A Google-cache snapshot of
https://kundoc.com/download/oscillococcinumr-in-patients-with-influenza-like-syndromes-a-placebo-controlled-_5b8907b0d64ab2b7b15e0539.htmlin the ice-box:
http://archive.is/1jUCjDetails:
"372 patients were enrolled in the study.
188 patients were randomly allocated to the verum group,
184 to the placebo group."This about the size of the Ferley "study" made about 10 years earlier. See above.
Something went wrong with the figures:
[*quote*]
Treatment efficacy
In the course of the trial period, 21 patients in
the verum group and 17 in the placebo group
violated the protocol, for instance, by insuf®-
cient compliance. These patients were not
considered in the following analyses of effec-
tiveness: situation after 48 hours, date of
absence of symptoms and final assessment.
In the following description, the reduced
sample of 334 patients comprises
167 in the
verum group and 167 in the placebo group.[*/quote*]
So it is
a) 167 "treated" with diluted water
b) 167 "treated" with placebo.
[*quote*]
Exclusion criteria
were:
patients under 12 or over 60 years of age;
patients who, for preventive reasons, needed to be given an anti-influenzal treatment during the first 48 hours of the study;
patients with immune system disorders or local infections and
patients who had been immunised against influenza;
patients who had been given additional therapy in the form of immuno-suppressants or immunostimulants;
or those who had taken anti-influenzal medicines, analgesics or antibiotics
during the first 48
hours of the trial.[*/quote*]
[*quote*]
Out of 188 patients in the verum group
86.2% were without concomitant medication
at the start of the study and during the first day
of treatment.
In the placebo group 91.3% out of
184 patients were without additional medica-
tion during this period (Table 1)
[*/quote*]
0,862 * 188=162,056
0,913 * 184=167,992
This does not fit with the figures
[*quote*]
"167 in the
verum group and 167 in the placebo group."[*/quote*]
[*quote*]
Concomitant medication
After the first 48 hours, some of the patients in
both groups received concomitant medication.
Analgesics and anti-rheumatics were the most
frequent, followed by cough medicine and
expectorants. Anti-influenzal medication as
concomitant therapy played a minor role in
both groups.9 The frequency of additional medi-
cation use was higher in the placebo group than in
the verum group. Over the course of the trial the
number of patients who received concomitant
medication clearly increased in both groups:
in
the verum group it increased from 13.8% to
30.3% and in the placebo group from 8.7% to
36.4%.This difference between the treatment
groups continued with the percentage of patients
in need of 2 or even 3 concomitant medications:
in the verum group 11.7% of the patients took 2
additional medicines and 2.1% used 3 medica-
tions. In the placebo 16.3% of the patients took 2
additional medicines and 3.3% took 3 different
preparations.[*/quote*]
So the whole "study" was totally messed up by other medicaments, the exact data of which are withheld in the "study" paper.
[*quote*]
However, not all of the verum
patients could be treated effectively with Oscil-
lococcinumR. The health of 12.6% of the
patients of the verum group (16.8% of the
placebo group) had not improved after 48
hours. Almost one third of the patients in the
verum group took additional medication during
the trial. The fact that according to final assess-
ment, 80% of the patients of the verum group
(77% of the placebo group) had recovered is not
surprising since the disease lasts only 5±10 days
even without medication.[*/quote*]
And now the showdown:
[*quote*]
OscillococcinumR either has a modest cura-
tive effect or, perhaps, it is more effective with
specific pathogens. Rather, it can be assumed
that OscillococcinumR has a non-specific effec-
tiveness, since in the present study it showed a
stronger effect after 48 hours (about 11% of the
patients were without symptoms after 2 days)
than in the Ferley (7%) study, which probably
investigated a different influenzal virus.
There-
fore, the statement of Ferley et al7 can be
confirmed: `The effect was modest ..., but
nevertheless is of interest'. The positive effects
of a treatment with OscillococcinumR were
more apparent when gradual changes were
considered. 62.9% of the patients had clearly
improved in their health condition after 48 hours
and only 12.6% had not improved. In the
placebo group 48.3% patients had clearly
improved and 22.1% showed no improvement.
This clinical trial confirms the curative effect
of OscillococcinumR. However, to investigate
prophylactic effectiveness, additional studies
must be carried out. But future studies might
be of great interest from the viewpoint of
personal well-being, as well as from adminis-
trative and economic points of view.[*/quote*]
No! There is no "modest" effect! There is no effect at all. Both "studies" are totally messed up. And all what Boiron has for its advertising is those 2 messed-up "studies". IN THIRTY YEARS!
Boiron is organized crime and all its "homeopathic" remedies are fraud.
in the ice-box:
http://archive.is/1jUCj[*quote*]
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Page 1
69
British Homoeopathic Journal
April1998, Vol. 87, pp. 69±76
Original research and audit
OscillococcinumR in patients with influenza-like
syndromes:
A placebo-controlled double-blind evaluation
ROSEMARIE PAPP*, GERT SCHUBACK**, ELMAR BECK***, GEORG BURKARDy,
JUÈ RGEN BENGELyy, SIEGFRIED LEHRL*, PHILIPPE BELON{{{
Abstract
A controlled clinical trial was conducted to assess the effectiveness of Oscillococci-
numR in the treatment of patients with influenza-like syndromes. 188 patients received
the test drug and 184 patients were assigned to the placebo. Data were recorded by the
participating physicians at the beginning of the treatment, after 48 hours and after 7±10
days. During the first few days, the patients recorded their rectal temperature twice a day
(mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat,
muscle pain, etc.), and use of medication. Recovery was defined as follows: `rectal
temperature < 37.5 C and no headache or muscle pain'. Effectiveness was defined as a
statistically significant greater decrease in symptoms after 48 hours in the verum group
or a shorter duration of symptoms in comparison to the placebo group. After 48 hours
the symptoms of the patients in the verum group were significantly milder (P ˆ 0.023)
than in the placebo group. The number of patients with no symptoms was significantly
higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%)
until the end of the patients' recording (day 5 in the evening: verum: 73.7%, placebo:
67.7%). The biggest group difference was recorded for the time between the evening of
the second day (10.6% more patients with no symptoms) and the morning of the fourth
day (10.2% more patients with no symptoms). The clinical trial showed that treatment
of influenza-like syndromes with OscillococcinumR has a positive effect on the decline
of symptoms and on the duration of the disease.
KEYWORDS: Influenza-like syndrome; OscillococcinumR; Homoeopathy; Absence of symptoms
Introduction and object of the study
In medicine, influenza-like syndromes are of
minor importance since this viral disease disap-
pears within 5±10 days and usually does not
result in negative consequences. However, the
impaired well-being of the patients makes
prophylactic and curative measures necessary.
Furthermore, for economic reasons, remedies
are needed as one third of absenteeism is due to
influenza-like syndromes.
So far more than 200 pathogenic organisms
are known to cause these infections of the upper
respiratory tract. 5 rhinotrope viral strains are
responsible for half of all colds. How the
infection is transmitted, either via droplet emis-
sion or transfer by hand (e.g. by shaking hands)
is not yet known.
However, help might be expected from a
homoeopathic preparation which is widely
used in France as prophylaxis and therapy
to patients suffering from influenza-like
syndromes. The drug is Anas Barbariae Hepatis
and Cordis Extractum HPUS 200K, commer-
* Department of Medical Psychology and Psycho-
pathometry of the University of Erlangen-Nurem-
berg, Kopfklinik, D-91054 Erlangen, Germany.
** Medical Practice, Haupststr. 12, D-91336
Heroldsbach, Germany.
y Anfomed ltd., RoÈttenbacher Str. 17, D-91096
MoÈhrendorf, Germany.
yy Medical Practice, Bahnhofstr. 14, D-91083
Baiersdorf, Germany.
{{{ Boiron, 20 rue de la LibeÂration, F-69110
Sainte-Foy-Les-Lyon, France.
Page 2
cialised under the trademark OscillococcinumR
(Boiron laboratories).
Despite the widely assumed methodological
difficulties in clinical trials of homoeo-
pathic medicines, quite a few studies have
been performed.2±6
The most rigorously
designed study on OscillococcinumR
was
performed by Ferley et al.7
This study was a placebo-controlled, rando-
mised double-blind evaluation on 478 patients
with a mild influenza-like syndrome during an
epidemic of the A H1N1 influenza virus. The
patients who were treated with Oscillococci-
numR recovered earlier, this was statistically
significant.
Our clinical trial was performed with
patients suffering from influenza-like syn-
dromes and was essentially a replication of
the study of Ferley et al.7 In addition, there
may also be a non-specific effect of the prepara-
tion, since it can be assumed that a different
virus from that of the Ferley study was respon-
sible for the infection in the present study.
The primary object of the study was to
answer the following questions:
1) After 48 hours of treatment with the active
drug, has the patient's condition improved
more than with the placebo?
2) Were the symptoms eliminated faster in
the verum group than in the placebo group?
Data on concomitant medication, compli-
ance and fitness for work were also collected.
Methods
Study design
The trial was a prospective placebo-controlled
double-blind multicentric study. Enrolment in
the study for 7±10 days was planned for 400
patients, to be recruited from 15±20 medical
practices of general practitioners or specialists
for internal diseases. The study was conducted
in Germany from November 1990 until Spring
1991.
Recruitment of patients
Patients included in the study were selected
from those who had consulted a clinician with
an influenza-like syndrome. The infection had
to have occurred less than 24 hours before entry
in the trial. Rectal temperature had to be equal
to or above 38 C and the patients had to suffer
from muscle pain and headache and at least
from one of the following symptoms: shiver-
ing, thoracic or periarticular pain, spinal pain,
cough, irritation of the nasal mucosa, or a
general feeling of illness. Exclusion criteria
were: patients under 12 or over 60 years of
age; patients who, for preventive reasons,
needed to be given an anti-influenzal treatment
during the first 48 hours of the study; patients
with immune system disorders or local infec-
tions and patients who had been immunised
against influenza; patients who had been given
additional therapy in the form of immuno-
suppressants or immunostimulants; or those
who had taken anti-influenzal medicines,
analgesics or antibiotics during the first 48
hours of the trial.
Patients gave written or oral consent before a
witness, after having been informed as to the
nature, meaning, and extent of the clinical trial.
The patients were randomly allocated to one
of the 2 treatment groups, OscillococcinumR or
placebo. The randomisation was performed in
two steps, verum and placebo were indistin-
guishable. At Laboratoires Boiron, each
placebo and each verum treatment was given a
number according to a random list of numbers.
Then all the verum and all the placebo treat-
ments were put in two plain boxes, one box
being verum and the other placebo. Next
Anfomed asked an independent person to
prepare a 4 treatment box for each doctor,
each containing 2 verum treatments and 2
placebo treatments. These 4 treatment boxes
in turn were known by the numbers of the 4
treatments they contained.
Study variables and study period
At the start of the trial, the clinician recorded
the patients' age, gender, weight, other diseases
or abnormalities, additional medication, rectal
temperature and symptoms. After 48 hours, the
clinician gave a global impression of the
changes in the patients' health and recorded
any additional prescriptions. At the end of the
trial period (after 7±10 days) the clinician
assessed the patients' compliance and recorded
adverse events, as well as absence of symptoms
and the date of fitness for work. Standardised
questionnaires were used.
Twice a day, mornings and evenings, during
the first 5 days of treatment the patients had to
record in a journal their rectal temperature and
medication taken, and to rate 9 symptoms
(cough, cold, sore throat, muscle pain, etc.)
Target variables were: 1) The overall impres-
sion of the clinician concerning changes in the
70
British Homoeopathic Journal
Page 3
patients' health after 48 hours, and 2) The date
of absence of symptoms. Recovery or absence
of symptoms was defined as `a rectal tempera-
ture less than 37.5 C and absence of headache
and muscle pain (taken from the patient's daily
journals)'.
Other variables were: severity of self-rated
symptoms, amount of medication taken, date of
return to work and adverse events. The severity
of the symptoms of the influenza infection was
determined by a total score. This total score had
a value between 9 ˆ absence of symptoms
(18 ˆ mild, 27 ˆ moderate) and 36 ˆ severe.
Adverse events served as a confidence vari-
able. They were taken from the patients' or the
clinicians' records. They gave information on
any pathological changes during the time of
treatment, whether they were linked to the
active drug or not. Additional variables were
premature termination of the trial and compli-
ance records.
Medication
The placebo was made of lactose and sacchar-
ose. It was presented like the active drug (see
introduction) in 3 boxes of 3 doses each, one
dose consisted of 200 globules. All patients
were asked to take the contents of the tube of
medication sublingually, 3 times a day for 3
days.
The first dose was administered at the
doctor's office but the following doses were
taken by the patients themselves in the morn-
ing, at lunch time and in the evening.
Statistical hypotheses and experimental study
design
The main object of the trial was to test the
effectiveness of OscillococcinumR in influen-
zal conditions. Effectiveness was considered
attained, if the number of patients in the verum
group, who showed no symptoms after the first
48 hours, surpassed the number in the placebo
group and/or if the time until elimination of the
symptoms was shorter in the verum group than
in the placebo group. In keeping with the aim of
this study, the following 2 null hypotheses were
formulated:
± H(0)1: The number of patients taking the
active medicine and showing no symptoms
after 48 hours is equal to the number of
patients taking placebo and showing no
symptoms.
± H(0)2: The duration of disease for the group
receiving verum treatment is equal to the
duration for the group receiving placebo
treatment.
The hypotheses were given a bilateral test in
relation to their respective alternate hypoth-
eses: variable `rates of patients who were
affected', and variable `duration of the
disease'. For the null hypotheses having the
lowest P value, probability of error was set at
alpha ˆ 0.025; for the null hypotheses having
the highest P value, probability of error was
alpha ˆ 0.05 (Holm procedure).8 The prob-
ability of experimental error was limited to 0.05.
In addition to the tests which served to verify the
null hypothesis, descriptive tests and tests of
inferential statistics were carried out.9 However,
these procedures were only of an exploratory
nature and did not serve as a confirmatory
testing of the formulated hypotheses.
Homogeneity of the treatment groups was
tested with the Fisher exact test and Krauth test.
All patients who were included in the study
and received the test drug were included in the
analyses for adverse events and compliance.
However, for 21 patients from the verum
group and 17 from the placebo group, admis-
sion and exclusion criteria as defined in the
study design were not met. These 38 were not
included in the per protocol analyses. Data
accuracy was secured by checking the patients'
questionnaires on complete and continuous
recording.
Findings
Patients
372 patients were enrolled in the study. 188
patients were randomly allocated to the verum
group, 184 to the placebo group.
Table 1 shows the distribution on factors of
age, gender etc.
The arithmetic mean for severity of symp-
toms at the start of the treatment, measured with
the total score, showed moderate symptoms.
At the start of the study, the average tempera-
ture of the patients in the OscillococcinumR
group was 38.8 C, in the placebo group 38.7 C.
15 patients in the verum group and 12 in the
placebo group suffered from additional disease.
Out of 188 patients in the verum group
86.2% were without concomitant medication
at the start of the study and during the first day
of treatment. In the placebo group 91.3% out of
Volume 87, April 1998
71
Page 4
184 patients were without additional medica-
tion during this period (Table 1).
Treatment efficacy
In the course of the trial period, 21 patients in
the verum group and 17 in the placebo group
violated the protocol, for instance, by insuffi-
cient compliance. These patients were not
considered in the following analyses of effec-
tiveness: situation after 48 hours, date of
absence of symptoms and final assessment.
In the following description, the reduced
sample of 334 patients comprises 167 in the
verum group and 167 in the placebo group.
Comparison after 48 hours
After 48 hours, the change in the patients'
condition was assessed. At this time point
19.2% of the verum group had no symptoms
and 43.7% had clearly improved (see Table 2,
Figure 1). In the placebo group, the patients'
condition had improved less. According to the
Krauth test, the null hypothesis (the number of
patients free of symptoms after 48 hours is
equal in both treatment groups) was contra-
dicted at a statistically significant level. The
data show a clear improvement in health in the
verum group.
Probability by the Krauth test: P ˆ 0.0028.
Date of absence of symptoms
The second question concerned the date of
elimination of the symptoms. The statistical
analysis was based on the mean date of elim-
ination of symptoms. The proportions of
patients with no symptoms were compared
after 48 hours. The distribution is given in
Figure 2. On the morning of the second day,
9.6% of the verum group and 1.8% of the
placebo group had no symptoms. On the
second day, in the evening 17.4% of the
verum group and 6.6% of the placebo group
were free of symptoms. After 5-day recording
of body temperature and influenzal symptoms,
26.4% of the verum patients and 32.3% of the
Verum group
Placebo group
Feature
n
m
sd
n
m
sd
Patients
188
184
female
93
88
male
95
96
age
35.1
12.7
34.9
12.1
Broca index at the start of the study
1.1
0.2
1.1
0.2
body temperature ( C)
38.8
0.4
38.7
0.5
severity of symptoms (total score)
24.7
5.4
24.7
5.1
Other additional studies
absolute
15
12
percent
8.0
6.5
TABLE 1. Statistical description of the patients.
no influenzal
symptoms
clear
improvement
improvement
no
improvement
worse
sample
n
%
n
%
n
%
n
%
n
%
verum
32
19.2
73
43.7
41
24.6
21
12.6
0
0.0
placebo
25
15.0
56
33.5
49
29.3
28
16.8
9
5.4
total
57
17.1
129
38.6
90
27.0
49
14.7
9
2.7
TABLE 2. Symptoms after 48 hours.
72
British Homoeopathic Journal
Page 5
placebo patients had not yet eliminated all their
symptoms. The difference in the treatment
groups concerning the date of elimination of
the symptoms was statistically significant.
Probability by the Krauth test: P ˆ 0.023.
Other variables
For further information on the effectiveness of
the preparation, the following were investi-
gated: severity curve of the symptoms, body
temperature, amount of medication taken and
date of fitness for work. The improvement
scores are given by categories (clearly
improved, improved ...) which were defined
in the protocol and results presented (Table 2).
Severity of symptoms and body temperature
The total score taken from the patient's journal
gives the severity of symptoms. In the verum
group, the values are lower from the first
evening compared to the placebo group.
The curve of the decline in individual symp-
toms runs parallel to the general trend9 as can
be seen in Figure 3 which gives a picture of the
FIGURE 1. Findings after 48 hours.
FIGURE 2. Absence of symptoms.
Volume 87, April 1998
73
Page 6
FIGURE 3A1. Evening symptoms/verum.
FIGURE 3A2. Evening symptoms/verum.
FIGURE 3B1. Evening symptoms/placebo.
74
British Homoeopathic Journal
Page 7
severity of symptoms in the evening, in both
treatment groups.
From the first morning of the trial until the
fourth evening, the mean values of the body
temperature were lower in the verum group
than in the placebo treatment group. However,
these additional variables do not provide any
new information since they were partially
included in the target variables.
Concomitant medication
After the first 48 hours, some of the patients in
both groups received concomitant medication.
Analgesics and anti-rheumatics were the most
frequent, followed by cough medicine and
expectorants. Anti-influenzal medication as
concomitant therapy played a minor role in
both groups.9 The frequency of additional medi-
cation use was higher in the placebo group than in
the verum group. Over the course of the trial the
number of patients who received concomitant
medication clearly increased in both groups: in
the verum group it increased from 13.8% to
30.3% and in the placebo group from 8.7% to
36.4%. This difference between the treatment
groups continued with the percentage of patients
in need of 2 or even 3 concomitant medications:
in the verum group 11.7% of the patients took 2
additional medicines and 2.1% used 3 medica-
tions. In the placebo 16.3% of the patients took 2
additional medicines and 3.3% took 3 different
preparations.Fitness for work
In the verum group the percentage of patients fit
for work was slightly higher throughout the
trial than in the placebo group. After 2 days, the
percentage was 16.3% in the verum and 9.3% in
the placebo group. After 4 days, 48.9% of the
patients in the verum group and 46.7% in the
placebo group felt fit for work.
Final assessment of effectiveness
7±10 days after the start of the trial the general
practitioners made a final assessment of the
patients' health. They found that 133 (80.1%)
of the verum patients had no symptoms. In the
placebo group 128 (77.1%) had recovered. 2
patients had not continued their daily journals.
The differences between the treatment groups
was not statistically significant (P ˆ 0.5073).
Premature termination of the study and
adverse events
95.7% of the verum patients and 89.1% of the
placebo patients finished the entire study. In
both groups the main reason for a premature
end to the trial was insufficient medication
compliance.
This was true for 2.7% of the patients in the
verum group and 8.2% in the placebo group. 5
patients reported adverse events. However,
according to the opinion of the physicians in
4 of the 5 cases, the adverse events were not
connected with the medication. Only one
patient suffered from headache which might
have been caused by the medication.
Discussion
This clinical trial in outpatient care was
designed to investigate whether the successful
treatment of influenza-like syndromes with
OscillococcinumR reported by Ferley et al7
could be repeated.
FIGURE 3B2. Evening symptoms/placebo.
Volume 87, April 1998
75
Page 8
With regard to the main points in question,
the study findings were quite coherent with
Ferley's findings:
1) The decline in symptoms after 48 hours
of treatment with the active drug was signifi-
cantly higher in the verum group than in the
placebo group.
2) Symptoms disappeared significantly faster
in the verum group than in the placebo group.
The results based on the patients' journals
recording: influenzal symptoms, concomitant
medication, fitness for work and compliance in
the verum group, all supported the effective-
ness of OscillococcinumR in influenza-like
syndromes. Side effects were apparently of no
consequence.
However, not all of the verum
patients could be treated effectively with Oscil-
lococcinumR. The health of 12.6% of the
patients of the verum group (16.8% of the
placebo group) had not improved after 48
hours. Almost one third of the patients in the
verum group took additional medication during
the trial. The fact that according to final assess-
ment, 80% of the patients of the verum group
(77% of the placebo group) had recovered is not
surprising since the disease lasts only 5±10 days
even without medication.OscillococcinumR either has a modest cura-
tive effect or, perhaps, it is more effective with
specific pathogens. Rather, it can be assumed
that OscillococcinumR has a non-specific effec-
tiveness, since in the present study it showed a
stronger effect after 48 hours (about 11% of the
patients were without symptoms after 2 days)
than in the Ferley (7%) study, which probably
investigated a different influenzal virus.
There-
fore, the statement of Ferley et al7 can be
confirmed: `The effect was modest ..., but
nevertheless is of interest'. The positive effects
of a treatment with OscillococcinumR were
more apparent when gradual changes were
considered. 62.9% of the patients had clearly
improved in their health condition after 48 hours
and only 12.6% had not improved. In the
placebo group 48.3% patients had clearly
improved and 22.1% showed no improvement.
This clinical trial confirms the curative effect
of OscillococcinumR. However, to investigate
prophylactic effectiveness, additional studies
must be carried out. But future studies might
be of great interest from the viewpoint of
personal well-being, as well as from adminis-
trative and economic points of view.References
1 Martenstein H, Elleringmann S. Nie wieder
Schnupfen? Geo, 2: 10±28.
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P, Belon P. Effect of Homoeopathic Treatment
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4 Kleijnen J, Knipschild P, Riet TG. Clinical Trials
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5 Boissel JP, Cucherat M, Haugh M, Gauthier E.
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Medicine Research Group 1996. Report to the
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Effects of Homoeopathy Placebo Effects? A
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Lancet 1997; 350: 834±843.
7 Ferley JP, Zmirou D, D'Adhemar D, Balducci F.
A Controlled Evaluation of a Homeopathic
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8 Lehmacher W. (1987) Verlaufskurven und
Crossover Berlin S. 156 f.
9 Beck E. (1992) Biometrischer Bericht zur
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blindstudie OscillococcinumR bei Patienten mit
grippalem Infekt. Interner Bericht. Anfomed:
MoÈhrendord.
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Address for correspondence
Philippe Belon
Boiron,
20 rue de la LibeÂration
F-69110 Sainte-Foy-Lts-Lyon
France
76
British Homoeopathic Journal
[*/quote*]
