eCAM Advance Access published August 17, 2009
Homeopathic Individualized Q-potencies versus Fluoxetine forModerate to Severe Depression: Double-blind, RandomizedNon-inferiority Trial
U. C. Adler, N. M. P. Paiva, A. T. Cesar, M. S. Adler, A. Molina, A. E. Padulaand H. M. Calil
Faculdade de Medicina de Jundiaı´, Homeopathy Graduation Programme, Department of Psychobiology,Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil
Homeopathy is a complementary and integrative medicine used in depression, The aim ofthis study is to investigate the non-inferiority and tolerability of individualized homeopathicmedicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as activecontrol. Ninety-one outpatients with moderate to severe depression were assigned to receive anindividualized homeopathic medicine or fluoxetine 20 mg day–1 (up to 40 mg day–1) in a pro-spective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacymeasure was the analysis of the mean change in the Montgomery & A˚sberg Depression RatingScale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondaryefficacy outcomes were response and remission rates. Tolerability was assessed with the sideeffect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scoresdifferences were not significant at the 4th (P ¼ 0.654) and 8th weeks (P ¼ 0.965) of treatment.
Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval(CI) for mean difference in MADRS change was less than the non-inferiority margin: meandifferences (homeopathy–fluoxetine) were À3.04 (95% CI À6.95, 0.86) and À2.4 (95% CIÀ6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences betweenthe percentages of response or remission rates in both groups. Tolerability: there were nosignificant differences between the side effects rates, although a higher percentage of patientstreated with fluoxetine reported troublesome side effects and there was a trend toward greatertreatment interruption for adverse effects in the fluoxetine group. This study illustrates thefeasibility of randomized controlled double-blind trials of homeopathy in depression and indi-cates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetinein acute treatment of outpatients with moderate to severe depression.
Keywords: depression – drug therapy – fluoxetine – homeopathy – integrative andalternative medicine – non-inferiority – Q-potencies – randomized controlled trial – remission –response
Depression was the most prevalent (19.2%) of the
For reprint and all correspondence: H. M. Calil, Department of
chronic diseases assessed by the Brazilian World Health
Psychobiology, Universidade Federal de Sa˜o Paulo, R. Napolea˜o de
Survey in 2003 (1), including asthma, arthritis, angina
Barros, 925 Sa˜o Paulo, SP 04024-002, Brazil. Tel: þ5511-2149-0155;Fax: þ5511-5572-5092; E-mail: [email protected]
ß 2009 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work isproperly cited.
There still remain flaws in the treatment of depres-
tolerability of individualized homeopathic Q-potencies
sion with antidepressants, in terms of efficacy, adverse
in adults with acute depression, as compared to fluoxet-
effects, non-compliance to treatment and delayed onset
ine, in a prospective, randomized, double-blind, double-
of their therapeutic response (2–5). Regarding efficacy,
response has been defined as a decrease of 50% ormore from baseline score in a rating scale, such as theHamilton Rating Scale for Depression (HAM-D) or the
(MADRS), whereas depression scores HAM-D 7 and
MADRS 10 are often used to characterize remission
Patients referred to the outpatient clinic of Homeopathy
(6). Unmet needs of the conventional treatment may con-
and Depression of Jundiaı´ Medical School (Faculdade de
tribute to the patients’ search for alternatives: depression
Medicina de Jundiaı´, Sa˜o Paulo, Brazil), who met DSM-
is one of the leading causes for use of complementary and
IV criteria for depression (single or recurrent episode)
integrative medicine (CIM) in the USA (7), although any
following a Structured Clinical Interview—SCID (19)
type of CIM has not yet conclusively had its efficacy
were included in the study. Capacity and willingness to
demonstrated over placebo in that disease (8).
give informed consent and to comply with study proce-
Homeopathy is an integrative medicine, also used in
depression (9) and recognized as a medical specialty in
Exclusion criteria were: psychosis, mania, hypomania
Brazil. The classical homeopathy treatment is customized
or any other Axis I disorder except panic disorder, per-
to the patient. The homeopathic medicine is individually
sonality disorders, history of seizures, history of alcohol
selected according to the similitude to the patient’s signs
or drug abuse 1 year prior to the screening, antidepres-
and symptoms, aiming at desensitizing the organism
sant use up to 30 days before screening, pregnancy or
to the physical and mental alterations induced by disease.
lactation, age 518 years, MADRS score 515, recent sui-
Minimal doses used in homeopathy are obtained by
cide planning or attempts, although these are symptoms
dynamization, the process developed by Hahnemann to
of depression, they are also standard exclusion criteria
prepare medicines through sequential agitated dilutions,
in depression clinical studies, including CAM trials in
in relatively small volumes (10). Hahnemann’s dynamiza-
tion gained support of physics: thermoluminescence
The 91 patients were consecutively recruited between
emitted by ‘ultra-high dilutions’ (dynamizations) of lith-
ium chloride and sodium chloride was specific of the saltsinitially dissolved, despite their dilution beyond theAvogadro number (11).
With homeopathic dynamized medicines given in such
‘uncommonly small doses’, Hahnemann aimed at achieving
A written informed consent was obtained from each
‘a rapid, gentle and permanent restoration of the health’,
participant. The study was approved by the Ethic
which seemed to him easier to achieve with his last
dynamization method known as fifty-millesimal, orQuinquagintamillesimal (Q-potencies), once the medicine
is diluted $50 000 times at each step (potency) of the dyna-mizing process (10). Hahnemann’s instructions for the use
The study was a prospective, randomized, double-blind,
and preparation of these potencies were part of a posthu-
double-dummy trial, with fluoxetine as active control.
mous publication (the 6th edition of the Organon),
The double-dummy methodology was used once it was
unknown by the homeopathic community until the last
not possible to make the homeopathic medication
(hydroalcoholic solutions of the medicinal globules) and
There is no controlled study of the homeopathic use
the fluoxetine capsules to look the same, so we created
of Q-potencies in depressive disorders and the overall
evidence for the efficacy of homeopathy in depression
Following inclusion, patients went through a homeo-
has been limited due to lack of clinical trials of high
quality (14,15). Nevertheless, Q-potencies have been
(U.C.A.) and received a prescription of the individualized
recently tested in randomized, controlled studies showing
homeopathic medicine and fluoxetine. The research
therapeutic effects in fibromyalgia and attention deficit
pharmacist randomly delivered homeopathy and placebo
hyperactivity disorder as compared to placebo (16,17).
or fluoxetine and placebo, according to a randomized
We have reported a series of cases of depression treated
assignment sequence to either homeopathy or fluoxetine
with individualized Q-potencies, stressing the need of
controlled studies (18). The present study was a further
with the code, 1 or 2, chosen by the study’s senior
step, aiming at investigating the non-inferiority and
The randomization sequence (one set of 100 non-
The homeopath has a medical degree and 20 years
unique numbers, ranging from 1 to 2, unsorted) was
recorded and sent to the research pharmacist at the
Hahnemann in 6th edition of the Organon (29).
start of the study. Only the senior author and thepharmacist had access to the code of the randomizedsequence during the study. After each patient completed
the 8-week trial (or in emergency interventions—clinical
Improvement was measured by the MADRS, applied
worsening, disturbing adverse effects) the pharmacist
by a collaborator blind to treatment groups or outcomes.
informed the PI if the individual patient was taking
The MADRS scale has been chosen because it has
homeopathy or fluoxetine (and the matched placebo)
been validated in Brazil and based on evidence that this
instrument most accurately reflects treatment inducedchange (21–23).
The primary efficacy measure was mean change in the
MADRS scores from baseline to the 4th and 8th weeksof treatment, whereas the secondary efficacy outcomes
Subjects at baseline received one of the following
were response and remission rates at the same intervals.
Tolerability was assessed with the side effect rating
(i) one drop of the prescribed Q-potency, three times
scale of the Scandinavian Society of Psychopharmacology
a week (on Mondays, Wednesdays and Fridays),
(24), applied by a collaborator blind to treatment groups
(ii) one hard white gelatine capsule containing 20 mg
fluoxetine-hydrochloride daily, in the morning,after breakfast.
(iii) plus their matching placebos. A double-dummy
The demographic characteristics and duration of illness
technique with matching placebos for each active
were compared with Student’s t-test for independent
samples. Fisher’s exact test was used for comparison of
seemed identical to their corresponding verum
marital status and analysis of dropouts between the two
A prefixed margin of non-inferiority (Á) of 1.45 was
HN-Cristiano Pharmacy, Pinheiros, Sa˜o Paulo, under
specified, according to recommendation that Á should be
the responsibility of a pharmacist (Cesar, AT). They
between one-third and one-half of the advantage of the
were supplied in 30 ml bottles, with one globule of the
active comparator over placebo and correspond with
indicated Q-potency dissolved in 20 ml of a 30% alcohol-
minimum difference that would be considered clinically
distilled water solvent. Patients began the study on Q2
important (25). The margin of non-inferiority was
potency and moved on to higher potencies in order: Q3,
assumed based on the mean MADRS-score changes ofthe placebo arm, from a multicenter placebo-controlled
Q4, etc. according to medical indications. Placebo bottles
clinical study of moderate to severe depression (26).
were filled with the same amount of 30% alcohol.
The non-inferiority analysis included all 91 randomized
Capsules of fluoxetine were provided by the High Cost
patients, using a ‘full analysis set’ (27), i.e. with all
Pharmacy of Jundiai’s public health system, under the
observed MADRS scores, but without filling in the miss-
ing data. Non-inferiority of homeopathic individualized
Lencioni Lovate). As the capsules available at the local
medicines over fluoxetine was accepted in a 0.025 level
public health system came in yellow–green color, they
test, if the upper limit of the 95% confidence interval (CI)
were re-encapsulated in white color by another pharma-
around the difference of the primary efficacy measures
cist (Regina Oliveira), at Pharmaesseˆncia Pharmacy,
was situated below the limit of non-inferiority.
Campinas, SP, to match placebo white capsules contain-
Analysis of the MADRS scores follow-up was made
ing celluloses, kaolin and talcum powder.
with repeated measures analysis of variance (ANOVA),
Both treatments were conducted as if the participants
with time as within factor and condition as between
were receiving active treatment. In case of no response
factor, and Bonferroni’s multiple comparisons method.
after 4 weeks of treatment, the patient blindly received:
Response and remission rates were analyzed with non-
(i) 40 mg of fluoxetine daily (20 mg b.i.d.) or two
parametric analysis for longitudinal data. Sample size
was not calculated because this trial was a sequence of
(ii) a changed homeopathic prescription, or placebo
a pilot study, with a smaller sample (n ¼ 59), but already
solution. The homeopath was allowed to change
sufficient to suggest the non-inferiority of homeopathy to
remedy, potency or posology prescriptions.
were also similar in the fluoxetine and homeopathygroups, as shown in Table 2.
This sample consisted of patients with moderate to severe
Twenty medicines were used to treat the 48 patients
depression, because their mean MADRS depression
scores were close to the 31 score cut-off for moderate
orientale, Arsenicum album, Aurum foliatum, Baryta car-
and severe depression (28). Initially, 284 subjects were
bonica, Calcarea carbonica, Carbo animalis, Causticum,
screened, 105 of them met the inclusion criteria, 14 out
Graphites, Hepar sulphuris calcareum, Kali carbonicum,
of them did not attend the first appointment, 91 were
randomized and 55 completed the 8-week trial. A detailed
muriaticum, Mezereum, Phosphorus, Sepia succus, Silicea
flow chart of subject progress through the study is shown
terra, Sulphur and Zincum. These medicines were selected
according to Hahnemann’s instructions, i.e. matching the
There were no significant differences between the pro-
characteristic symptoms (the stronger, well-marked and
portions of excluded and lost for follow-up patients inthe two groups (P ¼ 0.99), though there was a trend
Table 1. Excluded or lost for follow-up patients
toward greater treatment interruption for adverse effectsin the fluoxetine group, as can be seen in Table 1.
Almost all patients enrolled in the study were female:
89/91 (98%). One male patient was randomly assigned to
each group. There was no significant difference in the
marital status (married, single, widow, divorced) between
the two groups (P ¼ 0.86). Other baseline characteristics
Figure 1. Diagram flow of subjects throughout the study.
peculiar symptoms) of each case to very similar symp-
In line with the MADRS mean changes illustrated in
toms described by healthy volunteers in homeopathic
Fig. 2, the non-inferiority analysis showed that the indi-
vidualized homeopathic Q-potencies were not inferior to
Regarding concomitant psychoactive medications, in
fluoxetine, once the upper limit of the CIs lies to the left
the fluoxetine group three patients were taking clonaze-
of Á and includes zero (27), as represented by Fig. 3.
pam (1–2.5 mg) and two were on diazepam (5–10 mg).
In the homeopathy group, one patient was using clona-zepam and another one was on diazepam at the begin-
ning of the study (same dosage range). No patient
referred to this study was on psychotherapy.
response rates on the 4th (63.9 and 65.8%, respectively)and 8th (84.6 and 82.8%, respectively) weeks of treat-ment. Also no significant differences were found for theremission rates, on the 4th (47.2 and 55.3%, respectively,
Repeated measures ANOVA were used with time as
factor. The results showed significant differences fortime (within factor, P50.001), but not for treatment
group (between factor, P ¼ 0.105) interaction (P ¼ 0.749).
There were also no significant differences between the
Both treatment groups started with similar depression
side effects rates, although a higher percentage of patients
mean scores: fluoxetine 28.09 Æ 6.88 (n ¼ 43), homeopathy
treated with fluoxetine (21.4%) than those who received
27.21 Æ 6.22 (n ¼ 48, P ¼ 0.988) and improved during the
homeopathy (10.7%) reported ‘side effects that interfere
8 weeks of double-blind treatment. The statistical analysisshowed that the differences between the MADRS scoresin the two groups were not significant (as shown inFig. 2), neither at the 4th week—fluoxetine 12.33 Æ 8.52(n ¼ 36), homeopathy 9.29 Æ 8.31 (n ¼ 38, P ¼ 0.654) norat the 8th week—fluoxetine 8.85 Æ 7.48 (n ¼ 26), homeop-athy 6.21 Æ 4.99 (n ¼ 29, P ¼ 0.965).
Table 2. Baseline demographic and clinical characteristics
Figure 2. MADRS mean scores at baseline and on 4th and 8th weeks
of randomized treatment with fluoxetine or individualized homeopathic
Figure 3. Non-inferiority representation of the difference (homeopathy versus fluoxetine) in the mean change of the MADRS scores on the 4th and8th weeks of randomized, double-bind treatment. Error bars indicate two-sided 95% CIs. Tinted area indicates zone of non-inferiority. Deltaindicates the margin of non-inferiority. Mean differences (homeopathy–fluoxetine) were À3.04 (À6.95 to 0.86) and À2.64 (À6.05 to 0.77) atweeks 4th and 8th, respectively.
antidepressant interventions, favoring the hypothesis
that ‘the homeopathic consultation is in itself a thera-peutic intervention working independently or synergistic-ally with the prescribed remedy’ (36).
A placebo-arm was not included in the present study
because it was not authorized by the National Ethic
In this study, depressed outpatients were randomly
Council. Although placebo interventions are associated
assigned to a double-blind treatment with individualized
with mean response or remission rates of $35%
(37,38), a placebo effect cannot be ruled out, since the
homeopathic Q-potencies were compared with an anti-
Q-potencies were not inferior as compared to fluoxetine
depressant and ‘it is becoming more and more difficult
in treatment of this sample of outpatients with moderate
to prove that antidepressants—even well-established anti-
depressants—actually work better than placebo in clinical
This is the first randomized controlled double-blind
trials’ (39). Nevertheless, it also has to be taken into con-
trial with a reasonable number of subjects to draw con-
clusions about the homeopathic treatment of depression,
seems to be smaller in the trials aiming at mild to mod-
to the best of our knowledge. In fact, a recent systematic
erate depression (40,41) and the present sample consisted
review found only two randomized controlled trials
of patients suffering from moderate to severe depression.
examining the use of homeopathy to treat depression,
Placebo-controlled studies would be recommendable to
one of low methodological quality (non-blinded) and
the other with recruitment‘s difficulties: eleven partici-
Fluoxetine and homeopathy patients showed differ-
pants were included and only three completed the
ences, although not significant, in exclusion profiles and
tolerability. There was trend toward greater treatment
The current sample was not recruited by advertisement
interruption for adverse effects in the fluoxetine group,
and it was not composed by ‘consumers of alternative
what is in line with the higher percentage of troublesome
medicine’ (33), but by help-seeking patients referred to
adverse effects reported by patients receiving fluoxetine.
On the other hand, more patients randomized to hom-
Medical School by health care professionals within
eopathy than to fluoxetine were excluded due to worsen-
the public health system. The predominance of women
ing of their depressive symptoms. Possible explanations
participants in a proportion greater than normally
are that casual differences can occur in small samples, or
expected may be partially explained by men’s relatively
that homeopathy was not effective in protecting against
limited use of public health services in Brazil, a trend that
stressful situations or even that the medicines selected
has been associated with representation of caring as a
were non-homeopathic, i.e. not adequately individualized
female task, work-related issues, difficult access to ser-
to match the peculiar symptoms of each case. There is
vices and lack of services specifically targeting men’s
no data about the efficacy of homeopathy in protecting
against depression relapse or recurrence, but it’s known
The need of individual prescriptions in classical hom-
that stressful life events can cause recurrence of depres-
eopathy has been considered as ‘a severe obstacle for any
sion even in conventionally medicated patients (42).
double-blind trial’ by experienced researchers (17). In
The current study has other limitations besides the lack
fact, a study design in which the selection of a suitable,
of a placebo control, such as dependence on a single
individualized homeopathic medicine occurs during the
homeopathic practitioner, a relatively small sample and
a short period of treatment—the acute phase of depres-
the efficacy of homeopathy, but also the efficiency of
sion. A multicenter trial could include a larger number of
the homeopath in selecting and managing that medicine.
participants, from different homeopathic research centers,
A placebo substitution design (with an open-label phase
increasing the generalizability of the results. Nevertheless,
preceding the randomization) would be recommendable,
larger or multicenter trials aiming at repeating these
but in depression studies such a design is used for con-
results should take in account the need for properly train-
tinuation or maintenance trials (35) and not to assess the
ing the physicians in the homeopathic methodology used
(6th edition of the Organon), as well as the use of high
quality, exactly prepared Q-potencies.
MADRS scores differences were neither significant at
A recent meta-analysis of homeopathic trials concluded
that the results were ‘compatible with the notion that
(P ¼ 0.965). There were also no significant differences
clinical effects of homeopathy are placebo effects’ (43).
between response or remission rates in the two treatment
However, as demonstrated by Lu¨dtke et al., this conclu-
groups, which were over 70% and in some degree super-
sion was based on an arbitrarily chosen subset of eight
ior to those found in primary care settings for active
trials, out of 21 high-quality trials and the results favor
homeopathy, if another threshold to define a ‘large trial’
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Received March 7, 2009; accepted July 17, 2009
PgD-Jaarverslag 2011 Inleiding Dit verslag omvat een inhoudelijke samenvatting van de activiteiten van de PgD in 2011. Dit is onderverdeeld naar kwartalen. In dit jaarverslag is niet opgenomen welke voordrachten en cursussen er door de diverse PgD psychologen zijn georganiseerd. Ook is de jaarrekening niet bijgevoegd. Meer informatie is op te vragen bij de directie, via [email protected]
Chapitre 1 LA MALADIE DE PARKINSON ET SES TRAITEMENTS Ont contribué à l’élaboration, la rédaction et la révision de cette section : Line Beaudet Chantal Beauvais Sylvain Chouinard Manon Desjardins Michel Panisset Emmanuelle Pourcher Valérie Soland Maladie de Parkinson Thalamus Substance noire Tronc cérébral Noyau sous-thalamique Globus pallidus Putamen Noyau ca