Hormonen Anhang P.M.S.
[Carrie-Ann Laister]
THE EFFICACY OF HOMOEOPATHIC SIMILLIMUM IN THE TREATMENT OF PMS
(PMS).
ABSTRACT This study was intended to evaluate
the efficacy of homoeopathic simillimum in the
treatment of PMS (PMS). The sample group consisted of women between
18 - 40, living in the greater Durban area.
PMS: a condition characterized by nervousness,
irritability, anxiety, depression, and possibly headaches, oedema, and mastalgia, occurring during the 7 - 10 days before and
usually disappearing a few hours after the onset
of menses (Beers and Berkow,
1999:1932-1933). 75% of all women suffer from PMS to some degree (Hayman,
1996). A total of 39 participants with PMS were selected for the study on the
basis of inclusion and exclusion
criteria.
Participants were randomly divided into 2
groups (treatment and placebo) according to the randomisation sheet. There were
12 withdrawals from the study. 27 of the participants completed the study of
which, 14 were on placebo treatment and 13 on active treatment. The treatment
followed the initial consultation, which consisted of 3 powders containing
either active ingredient (i.e. simillimum) or
matching placebo and a 20ml bottle of liquid containing either active
ingredient or placebo. Each participant was required to take one powder daily
for three days from day 10 of their menstrual cycle followed by liquid
treatment daily till onset of menses. Each participant had 3 consultations with
the researcher over a 3 month period; each consultation a month apart.
Menstrual Distress Questionnaires (Appendix A) were completed by the
participants at each consultation.
The data
accumulated via the questionnaires was evaluated using non-parametric tests and
analyzed statistically using the Wilcoxon’s Signed
rank test and the Kruskal Wallis test. The results
were analysed at a 95% confidence rating with p ≤ 0.05. Data was analysed
using the SPSS (version 15.1®) for Windows® statistical software suite. The
intra-group analysis showed statistically significant changes in the subgroups
of water retention (p=.020) and appetite changes (p=.010) in the Treatment
Group. The Placebo Group showed statistical significant changes in the
subgroups of concentration (p=.029), autonomic reaction (p=.013) and appetite
changes (p=.035). The inter-group analysis failed to reveal any statistical
significance. Therefore, the conclusion is that homoeopathic simillimum was not effective in the treatment of PMS
(PMS). There were clinical improvements noted by participants during the study
which suggest that more research into the treatment of PMS should be conducted.
Studies with a larger sample group over a longer time frame with daily outcome
measures would give a better indication of the efficacy of
the homoeopathic
simillimum on PMS.
For thousands
of years - up to and including decades of the present century - very little, if
anything, was done to alleviate the unpleasant symptoms which the vast majority
of women experience while they are menstruating,
nor the whole
complex (or syndrome) of problems, mental and physical, which affect far more
women than is generally realized during the premenstrual phase of their cycle (Sheeve, 1992:14-15). PMS (PMS) is a condition
characterized by nervousness, irritability, anxiety, depression, and possibly
headaches, oedema, and mastalgia, occurring during
the 7 to 10 days before and usually disappearing a few hours after the onset of
menses (Beers
and Berkow, 1999:1932-1933). There are over 150 symptoms that
have been attributed to PMS (Lichten, 2005). PMS was
first identified as a true medical disorder by Dr Robert T Frank in 1931 in his
paper called “Hormonal Causes of Premenstrual Tension” (Dixie Health, 2006).
According to some studies, 75% of all women suffer from PMS to some degree
(Hayman, 1996). Of the estimated 40 million sufferers, more than 5 million
require medical treatment for marked mood and behavioural changes (Litchen, 2000). Approximately 2% to 5% of women have severe
PMS but many have only mild or moderate symptoms. PMS is most common in women
in their 20’s
and 30’s, and
ceases entirely at menopause (as cited by Sarawan,
2001).
In a study
conducted to assess the impact of premenstrual symptomatology
on functional and treatment-seeking behaviour for a community-based sample of
women in the U.S., U.K. and France it was found that functional impairment
tended to be highest at home, followed by social, school, and occupational
situations. Among working women, over 50% reported their occupational
functioning being at least somewhat affected. Of women
who ever
missed work because of symptoms, 1-7 days were missed in the past year. Almost
¾ of the women had never sought treatment, and symptom severity was an
important factor in treatment-seeking behaviour
(Hylan, et al. 1999). A study conducted in a UK women’s
prison showed that half the inmate’s offences had been committed in the praemenstruum time (4 days prior to the start of the menses
and first 4 days of menses)
(Hayman,
1996). 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). The simillimum
is the medical potency capable of producing a set of symptoms which are the
most similar to those in the case of disease to be cured (O’Reilly,
2001). Homoeopathy is considerably cheaper than conventional medicine, making
it a desirable alternative to allopathic medication (Ullman,
1991: 49). Homoeopathic treatments have no harmful side effects and are safe to
treat during pregnancy, menopause and for babies to take. The remedies work
gently to stimulate the body’s own natural defences with results
that may be powerful and long lasting (Traub, 2006).
Menstrual disorders at all ages and stages can be treated effectively with
homoeopathy (Bloch and Lewis, 2003).
The purpose
of this double-blind placebo controlled study was to evaluate the efficacy of
homoeopathic simillimum in the treatment of
Premenstrual 3 syndrome in terms of patient’s perception of the
treatment using the Moos Menstrual Distress Questionnaire (Moos, 1968).
Premenstrual
ailments are some of the most common disorders suffered by women today. It has
been shown that women can have radical behavioural, emotional and physical
reactions to the hormonal changes occurring in the premenstruum
that can impact all aspects of their lives (Hayman, 1998). Although extensive
research is still being done, medical science has not yet come up with the
perfect solution (Kirtland, 1995). PMS (PMS) is a recurrent luteal phase condition characterized by physical, psychological,
and behavioural changes of sufficient severity to result in deterioration of
interpersonal relationships and normal activity (Moreno, 2006).
Up to 80% of
women experience mood and physical symptoms associated with menstrual cycle.
Commonly reported symptoms are irritability, anger, fatigue, physical swelling
or bloating and weight gain (Hylan, et al. 1999).
More than
fifty years ago premenstrual tension was methodically investigated and
described by Dr. Robert T. Frank of New York, although, at the time he referred
to PMS as “premenstrual tension". PMS is
now
recognized the world over as being a widespread problem. In 1931 Dr. Frank read
his history making paper, "Hormonal Causes of Premenstrual Tension"
at a meeting of the New York Academy of Medicine.Scientists
who were investigating problems associated with menses were struck by the
constant appearance of what they labelled premenstrual tension (PMT). PMT was
their umbrella term for depression, extreme fatigue, and irritability. However
as research continued, it became clear that the "tension" evident
during the premenstrual time was only part of what had to be called a syndrome.
There were just too many other symptoms that constantly occurred prior
to menses.
Important findings about the distressing symptoms of PMS, and in fact, the term
PMS came from the efforts of two English physicians, Dalton and
Greene. In 1953 they published "The PMS", which was the
first PMS
paper in
medical literature in the British Medical Journal. (Dixie Health, 2006). Dalton
describes the PMS as the most prevalent of endocrine disorders. The
endocrine system consists of glands that secrete substances into the
blood. These
substances have an action on a specific organ. In her book, "The PMS",
she says this title covers a wide variety of cyclical symptoms which regularly
recur at the same phase of each menstrual cycle. The most
common time
for repeated symptoms is during the premenstruum or
early menses, but occasionally symptoms occur at ovulation. She says that the
onset of the full menstrual flow usually brings dramatic and complete relief,
but as there
may be slight menstrual loss for a day or two before the onset of full menses
it is not uncommon to find symptoms continuing through the first day or two of
each cycle (Dixie Health, 2006). Symptoms of PMS
have been
reported to affect as many as 80% of women of reproductive age some time during
their lives. Recent studies indicate that 14-88% of adolescent girls have
moderate-to-severe symptoms. Another 3-5% of women
meet the
criteria for Premenstrual Dysphoric Disorder (PMDD).
PMS affects women with ovulatory cycles. Older
adolescents tend to have more severe symptoms than younger adolescents. Women
in their fourth decade of life tend to be affected most severely. PMS resolves
completely at menopause (Moreno, 2006). Singh, Berman, Simpron
and Annechild (1998) found that women were more
frequently aware of symptoms related to PMS rather than
a recognition
of a formalised medical syndrome. Less than half the women reporting symptoms
had taken either over-the counter or prescription drugs. Women who tried
complementary therapies generally found them to be effective.
IMPACT OF PMS
A study
conducted in the USA surveyed 1052 women (aged 21-64) telephonically to find out
the respondent demographics, respondent knowledge of PMS, the incidence rate of
common symptoms and remedies being used to control symptoms. This study
concluded that 41% of the women indicated that they suffered from PMS, and an
additional 17% indicated that they experienced symptoms prior to their
menstrual cycle commonly associated with PMS, including pain, bloating, feeling
more emotional, weight gain and food cravings, although they did not associate
these symptoms explicitly with PMS. Of those women reporting PMS symptoms,
about 42% took either prescription or over-the-counter medications for relief
of symptoms. The conclusions drawn from the study were that women are more
frequently aware of symptoms related to PMS rather than a recognition of a formalised
medical syndrome. Women who tried complementary therapies generally found them
to be effective (Singh et al., 1998).
Economic impact
Dean and Borenstein (2004) conducted a study to investigate the
relationship between work productivity and impairment due to PMS.
They took a sample group of women aged between 18 to 45 years of age who, for
two
consecutive
menstrual cycles, completed a “daily rating of severity of problems” form to
record daily symptoms. In the workplace, women with PMS reported higher
absenteeism rates (2.5 days vs. 1.3 days) and more
workdays with
50% or less typical productivity per month (7.2 days vs. 4.2 days). Women with
PMS in one of two menstrual cycles reported a greater number of days with
impairment in routine work, school, and household activities in comparison with
women without PMS. The results indicated that PMS leads to substantial decrease
in normal daily activities and occupational productivity and significantly
increased work absenteeism.
Hylan, Sundell and Judge
(1999) conducted a study to assess the impact of premenstrual symptomatology on functional and treatment-seeking
behaviour for a community-based sample of women in the U.S., U.K. and France.
A sample of 1045 menstruating women (aged
18-49) completed a telephonic questionnaire that measured, at a point in time,
premenstrual symptoms, impact on functioning, and treatment-seeking behaviour.
Results were
generally consistent across the 3 countries.
Irritability / anger, fatigue, and physical swelling / bloating, or weight gain
were among the most commonly reported symptoms (approximately 80%). Functional
impairment tended
to be highest at home, followed by social,
school and occupational situations. Among working women, over 50% reported at
least somewhat affected occupational functioning. Of women who ever missed work
because of symptoms, 1-7 days were missed in the past year. Almost three
quarters of the women had never sought treatment, and symptom or symptoms’
severity was an important factor in treatment-seeking behaviour.
Social impact
A UK Medical
Committee conducted a study on women involved in car accidents and found that
48% of these accidents occur during the premenstruum.
The expected result would have been for 25% of accidents to occur as premenstruum accounts for one in four weeks. Another study
revealed that accidents are far more common during the premenstruum
than at any other time, based on increased hospital administrations and visits
to doctors’ surgeries. These findings indicated how in the premenstruum a woman is far more accident prone and so can
be more hazardous to have in the work place (Sheeve,
1992).
A study
conducted in a UK women’s prison showed that half the inmate’s
offences had been committed in the premenstruum time
- the three or four days before a period begins, when the symptoms of PMS would
be at their peak
(Hayman, 1996). Cases have been heard in the
courts of women who temporarily “lose their minds” during the premenstruum due to PMS and they have received lighter sentences.
One case in point was Mrs. Christine English
who had no criminal record but in a fit of rage
drove her car over her lover and killed him. Her intention was not to kill him
she stated that she „just snapped’ and jammed her foot on the
accelerator, intending to bump into him
and hurt him and shut him up. The courts
accepted her claim and she was given a conditional discharge for twelve months
and banned from driving for the same period (Sheeve,
1992).
TYPES OF PMS
The most
common symptoms during menses can be
divided into 5 subgroups: |
Symptoms |
PMS-A, anxiety |
Difficulty
sleeping, tense feelings, irritability, clumsiness, mood swings |
PMS-C, craving |
Headache, cravings
for sweet foods, cravings for salty foods, cravings for other types of food |
PMS-D, depression |
Depression,
angry feelings for no reason, feelings that are easily upset, poor concentration
or memory, feelings of low self-worth, violent feelings |
PMS-H, hydration |
Weight
gain, abdominal bloating, breast tenderness, swelling of extremities |
PMS-O, other |
Dysmenorrhea, change in bowel habits, frequent urination, hot flushes or cold
sweats, general aches or pains, nausea, acne, allergic reactions, upper
respiratory infections |
Type A
Characterised by
anxiety: irritability, crying without reason, verbal and sometimes physical
abuse, feeling “out of control”, or Dr. Jekyl-Mr Hyde
behaviour changes (Lichten, 2001). This type of PMS
is the most common
subtype affecting 65-75%
of PMS sufferers (Lockie and Geddes, 1992:67). In
some women the anxiety is followed by depression. The symptoms get worse in the
days before the menstrual period and are relieved by its onset.
The cause of type A is
most likely due to excessive levels of oestrogen and inadequate levels of
progesterone circulating in the body (Lark, 1984:27); however there is no
scientific evidence to confirm this theory (Sheeve,
1992).
Type C
Characterised by
cravings: food cravings, usually for sweets or chocolates; dairy products
including cheese, and on occasion, alcohol or food in general (Lichten, 2001). This subtype also includes symptoms like
headaches,
fatigue and
palpitations. This affects 24-35% of premenstrual women (Lockie
and Geddes, 1992:67). Many women note an increased craving for refined
carbohydrates (sugar/chocolate/pastries) and eat larger quantities of
these foods before their
period than they normally would. This craving is made worse by stress. A few
hours after indulging in these foods, many women experience fatigue, headaches,
shaking and dizziness (Lark, 1984:29).
Type D
Characterised by
depression: confusion, clumsiness, forgetfulness, withdrawal, fearfulness,
paranoia, suicidal thoughts and rarely, suicidal actions (Lichten,
2001). This affects 23-35% of women and is more commonly found
in combination with PMS
type A. The PMS type A occurs first and is followed by type D symptoms a few
days before the onset of the period (Lockie and
Geddes, 10 1992:67). In these women oestrogen levels are found to be abnormally
low, and the depressant effects of high or normal progesterone are not
counterbalanced by oestrogen (Lark, 1984:30).
Type H
Women complain of
heaviness or headaches: fluid retention leading to headaches, breast
tenderness, abdominal bloating and weight gain (Lichten,
2001). This affects 65-72% of sufferers (Lockie and
Geddes, 1992:67).
These women tend to
retain excess salt and fluid, caused by an excess production of the pituitary
hormone adreno-corticotrophic hormone (ACTH). The
ACTH is then circulated via the blood to the adrenal glands
(Lark, 1984:30). Aldosterone release causes the kidneys to retain water and
salt so less urine is excreted (Lockie and Geddes,
1992:67).
Type O
For all the other
symptoms not accounted for in the first 4 subgroups. Complaints: dysmenorrhoea,
change in bowel habits, frequent urination, hot flashes or cold sweats, general
aches or pains, nausea, acne, allergic reactions, upper respiratory infections
(Moreno, 2006). The above shows exactly how multifaceted PMS is, with 5
different problem entities often coexisting in the same women (Lark, 1984:30).
SIGNS AND SYMPTOMS
Most women experience
some symptoms which are related to the menstrual cycle. In many, women the
symptoms are not disabling and are of short duration, while others may
experience a broad range of symptoms that disturb normal ability to function
(Hayman, 1996).
The most common physical
symptoms are:
Headache
Swelling
of ankles, feet, and hands
Backache
Abdominal - cramps or heaviness/pain/fullness, feeling gaseous
Muscle spasms
Breast tenderness
Weight gain
Recurrent cold sores
Acne aggravations
Nausea
Bloating
Constipation or diarrhoea
Decreased coordination
Food cravings
Less tolerance for noises and light
Anxiety or panic
Confusion
Difficulty concentrating
Forgetfulness
Poor judgement
Depression
Irritability, hostility or aggressive behaviour
Increased guilt feelings
Fatigue
Slow, sluggish, lethargic movement
Decreased self-image
Sex drive change, loss of sex drive
Paranoia or increased fears
Low self-esteem
(Thompson, 2004)
POSSIBLE AETIOLOGY
For many years, PMS was dismissed
as a psychological problem. We now know that this is a physiological problem
and not purely a psychological one. However it is still far from clear what
causes all the symptoms. It is
possible that there is
more than one cause of PMS and that there may be different causes of symptoms
in different people. One of the reasons for PMS may be hormonal imbalance -
excessive levels of oestrogen and inadequate levels of progesterone - as well
as sensitivity to fluctuating hormones. Diet may be an important contributing
factor for some women. Unstable blood sugar levels are an important factor as
well. PMS has also been linked to
food allergies, changes
in carbohydrate metabolism, hypoglycaemia, and malabsorption.
Other suspected causes of PMS symptoms include erratic levels of
beta-endorphins (a narcotic like substance produced by the body).
All these play a part in
PMS. (Balch and Balch, 2003).
Hormonal imbalance
Oestrogen and progesterone imbalance
PMS occurs when there is
oestrogen dominance. Depression, loss of sex drive, sweet cravings, heavy
periods, weight gain, breast swelling and water retention can all be attributed
to oestrogen dominance. Oestrogen dominance
can be due to excessive
exposure to oestrogenic substances, or a lack of progesterone, or a combination
of both (Holford, 2004: 27-8). The variation of
oestrogen and progesterone levels coincides with the onset and relief of PMS.
However the evidence is inconsistent and is still inconclusive (Hayman, 1996).
Prolactin
Some studies have shown
that there is an increase in prolactin during the luteal phase. Halbreich found
that women with PMS had higher prolactin levels than
women who did not have PMS symptoms. Prolactin is
produced in
the pituitary gland and
its function is to stimulate the development and growth of breast tissue. If
the pituitary produces too much prolactin this will
lead to breast tenderness, lumpiness and enlargement, and it may also alter
the amount or balance of
oestrogen and progesterone produced in the body, and affect mood (Hayman,
1996).
Prostaglandins
A diet-related
explanation concerns the role of prostaglandins in PMS. These are essential
fatty acids that are made by the body and which are nutritionally important for
growth and health. The most important of these is linoleic
acid, a polyunsaturated fatty acid found in cereals, legumes and vegetables. If
most of the fat in a woman’s diet is obtained from animal fat she
may have a diet that is low in linoleic acid.
Prostaglandins are responsible for inflammation and pain in response to tissue
damage. They also have a regulating effect on hormones such as oestrogen,
progesterone and prolactin. A deficiency in
prostaglandins may lead to the imbalance in hormones that
causes PMS symptoms. The
dietary deficiency of essential fatty acids which leads to a deficiency in
prostaglandins would cause PMS. Some studies have indicated that prostaglandins
increase during the luteal phase and decline during
menses as a normal and natural part of the menstrual cycle (Hayman, 1996).
Opiods
One argument is that PMS
is linked to opium-like substances which are produced in the brain (endogenous opiod peptides or endorphins). These are produced to
control body temperature, bowel function and whether one feels tired, hungry,
happy or sad. PMS symptoms mimic the symptoms of narcotic withdrawal e.g.
nausea, cramps and depression. (Studies show that these opiods
are not only produced by the brain but some are also affected by chemicals
produced by the ovaries, so the levels may change throughout the menstrual
cycle.) If, in common with other ovarian hormones, the levels are low in the premenstruum, this may account for the drop in mood.
Further studies are
needed to substantiate this theory (Hayman, 1996).
Nutritional
Blood sugar
Another theory is that
PMS is related to low blood glucose. Glucose is the body’s chief
source of energy and is carried by the blood to all tissues. If one did not eat
for a long period, there would be a decrease in blood glucose levels. However,
usually the level is kept within fairly narrow limits by the action of various
hormones such as insulin, glucagon and adrenaline. Glucose can be stored in the
liver and muscles so that if these levels begin to drop these reserves can be
released. However the release of adrenaline to stimulate this effect has the
side effect of causing stress symptoms, making one tired and jittery. People
have 15
been noted to experience sweet cravings boost energy levels by eating
chocolates and sweets, which can actually make the situation worse. There is a
quick increase in blood glucose levels followed by an immediate “rebound”
reaction where the levels fall. The decrease in blood glucose causes the
release of more adrenaline which has a positive feedback effect aggravating the
situation. Adrenaline releases glucose from the cells causing water uptake,
which causes the bloating experienced by PMS sufferers (Hayman, 1996).
Dietary deficiencies
Another diet-related
argument is that PMS is linked to vitamin and mineral deficiencies. The
symptoms of various dietary deficiencies can be shown to be similar to those of
PMS, a lack of vitamin B6, E, zinc and magnesium,
and others. Modern diets
are frequently lacking in these essential dietary factors (Hayman, 1996). In
the premenstruum, women often have cravings for the B
vitamins, which is similar to a craving for sugar. Instead of ingesting
the vitamins, sugar is
eaten such as cakes and chocolates and the craving is satisfied. These cravings
should be dealt with by taking vitamins rather than sugars (Sandler, 1991). The
deficiency of the essential fatty acids (EFAs)
has come to light in
recent years as a likely cause of PMS as EFAs are
essential to the production and regulation of hormones. The deficiency of EFAs leads to the hormonal imbalance that results in
premenstrual symptoms.
The efficacy of Vitamin
B6 (pyridoxine) in the treatment of PMS has been attributed to its
role in metabolising EFA rather than a direct action on the hormones (Sheeve, 1992).
Calcium supplementation
has been shown to reduce many symptoms of PMS by as much as 30%. The deduction
from this is that calcium deficiency is a cause of PMS (Balch and Balch, 2003).
Magnesium deficiency has been linked with breast pain, water retention,
cravings, tension headaches, depression and anxiety (truestarhealth.com).
DIAGNOSTIC CRITERIA
According to Dalton
(1984) the diagnostic criteria for PMS are:
- Symptoms must occur exclusively during the second half of the
menstrual cycle.
- Symptoms increase in severity as the cycle progresses.
- Symptoms must be relieved by the onset of full menstrual flow.
- There must be an absence of symptoms in the postmenstruum.
- Symptoms have to be present for at least 2 consecutive cycles.
OUTCOME ASSESSMENT TOOL
The Moos Menstrual Distress
Questionnaire (MDQ) (Moos, 1968) (Appendix A) is one of the methods of
assessing premenstrual symptomatology. Other methods
include the Premenstrual Assessment form and the Daily Menstrual Charts. There
are 45 symptoms in the MDQ and these are divided into nine sub-scales. These
sub-scales are: pain, water retention, control, negative affect, autonomic
reaction, concentration, behavioural changes, appetite changes and arousal. The
subjects are asked to assign numerical weight according to their experience of
each of the 45 symptoms (Hawes, 1992). The MDQ was the main assessment tool
used in this study. The Moos Menstrual Distress Questionnaire (MDQ) was
selected for this trial due to its usage in all previous PMS research seen by
the researcher.
In a study to test the
efficacy of the MDQ it was concluded that the Moos factors effectively
represent the structure of the menstrual cycle symptoms. The aim of the study
was to determine whether Moos’ factors could be replicated based on
daily and prospective completion of the MDQ in women who were unaware of the
study’s aims. One hundred and 87 women from the general community
(mean age 30 years) completed a modified version
of the MDQ daily for 70
days. Principle components analysis of the modified MDQ items during the
follicular, late luteal and menstrual phase indicated
that a six-factor solution similar to that derived by Moos, best summarised the
data. A number of symptoms, however, loaded highly on more than one factor.
This created some instability in the solution and may explain the discrepancies
in previous research (Ross, et al. 2003). A study published in the
British Journal of Psychiatry found the Moos MDQ to be a useful method for
assessing menstrual distress. Nineteen volunteers completed a MDQ daily for a
period exceeding one menstrual cycle. The data were analysed, using a least
mean square method of fitting sine waves. The fact that the results obtained on
this group are essentially those found by other researchers looking at the
menstrual cycle suggests that this may be a useful method of assessing
menstrual distress (Sampson and Jenner, 1977). An assessment of the Moos
MDQ was done by the American Psychosomatic Society which found the MDQ to be
consistent and highly reliable in reporting symptoms of the menstrual cycle.
The MDQ was analysed for split-half and test-retest reliability. The
experimental group was given neutral instructions to determine if the knowledge
of the purpose of the questionnaire would affect the symptom rating. The results
indicated that the MDQ is internally consistent and does have high test-retest
reliability (Markum, 1976).
DD.:
Cyclic Pelvic Pain
Premenstrual Dysphoric Disorder (PMDD)
A condition associated with
severe emotional and physical problems that are linked closely to the menstrual
cycle. Symptoms occur regularly in the 2nd half of the cycle and end when
menses begins or shortly thereafter. PMDD is not just a new name for PMS
(PMS), a condition that affects as many as 75% of menstruating women. It is,
considered to be a very severe form of PMS that affects about 5% of
menstruating women. Both PMDD and
PMS share symptoms in
common that include depression, anxiety, tension, irritability and moodiness. Women
with PMDD experience severe PMS that disrupts their everyday lives to the point
that they can no longer function effectively (Madison Institute).
Dysmenorrhoea
Dysmenorrhoea is a
painful menstrual period (Dox et al., 1993).
This can be classified into congestive or spasmodic dysmenorrhoea. Spasmodic
dysmenorrhoea is not part of PMS. It is related to the uterine contractions
which cause shedding of the endometrial lining. The pain is due to the
interruption of the normal blood flow to the muscle fibres caused by to the
strong sustained contraction of the muscle which results in an accumulation of
chemical metabolites in the muscle causing pain. Spasmodic dysmenorrhoea occurs
most often in young women and girls in the time following menarche, before the
uterine muscles have received sufficient oestrogen to complete their
development. The pain experienced with spasmodic dysmenorrhoea is spasmodic and
occurs in the lower abdomen and small of the back and is a heavy, bloated,
dragging feeling sometimes accompanied by dull or shooting
pain in the genital
area. This is not a premenstrual symptom as it occurs during the period.
However it can occur in a person with PMS and so the distinction between PMS
and Dysmenorrhoea for the patient is difficult to distinguish. Congestive
dysmenorrhoea is not true dysmenorrhoea as it occurs before the onset of
menses. It is due to the congestion of blood in the vessels in the pelvis. The
pain is in the pelvic and genital regions and is a dull persistent pain in
contrast to period pain which is cramp-like. Congestive dysmenorrhoea is a
symptom of PMS (Sheeve, 1992).
Mittelschmertz Phenomenon
Mittelshmertz Phenomenon refers to a
frequently occurring unilateral lower abdominal pain that occurs mid-cycle due
to ovulation. Rupture of the follicle and subsequent irritation of the
peritoneum may produce pain.
The pain, although
sometimes severe, resolves spontaneously (Beers and Berkow,
1999).
Endometriosis
Endometriosis is an
abnormal condition in which the uterine mucous membrane invades other tissues
in the pelvic cavity (Dox et al., 1993). The
cyclical engorgement of this ectopic endometrial tissue results in pain,
bleeding, diarrhoea, constipation and lower back pain. The onset of
endometriosis is usually in females between the ages of 20-45 (Haslett, et
al. 2002). In the early stages of endometriosis pain is caused which starts
several days before
the menses and continues
through the first few days. This disorder becomes chronic and pain commonly
occurs at various times unrelated to the menstrual period (Beers and Berkow, 1999).
Affective disorders/ Mood disorders
Depression
Symptoms of major
depression include feelings of sadness, loss of interest in normally
pleasurable activities, changes in appetite and sleep, loss of energy, and
problems with concentration and decision-making. Women are
twice as likely as men
to experience major depression. Depression can also cause a wide variety of
physical complaints, such as gastrointestinal problems (indigestion,
constipation or diarrhoea), headache and backache. Many people with depression
also have symptoms of anxiety (International Society for Affective Disorders,
2006).
Seasonal Affective Disorder
Seasonal Affective
Disorder (SAD) is a pattern of depression related to changes in seasons and a
lack of exposure to sunlight. It may cause headaches, irritability and a low
energy level (Mayo Clinic, 2006).
Dysthmia
A chronic depression of
mood which does not currently fulfil the criteria for recurrent depressive
disorder in terms of either severity or duration of individual episodes. The
balance between individual phases of mild
depression and
intervening periods of comparative normality is very variable. Sufferers
usually have periods of days or weeks when they describe themselves as well,
but most of the time they feel tired and depressed; everything
is an effort and nothing
is enjoyable. They brood and complain, sleep badly and feel inadequate, but are
usually able to cope with the basic demands of everyday life (World Health
Organisation, 2007).
Adjustment Disorder
Adjustment
Disorder is when the response to a stressful or traumatic event is signs and
symptoms of depression or anxiety. The disorder can be acute (lasting less than
six months) or chronic. An adjustment disorder can develop following a single
stressful event or as result of an accumulation of stress. The behavioural
changes found in Adjustment Disorder are not restricted to the premenstruum but the behaviour could be misdiagnosed as PMS
(Mayo Clinic, 2006).
Other conditions
Peri-menopause
It may be difficult to
distinguish peri-menopause from PMS in certain
instances. If one is over 40, symptoms such as joint pain, depression, anxiety,
forgetfulness, increased urge to pass urine and cystitis may actually be caused
by the climacteric
(Hayman, 1996:65). In addition one should consider the possibility of premature
menopause in those women who are under the age of 40 (Beers and Berkow, 1999).
Chronic Pelvic Inflammatory Disease (PID)
PID is widespread infection
in the reproductive and pelvic organs. When chronic, there may be discharge,
pain and general ill health (Beer and Berkow, 1999).
PID may become worse before a period begins (Hayman, 1996:66).
Hypothyroidism
The signs and symptoms
of hypothyroidism vary widely, depending on the severity of the hormone
deficiency. In general, problems tend to develop slowly, often over a number of
years. At first there are symptoms such as
fatigue and
sluggishness. The metabolism continues to slow; more obvious signs and symptoms
of hypothyroidism develop, including: increased sensitivity to cold;
constipation; pale, dry skin; a puffy face; hoarse voice; an elevated blood
cholesterol level; unexplained weight gain; muscle aches, tenderness and
stiffness; pain, stiffness or swelling in the joints; muscle weakness; heavier
than normal menstrual periods and depression. Forgetfulness
and slowing of
comprehension are additional symptoms of hypothyroidism (Mayo Clinic, 2006). 22
TREATMENT OPTIONS
Non-pharmacologic Therapy
The most extreme form of treatment for PMS is a hysterectomy with a
bilateral oophorectomy. This is only considered in
cases of severe PMS where the women has had children and does not wish to have
any more.
This option is not viable to young girls or women due to the finality of
the surgery in relation to being able to have children (Moreno, 2006).
Lifestyle changes can play a big part in curbing symptoms of PMS. Eating
properly
and getting adequate exercise and rest are the simplest steps to help
relieve PMS. Reducing the intake of sodium during the premenstruum
will help reduce water retention. Avoiding caffeine assists as caffeine has
been linked
to symptoms of breast tenderness and anxiety.
The intake of caffeine also contributes to the depletion of important
nutrients due to its diuretic action.
Women who exercise regularly have been shown to have less PMS symptoms
than women who don’t so getting regular exercise is a good way to
control PMS (Balch and Balch, 2003).
Yoga has been found to help in the control of PMS for three reasons.
Firstly the postures and breathing technique are designed to instil a peaceful
and tranquil state which will calm the physical and mental tension associated
with PMS. It decreases tension in the body and so decreases muscular and
joint aches and pains. Yoga teaches the maintenance of an upright and balanced
posture which relieves fatigue, lethargy and lower back pain. Thirdly
some of the yoga postures have been attributed to directly helping with
congestive dysmenorrhoea (Sheeve, 1992).
Acupuncture: A placebo
controlled study was conducted to test the effectiveness. The participants were
classified as having severe symptoms and some were on medication (progestin and
fluoxetine). The treatment group showed
a 77.8% improvement of
symptoms in comparison to the 5.9% improvement found in the placebo group. The
positive result was attributed to the serotonin and opiod
releasing effects of the acupuncture treatment (Habek,
et al. 2002). A randomised clinical trial was conducted to determine the
efficacy of chiropractic therapy on PMS. In this trial 54 subjects diagnosed
with PMS (using the Moos PMS questionnaire plus daily symptom monitoring) and
30 subjects with no
diagnosable PMS were recruited. The PMS group had a higher positive response
for each of 12 measured spinal dysfunction indexes except for range of motion
of the lower back. The indexes where the increases were statistically
significant (P<.05) were cervical, thoracic, and lower back tenderness,
lower back orthopaedic testing, lower back muscle weakness, and the neck
disability index. An average of 5.4 of the 12 indexes were positive for the PMS
group compared with 3.0 for the non-PMS group. This study proved that there is
a relatively high incidence of spinal dysfunction in PMS sufferers compared
with a comparable group of non-PMS sufferers. This research suggests spinal
dysfunctions as a possible aetiological factor for PMS and that chiropractic
manipulation may offer a good alternative approach to treating PMS (Polus and Walsh, 1999). A study was conducted to see
the effect of consuming soy isoflavone on the
behavioural, somatic and affective symptoms in women with PMS. The study used
23 women with diagnosed PMS and took place over a seven menstrual cycle time
frame. It was a double-blind placebo-controlled, crossover intervention study.
The study proved that isolated soya protein containing soy isoflavones
may reduce specific premenstrual symptoms but on the totality of the
premenstrual symptoms there proved to be insignificant difference between the
placebo and active groups (Bryant, et al. 2005).
A systemic review was done on 27 randomised controlled trials conducted
to show the efficacy of various complementary therapies in the treatment of
PMS. (7 Herbal trials, 13 dietary supplement trials and 1 trial of each of the
following disciplines: homoeopathy, biofeedback, chiropractic, massage,
reflexology, relaxation.) This review showed that despite positive findings in
some of the trials reviewed there is very little evidence to prove that
complementary medicines are effective for the treatment of PMS (Ernst and Stevinson, 2001). The trials that were reviewed all had a
small sample size. The good clinical findings would be more indicative of the
efficacy of the therapies if conducted in a larger group because a larger
sample size yields more statistically significant results than a small sample.
Psychological treatment has also been found to relieve symptoms of PMS.
Education about PMS and using a diary to monitor symptoms has been noted
to help women feel more in control and reduce symptoms. Teaching women how to
relax by the use of the relaxation response, biofeedback and
guided imagery helps to relieve tension and so help the PMS. Cognitive
behavioural therapy has also been clinically noted to help symptoms of PMS
(Moreno, 2006).
Dietary Supplementation
Dietary supplements that
have been evaluated in women with PMS include vitamins (A,E, and B6), calcium, magnesium,
multivitamin/mineral supplements, and evening primrose oil. Most studies have
been small or poorly designed, efficacy needs to be confirmed in large,
well-designed clinical trial before evidence-based recommendations can be made
(Dickerson et al., 2003).
Pharmacologic Therapy
Over the Counter drugs (OTC) 2
OTC drugs that are useful to relieve symptoms of PMS include drugs
containing mild diuretics, analgesics, prostaglandin inhibitors and
anti-histamines. Caution must always be used when combining products due to
risk of inadequate dosing of some ingredients in the drugs and excessive dosing
of others. It is preferential to use a single product when using OTC drugs to
negate this issue (Dickerson et al., 2003). Herbal preparations and
vitamins (discussed in 2.8.2) are included as OTC.
Herbal treatments for PMS:
Agn.: Brustschwellung,
Depression und Akne vor der Periode.
Dioscorea villosa (Wild Yam) is known
historically to treat „women’s complaints’. It has been
used to relieve cramps and mood swings. Wild Yam contains the sterol, diosgenin, with progesterone-like effects which is why it
has been attributed to relieve symptoms of PMS (Dixie Health, 2006).
Agnus Castus (Chaste tree) has been
shown to help re-establish normal balance of oestrogen and progesterone during
the menstrual cycle. The action of re-establishing a normal hormonal balance
helps women whose PMS is
due to underproduction of progesterone or overproduction of oestrogen.
It has a calming soothing effect and relieves muscle cramps. Chaste tree needs
to be taken for at least four cycles to determine efficacy (Balch and Balch,
2003).
Angelica sinensis (Don Quai) is a
traditional Chinese medicine and is often referred to as female ginseng. It
helps promote normal hormonal balance and is useful for women suffering from
premenstrual cramping and pain
(Dixie Health, 2006). Don Quai acts as a mild sedative, laxative,
diuretic, antispasmodic and pain reliever along with assisting the usage of
hormones by the body (Balch and Balch, 2003).
Chamaelirium luteum
(False
Unicorn Root) is a Native American traditional medicine which is useful in
treating amenorrhoea, painful menses and other menstrual irregularities (Dixie
Health, 2006).
Psychotropic agents Anti-anxiety and anti-depressant drugs are often
utilised to treat the emotional symptoms of PMS (Hayman, 1997). Anti-anxiety
agents such as Alprazolam (Xanax)
and Buspirone (BuSpar) have
been effective in
helping the anxiety-related symptoms of PMS. The Selective Serotonin Re-Uptake
Inhibitors (SSRI), Fluoxetine (Prozac) and Sertraline (Zoloft), are the first-line drugs for severe
emotional symptoms.
They work best when
taken throughout the month. Clomipramine (Anafranil) given for the full cycle or half-cycle has been
effective in treatment of emotional symptoms. Nefazodone,
an antidepressant that blocks serotonergic
and noradrenergic
uptake, recently was shown to be effective in relieving symptoms (Moreno,
2006).
Diuretics Many women complain of bloating and cyclical weight gain due
to fluid retention. Diuretics help to turn these excess fluids in the body into
urine, increasing the frequency and quantity of urine. Side effects
of nausea and dizziness
are not uncommon. Some research suggests that not only is premenstrual bloating
a normal aspect of cyclical change, but that it is not associated with an
actual increase in girth. Fluid may shift around the body, and there may be an
increase in distension or pressure in the abdomen, but the actual external
measurements do not increase. If this is so diuretics would not be an
appropriate treatment (Hayman, 1998: 106). 27
Prostaglandin Inhibitors
Non-Steroidal Anti-Inflammatory (NSAIDS) are agents which are useful for
managing the general aches, pains, and dysmenorrhoea associated with PMS. Commonly
used drugs in the treatment of PMS are Ibuprofen and Mefenamic
Acid (Thompson, 2004). Agents used to alter the menstrual cycle The oral
contraceptive pill (OCP) has been used to regulate the menstrual cycle and
alleviate the symptoms of PMS. However in a study conducted in the Royal
Edinburgh Hospital where 276 women who considered themselves to have PMS were
studied, 171 of which were on the OCP, found that women on OCP experienced
delayed or more prolonged pattern of perimenstrual
negative mood (Bancroft and Rennie, 1993).
HOMOEOPATHY
Homoeopathic. prescription of
medicines is based on the “Law of Similars”. The idea
is that „like cures like’, that is, any substance which can produce
a totality of symptoms in a healthy human being can cure that totality of
symptoms in a sick human being. A homoeopathic remedy helps the body to heal
itself, by stimulating the body’s own energies or vital force. The
remedies initiate the vital force to rid the body of disease, helping the body
to return to health (Vithoulkas, 1998). Menstrual
disorders at all ages and stages can be treated effectively with homoeopathy
(Bloch, 2003).
HOMOEOPATHIC TREATMENT OF PMS
Martinez (1990)
conducted a double-blind placebo-controlled trial using Foll. in potencies 9C and 15C
in 32 participants. A questionnaire was given to all the participants
prescribed Folliculinum at their first consultation,
to
be collected at the
subsequent consultation. The duration of the treatment was 2 - 4 months. Of all
the participants, 88% showed a satisfactory response to the treatment according
to the questionnaire. Most of the participants (61%) noted an improvement from
the second cycle after having started the treatment. 93% of the participants
felt that the treatment had physiological effects while only 7% felt that the
effects might be due to the placebo effect. The most marked effect on
particular symptoms was on breast swelling, metorrhagia
and menstrual irregularities.
Kirtland (1995)
conducted a double-blind placebo controlled study involving 31 women from the
greater Durban area where she compared the effect of Foll. 15CH to placebo. The
results were based on a subjective questionnaire filled in by the participants.
The test group (16 women) had 89% improvement, 4% unchanged and 7% worsening of
the premenstrual symptoms. The placebo group (15 women) had 7% improvement, 4%
unchanged and 89%
worsening of premenstrual symptoms. The improvement ascertained during
the trial was statistically significant. A double-blind study of the
homoeopathic treatment of PMS used a complex, Premenstron®
(= Agn D1 + Cham-er.
D3
+ Lil-t. D3 + Caul. D4 + Equis-a. D4. + Zinc-valer + Ign. D 6 + Kali-c. D6) was compared to placebo.
Thirty participants were randomly selected and divided into their respective
groups. The statistical results were overall 53.3% improvement in the placebo
group while 46.7% worsened. In the treatment group 86.7% showed improvement and
12.3 % worsened. The improvement in the treatment group was not significant
enough to verify that the complex was effective when analysed statistically and
in comparison with the effect of the placebo (Sarawan,
2001). As the study was conducted as part of a mini-dissertation the test
sample was small which resulted in there
not being statistical significance in the findings. However based on the
clinical findings the homoeopathic complex had significant improvement to merit
further research.
A study was conducted in Israel to test the efficacy of treating PMS
with homoeopathic simillimum using the cluster method
to derive the remedy. The simillimum was selected by
the subject filling in a questionnaire which related to the keynote symptoms of
5 polychrest remedies commonly used in the treatment
of PMS:
Sep.
Nux-v.
Puls.
Nat-m.
Lach.
The prescription was made based on the cluster of „yes’
answers relating to each remedy. The remedy with the most positive response was
considered the simillimum. The subject was then given
a single powder (which was either the placebo or the selected simillimum). The subjects were then monitored for 3 months
on a once monthly basis to see the effect of their treatment. The study was a
double-blind and placebo-controlled in which the results were only correlated
at the end of the study. They observed improvements greater than 30% in 90% of
participants receiving the active treatment and in 37.5% receiving placebo (Yakir
et al., 2001). The limitation of this study was
the
restriction of homoeopathic remedies which could be prescribed for PMS. The
focus of the study was the efficacy of the method of prescribing rather than
the efficacy of a homoeopathic simillimum. Women were
excluded
if their
symptom profile did not correlate with the selected remedies. However, simillimum prescribing is a holistic process taking the
symptom profile of the entire person rather than just the premenstrual
symptoms.
Remedies were
prescribed at the first consultation for each participant, there was one
remedy prescribed. Carcinosin |
4 |
Sepia officinalis |
4 |
Calcarea carbonica |
3 |
Arsenicum album |
2 |
Natrum muriaticum |
6 |
Ignatia amara |
2 |
Sulphur |
1 |
Nux vomica |
1 |
Silica |
1 |
Phosphorus |
1 |
Pulsatilla nigrans |
1 |
Lachesis mutas |
1 |
Intra-group analysis
Table 4.1 demonstrates
that the Treatment Group showed a significant difference in the reduction of
symptoms in the subgroups of water retention (p=.020) and appetite changes (p=.010)
during the trial. Table 4.3 demonstrates that the significant difference in
regard to water retention occurred between the first and third consultation
(p=.034) and between the second and third consultation (p=.018). Table 4.3
indicates the difference in appetite changes occurred between the first and
second consultation (p=.009) and between the first and third consultation
(p=.013). No significant difference was noted in the subgroups of pain
(p=.076), concentration (p=.052), behavioural changes (p=.679), autonomic
reactions (p=.197), negative affects (p=.168), arousal (p=.690) or control
(p=.313) in the Treatment Group.
Table 4.2 demonstrates that the Placebo Group showed a significant
difference in the reduction of symptoms in the subgroups of concentration
(p=.029), autonomic reactions (p=.013) and appetite changes (p=.035) during the
trial. No significant differences were noted in the subscales of pain (p=.360),
behavioural changes (p=.078), water retention (p=.079), negative affects
(p=.125), arousal (p=.572), and control (p=.175).
Table 4.4 indicates that the significant difference in autonomic
reactions occurred between the first consultation and the second consultation
(p=.013). The significant differences in concentration (p=.050) and appetite
changes (p=.008) occurred between the first and third consultation.
Inter-group analysis
Inter-group analysis for
all aspects of the MDQ questionnaire revealed no statistically relevant results
(table 4.5), and hence the null hypothesis was accepted.
Conclusion - MDQ
The statistical evidence
indicates that homoeopathic simillimum is ineffective
in the treatment of PMS.
LIMITATIONS OF THE STUDY
DESIGN: A POST-HOC ANALYSIS
Participant Compliance
PMS is a chronic
condition so the study should have been conducted over a longer time period for
the effect of homoeopathic simillimum to be
adequately examined. The researcher feels that the limited duration of the
study would not have effectively shown the efficacy of the treatment. The
research should have incorporated telephonic follow up consultations in the
study design as this would have combated a large number of participant
withdrawals from the study due to poor accessibility at the Homoeopathic Day
Clinic due to various events outside of the researcher’s control.
Sample Size
Due to participant
non-compliance the researcher had to reduce sample size. The initial sample
size should have been larger to account for non-compliance and withdrawals so
that the final sample size would still be large enough to make the study
statistically viable. This would have indicated a true reflection of the effect
of homoeopathic simillimum on PMS.
Prescription
The study utilised three single unit
homoeopathic powders (active/ placebo) followed by 20ml homoeopathic liquid
(active/ placebo) remedies, which were given in drop form on a daily basis. The
powder medicines were
taken consecutively on a daily basis from day 10
of the menstrual cycle (10 days after onset on menses). The liquid medicine was
taken daily from day 13 of the menstrual cycle (13 days after the onset of
menses)
and continued daily till the onset of the
following menstrual cycle. The participants took the remedies for a single
menstrual cycle and then had no further treatment. The researcher believes a
daily remedy/placebo for the
duration of the study would have improved
overall compliance. Administration of medication (active/placebo) should have
taken place at each consultation as this would have given the researcher the
option to repeat
the simillimum if need
be or to give placebo treatment. This would have simply acted as a daily
reminder of the research being conducted which may have helped with overall
compliance in the study. The repetition of
prescription would negate the effect of life
stressors interrupting the study. The participants experienced great stress
over the research period, for example: examinations, marriage preparation,
pregnancy scares, crime and
others. All of which serve as interference to a
clear indication of the effect of homoeopathic simillimum.
Outcome measures
The use of a single
outcome measurement tool was exceedingly limiting in assessing the efficacy of
the condition, especially since the questionnaire was completed monthly
post-menses and relied upon the participant’s recollection. Participants were
not always clear about the meaning of the different categories of the
questionnaire, which may have led to mis-information.
The researcher should have given clear definitions of the 66
categories in the pre-research literature to prevent confusion with
regards to meanings. In addition to the MDQ the researcher should have elected
to use a daily rating scale of symptoms. The participants would then have
completed a questionnaire daily and the researcher would use the scores for the
7 days before the menstrual cycle to indicate the premenstrual scores. The act
of recording symptoms daily would serve as a reminder that they are
participating in a study and so would improve compliance. It would also increase
the accuracy of the results as the scores are not based on recollection but at
the time the participant experienced them. The MDQ would still be
done at each consultation using the scores for the 7-10 days before the
menses. The use of a second outcome measure would improve overall accuracy in
recording efficacy of treatment.
Inexperience of the researcher
Implicit to the
identification of the simillimum is the homoeopath.
Different practitioners vary in age, gender, expertise, experience and approach.
Thus the results of any trial involving the simillimum
are as much an evaluation of the practitioner as it is the modality (Bloch,
2002:59). Although the researcher received clinical supervision, it must be
noted that she is relatively inexperienced. The relative lack of experience on
the part of the researcher may have accounted for the prescription of broader
acting remedies, such as Natrum muriaticum, because the case-taking skills of the
researcher were not as honed as an experienced homoeopath, and so the nuances
of smaller remedies would be missed during consultation. However, the remedies
prescribed during the trial were all well indicated based on the information
gained from the participant. In a homoeopathic case there is some information,
which is objective but the majority of the information is subjective or
qualitative which is where the homoeopath’s case-taking/counselling skills come
into consideration. The interpretation of the information gained is varied with
experience and skill level of the homoeopath. 67
Swayne (1998:41) and Scholten (2002:825) state
that the skill and experience of the individual homoeopath is an important
factor in determining the use of remedies, and application of the simillimum method; consequently it will influence treatment
outcomes. Even with the inexperience of the researcher many participants noted
an improvement in general well being. Two of the women on active treatment
noted a complete 180 degree turn around of symptoms with energy levels
improving, sleep improving and general motivation to improve their lives
increasing. These improvements were only noted during the month of treatment
and not in the following observational month. However the scores at the end of
the trial were better than at the beginning (only by a small margin).
PLACEBO EFFECT
Placebo is any
therapeutic procedure (or component of therapeutic procedure) which is
deliberately given to have effect on, a symptom, syndrome or disease, but which
is without specific activity for a condition being treated (Liggins,
2002). In this study the consultation itself is a placebo as it brings about
improvements non-specific to the complaint. Most of the participants reported
changes to their general well being other than that relating to PMS irrespective
of which group they were allocated to in the trial. PMS has often reported high
rates of positive response to placebo (Freeman et al, 1999). The changes
noted in both groups, even if not statistically significant, did comply with
the above statement. The act of acknowledgement of PMS as a real complaint and
the suggestion of receiving a treatment for it was enough to cause a clinical
change.
Placebo group
Sarawan (2001) found that in
some aspects of his study the placebo out-performed the complex. Kirtland
(1995) found that in her study conducted to compare placebo to homoeopathic
preparation of Folliculinum 15CH, that the placebo
group only experienced a 7% improvement at the end of the trial in comparison
to the 89% improvement found in the Treatment Group. Intra-group analyses
revealed that concentration, autonomic response and appetite changes all had
significant improvement on placebo, which indicated a psychological aspect of
the condition. The case-taking process may account for the improvements in the
homoeopathic consultation, which allows the participants to express themselves
in a caring, quiet and empathetic environment, which causes positive changes in
their lives.
Treatment Group
If the therapeutic
potential of the consultation played a role in the placebo group there is a
high likelihood that it had a possible influence in the Treatment Group.
Assuming this to be the case, the positive affects seen in the Treatment Group
could simply be due to the placebo effect, especially considering how similar
the overall changes were between the two groups.
Remedies most often
prescribed in the research were: Natrum muriaticum, Carcinosin, Sepia officinalis and
Calcarea carbonica.
Natrum muriaticum (sea salt) was the most prescribed remedy with 12 prescriptions
being Natrum muriaticum of
the total 39 prescriptions made up in the research. Of this group 6 completed
the study. It was apparent that many of the women experiencing PMS had to be
“in control of themselves to protect themselves and keep their lives together”.
This is a common trend in the Natrum muriaticum women. Natrum muriaticum women are very sensitive
and protect themselves by working through hurts and “walling off” their
feelings. Their bodies do not necessarily comply with this mentality and,
therefore, manifest physically what they refuse to manifest emotionally. This
occurs around the time of menses. Natrum muriaticum is averse to consolation or company and
may have periods of involuntary and hysterical weeping. Natrum muriaticum is also known for symptoms
of water retention due to the very nature of sea salt and its affiliation for
attracting water. Some PMS symptoms experienced by Natrum muriaticum:
Aggravation before menses
Involuntary and hysterical weeping
Depression
Headache before menses
Craving salt
Insomnia
Feeling trapped
Anaemia
Aversion to sex
Water retention
Fastidious
(Vermeulen,
2002:958-967)
Carcinosin
was
prescribed 4 times out of the total 39 prescriptions. All 4 participants
completed the study.
Sepia officinalis was prescribed 5 times out of the total 39
prescriptions and of these, 4 completed the study and were able to be used for
statistical purposes.
Calcarea
carbonica was prescribed 4 times out of the total 39
prescriptions and of these, 3 completed the study.
CONCLUSION
There was an overall
clinical improvement in both groups even though it was not statistically
significant. Therefore due to statistical parameters homoeopathic simillimum was found to be ineffective in the treatment of
PMS. 71
Vorwort/Suchen. Zeichen/Abkürzungen. Impressum.