Schlaf Anhang 2
Alternative zu Psychopharmika.x
[Ashnie Maharaj]
https://www.vereniginghomeopathie.nl/sites/default/files/kvhn/Onderzoek-Slapeloosheid-Maharaj_2005.pdf
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
(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. A product
that can be used to improve sleep patterns. (Bruni, Ferri, Miano and Verrillo,
2004).
Passi.: 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).
Valer.: 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.
Lup.: 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 and
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. This 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 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.
his 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,
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.
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. 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).
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.
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.
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 wake up (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.