AND POSTMENOPAUSAL WOMEN (Pellow, 2002) Pellow (2002) conducted a qualitative study which examined the efficacy of the homoeopathic simillimum approach in the treatment of secondary insomnia in peri- and postmenopausal women. Homoeopathic remedies were prescribed in LM potency, taken once daily, and the patient’s progress was noted over the 3 month duration of the trial. This consisted of an initial consultation and 6 Follow-Up consultations at 2 week intervals. According to the study, homoeopathic simillimum treatment helped decrease fatigue and sleepiness in varying degrees in each subject and improved the subjects’ perception of the quality of their sleep. This study produced positive results although there were potential methodological flaws present. It was not a double-blind-placebo-controlled study and the sample size of the study was small (n = 10).

LM potencies were used which may have been restrictive. Each participant was asked to success the bottle each day before taking a dose, giving the bottle eight hard blows against the palm of the hand. One teaspoon of the remedy was then stirred into 100ml of water and taken once a day. The use of this method of administration of the remedy may have led to difficulties with compliance.

Unrestricted simillimum studies, however, would allow for the use of remedies in any potency. In cases where the remedy’s action appeared to aggravate the insomnia, participants were advised, by Pellow, to stop taking the remedy until the aggravation had passed. In cases where the participants were not responding adequately to the remedy, as reported by the participant and perceived by the researcher, they were advised to increase the frequency

of the dose. This results in significant inconsistencies in treatment administration in the study. Participants using hormone replacement therapy (HRT) were not excluded, as subjects with insomnia despite HRT were considered suitable, by the researcher, for the study. Oestrogen has powerful effects on several biological factors that directly influence sleep, including body temperature regulation and circadian rhythms. Oestrogen therapy most likely improves sleep as it alleviates vasomotor symptoms (Moe, 1999). Boyle and Murrihy (2001), reported that women who use HRT have decreased anxiety, less insomnia and fewer somatic symptoms. Therefore, it is difficult to assess whether the homoeopathic treatment or a combination of the homoeopathic treatment and HRT was effective in alleviating secondary insomnia in the study.

The study made use of the Stanford Sleepiness Scale (SSS) (Hoddes, Zarcone, Smythe, Phillips and Dement, 1973) and a Sleep Diary. The SSS was used to determine each participant’s subjective assessment of sleepiness in the morning, at lunch-time and in the evening every day for the duration of the study. The scale consists of seven statements that range from being wide awake and alert to being almost in a state of sleep (Hoddes, et al. 1973). Participants were asked to record the number between one and seven that best described their level of sleepiness. A Sleep Diary provided an indication of perceived total sleep time per night and number of nightly awakenings.

The information given in each questionnaire was evaluated and was used together with information obtained at each consultation to compile a descriptive study of individual cases. There was no use of statistical analysis of the

SSS and Sleep Diary readings, which would have expanded the subjective perceptions of the improved quality of sleep following homoeopathic intervention. According to Neuman (2000: 418), qualitative data analysis is less standardized. The wide variety in possible approaches to qualitative research is matched by the many approaches to data analysis. Quantitative researchers, on the other hand, choose from a standardized set of data analysis techniques. Quantitative analysis is highly developed and builds on applied mathematics (Neuman, 2000: 418). Due to the paucity of quantitative, double-blind-placebo-controlled clinical studies evaluating the efficacy of homoeopathic simillimum in the treatment of chronic primary insomnia; there is a need for further studies.

THE EFFECT OF AVENA SATIVA COMP®, A HOMOEOPATHIC COMPLEX REMEDY, ON SUBJECTIVE SLEEP MEASURES IN SUFFERERS OF SECONDARY INSOMNIA (Roohani, 1997)

Roohani showed that Avena Sativa Comp® decreased fatigue and evening sleepiness and improved subjective perception of sleep quality in self-diagnosed secondary insomniacs. Avena Sativa Comp® is manufactured by the pharmaceutical company, PharmaNatura (Pty) Ltd and contains the following in its 100ml dropper bottles: (Avena sativa (Ø ) 25ml/Humulus lupulus 1X 4ml/Passiflora incarnate (Ø ) 7.5ml/Valeriana officinalis (Ø ) 30ml/Coffea tosta D60 15 ml. 15ml Nominal Ethanol content 45%).

Ten male subjects complaining of secondary insomnia formed the sample group. They underwent a 14 day screening period, during which time they completed questionnaires relating to sleep.

The measurement tools used included a Sleep Diary, a Profile of Mood States (POMS) (McNair, Lorr and Droppelman, 1971: 27) form to assess psychological status, and an assessment of day-time sleepiness using the Stanford Sleepiness Scale (SSS) (Hoddes, et al. 1973). Analogue scales were used to indicate the subjective assessments of quality of the previous nights sleep (morning form) and to give an indication of the subject’s anxiety levels during the day (evening form). Each participant was required to complete a Sleep Diary for the duration of the study, to provide an indication of total sleep time per night and the number of nightly awakenings. The POMS (McNair,

Lorr and Droppelman, 1971: 27) was used to determine the mood states of the subjects, including tension-anxiety, depression-dejection, anger-hostility, vigour, fatigue and confusion-bewilderment. Scores were determined for each scale of the POMS questionnaire using the POMS scoring system. The SSS (Hoddes, et al. 1973) was used to determine daily subjective assessments of sleepiness in the morning, at lunchtime and in the evening for the 42 days of the study.

Participants were admitted to the study provided they had a minimum of four sleep deprived nights in the 14 day screening period. Thereafter the participants entered a double-blind crossover trial when the homoeopathic complex or placebo was administered nightly, for 14 days. Statistical analysis using Instat, Instant Statistics, Sandiego, California, Version 2.0. was conducted using all measurement tools. The Friedman test, combined with the Dunn’s statistical test to identify the origin of significance were used. Significance was set at p ≤ 0.05. The study concluded that Avena Sativa Comp® helped decrease fatigue (p<0.0001) and evening sleepiness, and improved

the subject’s perception of the quality of their sleep. This study produced positive results although there were potential methodological flaws present. Expansion of the sample size, as well as the inclusion of females into the study may have further validated the results. The placebo and treatment was administered by placing ten drops in half a glass of water after supper in the evening and just before going to bed. Participants could also take the medication if they awoke during the night. They were requested to record this information in their Sleep Diary. This results in significant inconsistencies in treatment administration in the study.

According to Lavery (1997: 28 - 36):

Many causes of secondary insomnia, including: MEDICAL CAUSES such as:

Non-prescription drugs e.g. caffeine, nicotine and „diet pills’ Prescription drugs e.g. Ritalin®, Ventolin® , Cardioquin® and Cylert. ® MEDICAL CONDITIONS such as:

Pain from any source or cause Thyrotoxicosis Dyspnoea from any cause Drug or alcohol intoxication or withdrawal Depression Post-traumatic stress disorder Mania or hypomania The sample group in Roohani’s study may not have been a homogenous group due to the various causes of secondary insomnia. Although the findings of the study were positive, the administration of complex homoeopathic remedies is in conflict with the principle of single remedy prescription (Kayne, 1997: 27). It is not necessary, and therefore not permissible to administer more than one, single homoeopathic medicinal substance to a patient (Vithoulkas, 1998: 217). All drug pictures in the materia medica have been determined on this basis. Provings have not been carried out on complexes of remedies and it is not known how and if remedies interact (Kayne, 1997: 28).

THE EFFECT OF HOMOEOPATHIC SIMILLIMUM IN POST TRAUMATIC STRESS DISORDER (Lankesar, 2004) researched the efficacy of simillimum treatment for post-traumatic stress disorder. Each participant completed the researcher’s questionnaire at each consultation and recorded their stress episodes on a calendar. The information from the stress episodes calendar was evaluated and was used together with information obtained at each consultation to compile a descriptive study of individual cases. Statistical analyses, of the findings from the measurement tools, were not conducted. This qualitative study indicated that the simillimum treatment was effective in reducing post traumatic stress frequency, severity and intensity. According to case histories, improvement in mental and emotional well-being, sleep patterns and energy levels were noted in all patients. The insomnia experienced by the participants can be classified as secondary insomnia. This study produced positive results although there were potential methodological flaws present. It was not a double-blind-placebo-controlled study and the sample size of the study was small (n = 10).

MEASUREMENT TOOLS Insomnia is a subjective complaint of insufficient or inadequate sleep. It occurs with few physical signs, and is defined largely on the basis of the patient’s self report (Aldrich, 1993). In this study, subjective questionnaires were used namely, a Sleep Diary , the Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993: 201-204) . 2.12.1 SLEEP DIARY A Sleep Diary is a daily, written record of an individual's sleep-wake pattern containing such information as time of retiring and arising, time in bed, estimated total sleep period, number and duration of sleep interruptions, quality of sleep, daytime naps, use of medications or caffeine beverages, nature of waking activities and other data (Kryger, Roth and Dement, 1998).

Sleep diaries can provide clinically useful information in the initial assessment of the complaint, particularly as it relates to the patient’s perception of the problem. But it has not been shown to differentiate subtypes of insomnia complaints (Chesson, Hartse, Anderson, Davila, Johnson, Littner, Wise and Rafecas, 2000).

Bakea (2003) suggested the inclusion of a subjective Sleep Diary. It had been designed by a patient of the sleep lab and was used by Bakea as a subjective measurement against polysomnograph readings. The Sleep Diary was suggested for use as a simple means for recording times asleep and awake. The SII and DBAS are subjective and retrospective. They provide important information regarding psychological and behavioural aspects of the sleep complaint (Morin, Stone, McDonald and Jones, 1994). According to Smith and Trinder (2001), the SII and DBAS distinguished effectively between the insomnia and control groups suggesting good specificity. They were found to be highly accurate discriminators and offer similar sensitivity in detecting insomnia. Self-report remains the easiest, cheapest and most widely used method of collecting data about an individuals’ health and risk factor status.

A number of relatively brief self-report measures have been developed to detect and quantify sleep impairment and insomnia. These include the Sleep Impairment Index (SII) (Morin, 1993) (Smith and Trinder, 2001) and the Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) (Morin, 1993) . 2.12.2 SLEEP IMPAIRMENT INDEX (SII) The SII is a 7-item measurement tool that yields a quantitative index of sleep impairment. It is a brief and global self-report instrument which provides valuable information on the patient’s perception of his or her insomnia, its severity, level of distress and impairment with daytime functioning (Morin, 1993: 73). The SII has been found to be sensitive to changes in insomnia outcome research. It is a reliable and valid measure for the assessment of insomnia severity in a clinical population. The instrument is a cost-efficient method to quantify perceived insomnia severity and may be used either as a screening device or as a measure of treatment outcome (Bastien, Lamoureux, Gagne and Morin, 2004). Although very brief, the sensitivity and specificity of the SII is sufficient for identification of insomnia in primary care settings (Smith and Trinder, 2001).

DYSFUNCTIONAL BELIEFS AND ATTITUDES ABOUT SLEEP SCALE (DBAS) Dysfunctional beliefs and attitudes about sleep are presumed to play an important role in perpetuating insomnia. The DBAS is a

30-item questionnaire designed to tap sleep-related cognitions. This instrument has proved extremely useful as a therapeutic tool for conducting cognitive therapy sessions. It helps to identify dysfunctional sleep-related cognitions and provides data on both treatment process and outcome (Morin, 1993: 73). Belleville, Belanger and Morin (2003) utilized the DBAS when assessing the usefulness of cognitive-behavioural therapy in changing sleep-related beliefs and attitudes in older insomniacs discontinuing their benzodiazepine hypnotic treatment. The DBAS proved extremely useful as it was used to evaluate the erroneous sleep-related cognitions in 76 older adults. The DBAS provides useful information relevant to intervention into insomnia. It contains sufficient items to increase the probability of test reliability and is recommended for use in a sleep clinic environment (Smith and Trinder, 2001).

PLACEBO is an inactive substance or preparation formerly given to please or gratify a patient, now also used in controlled studies to determine the efficacy of medicinal substances (Dorland’s Illustrated Medical Dictionary, 1994: 1298). The use may result in or be coincidentally associated with desirable or undesirable changes. This phenomenon is known as the placebo effect. It has two components: Anticipation of results due to an optimistic outlook. It is sometimes referred to as suggestibility and Spontaneous change. Some people improve spontaneously, without treatment. If this occurs, the placebo may incorrectly be “credited with or blamed for the result” (Beers, et al. 2003: 61).

The placebo effect is considered as an example of mind-body relation that depends on subconscious interactions between the doctor, the treatment process, and the patient. A physician’s attributes, dress, demeanor, voice and body language each contribute to a marked placebo effect. The benefit of placebo is considered transient, although its effects are not always short-lived (Pearce, 1995). Some scientists believe that homoeopathy goes against natural laws, and any effect produced by homoeopathic treatment, is due to the placebo effect. But the use of and growing belief in the effectiveness of homoeopathy, is widespread, and a scientific meta-analysis of published studies has concluded that there are measurable and reproducible effects compared to placebo (Linde, Clausius, Ramirez, Melchart, Eitel, Hedges and Jonas, 1997). 2.14 CONCLUSION Chronic insomnia, if untreated, can have social, economic and occupational impacts on the individual, as they are not functioning at their optimum (Morin, 1993: 9). There is a paucity of double-blind-placebo-controlled studies based on the efficacy of homoeopathic simillimum in the treatment of chronic primary insomnia. There are many side effects of allopathic drugs used to treat insomnia, therefore clinical studies should be conducted to question other treatment modalities (Roth, Roehrs, Costa e Silva and Chase, 1999: S419).

CHAPTER 3 METHODS AND MATERIALS 3.1 PROBLEM STATEMENT The purpose of this double-blind placebo-controlled study was to evaluate the efficacy of homoeopathic simillimum in the treatment of chronic primary insomnia in terms of the patient’s perception of the treatment using a Sleep Diary , the Sleep Impairment Index (SII) (Morin, 1993: 199) and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) (Morin, 1993: 201-204) . 3.2 SAMPLE GROUP All the measures and procedures that were used in the study were approved by the Faculty of Health Sciences Ethics Committee at the Durban Institute of Technology. 30 participants were selected via convenience sampling and were recruited on the basis of inclusion and exclusion criteria.

INCLUSION CRITERIA Participants were selected for the study according to the following criteria: 1. Participants had to be between the ages of 18 years to 70 years. 2. Participants had to be fluent in English. 3. Participants had to be literate in English. 4. Participants had to have taken no other prescribed insomnia medication for at least one week before the study. Use of over-the-counter sleep aids and prescription insomnia medication were prohibited during the study. 5. Participants had to fulfil the diagnostic criteria for 307.42 Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV TR) (2000: 604).

A. The predominant complaint is difficulty initiating or maintaining sleep, or

B. Nonrestorative sleep, for at least 1 month.

C. The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.

D. The sleep disturbance does not occur exclusively during the course of Narcolepsy, a Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder, or a Parasomnia.

E. The disturbance does not occur exclusively during the course of another mental disorder (e.g. Major Depressive Disorder, Generalised Anxiety Disorder, a delirium).

F. The disturbance is not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.

EXCLUSION CRITERIA

Participants were excluded from the study according to the following criteria:

1. Pregnant women.

2. Participants suffering from Narcolepsy, a Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder, or a Parasomnia. (Appendix E).

3. Participants diagnosed with Major Depressive Disorder, Generalised Anxiety Disorder or Schizophrenia (Appendix F).

4. Participants diagnosed with hyperthyroidism, hypertension, diabetes and hypercholesterolemia.

LOCATION OF THE STUDY Consultations conducted at the Homoeopathic Day Clinic at the Durban Institute of Technology, Steve Biko Campus, Berea. Consultations were conducted on weekdays between 13.30 h. and 16.30 h.

RECRUITMENT PROCESS Participants responded to advertisements that were placed on notice boards at the Durban Institute of Technology as well as local newspapers. An article was placed in the “Tribune Herald” on 18 April 2004 (Appendix G). The article, entitled “Bye-bye drowsiness - student offers help in beating sleepless night blues,” indicated that the researcher was recruiting individuals with chronic primary insomnia to evaluate homoeopathic treatment for the condition. The article informed potential participants about homoeopathy, the inclusion and exclusion criteria for the clinical trial, the free homoeopathic treatment and that their participation was on a voluntary basis. The researcher’s telephone number was included for further information. Approximately 109 interested individuals contacted the researcher about the study and participated in a brief telephone screening interview which verified inclusion and exclusion criteria . Of these, 21 people did not meet the inclusion criteria for chronic primary insomnia. 88 individuals were asked to contact the Homoeopathic Day Clinic to make appointment bookings. The first 30 callers, who had passed the telephone interview, were given appointments. The remainder of the callers were put on a waiting list.

During the study, there were 3 drop-outs from treatment. Reasons for dropping out included scheduling conflicts, personal issues and non-compliance with regards to taking the homoeopathic medication. Three people from the waiting list were then invited to participate in the trial to accommodate for the drop-outs.

ETHICAL ISSUES In this study, homoeopathic simillimum was compared to placebo in its effectiveness in treating chronic primary insomnia. Apart from participants being divided into Treatment and Placebo Groups, they were treated equally in all spheres.

Before the initial consultation, participants were given a subject information letter (Appendix I) to read. This informed participants of consultation times and assured them of the strict confidentiality with which all information was maintained. The researcher explained the need for the use of placebo for comparative purposes and that there was a 50% chance that they may be placed on the Placebo Group. Chronic primary insomnia is not considered a life threatening condition; therefore, participants were not placed in any serious health risk if they were to receive placebo powders. All participants were informed that upon unblinding, if it were discovered that they received placebo, the relevant homoeopathic remedy would be given to them at the end of the study, free of charge. If they met the selection criteria and were willing to participate further, they were given an informed consent form to sign. Participants understood that they were free to withdraw from the study at any time, without having to give a reason for withdrawing and without affecting their future health care. All participants agreed to participate voluntarily

in the study.

RANDOMISATION AND BLINDING This was a double-blind study. Participants were assigned numbers sequentially as they entered the study. The numbers corresponded to 30 numbers randomly allocated into two groups (by means of drawing from a hat) forming a randomisation sheet drawn up by the research supervisor. 14 participants were selected for the Treatment Group and sixteen for the Placebo Group. During the study, neither the participant nor the researcher was aware of which group the participant belonged to. Dispensing of medication was performed by the assigned laboratory technician at the Homoeopathic Day Clinic, according to the randomisation sheet.

The randomisation sheet was revealed to the researcher once all 30 participants had completed their three consultations. Participants that received placebo were then called to collect their homoeopathic remedies, free of charge.

TREATMENT consisted of approximately 10 medicated lactose granules which were placed into sachets containing lactose powder. The medicated granules were produced in accordance with method 10 of the German Homoeopathic Pharmacopoeia (British Homoeopathic Association, 1991). Lactose granules were impregnated with centesimal potencies of the relevant remedy, using 96% alcohol, prepared by Natura laboratories. A triple impregnation of the lactose granules at 1% v/v was conducted. Approximately 10 granules of the relevant remedy was then inserted into paper sachets containing lactose powder, as individual lactose powders act as an ideal means of conveyance for one single dose. The participants in the Placebo Group received approximately 10 unmedicated granules which were triple impregnated with 96% alcohol only. These granules were then placed into sachets.

The placebo powders were thus indistinguishable from the treatment powders. Each participant was given 6 powders - 3 powders at the first consult and 3 powders at the second consult.

The laboratory technician at the clinic dispensed the relevant medication according to the randomisation list. All participants were also given an instruction sheet for further clarification. Each participant was given clear instructions to dissolve a sachet of the remedy under their tongue at bedtime. This had to be adhered to for three consecutive nights. They were also told to abstain from any other insomnia treatment for the duration of the study. The researcher emphasized the importance of complying with all instructions. All possible measures were taken to ensure that instructions were correctly adhered to. Participants were encouraged to question the researcher or

the laboratory technician should any ambiguities or concerns with regards to taking the medication arise. A participant who did not comply with instructions was discontinued from the study. The remaining participants reported that there was no confusion concerning instructions about taking the homoeopathic medication and no irregularities arose. The researcher assumed that all participants were honest in their reporting. An assumption of the study

was that the participants took the homoeopathic remedies as prescribed.

CONSULTATION PROCEDURES Participants consulted with the researcher 3 times during the study. After the initial consultation, there were 2 Follow-Up consultations at 2 week intervals. Participants’ involvement in the study ended after this 4 week period.

FIRST CONSULTATION

1. This began as soon as the subject information letter (Appendix I) was read and the informed consent form (Appendix J) was signed.

2. A full homoeopathic case history was taken and a physical examination was performed to screen for any associated medical conditions that may have existed.

3. Participants were required to complete the DBAS and the SII . This was done before they received any treatment so as to provide a baseline measurement for statistical purposes. Each participant was instructed to start a Sleep Diary where they noted the hours slept for 1 week before taking the medication, so as to provide a baseline measurement for statistical purposes. Recordings of the Sleep Diary was continued throughout the trial. Medication was instructed to be taken on the eighth night after the initial consultation (i.e. after 1 week without any medication, during which time participants were to

record the hours slept only).

4. Participants were sent to the clinic reception area to collect their prescription.

5. The homeopathic dispenser on duty at the Homoeopathic Day Clinic dispensed the relevant medication to the respective groups according to the randomization sheet drawn up by the supervisor.

6. Treatment consisted of 3 powders containing either the simillimum or placebo.

7. Each participant was required to take one powder daily, at bedtime on the eighth, ninth and tenth day after the initial consultation.

8. Participants were asked to return for the second consultation two weeks later.

FOLLOW-UP ONE

1. This was a Follow-Up consultation which included checking of the vital signs.

2. The Sleep Diary was collected.

3. The patient was re-evaluated. The researcher either:

a) repeated the medication

b) changed the potency of the initial medication

c) changed the remedy or

d) left the remedy to act.

The above 4 options are consistent with standard practice in homoeopathic simillimum treatment (Naude, 2005).

4. Participants were asked to complete the DBAS and the SII. Participants were asked to complete a Sleep Diary and bring it to the next consult.

5. Each participant was required to take one powder daily, at bedtime for 3 consecutive nights.

6. Participants were asked to return for the third consultation two weeks later.

FOLLOW-UP TWO

1. The Sleep Diary was collected and

2. The vital signs were examined.

3. Participants were asked to complete the DBAS and SII .

4. Participants were given sleep hygiene rules developed by the Sleep Society of South Africa .

On completion of the study, participants from the Placebo Group were telephonically contacted, and invited to collect their medication (i.e simillimum) which they received free of charge. Various remedies were prescribed

during the study.

DATA COLLLECTION Patients were assessed using the Sleep Diary , the SII and DBAS.

HOMOEOPATHIC REMEDIES PRESCRIBED

19 remedies were prescribed during the study.

Percentage of remedies prescribed in the study (both groups)

Carcinosinum 7%

Calcarea carbonica 4%

Coffea cruda 4%

Ignatia 4%

Lachesis 15%

Nux vomica 13%

Sepia 9%

Lycopodium 7%

Natrium muriaticum 6%

Thuja 2%

Silicea 4%

Arsenicum album 2%

Kali carbonicum 2%

Calcarea arsenicosa 2%

Mercurius solubilis 4%

Medorrhinum 9%

Cannabis indica 2%

Tuberculinum 2%

Sulphur 6%

12 remedies prescribed and dispensed to the treatment group.

Lachesis 15%

Carcinosinum 15%

Nux vomica 11%

Sulphur 11%

Coffea cruda 8%

Natrium muriaticum 8%

Calcarea carbonica 8%

Ignatia amara 8%

Lycopodium 4%

Tuberculinum 4%

Medorrhinum 4%

Cannabis indica 4%

12 remedies prescribed but not dispensed to the participants in the placebo group until the end of the study.

The percentage of the various remedies prescribed in the placebo group.

Sepia 17%

Lachesis 14%

Nux vomica 14%

Lycopodium 10%

Arsenicum album 7%

Mercurius solubilis 6%

Medorrhinum 14%

Thuja 3%

Silicea 6%

Natrium muriaticum 3%

Calcarea arsenicosa 3%

Kalium carbonicum 3%

CHAPTER 5 DISCUSSION This double-blind placebo-controlled study was conducted to determine the efficacy of the homoeopathic simillimum approach in the treatment of chronic primary insomnia, in terms of patient’s perception of response to treatment. As can be seen from Table 4.1, intra-group analysis (within each group) of Sleep Diary readings indicated a significant difference in the total hours of sleep in the Treatment Group between baseline and weeks 2, 3 and 4, as well as between weeks 2 and 4. The total hours of sleep in the Treatment Group at baseline (week 1) was 35 hours. There was a significant increase in total hours of sleep to 45 hours at week 2.

The total hours of sleep in week 3 was 43 hours and at week 4 it stood at 41 hours of sleep at the end of the study The total hours of sleep improved significantly within the first week of treatment. The total hours slept then remained fairly consistent in the following weeks. This is the reason for the lack of significant differences between week 2 and week 3, as well as week 3 and week 4. However, the total hours of sleep at the end of the study (41 hours) was still significantly higher than baseline (35 hours) (p = 0.002).

As can be seen from Table 4.1, there were no significant differences between any of the weeks in the Placebo Group. Upon calculating means, it was revealed that there was an average net loss of 2 hours of sleep within the first week of treatment, in the Placebo Group. The readings then returned to baseline levels at week 3. At the last consultation, there was a net gain of 1 hour of sleep. Inter-group analysis (between the groups) of Sleep Diary readings indicates that the degree of sleeplessness was comparable between the two groups at baseline. When comparing the net gains in hours slept and total hours of sleep per week between groups, it is noted that there were significant differences between the groups at all weeks with the greatest difference being in week 2 The total hours gained in the Treatment Group is significant compared to that of the Placebo Group (p = 0.36). Intra-group analysis of Sleep Impairment Index (SII) readings comparing baseline and Follow-Up 1, within the Treatment Group, indicated significant differences in 9 of the 11 questions. At Follow-Up 1 Questions 1c and 6c did not have significant differences. Question 1c was a rating of problems with waking up too early and Question 6c was a reflection of bad sleeping habits. However, when comparing Follow-Up 1 and Follow-Up 2 as well as Follow-Up 2 and baseline, significant differences were noted in all questions. Perceptions may have changed through the weeks and confidence in the researcher, as well as the homoeopathic medicines, was increased.

According to intra-group analysis, significant differences were noted in 2 of the 11 questions in the Placebo Group, when comparing SII readings between Follow-Up 1 and Follow-Up 2, one week after the prescription of “medication”. These occurred in Questions 1a and 6a only. Question 1a rated the participants’ difficulty in falling asleep, and Question 6a rated the severity of cognitive disturbances on sleep. However, there were no significant differences in any question when comparing baseline to Follow-Up 1 and Follow-Up 2. Inter-group analysis of SII readings (see Table 4.10) resulted in significant differences in 2 of the 11 questions at baseline. This occurred in Questions 1b and 1c. However, these were only marginally different (0.42 and 0.49 respectively). At Follow-Up 1 (FU1), there were significant differences in 8 of the 11 questions. By the end of the trial (at Follow-Up 2) the significant differences had increased to 10 of the 11 questions. Intra-group analysis of Dysfunctional Beliefs and Attitudes about Sleep Scale readings comparing baseline and Follow-Up 1, within the Treatment Group, indicated significant differences in 10 of the 31 questions. When comparing Follow-Up 1 and Follow-Up 2 as well as baseline and Follow-Up2, there were significant differences in 14 and 15 of the 31 questions respectively.

This indicates a delayed positive change after Follow-Up 1.

When comparing baseline and Follow-Up 1 within the Placebo Group, there were significant differences in 2 of the 31 questions. However, this increased to 9 of 31 questions when comparing Follow-Up 1 and Follow-Up 2

and 5 of 31 questions at the end of the study. As can be seen from Table 4.11, inter-group analysis of DBAS scores revealed no significant differences at baseline. This indicates that all participants entered the study with no significant dissimilar dysfunctional beliefs and attitudes. Therefore the two groups were comparable. At Follow-Up 1, significant differences were noted for Questions 20 (p = 0.002) and 29 (p = 0.029) only. Question 20

assessed the participants’ ability to manage the negative consequences of disturbed sleep. Question 29 stated, “My sleep is getting worse all the time, and I don’t believe anyone can help me.” There was a significant difference

for Question 28 (p = 0.040) as measured at Follow-Up 2. Question 28 stated, “Medication is probably the only solution to sleeplessness.” This result reveals the participants’ belief in medications prescribed. This negative belief demonstrates the despondency of participants. Treating chronic insomnia should therefore involve a multi-disciplinary approach. Cognitive-behavioural therapies should be sought as a component of treatment.

The DBAS has proved extremely useful as a therapeutic tool for non-pharmacologic interventions such as cognitive therapy sessions. However, this measurement tool may not have been appropriate for the purposes of this trial

as some questions (e.g. Q7: When I have trouble getting to sleep, I should stay in bed and try harder) were not directly suited for a pharmacologic intervention, like Homoeopathy. In this study, no attempt was made to change cognitive perceptions through psychological analysis and verbal exchange, as there is in a cognitive therapy session. It is suggested that a modified DBAS or another measurement tool be selected for future studies.

The subjectivity of the questionnaires must also be considered. A more objective method may have showed more accurate findings. The placebo effect also needs to be addressed. The placebo effect is considered as an example

of mind-body relation that depends on subconscious interactions between the doctor, the treatment process, and the patient. A physician’s attributes, dress, demeanour, voice and body language each contribute to a marked

placebo effect. The benefit of placebo is considered transient, although its effects are not always short-lived (Pearce, 1995). Due to the clear significant differences between the Treatment Group and the Placebo Group in terms

of the Sleep Diary and the SII, one can conclude that the placebo effect was not a major factor in this study.

A review of the related literature revealed three studies similar to this one. Pellow (2002) and Roohani (1997) assessed the efficacy of simillimum treatment and complex remedy prescription for secondary insomnia respectively. Lankesar (2004) assessed the efficacy of simillimum treatment for post-traumatic stress disorder. All three studies concluded that homoeopathic treatment was effective, although only Roohani used statistical analysis. The most similar study to this was a qualitative analysis conducted by Pellow (2002). The study was not a double-blind-placebo-controlled study and the sample size consisted of 10 females only. A descriptive study of individual cases was compiled based on the readings of the measurement tools. Statistical analyses were not conducted. Thus, this study concurred with the findings of the above three studies; that homoeopathy can be effective in treating insomnia. However, a direct comparison of results is not possible due to the many methodological differences of the studies (as discussed in Chapter 2) and the qualitative analysis of their findings. This study used quantitative analysis to form a statistically viable research project.

As can be seen in Figure 4.47, Lachesis and Nux vomica were the most common remedies prescribed in the study. Lachesis was prescribed in 15% of the cases and Nux vomica in 13% of the cases, taking both treatment and placebo groups into account. Lachesis and Carcinosinum were the most commonly prescribed remedies in the treatment group (figure 4.48). Both were prescribed in 15% of the cases. It is interesting to note that Carcinosinum

was not prescribed to any participants of the placebo group. Carcinosinum was the 5th highest remedy prescribed in the study and in 7% of the total cases taken in the study. Sepia was the most common remedy prescribed in

the placebo group, being prescribed in 17% of the cases in the placebo group (figure 4.28). Lachesis, Nux Vomica and Medorrhinum were prescribed in 14% of the cases. Sepia was not prescribed to any of the participants in the treatment group. Due to the high occurrence of Lachesis, Carcinosinum and Nux vomica in the study, it is interesting to note the mental disposition and sleeping difficulties reflected in the materia medica of these remedies.

Lachesis: has qualities of competitiveness, aggressiveness, attractiveness, sexuality, clairvoyance and deception. Extremely talkative and jealous individuals/mental labour is best performed at night (Sankaran, 1997: 113).

Often suspicious/a quality of religious mania. Often sleepy, yet unable to fall asleep. Sleep disturbed by the least noise and sometimes afraid to go to sleep for fear that they will die before they awake (Boericke, 1999: 387).

The sleeplessness is a result of the anxiety experienced (before midnight). They often awake at night and can not sleep thereafter. Their dreams are frightful

and are usually of snakes and death. Even short naps are disturbed by frightful dreams and the person springs up in bed with terror and a feeling of suffocation with palpitations (Vermeulen, 2000: 929).

Carcinocinum: the main feeling: one’s survival depends on performing tasks which one feels incapable of doing. They often go beyond their capacity, to the utmost in the hope of success, because failure means death and destruction. A history of too much responsibility at a young age, having very high expectations placed on them and excessive parental control during childhood. They reach out for perfection in all they do. This need for

perfection makes them fastidious in all spheres of their life to the point of being faultless (Sankaran, 1997: 55). This remedy is noted for the sleeping difficulties that patients experience. There is tremendous sleeplessness in children from birth. Commonly prescribed for chronic sleeplessness (Vermeulen, 2000: 412).

Nux vomica: main expressions: hard, zealous, ambitious and impatient. Hard task masters and irritable, passionate and fastidious (Vermeulen, 2000: 1151 - 1152). These individuals are usually disposed to reproach others and

may have a sullen disposition. They do a good deal of mental work and lead a sedentary lifestyle. This indoor life with business cares and anxieties leads to the excessive use of coffee, wine, tobacco and other stimulants.

These conditions produce irritable and hypersensitive responses (cannot bear noises, odours or light). There is extreme difficulty in initiating sleep due to the occurrence of rapid thoughts about business and finances.

Usually wake in the morning feeling wretched. These people are usually drowsy after meals and in early evening. Their dreams are full of bustle and hurry. > after a short sleep, unless aroused (Boericke: 1999: 477 - 478). Considering the characteristics of Lachesis, Carcinosinum and Nux vomica it is understandable that they featured prominently in the study. On careful analyses of the prescriptions to participants in the treatment group, it is observed that 11 of the 14 participants received the same remedy at both consultations. Any need for repetition is determined by the response to the first dose. A favourable response followed by a return of some or all symptoms indicates a repetition of the remedy (Carlston, 2003:116).

After selecting the appropriate remedy, a homoeopath makes a decision about the potency of the remedy. Common potencies prescribed in this study include a medium potency of 30CH, a high potency of 200CH, and higher

levels of potency consisting of 1M and 10M.

200CH was the most common potency prescribed. It was prescribed in 54% of the total cases in the study (in both groups). 1M was prescribed in 27% of cases. Similar results, with 54% of the participants in the treatment group receiving their remedies in 200CH and 31% in the 1M potency level. According to Carlston (2003: 116), the homoeopath must first decide whether the key indicating symptoms (mental, physical or emotional) are mild or intense. If the prescribing symptoms are intense, particularly the mental or emotional symptoms, a high potency is required. The homoeopath may choose the 200CH, 1M or 10M potency level. Carlston further explains that patients who are chronically ill, with a few clear symptoms that are intense, or start from a single point in time, may be easily treated with doses of a high-potency centesimal remedy such as 200CH or higher. de Schepper (2001: 75) also recommends the use of 200CH for strong conditions such as emotional or physical traumas. Insomnia is considered a pathology related to the mental plane.

Often accompanied by intense emotions and therefore relates to the emotional plane of an individual as well. It is therefore understandable that the 200CH potency level was the most common potency used in the study.

7 of the 14 participants in the treatment group received a higher potency of the same remedy at their first follow-up. 4 of the 14 participants received their remedies in ascending potencies (30CH, 200CH and 1M), 3 of which received it at the initial consultation. An ascending collective single dose prescription is a variant of the principle of single remedy prescription (see Chapter 2, 2.10.2.3) This method is employed to ensure that the remedy has „taken hold’ and to minimise any adverse reactions to the remedy in hypersensitive people. This form of prescription makes use of three doses of the same remedy in ascending potencies, e.g. 30CH - 200CH - 1M, at intervals

of 4 - 24 hours (Watson, 1995: 16). In this study, instructions were that all remedies be taken every 24 hours. Although the study revealed positive results, certain methodological recommendations need to be considered.

The first Follow-Up consult was 1 week after the initial prescription. Patients may have benefited from a longer Follow-Up period. The sample size of this study was 30 participants. A larger number sample size would ensure parametric statistical analysis.

CONCLUSION

The results of this study lead to the conclusion that homoeopathic simillimum was shown to be statistically more effective than placebo in the treatment of chronic primary insomnia in terms of Sleep Diary and SII readings. The study showed that homoeopathy can offer significant relief for insomniacs, when the simillimum is prescribed. Therefore, homoeopathy forms a viable alternative in the treatment of chronic primary insomnia.

Vorwort/Suchen. Zeichen/Abkürzungen. Impressum.