Homeopathy for insomnia: A systematic review of research evidence

Article (PDF Available)inSleep Medicine Reviews 14(5):329-37 · March 2010with172 Reads
DOI: 10.1016/j.smrv.2009.11.005 · Source: PubMed
Abstract
Insomnia is a common problem which impacts on quality of life. Current management includes psychological and behavioural therapies and/or pharmacological treatments. To systematically review research evidence for effectiveness of homeopathy in the management of insomnia. Comprehensive searches of biomedical databases (MEDLINE, EMBASE, CINAHL, Cochrane library, Science Citation Index), homeopathy-specific and complementary medicine-specific databases were conducted. (A) Homeopathic medicines: four randomised controlled trials (RCTs) compared homeopathic medicines to placebo. All involved small patient numbers and were of low methodological quality. None demonstrated a statistically significant difference in outcomes between groups, although two showed a trend favouring homeopathic medicines and three demonstrated significant improvements from baseline in both groups. A cohort study reported significant improvements from baseline. (B) Treatment by a homeopath: No randomised controlled trials of treatment by a homeopath were identified. One cohort study, three case series and over 2600 case studies were identified. The limited evidence available does not demonstrate a statistically significant effect of homeopathic medicines for insomnia treatment. Existing RCTs were of poor quality and were likely to have been underpowered. Well-conducted studies of homeopathic medicines and treatment by a homeopath are required to examine the clinical and cost effectiveness of homeopathy for insomnia.

Figures

This article appeared in a journal published by Elsevier. The attached
copy is furnished to the author for internal non-commercial research
and education use, including for instruction at the authors institution
and sharing with colleagues.
Other uses, including reproduction and distribution, or selling or
licensing copies, or posting to personal, institutional or third party
websites are prohibited.
In most cases authors are permitted to post their version of the
article (e.g. in Word or Tex form) to their personal website or
institutional repository. Authors requiring further information
regarding Elsevier’s archiving and manuscript policies are
encouraged to visit:
http://www.elsevier.com/copyright
Author's personal copy
CLINICAL REVIEW
Homeopathy for insomnia: A systematic review of research evidence
Katy L. Cooper
*
, Clare Relton
a
School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK
article info
Article history:
Received 11 August 2009
Received in revised form
27 November 2009
Accepted 27 November 2009
Available online 11 March 2010
Keywords:
Systematic review
Insomnia
Homeopathy
Homeopathic medicines
Treatment by a homeopath
summary
Background: Insomnia is a common problem which impacts on quality of life. Current management
includes psychological and behavioural therapies and/or pharmacological treatments.
Objective: To systematically review research evide nce for effectiveness of homeopathy in the manage-
ment of insomnia.
Methods: Comprehensive searches of biomedical databases (MEDLINE, EMBASE, CINAHL, Cochrane
library, Science Citation Index), homeopathy-specific and complementary medicine-specific databases
were conducted.
Results: (A) Homeopathic medicines: four randomised controlled trials (RCTs) compared homeopathic
medicines to placebo. All involved small patient numbers and were of low methodological quality. None
demonstrated a statistically significant difference in outcomes between groups, although two showed
a trend favouring homeopathic medicines and three demonstrated significant improvements from
baseline in both groups. A cohort study reported significant improvements from base line.
(B) Treatment by a homeopath: No randomised controlled trials of treatment by a homeopath were
identified. One cohort study, three case series and over 2600 case studies were identified.
Conclusions: The limited evidence available does not demonstrate a statistically significant effect of
homeopathic medicines for insomnia treatment. Existing RCTs were of poor quality and were likely to
have been underpowered. Well-conducted studies of homeopathic medicines and treatment by
a homeopath are required to examine the clinical and cost effectiveness of homeopathy for insomnia.
Ó 2009 Elsevier Ltd. All rights reserved.
Introduction
Insomnia and current management
Insomnia is a disturbance of normal sleep patterns commonly
characterised by difficulty in initiating or maintaining sleep.
1
A
systematic review reported that 16–21% of people in the UK expe-
rience insomnia symptoms often or always.
2
Current management
of insomnia may include psychological and behavioural therapies
and/or pharmacological treatments such as benzodiazepine
receptor agonists (BZRAs), melatonin receptor agonists, and other
agents.
3
Pharmacological treatments have been shown to improve
sleep outcomes, but may be associated with a risk of adverse effects
and dependence in some patients.
1,4
There remains a shortage of
studies assessing the risk-benefit ratio of long-term use of these
treatments, although recent studies of eszopiclone and zaleplon
have indicated favourable safety profiles with treatment up to 1
year.
3,6
In terms of psychological and behavioural therapies for
insomnia, the following have been shown to be effective: stimulus
control therapy, relaxation techniques, paradoxical intention, sleep
restriction, and cognitive behaviour therapy.
7
Studies and reviews of
cognitive behavioural therapy (CBT) for insomnia have reported
improvements in sleep quality and reductions in hypnotic drug use,
although studies vary in terms of the techniques used and the
setting in which they are delivered.
6,8–12
Access to many non-
pharmacological therapies is restricted due to lack of trained
providers, cost, and a poor understanding of available options.
7,13–15
A number of complementary and alternative medicines (CAM)
have been investigated for treatment of insomnia. These include
acupuncture,
16,17
as well as herbal remedies such as valerian
18,19
and other herbal preparations.
20
The focus of this review relates to
homeopathy for the treatment of insomnia.
Homeopathy
Homeopathy is a ‘system of therapeutics’ that uses doses of
substances (known as homeopathic medicines or remedies)
prescribed according to two principles: similitude (‘‘like cures
like’’)
53
and potentisation (serial dilution and succussion; see
*
Corresponding author. Tel.: þ44 0114 222 0773; fax: þ44 0114 272 4095.
E-mail addresses: k.l.cooper@sheffield.ac.uk (K.L. Cooper), c.relton@sheffield.ac.
uk (C. Relton).
a
Tel.: þ44 0114 222 0796; fax: þ44 0114 222 0791.
Contents lists available at ScienceDirect
Sleep Medicine Reviews
journal homepage: www.elsevier.com/locate/smrv
1087-0792/$ see front matter Ó 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.smrv.2009.11.005
Sleep Medicine Reviews 14 (2010) 329–337
Author's personal copy
Glossary for further details). Homeopathic medicines can be
prescribed as either formulaic (according to the medical diagnosis)
or individualised (according to the overall symptom picture of the
patient). Homeopathy is provided in many publicly funded health-
care systems. It is important to distinguish between homeopathic
medicines and treatment by a homeopath.
21
Homeopathic medicines
Homeopathic medicines can be obtained over the counter in
pharmacies, supermarkets and health food shops or ordered
directly from homeopathic pharmacies. A United Kingdom (UK)
population-based survey reported that 8.6% of respondents had
purchased a homeopathic medicine in the previous twelve months
and 14.6% of respondents had bought an over-the-counter
homeopathic medicine in their lifetime.
22
A trial of homeopathic
medicines is one which compares a homeopathic medicine to
a comparator, but does not randomise patients in terms of whether
or not they receive consultations with a homeopath.
Treatment by a homeopath
Treatment by a homeopath involves taking a detailed case history
which aims to build up a ‘symptom picture of the patient which is
then matched with a ‘homeopathic drug picture’ as described in the
homeopathic materia medica.
23
On this basis, the homeopath
prescribes one or more individualised homeopathic medicines.
Treatment by a homeopath is a complex intervention
24
which
incorporates assessment, discussion and advice regarding the
patient’s overall health profile and otheraspects of the patient’s life, in
addition toprescription of a medicine.
25
AUK survey showed that1.9%
of the UK population had consulted a homeopath in the previous 12
months.
22
A trial of treatment by a homeopath is one which compares
treatment by a homeopath to a comparator (e.g., usual care).
Health service perspective on homeopathy
The traditional way of understanding or modelling ‘homeopathy’
is that the homeopathic medicine provides the specific effect.
However, clinical guidance is primarily based on overall clinical and
cost effectiveness of an intervention. There are an estimated 120,000
visits to homeopaths annually within the UK National Health Service
(NHS), with an NHS expenditure of £3.3 million. NHS spending on
homeopathic medicines accounts for around 5% of this total
amount,
21
while the bulk of the cost of ‘homeopathy’ in the NHS is
the cost of the treatment by a homeopath, i.e., consultation(s) with
the homeopath and the infrastructure to facilitate this. Thus the
evidence that is required to inform the debate regarding NHS
spending on what is termed ‘homeopathy is largely evidence of the
clinical and cost effectiveness of treatment by a homeopath.
21
Homeopathy for insomnia
Two recent surveys reported that 4.5–18.5% of people with
insomnia symptoms had used complementary and alternative
medicines (CAM) or natural products to manage their insomnia,
26,27
and a recent study showed that insomnia is one of the most
commonly-treated complaints within homeopathic hospitals in the
UK.
28
Three surveys of homeopathic consultations in the UK
reported that 0.4%, 4% and 7% of cases related to insomnia,
respectively.
29–31
This review systematically assesses current
research evidence for the effectiveness of homeopathic medicines
and treatment by a homeopath in the management of insomnia.
Methods
Search methods for identification of studies
A comprehensive search was carried out, including searching of
biomedical databases, homeopathy-specific and complementary
medicine-specific databases. The following biomedical databases
were searched: MEDLINE, EMBASE, CINAHL, Cochrane Central
Register of Controlled Trials (CENTRAL), Cochrane Database of
Systematic Reviews, Database of Abstracts of Reviews of Effective-
ness (DARE), Science Citation Index, and BIOSIS Previews. Searches
were also undertaken of the Allied and Complementary Medicine
(AMED) database and homeopathy-specific databases including
Hom-Inform,
32
ReferenceWorks
33
and a further database of trials of
homeopathy.
34
Database searches were carried out in July 2009. No
date or language restrictions were applied.
When searching the standard medical databases such as MED-
LINE, search terms incorporated terms for homeopathy (homeo-
path*, homoeopath*, and homeopathy subject headings) together
with terms for insomnia (insomnia*, sleep*, and insomnia subject
headings). When searching the homeopathy-specific databases,
only ‘‘insomnia*’’ and ‘‘sleep*’’ search terms were used to increase
search sensitivity.
Inclusion and exclusion criteria
This review aimed to identify any clinical studies of homeo-
pathic medicines or treatment by a homeopath. In particular,
Nomenclature
AMED Allied and complementary medicine database
BZRA Benzodiazepine receptor agonist
CAM Complementary and alternative medicine
CBT Cognitive behavioural therapy;
CENTRAL Cochrane central register of controlled trials
CINAHL Cumulative index to nursing and allied health
literature
DARE Database of abstracts of reviews of effectiveness
EMBASE Excerpta medica database
MEDLINE Medical literature analysis and retrieval system
online
NHS National health service (UK)
RCT Randomised controlled trial
UK United Kingdom
Glossary
Similitude: If a substance can cause symptoms in a healthy
person, then a homeopathic ‘potency’ of the substance
has the potential to provoke a healing response in ill
people with these same symptoms, known colloquially as
‘‘like cures like’’. This is known as similitude.
Potentisation: The more that a homeopathic remedy is diluted
and succussed (vigorously shaken), the more effective or
‘potent’ it becomes. This is known as potentisation. The most
potent remedies are unlikely to contain any molecules of the
original substance. The apparent implausibility of the prin-
ciple of potentisation has given rise to much scientific
controv ersy about homeopathic treatment.
Formulaic homeopathic medicine: A homeopathic medicine
prescribed according to the medical diagnosis.
Individualised homeopathic medicine: A homeopathic medi-
cine prescribed according to the overall symptom picture of
the patient.
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337330
Author's personal copy
controlled trials were sought. Observational studies and case
studies were identified as far as possible. Studies addressing
insomnia as the primary condition were included, while studies
with insomnia as a secondary symptom of another primary
condition were excluded. No language restrictions were applied.
Animal studies and laboratory-based experimental studies were
excluded. Identification of relevant studies was carried out by two
reviewers.
Data extraction and analysis
Data was extracted using a form designed for this study. Data
extracted was checked by a second reviewer. Controlled trials were
assessed for study quality using a standard appraisal form based on
criteria recommended by the Centre for Reviews and Dissemina-
tion.
35
Observational studies were assessed for study quality based
on criteria recommended by the Critical Appraisal Skills Pro-
gramme (CASP).
36
Results
Included studies
The literature search identified 296 citations (Fig. 1). Of these, 39
were relevant for inclusion.
(A) Studies of homeopathic medicines: the review identified 4
placebo-controlled RCTs
37–40
plus one uncontrolled cohort
study
41
(Table 1).
(B) Studies of treatment by a homeopath: No RCTs of treatment by
a homeopath were identified. However, the review identified
one cohort study,
42
three case series
31,43,44
and over 2600 case
studies (30 from the literature search and 2580 from a search of
the homeopathy database ReferenceWorks) (Table 2).
Excluded studies
A crossover RCTevaluated homeopathic medicine versus placebo
for circadian dysrhythmia (‘‘shift lag’’) in 28 nurses working night
shifts in an intensive care unit.
45
However, this study was excluded
from the analysis as it did not specifically address insomnia.
Studies of homeopathic medicines
Four RCTs and one uncontrolled cohort study of homeopathic
medicines were identified (Table 1).
Randomised controlled trials
The literature search identified one crossover RCT of indi-
vidualised homeopathic medicines versus placebo,
37
and thre e
RCTs of formulaic homeopathic medicines versus place bo.
38–40
Carlini et al.
37
assessed 44 patients with severe insomnia, who
had a course of seven appoi ntments with a homeopath. Patients
received either individualised homeopathic remedies for 45 days
foll owed by pla cebo for 45 days or vice versa. Of the 26 patients
who had full follow-up data, no consistent difference was
observed between patients starting on homeopathic remedies or
placebo, although analysis was complicated by the crossover
design and the fact that all patients received a course of treat-
ment by a homeopath. Both groups showed statistical ly signifi-
cant improvements from baseline by day 15 and for the full 90-
Citations identified via literature search:
N = 296 citations
Citations rejected at title or
abstract stage:
N = 256 citations
Citations included:
N = 39 citations from literature search (plus 2,580 case
studies from ReferenceWorks)
Studies of homeopathic medicines:
RCTs: N = 4
Cohort studies: N = 1
Studies of treatment by a homeopath:
RCTs: N = 0
Cohort studies: N = 1
Case series: N = 3
Case studies: N = over 2,600 (30 from main literature
search plus 2,580 from ReferenceWorks)
Citations rejected at full text stage:
N = 1 citation
(RCT of homeopathy for effects
of night shift work)
Citations examined as full texts:
N = 40
Search of the homeopathy
database ReferenceWorks for
relevant case studies
Fig. 1. Flow chart for identification of relevant studies.
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337 331
Author's personal copy
Table 1
Homeopathic medicines: characteristics and results of included studies.
Reference Study type Population Intervention and N Control Results Quality/methodology/
clinical comments
Randomised controlled trials (RCTs)
Carlini et al.
37
RCT, crossover, Brazil
(article in Portuguese)
Patients with severe
insomnia
N ¼ 44 randomised,
26 analysed
Mean age: not reported
Individualised homeopathic
medicine (agreed by 2
homeopaths) then placebo.
N ¼ 25 randomised, 13
analysed up to day 45, 9
analysed up to 3 months
Duration: 45 days
homeopathy then
45 days placebo
Placebo then individualised
homeopathic medicine.
N ¼ 19 randomised, 13
analysed up to day 45,
9 analysed up to 3 months
Duration: 45 days placebo
then 45 days homeopathy
The following outcomes were
measured every 15 days up to
3 months: sleep duration,
sleep latency, sleep quality,
and clinical evaluation
by homeopaths.
Both groups showed significant
improvement from baseline
by day 15 and at all timepoints
until 3 months, on all outcomes.
No consistent differences
between patients starting on
intervention or placebo, although
difficult to analyse due to
crossover design.
Withdrawals: 18/44 (41%)
withdrew by day 45 and
not included in any
analysis; 26/44 (59%)
withdrew by end of
study and not included
in 3-month analysis
Allocation concealment:
Yes
Blinding: Double-blind
Comparability between
groups: Not reported
Statistical power:
Not reported
Cialdella
et al.
38
RCT,
France
(article in French)
Patients with insomnia
having received low-dose
benzodiazepines
for 3 months
N ¼ 96 randomised,
61 analysed
Mean age: 54
Formulaic homeopathic
medicines: Homeogene-46
a
or Sedatif-PC
a
N randomised
per group not reported.
N analysed:Homeogene-46:
15;Sedatif-PC: 20;
Placebo: 26.
Duration: 1 month
Placebo
N randomised per group
not reported.
N analysed: 26.
Duration: 1 month
Patients meeting primary outcome
(completed study and showed
improvement or no change in
symptoms on Clinical Global
Impression Improvement scale
at 1 month): Homeogene-46:
10/15 (67%); Sedatif-PC: 12/20 (60%);
placebo: 13/26 (50%); no significant
difference between groups.
Secondary outcomes at 30 days:
treatment preferences (see below);
patients requesting return to BZD
treatment; scale scores on a range
of questionnaires.
No significant differences between
3 groups (but did not test for
difference between homeopathy
or placebo).
Percentage of patients preferring
(at 1 month) (i) study treatment,
(ii) prior benzodiazepine therapy, or
(iii) no treatment/other treatment/no
preference were as follows:
homeopathy groups: 33%, 30%, 37%;
placebo group: 19%, 38%,
43% respectively.
Withdrawals: 35/96
(36%) not included
in analysis (due to
violation of entry
criteria or absence
of data). Of patients
analysed, 19/61 (31%)
withdrew from
treatment but still
analysed.
Allocation concealment:
Yes
Blinding: Double-blind
Comparability between
groups: Yes
Statistical power:
Lack of statistical power
due to accrual difficulties
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337332
Author's personal copy
Wolf
39
RCT, Germany
(article in German)
Patients with difficulties
falling asleep or staying
asleep (both groups
sleeping for average of
8 h per night at baseline)
N ¼ 29 randomised,
28 analysed
Mean age: Not reported (range 19–73)
Formulaic homeopathic medicine -
Requiesan
a
N ¼ 15 randomised,
14 analysed
Duration: 1 month
Placebo
N ¼ 14
randomised,
14 analysed
Duration:
1 month
At 1 month:
Proportion of patients reporting
improvement was 8/14 (57%)
in homeopathy group and 4/14
(29%) in placebo group
(difference between groups
not significant)
Sleep time increased by 30 min
in homeopathy group (non-significant
change from baseline); unchanged
in placebo group.
Sleep latency decreased
significantly from
baseline in both groups (from 1 h
to 30 min in homeopathy group
and from 30 min to 20 min in
placebo group)
Night waking decreased significantly in
both groups.
Sleep quality improved
significantly in both groups.
Withdrawals: 1/29 (3%)
not included in main
analysis
Allocation concealment:
Not reported
Blinding: Double-blind
Comparability between
groups: Not reported
Statistical power:
Not reported
Other:
Not clear whether
reported p-values
refer to differences
between groups or
from baseline
Kolia-Adam
et al.
40
RCT,
South Africa
People with insomnia
lasting >1 year, with
difficulty in falling
asleep due to nervous
excitability and flow
of ideas (excluded
people taking
medication for insomnia)
N ¼ 30 randomised and
analysed
Mean age: 32–33
Formulaic homeopathic
medicine:
Coffea cruda 200c
N ¼ not reported
Duration: 1 month
Placebo
N ¼ not reported
Duration: 1 month
Increase in sleep duration in
both groups (38 min in
homeopathy group, p ¼ 0.003
from baseline; 35 min in
placebo group; p ¼ 0.007
from baseline); no significant
difference between groups
Improvement in sleep pattern
in both groups: p ¼ 0.002
from baseline in homeopathy
group; p ¼ 0.011 from baseline
in placebo group. Not reported
whether significant difference
between groups.
Withdrawals: not
stated
Allocation concealment:
Yes
Blinding: Double-blind
Comparability between groups:
Not reported
Statistical power: Not reported
Other:
Poorly reported; p-values
misinterpreted in
original paper. Patients
chose homeopathic
or placebo bottle,
therefore randomisation
poor.
Observational studies
Waldschutz and
Klein
41
Prospective cohort
study (non-randomised),
Germany, 89 centres
Patients with mild-to-
moderate insomnia
N ¼ 409 enrolled,
320 analysed
Mean age: 50
Formulaic homeopathic
treatment with
Neurexan
a
,
N ¼ 197 enrolled, 156 analysed.
OR
Herbal medicine: valerian,
N ¼ 212 enrolled,
164 analysed
Duration: 1 month
None Significant improvements from
baseline in homeopathy group
and valerian group on the
following outcomes:
sleep duration at 2 weeks
(increase of 2.2 h for
homeopathy; 2.0 h for valerian)
sleep latency at 2 weeks
(reduced by 37 min for
homeopathy; 38 min for valerian)
sleep quality at 4 weeks
daytime fatigue at 4 weeks
(majority in both groups reported
improvement; 49% for homeop-
athy and 32% for valerian reported
no daytime fatigue)
Design: Not randomised
or blinded.
Withdrawals:
89/409 (22%) excluded
from analysis due to
protocol violation
a
Homeogene-46 contained: Stramonium 3DH, Hyoscyamus niger 3DH, Passiflora incarnata 3DH, Ballota foetida 3DH and Nux moschata 4CH. Sedatif-PC contained: Aconitum napellus 6CH, Belladonna 6CH, Calendula
officinalis 6CH, Abrus precatorius 6CH, Chelidonium majus 6CH and Viburnum opulus 6CH. Requiesan contained two herbal medicines: California sleep poppy (Radix Eschscholzia californica) and green oats (Avena sativa), and
two homeopathic medicines: Coffea D3 and Arnica D3. Neurexan contained: Passiflora incarnata D2, Avena sativa D2, Coffea arabica D12 and Zincum isovalerianicum D4.
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337 333
Author's personal copy
Table 2
Treatment by homeopath: characteristics and results of included studies.
References Study type Population Intervention and N Control Results Quality/methodology/clinical comments
Observational studies
Witt et al.
42
Cohort study
(patients chose
own treatment),
Germany
493 patients with chronic
conditions, including
35 with insomnia
Mean age: 42
(homeopathy), 49
(conventional treatment)
Homeopathy (no further details)
N ¼ 12 (insomnia), 253
(other conditions)
Duration: 1 year follow-up
(treatment duration not reported)
Number of consultations:
Not reported.
Conventional treatment
N ¼ 23 (insomnia), 205
(other conditions)
No data available relating
to 35 patients with insomnia.
For all 493 patients with a
range of chronic conditions,
patient assessments of
symptom severity over
12 months showed
greater improvement
in homeopathy group,
while physician
assessments of
symptom severity
improved significantly
in both groups with
no difference between
groups. Overall cost per
patient was similar
in each group.
Design: Not randomised or blinded.
Patients made their own choice
of treatment.
Withdrawals: None reported.
Rogers
43
Case series 5 patients with sleep
disorders related to
alcohol dependency
Individualised homeopathy
treatment.
N ¼ 5
(completed and analysed)
Duration: 3 months
Number of consultations:
Not reported.
None 5 patients completing
study showed improvements
on all measures of sleep
quality (sleep diaries,
Pittsburgh Sleep Quality Index,
interviews) and measures of
alcohol dependence. 2 patients
had marked improvements,
2 slight improvements and
1 no change.
Design: Not randomised or blinded.
Withdrawals: 0/5 (0%)
Other: A controlled clinical trial
was attempted, but not feasible
due to issues of blinding,
recruitment of adequate numbers,
and clients not wishing to
receive placebo.
Crump
31
Case series 234 consecutive cases
consulting a homeopath,
17 with insomnia
Individualised homeopathy
treatment.
Duration: 3 months
None Of 17 patients:
- 6 (35%) no follow-up data
- 2 (12%) no change
- 7 (41%) reported as ‘‘better’’
- 2 (12%) reported as ‘‘much better’’
Design: Not randomised or blinded.
Withdrawals: 6/17 (35%) no
follow-up data
Treuherz
44
Case series 500 consecutive cases
referred via general
practice in UK, at
least 5 with insomnia
One or more consultations
with homeopath
None Of 5 insomnia cases described,
4 showed improvement; however,
the total number of insomnia
cases within the series was
not reported.
Design: Not randomised or blinded.
Withdrawals: Not reported
Various
43,47–51
Case studies Patients with insomnia One or more consultations
with homeopath
None Of six described here, all
reported benefit, but no
validated outcome measures used.
Potential drawbacks of case studies:
- Lack of validated outcome measures
- Reporting bias
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337334
Author's personal copy
day follow-up on the followi ng outcomes: sleep durat ion, sleep
latency, sleep quality, and clinical evaluation by a homeopath.
Three further RCTs assessed formulaic/complex homeopathic
remedies versus placebo. Cialdella et al.
38
describe the outcomes of
61 patients with insomnia previously receiving low-dose benzo-
diazepines whose treatment was substituted for 1 month with one
of two complex homeopathic remedies or placebo. There was
a trend towards more patients in the homeopathic remedy groups
meeting the primary outcome (completing the study and showing
improvement or no change in symptoms at 1 month), but the
difference between the groups was not significant for this outcome
or the secondary outcomes. This study lacked statistical power due
to accrual difficulties.
Kolia-Adam et al.
40
reported an RCT comparing the formulaic
homeopathic medicine Coffea cruda or placebo, given for 1 month
to 30 patients with insomnia. There were statistically significant
improvements from baseline in both groups in terms of sleep
duration (increase of approximately 40 min) and sleep pattern, but
no significant difference was reported between the groups.
In the RCT reported by Wolf,
39
28 patients with insomnia
received a combination of four formulaic homeopathic medicines
or placebo for 1 month. The proportion of patients reporting
improvement in symptoms was 8/14 (57%) in the homeopathic
medicine group and 4/14 (29%) in the placebo group; however, the
difference between groups was not significant, probably due to the
small patient numbers. Sleep latency, night waking and sleep
quality improved significantly in both groups.
All four RCTs involved small patient numbers, with the largest
reporting a lack of statistical power due to accrual difficulties.
38
The
included RCTs were poorly reported with high patient withdrawal
rates.
Observational studies
Cohort studies. Waldschutz and Klein
41
undertook a prospective
cohort study (non-randomised) of 409 individuals with mild-to-
moderate insomnia receiving either a combination homeopathic
medicine or the herbal medicine valerian, for 1 month. Significant
improvements from baseline were observed in both groups for the
following outcomes: sleep duration at 2 weeks (increased by
approximately 2 h in both groups); sleep latency at 2 weeks
(reduced by approximately 40 min in both groups); sleep quality at
1 month; and daytime fatigue at 1 month.
Studies of treatment by a homeopath
No RCTs, one cohort study,
42
three case series
31,43,44
and over
2600 case studies
33
were identified which assessed treatment by
a homeopath (Table 2).
Randomised controlled trials
There were no RCTs assessing treatment by a homeopath.
Observational studies
Cohort studies. Witt et al. (2005)
42
undertook a comparative cohort
study (non-randomised) of treatment by homeopaths or conven-
tional medicine practitioners for 493 patients with chronic condi-
tions. This study included 35 patients with insomnia, but no data
was available relating specifically to this subgroup. Overall, for all
493 patients, patient assessments of symptom severity over 12
months showed greater improvement in the homeopathy group
than the conventional treatment group, while physician assess-
ments of symptom severity improved significantly in both groups
with no difference between the groups. Overall cost per patient was
similar in each group.
Case series. A case series by Rogers
43
assessed treatment by
a homeopath for 5 patients with sleep disorders related to alcohol
dependency. Sleep quality and alcohol dependence were measured
at 3 months, with 2 patients showing marked improvements, 2
slight improvements and 1 no change. A controlled clinical trial was
attempted, but was found to be not feasible due to issues of blinding,
recruitment of adequate numbers, and clients not wishing to receive
placebo. This report also included a case study, described below.
43
A case series by Crump
31
assessed 234 consecutive cases treated
by one of 25 homeopaths, with follow-up at 3 months. The series
included 17 cases of insomnia, for which 6 had no follow-up data, 2
showed no change, 7 were reported as ‘‘better’’ and 2 as ‘‘much
better’’ (53% reported as better or much better).
A further case series by Treuherz
44
assessed 500 consecutive
patients referred via general practice in the UK. Of five insomnia
cases described, four showed improvement; however, the total
number of insomnia cases within the series was not reported.
Case studies. It would be difficult to attempt a comprehensive
identification of all case studies since many are reported only in the
grey literature (in sources that are difficult to search), are incon-
sistently indexed, and include other clinical symptoms in addition
to insomnia. However, our search identified over 2600 case studies
reporting treatment by a homeopath for patients with insomnia: 30
from the main literature search, and a further 2580 from the large
electronic online materia medica library ReferenceWorks.
33
Six of
these 2600þ case studies are described here for illustration. All
patients were prescribed individualised homeopathic medicines
after one or more consultations with a homeopath.
One case study (reported alongside a case series of treatment by
a homeopath for sleep problems related to alcohol dependence) uses
validated outcome measures.
43
The patient had insomnia related to
alcohol dependence and a history of sexual abuse, and would go 3–4
nights without sleep. The patient had received treatment from their
general practitioner which partly addressed the alcohol problem but
had little effect on the insomnia. The patient received individualised
homeopathic treatment (including 2 doses of the homeopathic
medicine Staphysagria 1 M). The Pittsburgh Sleep Quality Index,
measured at baseline and over 3 months, indicated that mean sleep
time per night increased from approximately 3 hours to 8 hours and
the number of nights with total insomnia decreased from 8 to 0;
improvements were also observed in terms of alcohol dependence
and general health.
A selection of further case studies which did not use validated
outcome measures are described as follows. In one, a 40-year-old
woman with insomnia and other symptoms was prescribed Ptelea
trifoliata, which was described as alleviating all the symptoms.
47
In
another, an elderly woman suffering from insomnia with no sleep
until 07:00h was prescribed a single dose of Cypripedium 1 M, and
was reported to have felt better and slept well since then.
48
Another
case involved a 62-year-old woman who had had insomnia for 7
years following a traumatic event; af ter receiving a single dose of
Stramonium, her insomnia and other symptoms were reported as
having improved over the following month.
49
In a further case,
a 45-year-old man who had suffered from insomnia for 4 years and
sometimes had no sleep for 3 days received a dose of Calcarea-carb
1 M which was reported to have ended the insomnia.
50
In another
case study, a 30-year-old man suffering from insomnia, often
sleeping only from midnight to 04:00h, was reported as sleeping
well following a dose of Hyoscyamus 200c.
51
Safety of homeopathy
None of the included studies reported any adverse
effects among participants. Homeopathy is thought to be
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337 335
Author's personal copy
a generally safe intervention when administered by trained
professionals.
52
Discussion
Summary of review findings
Homeopathic medicines
Four RCTs compared homeopathic medicines to placebo; one
assessing individually-prescribed medicines
37
and three assessing
formulaic medicines.
38–40
None demonstrated a statistically
significant difference in outcomes between groups, although two
showed a trend towards better outcomes in the homeopathy
treatment groups.
38,39
Three of the RCTs demonstrated significant
improvements from baseline in measures of sleep quality in both
the homeopathy and placebo groups
37,39,40
All four RCTs involved
small patient numbers and were underpowered, and were poorly
reported with high patient withdrawal rates. The use of a crossover
design in one study made the results difficult to interpret.
37
An
uncontrolled cohort study was also identified; this reported
statistically significant improvements from baseline for the group
receiving formulaic homeopathic medicine.
41
Treatment by a homeopath
There were no RCTs assessing treatment by a homeopath. A
single cohort study reported greater improvement with treatment
by a homeopath than with conventional treatment for a range of
chronic conditions including insomnia, although no data was
available for the insomnia subgroup specifically.
42
Three case series
of treatment by a homeopath reported improvement in some
patients.
31,43,44
However, lack of a randomised control group
necessitates caution in interpreting results of these studies. A large
number of case studies of treatment by a homeopath for insomnia
were also identified. However, the lack of control groups, lack of
consistent outcome measures, and tendency to report only positive
results (reporting bias) means that it is not possible to definitively
ascribe the reported improvements to the treatment.
Conclusions
Homeopaths often treat insomnia. However, there is currently
a lack of high-quality studies assessing the effectiveness of home-
opathy in treating this condition. The limited evidence available
does not demonstrate a statistically significant effect of homeo-
pathic medicines for the treatment of insomnia. Existing RCTs were
of poor quality and were likely to have been underpowered. Well-
conducted studies of homeopathic medicines and treatment by
a homeopath are required to fully examine the clinical and cost
effectiveness of homeopathy for insomnia.
Acknowledgements
Many thanks to Francis Treuherz who undertook the search of
ReferenceWorks to provide an estimate of the number of insomnia
case studies.
References
1. National Institute for Health and Clinical Excellence (NICE). Guidance on the
use of zaleplon, zolpidem and zopiclone for the short-term management of
insomnia. 2004. [Report]
2. Ohayon MM. Epidemiology of insomnia: what we know and what we still
need to learn. Sleep Med Rev 2002;6(2):97–111.
3. Krystal AD. A compendium of placebo-controlled trials of the risks/benefits of
pharmacological treatments for insomnia: the empirical basis for U.S. clinical
practice. Sleep Med Rev 2009;13(4):265–74.
4. National Institute of Health (NIH). State-of-the-science conference statement on
manifestations and management of chronic insomnia in adults, vol. 22(2). NIH;
2005. 1–30.
6. Riemann D, Perlis ML. The treatments of chronic insomnia: a review of
benzodiazepine receptor agonists and psychological and behavioral therapies.
Sleep Med Rev 2009;13(3):205–14.
7. Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psycho-
logical and behavioral treatment of insomnia: update of the recent evidence
(1998–2004). Sleep 2006;29(11):1398–414.
8. Montgomery P, Dennis J. Cognitive behavioural interventions for sleep prob-
lems in adults aged 60þ (review). Cochrane 2003;(1).
9. Morgan K, Dixon S, Mathers N, Thompson J, Tomeny M. Psychological treat-
ment for insomnia in the management of long-term hypnotic drug use:
a pragmatic randomised controlled trial. Br J Gen Pract 2003;53(497):923–8.
10. Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM,
et al. Randomized clinical effectiveness trial of nurse-administered small-
group cognitive behavior therapy for persistent insomnia in general practice.
Sleep 2007;30(5):574–84.
11. Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, et al.
Randomized controlled clinical effectiveness trial of cognitive behavior
therapy compared with treatment as usual for persistent insomnia in patients
with cancer. J Clin Oncol 2008;26(28):4651–8.
12. Ong JC, Shapiro SL, Manber R. Mindfulness meditation and cognitive behav-
ioral therapy for insomnia: a naturalistic 12-month follow-up. Explore
(J Sci Healing) 2009;5(1):30–6.
13. Morgan K, Dixon S, Mathers N, Thompson J, Tomeny M. Psychological treat-
ment for insomnia in the regulation of long-term hypnotic drug use. Health
Technol Assess 2004;8(8):iii. 68.
14. Baillargeon L, Demers M, Gregoire JP, Pepin M. [Study on insomnia treatment
by family physicians]. Can Fam Physician 1996;42:426–32.
15. Krystal AD. The changing perspective on chronic insomnia management. J Clin
Psychiatry 2004;8(65 Suppl.):20–5.
16. Cheuk DKL, Yeung WF, Chung KF, Wong V. Acupuncture for insomnia (review).
Cochrane 2007;(3).
17. Huang W, Kutner N, Bliwise DL. A systematic review of the effects of
acupuncture in treating insomnia. Sleep Med Rev 2009;13(1):73–104.
18. Coxeter PD, Schluter PJ, Eastwood HL, Nikles CJ, Glasziou PP. Valerian does not
appear to reduce symptoms for patients with chronic insomnia in general
practice using a series of randomised n-of-1 trials. Complement Ther Med
2003;11 (4):215–22.
19. Ziegler G, Ploch M, Miettinen-Baumann A, Collet W. Efficacy and tolerability of
v
alerian
extract LI 156 compared with oxazepam in the treatment of non-
organic insomnia–a randomized, double-blind, comparative clinical study. Eur
J Med Res 2002;7(11):480–6.
20. Farag NH, Mills PJ. A randomised-controlled trial of the effects of a traditional
herbal supplement on sleep onset insomnia. Complement Ther Med
2003;11 (4):223–5.
*21. Relton C, O’Cathain A, Thomas KJ. ‘Homeopathy’: untangling the debate.
Homeopathy 2008;97(3):152–5.
Practice points
1) Patients currently use homeopathy for insomnia, either
purchasing homeopathic medicines over the counter or
via treatment by a homeopath.
2) Four existing placebo-controlled RCTs of homeopathic
medicines for insomnia did not show a significant
difference in sleep outcomes between groups. All
included RCTs involved small patient numbers, experi-
enced high withdrawal rates and were poorly reported.
3) No published RCTs assess treatment by a homeopath.
Observational evidence reports benefit associated with
treatment by a homeopath, but these studies lack
randomised control groups.
Research agenda
1) Adequately-powered well-designed and well-reported
trials of homeopathy for insomnia are required.
2) Pragmatic RCTs of treatment by a homeopath compared
to usual care would inform clinical decision-making and
health service commissioning.
*
The most important references are denoted by an asterisk.
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337336
Author's personal copy
22. Thomas KJ, Nicholl JP, Coleman P. Use and expenditure on complementary medi-
cine in England: a population based survey. Complement Ther Med 2001;9(1):2–11.
23. Vermeulen F. Concordant materia medica. Haarlem, The Netherlands: Emryss
Publishers; 2000.
24. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P,
Spiegelhalter D, et al. Framework for design and evaluation of complex
interventions to improve health. BMJ 2000;321(7262):694–6.
25. Zollman C, Vickers A, Richardson J. ABC of complementary medicine. 2nd ed.
BMJ Books; 2008.
26. Pearson NJ, Johnson LL, Nahin RL. Insomnia, trouble sleeping, and comple-
mentary and alternative medicine: analysis of the 2002 national health
interview survey data. Arch Intern Med 2006;166(16):1775–82.
27. Sanchez-Ortuno M, Belanger L, Hans I, Leblanc N, Morin C. Use of natural
products as sleep aids: a common practice? J Sleep Res 2008;17(Suppl. 1):212–3.
28. Thompson EA, Mathie RT, Baitson ES, Barron SJ, Berkovitz SR, Brands M, et al.
Towards standard setting for patient-reported outcomes in the NHS homeo-
pathic hospitals. Homeopath: J Fac Homeopathy 2008;97(3):114–21.
29. Swayne JM. Survey of the use of homoeopathic medicine in the UK health
system. J R Coll Gen Pract 1989;39(329):503–6.
30. Relton C, Chatfield K, Partington H, Foulkes L. Patients treated by homeopaths
registered with the Society of homeopaths: a pilot study. Homeopathy
2007;96(2):87–9.
*31. Crump S. The society of homoeopaths research group. Report on the pilot
audit. Homeopath (J Soc Homeopath UK) 1996;60:507–9.
32. Hom-Inform database. British homoeopathic library, UK, http://hominform.
soutron.com/; 2009 [Report].
33. ReferenceWorks. Version 4.2.1, David Warkentin, Kent Homeopathic Associ-
ates, San Rafael, CA, http://www.kenthomeopathic.com/referenceworks.html;
2009 [Report].
34. Dean ME. The trials of homeopathy: origins, structure and development. Essen:
KVC: Verlag; 2004.
35. NHS Centre for reviews and dissemination. Report 4: undertaking systematic
reviews on effectiveness; CRD’s guidance for those carrying out or commis-
sioning reviews; 2001 [Report].
36. Critical Appraisal Skills Programme (CASP). Critical appraisal checklist for cohort
studies, http://www.phru.nhs.uk/Pages/PHD/resources.htm; 2009 [Report].
*37. Carlini EA, Braz S, Troncone LR, Tufik S, Romanach AK, Pustiglione M, et al.
[Hypnotic effect of homeopathic medication and placebo. Evaluation by
double-blind and crossing technics]. Revista Da Associacao Medica Brasileira
1987;33(5–6):83–8 [Portuguese].
*38. Cialdella P, Boissel JP, Belon P. [Homeopathic specialties as substitutes for
benzodiazepines: double-blind vs. placebo study]. Therapiewoche
2001;56(4):397–402.
*39. Wolf J. Schlafstorungen ohne Hang-over behandeln. Natura Med 1992;
7(9):586–9.
*40. Kolia-Adam N, Solomon E, Bond J, Deroukakis M. Double-blind placebo
controlled study with coffea for insomnia. Simillimum 2008;21
[Winter/
Spring].
*4
1
. Waldschutz R, Klein P. . The homeopathic preparation Neurexan vs. valerian
for the treatment of insomnia: an observational study. The Scienti-
ficWorldJournal 2008;8:411–20.
*42. Witt C, Keil T, Selim D, Roll S, Vance W, Wegscheider K, et al. Outcome and
costs of homoeopathic and conventional treatment strategies: a comparative
cohort study in patients with chronic disorders. Complement Ther Med
2005;13(2):79–86.
*43. Rogers J. Homoeopathy and the treatment of alcohol-related problems.
Complement Ther Nurs Midwifery 1997;3(1):21–8.
*44. Treuherz F. Bounds green group practice. An audit of 500 consecutive patients
referred in general practice 1993–1998. 1998. London [Report].
45. La Pine MP, Malcomson FN, Torrance JM, Marsh NV. Night shift: can
a homeopathic remedy alleviate shift lag? DCCN Dimensions Crit Care Nurs
2006;25(3):130–6.
47. Fanciola A. A case of Ptelea. Homeopathy 2007;96:128–31.
48. Hubbard E. Short cases: case 1. Natl J Homoeopath(6), http://www.njhonline.
com/1993/nov_dec_93_vol_11_no_6/cases/short_cases.shtml, 1993;2.
49. Case Nagar R. 13: I have not slept till 7 years. Natl J Homoeopath, http://www.
njhonline.com/rapid-cases/2005/rapid_cases13.shtml; 2006.
50. Kasiviswanathan TK. Case 17: trio of sleepless nights. Natl J Homoeopath,
http://www.njhonline.com/rapid-cases/2005/rapid_cases17.shtml; 2006.
51. Parthasarathy V, He Dreamt Sridevi. Natl J Homoeopath, http://www.
njhonline.com/1993/jan_feb_93_vol_11_no_1/cases/sridevi_he_dreamt.shtml;
1993.
52. Dantas F, Rampes H. Do homeopathic medicines provoke adverse effects?
A systematic review. Br Homeopath J 2000;1(89 Suppl):S35–S38.
53. Teixeira MZ. Similitude in modern pharmacology. Br Homeopath J 1999;
88(3):112–20.
K.L. Cooper, C. Relton / Sleep Medicine Reviews 14 (2010) 329–337 337
    • "Several placebo-controlled trials have investigated the efficacy of homeopathy in the treatment of adults with sleep problems (insomnia) with inconsistent results. In a systematic review including four randomized controlled trials (RCTs), no statistically significant differences were found between homeopathic and placebo treatment for insomnia [16]. Since then, one RCT on individualized homeopathy has been published that found a significant increase in the duration of sleep throughout the study in favor of homeopathy compared to placebo [17]. "
    [Show abstract] [Hide abstract] ABSTRACT: A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 ( N = 89 ) or comparator glycine ( N = 90 ). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14), p < 0.0001 , POM overall treatment related effect ). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints ( p = 0.0258 ). Treatment effectiveness ( p < 0.0001 ) and satisfaction assessments ( p < 0.0001 ) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2 , glycine: N = 1 ) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children.
    Full-text · Article · May 2016
    • "Sog. " individualisierte " Homöopathika werden in Anlehnung an die aus diesen Prüfungen abgeleiteten, homöopathischen Arzneimittelbilder gemäß der vonCooper & Relton, 2010; Ernst, 2007; Jonas et al., 2003). Ursprünglich sollte die Potenzierungsmethode Aggravationen und Toxizität reduzieren (Teixeira et al., 2010), später behauptete Hahnemann aber, dadurch die " vitale " bzw. "
    [Show abstract] [Hide abstract] ABSTRACT: Die akute psychosoziale Stressreaktion gesunder Probanden nach offener Verabreichung eines Komplexmittels verglichen mit dem natürlichen Verlauf - I n a u g u r a l-D i s s e r t a t i o n zur Erlangung des Doktorgrades der Naturwissenschaften in der Medizin durch die Medizinische Fakultät der Universität Duisburg-Essen
    Full-text · Thesis · Dec 2013 · Evidence-based Complementary and Alternative Medicine
    • "In 2005 Shang et al. reviewed 110 randomized placebocontrolled trials on homeopathy [5] and found that smaller trials were more likely to produce results in favour of homeopathy than larger trials and that no overall effect of homeopathic medicines can be found that exceeds a placebo effect (odds ratio 0.88; CI: 0.65 to 1.19 ). More recent systematic reviews make a clear distinction between the effects of (highly diluted) homeopathic medicines and the effects of a homeopathic package of care [9]. Only few randomized controlled trials exist which compare a homeopathic package of care with a conventional treatment . "
    [Show abstract] [Hide abstract] ABSTRACT: Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM). Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects. Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua's modified t-test. Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06-0.19, P < 0.001) in the mental and 0.25 (0.22-0.28, P < 0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses. Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.
    Full-text · Article · Dec 2013
Show more