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Complementary Therapies in Medicine (2005) xxx, xxx—xxx
The effect of the homeopathic remedies Arnica
montana and Bellis perennis on mild postpartum
bleeding—A randomized, double-blind,
placebo-controlled study—Preliminary results?
Menachem Oberbauma,∗, Narine Galoyanb, Liat Lerner-Gevac, Shepherd
Roee Singera, Sorina Grisarub, David Shashard, Arnon Samueloffb
aThe Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem 91031,
bDepartment of Gynecology, Shaare Zedek Medical Center, Jerusalem, Israel
cWomen and Children’s Health Research Unit, Gertner Institute for Epidemiology and Health Policy
Research, Chaim Sheba Medical Center, Tel Hashomer, Israel
dDepartment of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel Hashomer, Israel
Objective: To evaluate the effect of Arnica Montana and Bellis perennis on postpar-
tum blood loss.
Design: Double blind, placebo-controlled, randomized, clinical trial.
Setting: Department of Gynecology, Shaare Zedek Medical Center, Jerusalem.
Interventions: Forty parturients were randomized to one of three groups: Arnica
montana C6 and Bellis perennis C6 (n=14), Arnica montana C30 and Bellis perennis
C30 (n=14), or double placebo (n=12). After 48h the Arnica/placebo was halted,
and patients continued the Bellis/placebo until cessation of lochia.
Main outcome measures: Hemoglobin levels (Hb) at 48 and 72h postpartum.
Results: At 72h postpartum, mean Hb levels remained similar after treatment with
homeopathic remedies (12.7 versus 12.4) as compared to a significant decrease in
Hb levels in the placebo group (12.7 versus 11.6; p<0.05), in spite of less favorable
initial characteristics of the treatment group. The mean difference in Hb levels at
72h postpartum was −0.29 (95% CI −1.09; 0.52) in the treatment group and −1.18
(95% CI −1.82; −0.54) in the placebo group (p<0.05).
Conclusion: Treatment with homeopathic Arnica montana and Bellis perennis may
reduce postpartum blood loss, as compared with placebo.
© 2005 Published by Elsevier Ltd.
?The funding source was not involved in any way in the collection, analysis, and interpretation of data; in the writing of the
report; and in the decision to submit the paper for publication.
* Corresponding author. Tel.: +972 2 6666 395; fax: +972 2 6666 975.
E-mailaddresses:email@example.com, firstname.lastname@example.org (M. Oberbaum).
0965-2299/$ — see front matter © 2005 Published by Elsevier Ltd.
YCTIM 765 1—4
2 M. Oberbaum et al.
Postpartum hemorrhage (PPH) is a major cause of
perinatal morbidity and mortality worldwide. It oc-
curs in 4% of all vaginal deliveries and is the third
leading cause of maternal mortality in the USA.1
Worldwide, PPH is responsible for up to 125,000 ma-
ternal deaths, and morbidity in 20 million women
annually. Prophylactic administration of oxytocic
agents is the standard of care for this condition,
reducing the incidence of PPH by 40%.2However,
these intravenous agents have significant side ef-
fects and contraindications. Therefore, an alterna-
tive hemostatic therapy, administered orally, de-
void of side effects and safe to use while breast-
feeding would be a welcome advent.
For more than 200 years, homeopathy has been
used during pregnancy and labor (e.g. Ref.3), but
only few, poorly performed studies have been per-
formed to investigate its effect.4The need for indi-
vidualization presents a major obstacle to the sci-
entific evaluation of homeopathic remedies. Home-
opathic medications are generally prescribed based
upon the characteristics of the individual patient,
and only secondarily upon diagnosis. A few ex-
ceptions exist, in which a particular homeopathic
medicine may be employed based upon a spe-
cific indication. Two of these are Arnica montana
(Leopard’s bane), and Bellis perennis (the common
daisy).3,5Arnica is used to treat trauma in any sys-
tem, particularly with extravasation of blood, while
Bellis is widely employed in trauma to the uterus,
including the trauma of labor and cesarean sec-
tion. Both drugs are considered anti-hemorrhagic
and analgesic. Therefore, both are commonly used
in homeopathy to treat complaints developing in
of these two medicines in preventing PPH in a dou-
ble -blinded, randomized placebo controlled trial.
Between February and August 2003, parturients at
Shaare Zedek Medical Center who fulfilled inclusion
criteria were invited to participate in the study. In-
cluded were women aged 20—35, at week 37—43
of pregnancy, after one to four previous deliveries,
and scheduled for spontaneous vaginal delivery of
a single fetus. Exclusion criteria were previous ce-
sarean section, antepartum or postpartum hemor-
rhage in previous pregnancies, and coagulopathies.
All women received standard obstetric care. The
study was approved by the hospital’s institutional
After obtaining informed consent, patients were
randomized in a double-blinded manner using block
randomization lists6into three groups: (1) Arnica
and Bellis, both in a dilution of 10−6of the stem
solution; (2) Arnica and Bellis, both in dilution of
10−60; and (3) identical placebos. Two different
potencies were chosen in order to be able to
compare the effect of remedies below (10−12) to
remedies above Avogadro’s number (10−60). Based
on the experience, low potencies have a weaker
effect than high potencies, but their specificity is
not as pronounced as high potencies. We added this
explanation in Patients where withdrawn from the
study if cesarean section or instrumental delivery
was later required.
Experimental and placebo drugs were prepared
by Ainsworth Pharmacy, London, in accordance
with the British Homoeopathic Pharmacopoeia. The
stem tinctures of Arnica, Bellis, and 40% alcohol as
placebo were diluted by a factor of ten with 40% al-
cohol, and vigorously shaken. This was repeated 6
and 30 times, yielding final concentrations of 10−12
and 10−60, respectively. One drop of each of the fi-
nal dilutions was impregnated separately on seven
grams of 3—4mm spherical sucrose pills (Werners,
Germany). One dose of all medications consisted of
The study medications were distributed in two
vials containing pills impregnated with either
Arnica and Bellis 10−12, Arnica and Bellis 10−60,
or two placebos. Patients were treated immedi-
ately after delivery by sucking three pills of the
medicated or placebo Arnica pills, followed a few
minutes later by medicated or placebo Bellis. This
was repeated every 5h for the first 24h, then three
times daily. After 48h the Arnica/placebo was
halted and patients continued the Bellis/placebo
until cessation of lochia.
Venous hemoglobin levels were measured before
delivery (baseline) and 48 and 72h later.
Non-compliance was defined as failure to take
medications during the first 48h (during hospital-
ization). Non-compliant patients were included in
their intention to treat group for the purpose of
This report presents preliminary results of an
on going clinical trial. The sample size for the
entire trial was calculated to be 210 eligible pa-
tients, under the assumptions of ˛=0.05, power
80%, expected differences in Hb level 1gram% in
the placebo and 0.4gram% in the treatment groups.
We present herein the preliminary results of the
first 45 patients that were enrolled. For purposes
of analysis of this pilot sample, patients receiv-
ing Arnica and Bellis in either dilution were ag-
gregated (treatment group) and compared with
YCTIM 765 1—4
Effect of homeopathic remedies on mild postpartum bleeding3
Baseline characteristics of the homeopathy and placebo groups.
Maternal age (years)
Birth weight (g)
Birth weight ≥4000g (n)
Oxytocin use (yes)
Hct at baseline (%)
Hemoglobin level at baseline (gram%)
Treatment group (n=28)
Control group (n=12)
placebo, in order to achieve the most conservative
Primary endpoint was change in average Hb
levels at 48 and 72h postpartum as compared
with baseline. Statistical methods included two-
sample T-test and non-parametric test for evaluat-
ing differences between the study groups for quan-
titative parameters. The paired T-test and non-
parametric Sign rank test were applied for test-
ing differences between baseline assessment and
post-baseline assessment. Due to the small sample
size, all analyses were performed using both meth-
ods. Since similar results were evident, T-test and
paired T-test calculations are presented. All statis-
tical analysis was performed using SAS statistical
Forty-five patients enrolled in the study, 31 in the
treatment group and 14 in the control group. Five
patients, three in the treatment group and two in
the control group, were excluded because of need
for cesarean section or instrumental delivery; thus
40 women, 28 in the treatment group and 12 in the
control group concluded the study. One patient in
each group was defined as non-compliant.
Table 1 summarizes the baseline characteristics
of women in two groups. There was no difference in
the baseline mean Hb level (Hb=12.7) in the treat-
ment and placebo groups (95% CI 12.3; 13.3 and 95%
CI 11.8; 13.6, respectively). At 48h following deliv-
ery, the mean Hb levels were 12.5 (95% CI 12.3;
13.2) and 11.4 (95% CI 11.7; 13.6) in the treatment
and placebo groups, respectively (n.s.).
At 72h the mean Hb levels were 12.4 (95% CI
11.5; 13.3) and 11.6 (95% CI 10.4; 12.8) in the treat-
ment and placebo groups, respectively (p<0.05)
The mean difference in Hb levels at 72h postpar-
tum was −0.29 (95% CI −1.09; 0.52) in the treat-
Figure 1 Mean Hb levels at baseline, after 48 and 72h
in the treatment and placebo groups.
ment group and −1.18 (95% CI −1.82; −0.54) in the
placebo group (p<0.05).
No side effects were recorded in either group.
Discussion and conclusion
To the best of our knowledge, this is the first study
that examines homeopathic treatment in a double
blinded, randomized, placebo controlled trial in a
delivery ward setting. While the hemoglobin level
following delivery dropped in the control group as
expected, the hemoglobin level in the treatment
group remained stable.
The therapeutic effect was marked and statisti-
cally significant at 72h. No side effects were ob-
served in either group. Our results may be limited
by the small sample size and possible imbalance in
initial parameters. However, in comparing groups
we note more nulipara (28.57% versus 16.67%), epi-
siotomies (32.14% versus 25.00%) and macrosomia’s
(14.28% versus 8.33%) in the treatment group than
in the placebo group (Table 1), suggesting that the
the control group, enhancing rather than mitigat-
ing our findings. We are aware on no similar stud-
ies with which to compare our results. We have
no plausible biological explanation for our findings
UNCORRECTED PROOF Download full-text
YCTIM 765 1—4
4 M. Oberbaum et al.
in light of the miniscule concentrations of homeo-
pathic medicines involved.
A larger study is currently in progress to cor-
roborate these findings, as well as evaluate the
analgesic effect of this combination.
Conflict of interest statement
This study was supported by the Mirski Foundation,
Shaare Zedek Medical Center, Jerusalem.
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