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BMC Public Health
Open AccessResearch article
How healthy are chronically ill patients after eight years of
homeopathic treatment? – Results from a long term observational
study
Claudia M Witt*1, Rainer Lüdtke2, Nils Mengler1 and Stefan N Willich1
Address: 1Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, D-10098 Berlin, Germany and
2Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany
Email: Claudia M Witt* - claudia.witt@charite.de; Rainer Lüdtke - r.luedtke@carstens-stiftung.de; Nils Mengler - nilsmengler@web.de;
Stefan N Willich - stefan.willich@charite.de
* Corresponding author
Abstract
Background: Homeopathy is a highly debated but often used medical treatment. With this cohort
study we aimed to evaluate health status changes under homeopathic treatment in routine care.
Here we extend former results, now presenting data of an 8-year follow-up.
Methods: In a prospective, multicentre cohort study with 103 homeopathic primary care practices
in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the
first time were observed. The main outcome measures were: The patients' perceived change in
complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and
quality of life as measured by the SF-36 at baseline, and after 2 and 8 years.
Results: A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline
41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up.
The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and
multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001)
between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1
± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably.
Younger age, female gender and more severe disease at baseline were factors predictive of better
therapeutic success.
Conclusion: Patients who seek homeopathic treatment are likely to improve considerably. These
effects persist for as long as 8 years.
Background
Homeopathy is based on the 'principle of similars',
whereby substances that cause symptoms in healthy indi-
viduals are used to stimulate healing in patients who have
similar symptoms when ill [1]. Usually, these substances
are used in extremely high dilutions, which makes home-
opathy a controversially debated system.
However, homeopathy is becoming increasingly popular
in the world and constitutes an important factor of public
Published: 17 December 2008
BMC Public Health 2008, 8:413 doi:10.1186/1471-2458-8-413
Received: 4 August 2008
Accepted: 17 December 2008
This article is available from: http://www.biomedcentral.com/1471-2458/8/413
© 2008 Witt et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413
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health systems. For example, in the US the proportion of
patients obtaining homeopathic care has quadrupled
from 1991 to 1997 [2]. In the UK it was estimated that 2%
had visited a homeopathic practitioner in the last 12
months [3] and that annual expenditures for homeopathy
reached 34.04 million (out-of-pocket 30.74 million, NHS
3.3 million) [4]. In Germany, the country in which home-
opathy originated, a survey demonstrated that approxi-
mately 10% of men and 20% of women in the general
population used homeopathic medicines during the pre-
vious year [5]. Here the General Medical Council grants an
official additional certification in homeopathy upon suc-
cessful completion of a three-year-long training pro-
gramme. This is held by approximately 4,500 physicians
[6].
Meta-analyses of placebo controlled trials on homeopa-
thy have shown inconsistent results [7-9]. However, there
is only little data on the effectiveness and patients' satis-
faction of homeopathic health care in everyday practice.
Ten years ago we started a cohort study in nearly 4.000
patients aiming to systematically collect data about diag-
noses and treatment in the area of homeopathic health
care in Germany, including data on the patients' health
status. Our first results, based on a two year follow-up,
were published some years ago [10]. This paper extends
our former report, now for the first time presenting data 8
years after the primary homeopathic treatment.
Methods
Study design
In this prospective multi-centre cohort study, patients
were included consecutively upon their first consultation
with a participating homeopathic physician. All study
physicians hold an additional certification in classical
homeopathy and had at least three years of experience in
its practice. No restrictions on diagnoses were made. For
details on inclusion criteria or on the selection of physi-
cians see [10]. Recruitment period was between Septem-
ber 1997 and December 1999, and measurements of
health status were taken at 3, 12, and 24 months using
standardised questionnaires. The study protocol was
approved by the ethics review board of the Charité Uni-
versity Medical Center. In total 3,981 (2,851 adults, 1,130
children) were originally included in the study.
In 2006 3,677 patients (2,603 adults, 1,074 children)
were contacted again to provide an 8-year follow-up.
Patients were not contacted if they were known to have
deceased (32 adults), had withdrawn their consent to par-
ticipation in this study (207 adults, 53 children) or their
actual place of residence could not be identified (9 adults,
3 children).
In this paper we present only the long-term results (8
years), for more details on earlier time points refer to [10].
Outcome measures
Standardized questionnaires were designed to document
sociodemographic data, as well as information on prior
medical history, patient symptoms and complaints, qual-
ity of life, and the use of any treatment other than home-
opathy. At study entry, all patients recorded the
complaints that led them to consider homeopathic treat-
ment, for children below the age of 8 their parents were
asked to do so. Independently of their physicians, patients
rated the severity of their complaints on a numeric rating
scale (NRS, 0 = no complaints, 10 = maximum severity).
All complaints listed by patients in their baseline ques-
tionnaire were transferred to their follow-up question-
naires by the study office personnel. This ensured that
each baseline complaint was assessed at each subsequent
follow-up. For statistical purposes we averaged the ratings
of the first four listed complaints and used this average as
the main outcome measure.
For adults (16 years or older at study entry), general
health-related quality of life (QoL) was assessed using the
German MOS SF-36 questionnaire [11]. The results of the
SF-36 are presented in normalised scores, the results being
scaled in such a way that the normal German population
has a mean score of 0 and a standard deviation of 1.
The first questionnaire was distributed to the patients by
the study physician and completed prior to case taking
and the start of therapy (baseline). Patients sent their
completed questionnaires to the study office in sealed
envelopes. Follow-up questionnaires were sent to all
patients by the study office.
At the 8-year follow-up we additionally measured the
overall patient satisfaction with treatment on a 4-point
Likert scale, ranging from 1 ("little satisfied") to 4 ("very
satisfied"). Moreover, we asked the patients to rate
whether they "would let their disease be treated homeo-
pathically again", "would try homeopathy in other diag-
noses", "would recommend homeopathy to a friend", and
"find homeopathy logically comprehensible", each on a
NRS (0 = "I totally disagree" 10 = "I absolutely agree").
All patients were asked whether they were still under
homeopathic treatment. If not, the specific reasons for
stopping treatment were recorded and classified into (1)
"treatment successful", including "complete healing" and
"major improvement"; (2) "treatment success unsatisfac-
tory", including "unsatisfactory patient-physician rela-
tionship" "hospitalisation", "treatment not helpful",
"deterioration", "other therapies preferred", and "too long
distance"; (3) "unrelated to treatment success", including
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"physician deceased or retired", "physician or patient
moved", "pregnancy", "limited time", "treatment too
expensive". In case of multiple answers we assumed
"treatment success unsatisfactory" if only one of the above
listed reasons was given, regardless what the other reasons
were.
Treatments
To reflect usual care all physicians were completely free to
choose a treatment. This usually included the prescription
of homeopathic medicines according to homeopathic
principles, but also could include the onset, change, or
withdrawal of a conventional medicine, referrals to spe-
cialists, or admission to a hospital.
At the 8-year follow-up all patients were asked to specify
which, if any, complementary or conventional therapies
they used besides homeopathy. For reasons of clarity we
grouped these therapies into non-homeopathic medical
therapies (phytotherapy, Chinese herbal medicine), relax-
ation therapies (meditation, autogenous training), ener-
getic therapies (bioresonance therapy, reiki, shiatsu,
kinesiology, Feldenkrais), exercise therapies (yoga, tai chi,
qigong), and manual therapies (osteopathy, cupping).
Statistics
Statistical analysis (using SAS/STAT© 9.1 software) fol-
lowed the intention-to-treat principle and included those
3,709 patients (2,635 adults, 1074 children) who were
contacted at the 8-years follow-up or were known to have
deceased.
If patients reported that their complaints were cured we
replaced missing values with a severity = 0 in subsequent
records. Deceased patients were assigned a severity = 10.
The remaining missing values were multiply imputed
according to Rubin [12]: Each was given several plausible
values (drawn from a multivariate normal distribution),
generating a total of 5 distinct complete data tables, each
without any missing value. These were analyzed sepa-
rately (see below), and the results pooled to calculate
treatment effects and p-values.
For each imputed data set, we fitted a generalised multiple
linear regression model to the data [13], where time was
taken as a three-level (baseline, 2 years, 8 years) within-
patient factor and the serial correlation was assumed to be
exponential with time. For comparability purposes with
other studies we divided the estimated mean changes
from this model by the standard deviation at baseline.
This standardised mean change also allows assessing the
clinical relevance of effects.
Moreover, we aimed to identify factors that predict treat-
ment success. For this, we dichotomised the change of
complaint severity at a cut point of 2 pts: improvements
of 2 pts or more were defined as a clinically relevant suc-
cess, smaller improvements or deteriorations were
defined as inadequate success. A 2-point improvement in
the NRS approximately represents the improvement of
one standard deviation at baseline and can thus be seen as
a threshold of clinical relevance. At first a list of potential
predictors was compiled. This list included mean severity
of complaints at study entry, age at study entry (linear fac-
tors), sex, the most frequent diagnoses at study entry
(migraine, tension type headache, sleep disorders, depres-
sion, anxiety disorders, multiple eczemas, psoriasis, aller-
gic dermatitis, allergic rhinitis, allergies, dysmenorrhea,
multiple infections, hypertension, low back pain,
asthma), concomitant therapies (conventional medicine,
anthroposophic medicine, acupuncture, other TCM ther-
apies, phytotherapy, osteopathy, other manual therapies,
yoga, other exercise therapies, relaxation therapies,
naturopathy), additional visits to other doctors (conven-
tional, TCM, anthroposophic, naturopathic), hospital
admission, and reasons for stopping treatment (treatment
successful, treatment success unsatisfactory). Afterwards,
predictors were identified by backward selection in a
logistic regression model.
Data for adults (>16 years at study entry) and children
(<16 years) were analysed separately.
Results
Response rates and basic characteristics
In total 2,722 (1,903 adults, 819 children) contributed
data to the 8-years follow-up. Patients in this study suf-
fered from long-term chronic diseases (table 1). Response
rates were considerable higher in female than in male
adults (74.3% vs. 67.2%) but similar in female and male
children (76.9% vs. 75.7%). Thus, male adults are some-
what a bit underrepresented in our sample. Age at study
entry matched the data of the complete sample (table 1).
The majority of the patients were highly educated female
adults, most of them fairly below the age of 60 (table 1).
Adults mainly suffered from headache (tension type and
migraine), allergic diseases, or skin diseases, children
from atopic eczema or multiple infections. The average
number of diseases at baseline was 2.8 ± 1.1 in adults and
2.3 ± 1.0 in children.
Treatments
Eight years after study entry one third of the patients (n =
897, 32.9%) still were under homeopathic treatment. 657
patients (24.1%) still consulted that homeopathic physi-
cian they had chosen at study entry, 240 (8.8%) had
changed to another homeopath. Three in ten patients had
stopped homeopathic treatment because they perceived
major improvements of health status (n = 794, 29.2%).
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On the other hand, a similar percentage of patients
stopped treatment because they did not feel homeopathy
could help them sufficiently (n = 708, 26.0%), including
those 42 patients (1.5%) who reported a deterioration.
194 patients (7.1%) said they stopped treatment for rea-
sons unrelated to the therapy success (moving, financial
shortage, physician retired etc.), 97 (3.6%) did not give
any reason. These figures differed considerably between
adults and children: the percentage of children who
stopped treatment because of major improvements was
twice that of adults (n = 378 (46.2%) vs. n = 416
(21.9%)). In contrast, adults more often stopped treat-
ments because of perceived treatment failure (n = 567
(29.8%) vs. n = 141 (17.2%)).
Nearly half of the patients (n = 1118, 41.1%) reported to
have consulted another CAM therapist (not homeo-
pathic) during the study period, including naturopathic
doctors, physicians for Traditional Chinese Medicine, and
non-medical therapists (German "Heilpraktiker"). Four in
ten patients were treated with conventional remedies, this
rate being considerably higher in adults than in children
(table 2). Similarly, children used less frequently other
CAM therapies (table 2). Differences between those who
stopped homeopathic treatment and those who contin-
Table 1: Patient characteristics (values are absolute numbers and percent or mean ± standard deviation)
Study population Responders only
Adults (n = 2,635) Children (n = 1,074) Adults (n = 1,903) Children (n = 819)
Sex (male: female) 771:1864 559:515 518:1385 423:396
Age at study entry (years) 40.6 ± 12.4 6.7 ± 4.1 41.0 ± 12.3 6.5 ± 4.0
Age at 8-year follow-up (years) 48.3 ± 12.4 14.2 ± 4.2 48.8 ± 12.3 14.1 ± 4.2
Marital status (living in partnership) 1916 (72.7%) 1405 (73.9%)
Education (attending school >10 years) 1570 (59.6%) 1155 (60.7%)
Belief in homeopathy at study entry 1744 (66.2%) 739 (68.8%) 1283 (67.4%) 567 (69.2%)
Duration of disease at study entry (years) 10.0 ± 9.6 4.3 ± 2.7 9.8 ± 8.7 4.2 ± 3.5
Intake of conventional drugs at study entry 1318 (50.0%) 340 (31.7%) 965 (50.7%) 273 (33.3%)
Primary diagnosis at study entry *
Allergies (ICD9: 995.3) 154 (5.8%) 65 (6.1%) 114 (6.0%) 51 (6.2%)
Anxiety (ICD9: 300.0) 137 (5.2%) 44 (4.1%) 94 (4.9%) 34 (4.2%)
Asthma (ICD9: 493.9) 109 (4.1%) 67 (6.2%) 88 (4.6%) 51 (6.2%)
Depression (ICD9: 311.0) 157 (6.0%) 5 (0.5%) 110 (5.8%) 2 (0.2%)
Eczema (ICD9: 692.9) 200 (7.6%) 48 (4.5%) 154 (8.1%) 42 (5.1%)
Multiple infections (ICD9: 796.6) 140 (5.3%) 183 (17.0%) 105 (5.5%) 141 (17.2%)
Migraine (ICD9: 346.9) 202 (7.7%) 16 (1.5%) 146 (7.7%) 12 (1.5%)
Atopic dermatitis (ICD9: 691.8) 131 (5.0%) 216 (20.1%) 99 (5.2%) 175 (21.4%)
Allergic rhinitis (ICD9: 477.9) 215 (8.2%) 58 (5.4%) 161 (8.5%) 45 (5.5%)
Headache (ICD9: 784.0) 216 (8.2%) 71 (6.6%) 155 (8.1%) 45 (5.5%)
Sleep disorders (ICD9: 780.5) 185 (7.0%) 77 (7.2%) 127 (6.7%) 58 (7.1%)
* Multiple diagnoses allowed
Table 2: Number of patients receiving non-homeopathic treatments during the last 5 years of follow-up, grouped whether or not they
still were under homeopathic treatment
Adults Children
total still under treatment treatment stopped total still under treatment treatment stopped
Conventional medicines 881* (46.3%) 255 (37.6%) 625 (52.5%) 154 (18.8%) 40 (18.3%) 114 (19.0%)
Acupuncture 402 (21.1%) 155 (22.9%) 247 (20.8%) 38 (4.6%) 8 (3.7%) 30 (5.0%)
Yoga 181 (9.5%) 79 (11.7%) 102 (8.6%) 10 (1.2%) 6 (2.7%) 4 (0.7%)
Relaxation therapies# 176 (9.2%) 56 (8.3%) 120 (10.1%) 13 (1.6%) 2 (0.9%) 11 (1.8%)
Energetic therapies# 188 (9.9%) 68 (10.0%) 120 (10.1%) 56 (6.8%) 20 (9.1%) 36 (6.0%)
Exercise therapies# 249 (13.1%) 109 (16.1%) 140 (11.8%) 11 (1.3%) 6 (2.7%) 5 (0.8%)
Manual therapies# 108 (5.7%) 53 (7.8%) 55 (4.6%) 16 (2.0%) 9 (4.1%) 7 (1.2%)
Non-conventional
medicines#
60* (3.2%) 15 (2.2%) 44 (3.7%) 6 (0.7%) 2 (0.9%) 4 (0.7%)
* Due to missing values frequencies in subgroups do not add to total frequencies
# For definitions see methods section
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ued were small in children. However in adults patients
who stopped treatment used more frequently conven-
tional medication (53% vs. 38%).
Severity of complaints and quality of life
During the study mean severity of complaints improved
from baseline 6.2 ± 1.7 to 2.7 ± 2.1 after 8 years in adults
and from 6.1 ± 1.8 to 1.7 ± 1.9 in children (table 3, figure
1). From the generalised linear model the respective
standardised mean changes (mean changes divided by
standard deviations at baseline) were estimated at 1.61 for
adults (CI: 1.54 to 2.68, p < 0.001) and 2.01 for children
(CI: 1.89 to 2.12, p < 0.001).
At the 8-years follow-up one in two patients reported
improvements of complaint severity by 50% or more.
These percentages were similar in patients who were still
under homeopathic treatment and those who were not
(table 4).
Accordingly, QoL in adults improved considerably (table
3). This results in effect size estimates of 0.39 (CI: 0.35 to
0.45, p < 0.001) in the physical score and 0.54 (CI: 0.48
to 0.60, p < 0.001) in the mental score, respectively.
These 8-year figures were nearly identical to those after 2
years (table 3) suggesting that the patients' health status
did not worsen along time. Again, in children there were
no relevant differences between those who stopped
homeopathic treatment and those who continued,
whereas in those adults who continued treatment we
found slightly higher effects.
Overall satisfaction
731 (38.4%) adults and 342 (41.8%) children reported to
be "very satisfied" with the treatment, in contrast only 246
(12.9%) adults and 84 (10.3%) children were "little satis-
fied". Accordingly, most patients would use homeopathy
again and recommend it to friends with similar com-
plaints (table 5).
Predictors of success
1283 adults (67.4% of the study population, 48.7% of all
responders) and 655 children (80.0%/61.0%) experi-
enced a clinically relevant treatment success, defined as an
improvement of complaint severity of 2 pts or more. From
the logistic regression we found that this was more likely
in women than in men, and in children than in adults.
Patients who simultaneously used other treatments (con-
ventional or complementary) had a smaller chance to
improve relevantly, as did those suffering from allergies,
allergic rhinitis, or headache. In contrast, a diagnosis of
multiple infections was a positive predictor (table 6).
Discussion
In our study we extended former results on the course of
disease in patients receiving homeopathic treatment, now
presenting data from an 8-year follow-up. These data con-
sistently show substantial health improvements in
patients under homeopathic treatment, which persisted
Table 3: Course of mean complaint severity and quality of life during the study, grouped whether or not the patients still were under
homeopathic treatment
baseline 2 years 8 years 2 years change 8 years change
Adults
Severity of complaints
total 6.2 ± 1.7 2.9 ± 2.2 2.7 ± 2.1 3.2 ± 2.4 3.5 ± 2.4
still under hom. treatment 6.0 ± 1.6 2.6 ± 1.9 2.4 ± 1.9 3.4 ± 2.3 3.6 ± 2.2
hom. treatment stopped 6.2 ± 1.8 3.0 ± 2.3 2.8 ± 2.2 3.2 ± 2.4 3.4 ± 2.5
Quality of life, physical score
total -0.36 ± 0.96 0.08 ± 0.85 0.08 ± 0.89 0.42 ± 0.91 0.41 ± 1.00
still under hom. treatment -0.34 ± 0.92 0.16 ± 0.79 0.15 ± 0.81 0.48 ± 0.89 0.48 ± 0.95
hom. treatment stopped -0.37 ± 0.39 0.04 ± 0.89 0.04 ± 0.93 0.41 ± 0.91 0.38 ± 1.02
Quality of life, mental score
total -1.47 ± 1.43 -0.56 ± 1.23 0.53 ± 1.26 0.87 ± 1.41 0.95 ± 1.51
still under hom. treatment -1.43 ± 1.44 -0.49 ± 1.19 -0.43 ± 1.17 0.89 ± 1.41 1.00 ± 1.52
hom. treatment stopped -1.50 ± 1.43 -0.61 ± 1.24 -0.59 ± 1.31 0.86 ± 1.48 0.92 ± 1.51
Children
Severity of complaints
total 6.1 ± 1.8 2.2 ± 2.0 1.7 ± 1.9 3.9 ± 2.5 4.4 ± 2.6
still under hom. treatment 6.1 ± 1.7 2.1 ± 1.9 1.8 ± 1.9 4.0 ± 2.4 4.3 ± 2.4
hom. treatment stopped 6.1 ± 1.8 2.2 ± 2.1 1.7 ± 1.9 3.9 ± 2.6 4.4 ± 2.6
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through the whole observation period. Improvements
were more pronounced in younger patients, females, and
those with greater disease severity at baseline.
The methodological strengths of our study include con-
secutive enrolment of a large sample size, the participa-
tion of approximately 1% of all physicians certified to
practice homeopathy in Germany and the use of standard-
ised outcome instruments also used in studies on conven-
tional therapy.
Moreover, our study provides a reasonably representative
sample of all patients attending a doctor practicing classi-
cal homeopathy in Germany. The subset of patients
responding to the 8-year follow up matched fairly well the
data of the complete sample: although female adults were
slightly overrepresented in this sample, data on age, com-
plaint severity at baseline or duration of disease were
nearly identical between those who responded after 8
years and those who did not. We therefore believe that
selection bias is small and that our data are generalisable.
Severity of complaints (mean ± standard deviation)Figure 1
Severity of complaints (mean ± standard deviation).
0
2
4
6
8
10
study entry 2 years 8 years
meancomplaint(NRS)
children
adults
Table 4: Number of patients whose change in symptom scores indicates improvements or worsening of complaints at the 8-years
follow-up, grouped whether or not they still were under homeopathic treatment
Adults
n (%)
Children
n (%)
total still under treatment treatment stopped total still under treatment treatment stopped
cured
(all complaints vanished)
243 (12.8%) 86 (12.7%) 157 (13.2%) 247 (30.2%) 62 (28.3%) 185 (30.9%)
complaint severity improved
≥ 50%
918 (48.2%) 372 (54.9%) 545 (45.8%) 397 (48.5%) 111 (50.7%) 286 (47.7%)
complaint severity improved
≥ 10%
488 (25.6%) 162 (23.9%) 326 (27.4%) 121 (14.8%) 31 (14.2%) 90 (15.0%)
complaint severity worsened
≥ 10%
90 (4.7%) 21 (3.1%) 69 (5.8%) 32 (3.9%) 8 (3.7%) 24 (4.0%)
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Our study was designed to evaluate homeopathic treat-
ment in patients with various multiple diagnoses. This
disallowed the use of disease-specific measurement
instruments. Instead we used a numeric rating scale which
is validated, often used [14] and allowed for assessments
of a specific complaint as well as for generalization and
interpretation across various diagnoses. Using generic
QoL questionnaires served the same purpose.
As patients were allowed to use conventional therapies
and other complementary therapies during the study
period, the observed improvements cannot be attributed
to homeopathic treatment alone. The aim of this study,
however, was not to test the effectiveness of homeopathic
drug treatment, but rather provide an unbiased represen-
tation of contemporary homeopathic health care and its
outcome in routine care.
The mean change of the severity ratings after 8 years was
large. This may be partly explained by placebo and/or
regression to the mean effects that our study was not
designed to control. We thus cannot rule out overestima-
tion of the treatment effect. The QoL improvements, on
the other hand, may have been greater than recorded: The
SF-36 is unlikely to overestimate changes, its mental scales
have been found to be less sensitive than the mental und
social scales of other instruments such as the Duke Health
Profile [15]. It is most unlikely that regression to the mean
accounts for all QoL improvement that we have described:
on the physical scale the adults scored even better than the
average German population. Moreover, patients in this
study suffered from long-term chronic diseases and nearly
all of them were conventionally pretreated [10]. This
strengthens the likelihood that the improvement is not
purely due to the natural history of the condition.
It is of note that the differences in the outcome between
those patients who stopped treatment and those who still
continued were small. Most patients reported improve-
ments and only 5% of patients stopped treatment because
of aggravations.
Moreover, only few diagnoses turned out as a predictive
factor for treatment success. This might be taken as an
indicator that the difference in outcome was similar for
most diagnoses and that diagnosis was not a factor
severely confounding our results.
Patients who used additional treatments had a worse out-
come than those who did not. This presumably does not
reflect the fact that these treatments were ineffective or
even harmful, but is more likely a consequence from self-
selection: patients who did not benefit from the homeo-
pathic treatment are more likely to seek additional treat-
ment.
To our knowledge, the present study is the first to evaluate
systematically health effects under homeopathic treat-
Table 5: Patients' assessments of homeopathic treatment (each scale assessed on a NRS from 0 = I totally disagree to 10 = I absolutely
agree; mean ± standard deviation)
Adults Children
"I would let my disease be treated again homeopathically" 7.5 ± 3.2 7.7 ± 3.0
"I would recommend homeopathy to my friends" 7.7 ± 3.0 7.8 ± 2.9
"I would use homeopathy with other diseases" 8.2 ± 2.6 8.0 ± 2.5
"I find homeopathy logically comprehensible" 7.3 ± 2.8 6.5 ± 2.8
Table 6: Prediction of treatment success (mean complaint improvement >2 pts on a NRS from 0–10) from a logistic regression
analysis
Predictor Odds-ratio p-value
Mean complaint at baseline (each pt) 1.74 (1.63 to 1.85) <.001
Age (each 10 years) 0.83 (0.78 to 0.88) <.001
Men (vs women) 0.73 (0.59 to 0.89) 0.003
Additional non-homeopathic co-medication 0.46 (0.37 to 0.56) <.001
Additional treatment at naturopath 0.72 (0.57 to 0.90) 0.003
Additional treatment: Cupping 0.46 (0.23 to 0.91) 0.025
Additional treatment: Osteopathy 0.63 (0.38 to 1.06) 0.081
Diagnosis: allergy (ICD9: 995.3) 0.63 (0.43 to 0.91) 0.014
Diagnosis: allergic rhinitis (ICD9: 477.9) 0.66 (0.47 to 0.92) 0.013
Diagnosis: multiple infections (ICD9: 796.9) 1.60 (1.09 to 2.34) 0.016
Diagnosis: headache (ICD9: 784.0) 0.68 (0.48 to 0.97) 0.033
BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413
Page 8 of 9
(page number not for citation purposes)
ment for such a long observation period and with a high
follow-up rate. Güthlin et al., for example, investigated
933 chronically ill German homeopathy patients for a
period of 30 months (only 129 providing data at that time
point) and found comparable QoL effect sizes [16]. In
England, Spence et al. followed over 6.500 patients from
a single homeopathic outpatient unit for an individual
time period (maximum 6 years, average unknown) [17].
Using a 7-point Likert scale of global clinical impression
as an outcome measure they estimated that about 50% of
all patients showed relevant improvements, a figure that
matches our estimates. Several other investigations from
different countries in Europe or America report similar
health effects in various diseases within the first year after
homeopathic treatment. Here the percentages of patients
who experienced substantial improvements were consist-
ently above 50%, [15,18-28], although conventional
medication was reduced [20,23,24].
Conclusion
Our findings demonstrate that patients who seek homeo-
pathic treatment are likely to improve considerably,
although this effect must not be attributed to homeo-
pathic treatment alone. These effects persisted for 8 years.
Competing interests
The authors declare that they have no competing interests.
Authors' contributions
CMW was substantially involved in the conception and
design of the study, supervised it, helped to interpret the
data, and revised the manuscript critically. RL was respon-
sible for the analysis and interpretation of data and wrote
the first draft of the manuscript. NM was responsible for
data acquisition, helped to interpret the data and revised
the manuscript critically. SNW was substantially involved
in the conception and design of the study, acquired fund-
ing, and revised the manuscript critically. All authors read
and approved the final manuscript.
Acknowledgements
This study was supported by a grant from the Karl and Veronica Carstens-
Foundation, Essen, Germany. We thank all participating physicians and
patients and Iris Bartsch for data collection and Katja Wruck for data man-
agement.
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BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413
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28. Neville-Smith R: Community Hospital Homeopathy Clinic:
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Pre-publication history
The pre-publication history for this paper can be accessed
here:
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How healthy are chronically ill patients after eight years of homeopathic treatment? - Results from a long term observational study. (December 17, 2008)

  • 1. BioMed Central Page 1 of 9 (page number not for citation purposes) BMC Public Health Open AccessResearch article How healthy are chronically ill patients after eight years of homeopathic treatment? – Results from a long term observational study Claudia M Witt*1, Rainer Lüdtke2, Nils Mengler1 and Stefan N Willich1 Address: 1Institute for Social Medicine, Epidemiology and Health Economics, Charité University Medical Center, D-10098 Berlin, Germany and 2Karl and Veronica Carstens-Foundation, Am Deimelsberg 36, D-45276 Essen, Germany Email: Claudia M Witt* - claudia.witt@charite.de; Rainer Lüdtke - r.luedtke@carstens-stiftung.de; Nils Mengler - nilsmengler@web.de; Stefan N Willich - stefan.willich@charite.de * Corresponding author Abstract Background: Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. Methods: In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. Results: A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1 ± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. Conclusion: Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years. Background Homeopathy is based on the 'principle of similars', whereby substances that cause symptoms in healthy indi- viduals are used to stimulate healing in patients who have similar symptoms when ill [1]. Usually, these substances are used in extremely high dilutions, which makes home- opathy a controversially debated system. However, homeopathy is becoming increasingly popular in the world and constitutes an important factor of public Published: 17 December 2008 BMC Public Health 2008, 8:413 doi:10.1186/1471-2458-8-413 Received: 4 August 2008 Accepted: 17 December 2008 This article is available from: http://www.biomedcentral.com/1471-2458/8/413 © 2008 Witt et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
  • 2. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 2 of 9 (page number not for citation purposes) health systems. For example, in the US the proportion of patients obtaining homeopathic care has quadrupled from 1991 to 1997 [2]. In the UK it was estimated that 2% had visited a homeopathic practitioner in the last 12 months [3] and that annual expenditures for homeopathy reached 34.04 million (out-of-pocket 30.74 million, NHS 3.3 million) [4]. In Germany, the country in which home- opathy originated, a survey demonstrated that approxi- mately 10% of men and 20% of women in the general population used homeopathic medicines during the pre- vious year [5]. Here the General Medical Council grants an official additional certification in homeopathy upon suc- cessful completion of a three-year-long training pro- gramme. This is held by approximately 4,500 physicians [6]. Meta-analyses of placebo controlled trials on homeopa- thy have shown inconsistent results [7-9]. However, there is only little data on the effectiveness and patients' satis- faction of homeopathic health care in everyday practice. Ten years ago we started a cohort study in nearly 4.000 patients aiming to systematically collect data about diag- noses and treatment in the area of homeopathic health care in Germany, including data on the patients' health status. Our first results, based on a two year follow-up, were published some years ago [10]. This paper extends our former report, now for the first time presenting data 8 years after the primary homeopathic treatment. Methods Study design In this prospective multi-centre cohort study, patients were included consecutively upon their first consultation with a participating homeopathic physician. All study physicians hold an additional certification in classical homeopathy and had at least three years of experience in its practice. No restrictions on diagnoses were made. For details on inclusion criteria or on the selection of physi- cians see [10]. Recruitment period was between Septem- ber 1997 and December 1999, and measurements of health status were taken at 3, 12, and 24 months using standardised questionnaires. The study protocol was approved by the ethics review board of the Charité Uni- versity Medical Center. In total 3,981 (2,851 adults, 1,130 children) were originally included in the study. In 2006 3,677 patients (2,603 adults, 1,074 children) were contacted again to provide an 8-year follow-up. Patients were not contacted if they were known to have deceased (32 adults), had withdrawn their consent to par- ticipation in this study (207 adults, 53 children) or their actual place of residence could not be identified (9 adults, 3 children). In this paper we present only the long-term results (8 years), for more details on earlier time points refer to [10]. Outcome measures Standardized questionnaires were designed to document sociodemographic data, as well as information on prior medical history, patient symptoms and complaints, qual- ity of life, and the use of any treatment other than home- opathy. At study entry, all patients recorded the complaints that led them to consider homeopathic treat- ment, for children below the age of 8 their parents were asked to do so. Independently of their physicians, patients rated the severity of their complaints on a numeric rating scale (NRS, 0 = no complaints, 10 = maximum severity). All complaints listed by patients in their baseline ques- tionnaire were transferred to their follow-up question- naires by the study office personnel. This ensured that each baseline complaint was assessed at each subsequent follow-up. For statistical purposes we averaged the ratings of the first four listed complaints and used this average as the main outcome measure. For adults (16 years or older at study entry), general health-related quality of life (QoL) was assessed using the German MOS SF-36 questionnaire [11]. The results of the SF-36 are presented in normalised scores, the results being scaled in such a way that the normal German population has a mean score of 0 and a standard deviation of 1. The first questionnaire was distributed to the patients by the study physician and completed prior to case taking and the start of therapy (baseline). Patients sent their completed questionnaires to the study office in sealed envelopes. Follow-up questionnaires were sent to all patients by the study office. At the 8-year follow-up we additionally measured the overall patient satisfaction with treatment on a 4-point Likert scale, ranging from 1 ("little satisfied") to 4 ("very satisfied"). Moreover, we asked the patients to rate whether they "would let their disease be treated homeo- pathically again", "would try homeopathy in other diag- noses", "would recommend homeopathy to a friend", and "find homeopathy logically comprehensible", each on a NRS (0 = "I totally disagree" 10 = "I absolutely agree"). All patients were asked whether they were still under homeopathic treatment. If not, the specific reasons for stopping treatment were recorded and classified into (1) "treatment successful", including "complete healing" and "major improvement"; (2) "treatment success unsatisfac- tory", including "unsatisfactory patient-physician rela- tionship" "hospitalisation", "treatment not helpful", "deterioration", "other therapies preferred", and "too long distance"; (3) "unrelated to treatment success", including
  • 3. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 3 of 9 (page number not for citation purposes) "physician deceased or retired", "physician or patient moved", "pregnancy", "limited time", "treatment too expensive". In case of multiple answers we assumed "treatment success unsatisfactory" if only one of the above listed reasons was given, regardless what the other reasons were. Treatments To reflect usual care all physicians were completely free to choose a treatment. This usually included the prescription of homeopathic medicines according to homeopathic principles, but also could include the onset, change, or withdrawal of a conventional medicine, referrals to spe- cialists, or admission to a hospital. At the 8-year follow-up all patients were asked to specify which, if any, complementary or conventional therapies they used besides homeopathy. For reasons of clarity we grouped these therapies into non-homeopathic medical therapies (phytotherapy, Chinese herbal medicine), relax- ation therapies (meditation, autogenous training), ener- getic therapies (bioresonance therapy, reiki, shiatsu, kinesiology, Feldenkrais), exercise therapies (yoga, tai chi, qigong), and manual therapies (osteopathy, cupping). Statistics Statistical analysis (using SAS/STAT© 9.1 software) fol- lowed the intention-to-treat principle and included those 3,709 patients (2,635 adults, 1074 children) who were contacted at the 8-years follow-up or were known to have deceased. If patients reported that their complaints were cured we replaced missing values with a severity = 0 in subsequent records. Deceased patients were assigned a severity = 10. The remaining missing values were multiply imputed according to Rubin [12]: Each was given several plausible values (drawn from a multivariate normal distribution), generating a total of 5 distinct complete data tables, each without any missing value. These were analyzed sepa- rately (see below), and the results pooled to calculate treatment effects and p-values. For each imputed data set, we fitted a generalised multiple linear regression model to the data [13], where time was taken as a three-level (baseline, 2 years, 8 years) within- patient factor and the serial correlation was assumed to be exponential with time. For comparability purposes with other studies we divided the estimated mean changes from this model by the standard deviation at baseline. This standardised mean change also allows assessing the clinical relevance of effects. Moreover, we aimed to identify factors that predict treat- ment success. For this, we dichotomised the change of complaint severity at a cut point of 2 pts: improvements of 2 pts or more were defined as a clinically relevant suc- cess, smaller improvements or deteriorations were defined as inadequate success. A 2-point improvement in the NRS approximately represents the improvement of one standard deviation at baseline and can thus be seen as a threshold of clinical relevance. At first a list of potential predictors was compiled. This list included mean severity of complaints at study entry, age at study entry (linear fac- tors), sex, the most frequent diagnoses at study entry (migraine, tension type headache, sleep disorders, depres- sion, anxiety disorders, multiple eczemas, psoriasis, aller- gic dermatitis, allergic rhinitis, allergies, dysmenorrhea, multiple infections, hypertension, low back pain, asthma), concomitant therapies (conventional medicine, anthroposophic medicine, acupuncture, other TCM ther- apies, phytotherapy, osteopathy, other manual therapies, yoga, other exercise therapies, relaxation therapies, naturopathy), additional visits to other doctors (conven- tional, TCM, anthroposophic, naturopathic), hospital admission, and reasons for stopping treatment (treatment successful, treatment success unsatisfactory). Afterwards, predictors were identified by backward selection in a logistic regression model. Data for adults (>16 years at study entry) and children (<16 years) were analysed separately. Results Response rates and basic characteristics In total 2,722 (1,903 adults, 819 children) contributed data to the 8-years follow-up. Patients in this study suf- fered from long-term chronic diseases (table 1). Response rates were considerable higher in female than in male adults (74.3% vs. 67.2%) but similar in female and male children (76.9% vs. 75.7%). Thus, male adults are some- what a bit underrepresented in our sample. Age at study entry matched the data of the complete sample (table 1). The majority of the patients were highly educated female adults, most of them fairly below the age of 60 (table 1). Adults mainly suffered from headache (tension type and migraine), allergic diseases, or skin diseases, children from atopic eczema or multiple infections. The average number of diseases at baseline was 2.8 ± 1.1 in adults and 2.3 ± 1.0 in children. Treatments Eight years after study entry one third of the patients (n = 897, 32.9%) still were under homeopathic treatment. 657 patients (24.1%) still consulted that homeopathic physi- cian they had chosen at study entry, 240 (8.8%) had changed to another homeopath. Three in ten patients had stopped homeopathic treatment because they perceived major improvements of health status (n = 794, 29.2%).
  • 4. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 4 of 9 (page number not for citation purposes) On the other hand, a similar percentage of patients stopped treatment because they did not feel homeopathy could help them sufficiently (n = 708, 26.0%), including those 42 patients (1.5%) who reported a deterioration. 194 patients (7.1%) said they stopped treatment for rea- sons unrelated to the therapy success (moving, financial shortage, physician retired etc.), 97 (3.6%) did not give any reason. These figures differed considerably between adults and children: the percentage of children who stopped treatment because of major improvements was twice that of adults (n = 378 (46.2%) vs. n = 416 (21.9%)). In contrast, adults more often stopped treat- ments because of perceived treatment failure (n = 567 (29.8%) vs. n = 141 (17.2%)). Nearly half of the patients (n = 1118, 41.1%) reported to have consulted another CAM therapist (not homeo- pathic) during the study period, including naturopathic doctors, physicians for Traditional Chinese Medicine, and non-medical therapists (German "Heilpraktiker"). Four in ten patients were treated with conventional remedies, this rate being considerably higher in adults than in children (table 2). Similarly, children used less frequently other CAM therapies (table 2). Differences between those who stopped homeopathic treatment and those who contin- Table 1: Patient characteristics (values are absolute numbers and percent or mean ± standard deviation) Study population Responders only Adults (n = 2,635) Children (n = 1,074) Adults (n = 1,903) Children (n = 819) Sex (male: female) 771:1864 559:515 518:1385 423:396 Age at study entry (years) 40.6 ± 12.4 6.7 ± 4.1 41.0 ± 12.3 6.5 ± 4.0 Age at 8-year follow-up (years) 48.3 ± 12.4 14.2 ± 4.2 48.8 ± 12.3 14.1 ± 4.2 Marital status (living in partnership) 1916 (72.7%) 1405 (73.9%) Education (attending school >10 years) 1570 (59.6%) 1155 (60.7%) Belief in homeopathy at study entry 1744 (66.2%) 739 (68.8%) 1283 (67.4%) 567 (69.2%) Duration of disease at study entry (years) 10.0 ± 9.6 4.3 ± 2.7 9.8 ± 8.7 4.2 ± 3.5 Intake of conventional drugs at study entry 1318 (50.0%) 340 (31.7%) 965 (50.7%) 273 (33.3%) Primary diagnosis at study entry * Allergies (ICD9: 995.3) 154 (5.8%) 65 (6.1%) 114 (6.0%) 51 (6.2%) Anxiety (ICD9: 300.0) 137 (5.2%) 44 (4.1%) 94 (4.9%) 34 (4.2%) Asthma (ICD9: 493.9) 109 (4.1%) 67 (6.2%) 88 (4.6%) 51 (6.2%) Depression (ICD9: 311.0) 157 (6.0%) 5 (0.5%) 110 (5.8%) 2 (0.2%) Eczema (ICD9: 692.9) 200 (7.6%) 48 (4.5%) 154 (8.1%) 42 (5.1%) Multiple infections (ICD9: 796.6) 140 (5.3%) 183 (17.0%) 105 (5.5%) 141 (17.2%) Migraine (ICD9: 346.9) 202 (7.7%) 16 (1.5%) 146 (7.7%) 12 (1.5%) Atopic dermatitis (ICD9: 691.8) 131 (5.0%) 216 (20.1%) 99 (5.2%) 175 (21.4%) Allergic rhinitis (ICD9: 477.9) 215 (8.2%) 58 (5.4%) 161 (8.5%) 45 (5.5%) Headache (ICD9: 784.0) 216 (8.2%) 71 (6.6%) 155 (8.1%) 45 (5.5%) Sleep disorders (ICD9: 780.5) 185 (7.0%) 77 (7.2%) 127 (6.7%) 58 (7.1%) * Multiple diagnoses allowed Table 2: Number of patients receiving non-homeopathic treatments during the last 5 years of follow-up, grouped whether or not they still were under homeopathic treatment Adults Children total still under treatment treatment stopped total still under treatment treatment stopped Conventional medicines 881* (46.3%) 255 (37.6%) 625 (52.5%) 154 (18.8%) 40 (18.3%) 114 (19.0%) Acupuncture 402 (21.1%) 155 (22.9%) 247 (20.8%) 38 (4.6%) 8 (3.7%) 30 (5.0%) Yoga 181 (9.5%) 79 (11.7%) 102 (8.6%) 10 (1.2%) 6 (2.7%) 4 (0.7%) Relaxation therapies# 176 (9.2%) 56 (8.3%) 120 (10.1%) 13 (1.6%) 2 (0.9%) 11 (1.8%) Energetic therapies# 188 (9.9%) 68 (10.0%) 120 (10.1%) 56 (6.8%) 20 (9.1%) 36 (6.0%) Exercise therapies# 249 (13.1%) 109 (16.1%) 140 (11.8%) 11 (1.3%) 6 (2.7%) 5 (0.8%) Manual therapies# 108 (5.7%) 53 (7.8%) 55 (4.6%) 16 (2.0%) 9 (4.1%) 7 (1.2%) Non-conventional medicines# 60* (3.2%) 15 (2.2%) 44 (3.7%) 6 (0.7%) 2 (0.9%) 4 (0.7%) * Due to missing values frequencies in subgroups do not add to total frequencies # For definitions see methods section
  • 5. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 5 of 9 (page number not for citation purposes) ued were small in children. However in adults patients who stopped treatment used more frequently conven- tional medication (53% vs. 38%). Severity of complaints and quality of life During the study mean severity of complaints improved from baseline 6.2 ± 1.7 to 2.7 ± 2.1 after 8 years in adults and from 6.1 ± 1.8 to 1.7 ± 1.9 in children (table 3, figure 1). From the generalised linear model the respective standardised mean changes (mean changes divided by standard deviations at baseline) were estimated at 1.61 for adults (CI: 1.54 to 2.68, p < 0.001) and 2.01 for children (CI: 1.89 to 2.12, p < 0.001). At the 8-years follow-up one in two patients reported improvements of complaint severity by 50% or more. These percentages were similar in patients who were still under homeopathic treatment and those who were not (table 4). Accordingly, QoL in adults improved considerably (table 3). This results in effect size estimates of 0.39 (CI: 0.35 to 0.45, p < 0.001) in the physical score and 0.54 (CI: 0.48 to 0.60, p < 0.001) in the mental score, respectively. These 8-year figures were nearly identical to those after 2 years (table 3) suggesting that the patients' health status did not worsen along time. Again, in children there were no relevant differences between those who stopped homeopathic treatment and those who continued, whereas in those adults who continued treatment we found slightly higher effects. Overall satisfaction 731 (38.4%) adults and 342 (41.8%) children reported to be "very satisfied" with the treatment, in contrast only 246 (12.9%) adults and 84 (10.3%) children were "little satis- fied". Accordingly, most patients would use homeopathy again and recommend it to friends with similar com- plaints (table 5). Predictors of success 1283 adults (67.4% of the study population, 48.7% of all responders) and 655 children (80.0%/61.0%) experi- enced a clinically relevant treatment success, defined as an improvement of complaint severity of 2 pts or more. From the logistic regression we found that this was more likely in women than in men, and in children than in adults. Patients who simultaneously used other treatments (con- ventional or complementary) had a smaller chance to improve relevantly, as did those suffering from allergies, allergic rhinitis, or headache. In contrast, a diagnosis of multiple infections was a positive predictor (table 6). Discussion In our study we extended former results on the course of disease in patients receiving homeopathic treatment, now presenting data from an 8-year follow-up. These data con- sistently show substantial health improvements in patients under homeopathic treatment, which persisted Table 3: Course of mean complaint severity and quality of life during the study, grouped whether or not the patients still were under homeopathic treatment baseline 2 years 8 years 2 years change 8 years change Adults Severity of complaints total 6.2 ± 1.7 2.9 ± 2.2 2.7 ± 2.1 3.2 ± 2.4 3.5 ± 2.4 still under hom. treatment 6.0 ± 1.6 2.6 ± 1.9 2.4 ± 1.9 3.4 ± 2.3 3.6 ± 2.2 hom. treatment stopped 6.2 ± 1.8 3.0 ± 2.3 2.8 ± 2.2 3.2 ± 2.4 3.4 ± 2.5 Quality of life, physical score total -0.36 ± 0.96 0.08 ± 0.85 0.08 ± 0.89 0.42 ± 0.91 0.41 ± 1.00 still under hom. treatment -0.34 ± 0.92 0.16 ± 0.79 0.15 ± 0.81 0.48 ± 0.89 0.48 ± 0.95 hom. treatment stopped -0.37 ± 0.39 0.04 ± 0.89 0.04 ± 0.93 0.41 ± 0.91 0.38 ± 1.02 Quality of life, mental score total -1.47 ± 1.43 -0.56 ± 1.23 0.53 ± 1.26 0.87 ± 1.41 0.95 ± 1.51 still under hom. treatment -1.43 ± 1.44 -0.49 ± 1.19 -0.43 ± 1.17 0.89 ± 1.41 1.00 ± 1.52 hom. treatment stopped -1.50 ± 1.43 -0.61 ± 1.24 -0.59 ± 1.31 0.86 ± 1.48 0.92 ± 1.51 Children Severity of complaints total 6.1 ± 1.8 2.2 ± 2.0 1.7 ± 1.9 3.9 ± 2.5 4.4 ± 2.6 still under hom. treatment 6.1 ± 1.7 2.1 ± 1.9 1.8 ± 1.9 4.0 ± 2.4 4.3 ± 2.4 hom. treatment stopped 6.1 ± 1.8 2.2 ± 2.1 1.7 ± 1.9 3.9 ± 2.6 4.4 ± 2.6
  • 6. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 6 of 9 (page number not for citation purposes) through the whole observation period. Improvements were more pronounced in younger patients, females, and those with greater disease severity at baseline. The methodological strengths of our study include con- secutive enrolment of a large sample size, the participa- tion of approximately 1% of all physicians certified to practice homeopathy in Germany and the use of standard- ised outcome instruments also used in studies on conven- tional therapy. Moreover, our study provides a reasonably representative sample of all patients attending a doctor practicing classi- cal homeopathy in Germany. The subset of patients responding to the 8-year follow up matched fairly well the data of the complete sample: although female adults were slightly overrepresented in this sample, data on age, com- plaint severity at baseline or duration of disease were nearly identical between those who responded after 8 years and those who did not. We therefore believe that selection bias is small and that our data are generalisable. Severity of complaints (mean ± standard deviation)Figure 1 Severity of complaints (mean ± standard deviation). 0 2 4 6 8 10 study entry 2 years 8 years meancomplaint(NRS) children adults Table 4: Number of patients whose change in symptom scores indicates improvements or worsening of complaints at the 8-years follow-up, grouped whether or not they still were under homeopathic treatment Adults n (%) Children n (%) total still under treatment treatment stopped total still under treatment treatment stopped cured (all complaints vanished) 243 (12.8%) 86 (12.7%) 157 (13.2%) 247 (30.2%) 62 (28.3%) 185 (30.9%) complaint severity improved ≥ 50% 918 (48.2%) 372 (54.9%) 545 (45.8%) 397 (48.5%) 111 (50.7%) 286 (47.7%) complaint severity improved ≥ 10% 488 (25.6%) 162 (23.9%) 326 (27.4%) 121 (14.8%) 31 (14.2%) 90 (15.0%) complaint severity worsened ≥ 10% 90 (4.7%) 21 (3.1%) 69 (5.8%) 32 (3.9%) 8 (3.7%) 24 (4.0%)
  • 7. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 7 of 9 (page number not for citation purposes) Our study was designed to evaluate homeopathic treat- ment in patients with various multiple diagnoses. This disallowed the use of disease-specific measurement instruments. Instead we used a numeric rating scale which is validated, often used [14] and allowed for assessments of a specific complaint as well as for generalization and interpretation across various diagnoses. Using generic QoL questionnaires served the same purpose. As patients were allowed to use conventional therapies and other complementary therapies during the study period, the observed improvements cannot be attributed to homeopathic treatment alone. The aim of this study, however, was not to test the effectiveness of homeopathic drug treatment, but rather provide an unbiased represen- tation of contemporary homeopathic health care and its outcome in routine care. The mean change of the severity ratings after 8 years was large. This may be partly explained by placebo and/or regression to the mean effects that our study was not designed to control. We thus cannot rule out overestima- tion of the treatment effect. The QoL improvements, on the other hand, may have been greater than recorded: The SF-36 is unlikely to overestimate changes, its mental scales have been found to be less sensitive than the mental und social scales of other instruments such as the Duke Health Profile [15]. It is most unlikely that regression to the mean accounts for all QoL improvement that we have described: on the physical scale the adults scored even better than the average German population. Moreover, patients in this study suffered from long-term chronic diseases and nearly all of them were conventionally pretreated [10]. This strengthens the likelihood that the improvement is not purely due to the natural history of the condition. It is of note that the differences in the outcome between those patients who stopped treatment and those who still continued were small. Most patients reported improve- ments and only 5% of patients stopped treatment because of aggravations. Moreover, only few diagnoses turned out as a predictive factor for treatment success. This might be taken as an indicator that the difference in outcome was similar for most diagnoses and that diagnosis was not a factor severely confounding our results. Patients who used additional treatments had a worse out- come than those who did not. This presumably does not reflect the fact that these treatments were ineffective or even harmful, but is more likely a consequence from self- selection: patients who did not benefit from the homeo- pathic treatment are more likely to seek additional treat- ment. To our knowledge, the present study is the first to evaluate systematically health effects under homeopathic treat- Table 5: Patients' assessments of homeopathic treatment (each scale assessed on a NRS from 0 = I totally disagree to 10 = I absolutely agree; mean ± standard deviation) Adults Children "I would let my disease be treated again homeopathically" 7.5 ± 3.2 7.7 ± 3.0 "I would recommend homeopathy to my friends" 7.7 ± 3.0 7.8 ± 2.9 "I would use homeopathy with other diseases" 8.2 ± 2.6 8.0 ± 2.5 "I find homeopathy logically comprehensible" 7.3 ± 2.8 6.5 ± 2.8 Table 6: Prediction of treatment success (mean complaint improvement >2 pts on a NRS from 0–10) from a logistic regression analysis Predictor Odds-ratio p-value Mean complaint at baseline (each pt) 1.74 (1.63 to 1.85) <.001 Age (each 10 years) 0.83 (0.78 to 0.88) <.001 Men (vs women) 0.73 (0.59 to 0.89) 0.003 Additional non-homeopathic co-medication 0.46 (0.37 to 0.56) <.001 Additional treatment at naturopath 0.72 (0.57 to 0.90) 0.003 Additional treatment: Cupping 0.46 (0.23 to 0.91) 0.025 Additional treatment: Osteopathy 0.63 (0.38 to 1.06) 0.081 Diagnosis: allergy (ICD9: 995.3) 0.63 (0.43 to 0.91) 0.014 Diagnosis: allergic rhinitis (ICD9: 477.9) 0.66 (0.47 to 0.92) 0.013 Diagnosis: multiple infections (ICD9: 796.9) 1.60 (1.09 to 2.34) 0.016 Diagnosis: headache (ICD9: 784.0) 0.68 (0.48 to 0.97) 0.033
  • 8. BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 8 of 9 (page number not for citation purposes) ment for such a long observation period and with a high follow-up rate. Güthlin et al., for example, investigated 933 chronically ill German homeopathy patients for a period of 30 months (only 129 providing data at that time point) and found comparable QoL effect sizes [16]. In England, Spence et al. followed over 6.500 patients from a single homeopathic outpatient unit for an individual time period (maximum 6 years, average unknown) [17]. Using a 7-point Likert scale of global clinical impression as an outcome measure they estimated that about 50% of all patients showed relevant improvements, a figure that matches our estimates. Several other investigations from different countries in Europe or America report similar health effects in various diseases within the first year after homeopathic treatment. Here the percentages of patients who experienced substantial improvements were consist- ently above 50%, [15,18-28], although conventional medication was reduced [20,23,24]. Conclusion Our findings demonstrate that patients who seek homeo- pathic treatment are likely to improve considerably, although this effect must not be attributed to homeo- pathic treatment alone. These effects persisted for 8 years. Competing interests The authors declare that they have no competing interests. Authors' contributions CMW was substantially involved in the conception and design of the study, supervised it, helped to interpret the data, and revised the manuscript critically. RL was respon- sible for the analysis and interpretation of data and wrote the first draft of the manuscript. NM was responsible for data acquisition, helped to interpret the data and revised the manuscript critically. SNW was substantially involved in the conception and design of the study, acquired fund- ing, and revised the manuscript critically. All authors read and approved the final manuscript. Acknowledgements This study was supported by a grant from the Karl and Veronica Carstens- Foundation, Essen, Germany. We thank all participating physicians and patients and Iris Bartsch for data collection and Katja Wruck for data man- agement. References 1. Jonas W, Jacobs J: Healing With Homeopathy New York: Warner Books; 1996. 2. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, van Rompay M, Kessler RC: Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national sur- vey. JAMA 1998, 280(18):1569-1575. 3. Thomas K, Coleman P: Use of complementary or alternative medicine in a general population in Great Britain. Results from the National Omnibus survey. Journal of public health (Oxford, England) 2004, 26(2):152-157. 4. Thomas KJ, Nicholl JP, Coleman P: Use and expenditure on com- plementary medicine in England: a population based survey. Complementary therapies in medicine 2001, 9(1):2-11. 5. Härtel U, Volger E: Inanspruchnahme und Akzeptanz klas- sischer Naturheilverfahren und alternativer Heilmethoden in Deutschland – Ergebnisse einer repräsentativen Bev- ölkerungsstudie. Forsch Komplementarmed Klass Naturheilkd 2004, 11(6):327-334. 6. Marstedt G, Moebus S: Inanspruchnahme alternativer Meth- oden in der Medizin. In Gesundheitsberichterstattung des Bundes, Heft 9 Robert-Koch-Institut; 2002. 7. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges L, Jonas WB: Are the clinical effects of homoeopathy placebo effects? – A meta-analysis of placebo-controlled trials. Lancet 1997, 350:834-843. 8. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M: Are the clinical effects of homoeopathy placebo effects? 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  • 9. Publish with BioMed Central and every scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical research in our lifetime." Sir Paul Nurse, Cancer Research UK Your research papers will be: available free of charge to the entire biomedical community peer reviewed and publishedimmediately upon acceptance cited in PubMed and archived on PubMed Central yours — you keep the copyright Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp BioMedcentral BMC Public Health 2008, 8:413 http://www.biomedcentral.com/1471-2458/8/413 Page 9 of 9 (page number not for citation purposes) 27. Treuherz F: Homeopathy in general practice: a descriptive report of work with 500 consecutive patients. Brit J Hom 2000, 89(Suppl 1):S43. 28. Neville-Smith R: Community Hospital Homeopathy Clinic: Autor of the first 12 months activity. Brit Hom J 1999, 88:20-23. Pre-publication history The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2458/8/413/pre pub