Homoeopathic Genus Epidemicus 'Bryonia alba' as a prophylactic during an outbreak of Chikungunya in India: A cluster ‑randomised, double ‑blind, placebo‑ controlled trial

Abstract

Objective: The objective was to assess the usefulness of homoeopathic genus epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic outbreak in the state of Kerala, India. Materials and Methods: A cluster‑ randomised, double‑ blind, placebo ‑controlled trial was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in August‑September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo = 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82 clusters; placebo = 76 clusters). Healthy participants (absence of fever and arthralgia) were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly follow‑up was done for 35 days. Infection rate in the study groups was analysed and compared by use of cluster analysis. Results: The findings showed that 2525 out of 19750 persons of Bryonia alba 30 C group suffered from chikungunya, compared to 2919 out of 18479 in placebo group. Cluster analysis showed significant difference between the two groups [rate ratio = 0.76 (95% CI 0.14 ‑ 5.57), P value = 0.03]. The result reflects a 19.76% relative risk reduction by Bryonia alba 30C as compared to placebo. Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in decreasing the incidence of chikungunya in Kerala. The efficacy of genus epidemicus needs to be replicated in different epidemic settings.

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Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 160
ORIGINAL ARTICLE
Homoeopathic Genus Epidemicus ‘Bryonia
alba’ as a prophylactic during an outbreak
of Chikungunya in India: A cluster
‑randomised, double ‑blind, placebo‑
controlled trial
K. R. Janardanan Nair, S. Gopinadhan1, T. N. Sreedhara Kurup2,
Bonthu Sundara Jaya Raja Kumar3, Abha Aggarwal4, Roja Varanasi5,
Debadatta Nayak5, Maya Padmanabhan6, Praveen Oberai7, Hari Singh8,
Vijay Pratap Singh9, Chaturbhuja Nayak10
ABSTRACT
Objective: The objective was to assess the usefulness of homoeopathic genus
epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic
outbreak in the state of Kerala, India.
Materials and Methods: A cluster‑ randomised, double‑ blind, placebo ‑controlled trial
was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in
August‑September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo
was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo
= 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82
clusters; placebo = 76 clusters) . Healthy participants (absence of fever and arthralgia)
were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly
follow‑up was done for 35 days. Infection rate in the study groups was analysed and
compared by use of cluster analysis.
Results: The ndings showed that 2525 out of 19750 persons of Bryonia alba 30 C
group suffered from chikungunya, compared to 2919 out of 18479 in placebo group.
Cluster analysis showed signicant difference between the two groups [rate ratio = 0.76
(95% CI 0.14 ‑ 5.57), P value = 0.03]. The result reects a 19.76% relative risk reduction
by Bryonia alba 30C as compared to placebo.
Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in
decreasing the incidence of chikungunya in Kerala. The efcacy of genus epidemicus
needs to be replicated in different epidemic settings.
Keywords: Bryonia alba, Chikungunya, Genus epidemicus, Homoeopathy,
Prophylactic
INTRODUCTION
Chikungunya is a relatively rare form of viral fever
caused by an alpha virus that is spread by bite of
IHJ R
Assistant Director (H), Scientist‑IV,
1Research Ofcer (H), Scientist‑IV,
2Former Assistant Director (H),
Scientist-IV, Central Research
Institute (H), Kottayam, Kerala,
3Research Ofcer (H), Scientist‑IV,
Regional Research Institute (H),
Gudivada, Andhra Pradesh, India,
4Deputy Director, National Institute
of Medical Statistics, Indian
Council of Medical Research,
5Research Ofcer (H), Scientist‑I,
6Statistical Assistant, 7Research
Ofcer (H), Scientist‑IV, 8Former
Research Ofcer (H), Scientist‑III,
9Former Assistant Director (H),
Scientist-III, 10Former Director
General, Central Council for Research
in Homoeopathy, New Delhi
Address for correspondence:
Dr. Debadatta Nayak,
Research Ofcer (H), Scientist‑I,
Central Council for Research
in Homoeopathy, 61-65,
Institutional Area, Janakpuri,
New Delhi - 110 058, India.
E-mail: drdnayak@gmail.com
Received: 25-12-2013
Accepted: 11-09-2014
Access this article online
Website:
www.ijrh.org
DOI:
10.4103/0974-7168.141739
Quick Response Code:
Aedes aegypti mosquito. The incubation period is
usually 2-3 days, with a range of 1-12 days. The
word ‘Chikungunya’ is derived from the Swahili
word, meaning ‘that which bends up’ in reference
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Nair, et al.: A preventive study on viral fever/chikungunya with genus epidemicus in India
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 161
to the stooped posture developed as a result of
the arthritic symptoms of the disease. It is an
acute illness characterised by sudden onset of
fever with several of the following symptoms:
Joint pain, headache, backache, photophobia,
arthralgia and rash.[1] In India, after quiescence of
about three decades, an outbreak of chikungunya
with sporadic cases of dengue is being reported
from different parts of India. Cases of chikungunya
like fever were increasingly reported from the
state of Andhra Pradesh, Maharashtra, Karnataka
since December 2005.[1] During 2007, chikungunya
outbreak in India, the worst affected state was
Kerala, with 55.8% of the suspected chikungunya
fever cases in the country.[2]
According to Shephard,[3] Homoeopathy offers the
best solution. Historically, Homoeopathy has had
a significant role in the control and management
of infectious epidemic diseases, particularly before
the advent of modern sanitation, vaccinations and
antibiotics. Samuel Hahnemann[4] himself prevented
many epidemic diseases like scarlet fever with
Belladonna. Homoeopathy became particularly popular
in the United States and Europe in 19th century, due
to its success in the treatment of several epidemics,
including typhus, cholera, yellow fever, scarlet fever,
small pox, diphtheria, spanish flu, meningitis and
polio.[5,6]
The concept of using homoeopathic medicines
as ‘genus epidemicus’ in epidemic diseases was
originally formulated by Samuel Hahnemann[4] who
laid the guidelines in Organon of Medicine (§241)
as “…each single epidemic is of a peculiar, uniform
character common to all the individuals attacked,
and when this character is found in the totality of
the symptoms common to all, it guides us to the
discovery of homoeopathic (specific) remedy suitable
for all the cases…”
Kent[7] also affirms that the totality of symptoms of
a given epidemic corresponding to the nature of the
epidemic disease can be obtained after observing
about 20 patients and recording the symptoms of
each one. Thus the pathognomonic symptoms of the
epidemics are identified. Repertory analysis would
guide to a group of six or seven remedies known as
“epidemic remedies” for that particular epidemic, from
which the physician would choose the most suitable
after going through the Materia Medica.
A preventive study was carried out by the Central
Council for Research in Homoeopathy (CCRH)[8] on
Japanese encephalitis in 96 villages in the state
of Uttar Pradesh in India during an outbreak of
epidemic during 1991. None of 39250 subjects who
were given Belladonna 200C (genus epidemicus during
the epidemic) had developed the disease.
A study by Rejikumar et al.[9] on 1061 people living
in parts of Kerala, most affected by chikungunya
epidemic showed that homoeopathic medicine
Eupatorium perfoliatum 200C, (three doses daily for
5 consecutive days) helped prevent chikungunya in
82.19%.
From (June - August) 2007, there was an outbreak of
viral fever with arthralgia in epidemic form in many
parts of Kerala. Many of the cases were diagnosed
as chikungunya. CCRH undertook a double-blind
placebo-controlled trial to assess the efficacy of
genus epidemicus in containing the spread of this
chikungunya.
MATERIALS AND METHODS
Study design
A cluster -randomised, double-blind, placebo-controlled
trial was conducted in the two districts of Quilon
and Alapuzha covering three panchayats i.e. Yeroor,
Alapattu and Aratupuzzha, respectively, during
the period August-September 2007, the areas
where outbreak of chikungunya had occurred and
where no preventive measures were taken either by
the Government of Kerala or any private organisations.
Ethical clearance was obtained from the Council’s
Ethical Committee prior to initiation of the study.
Selection of
genus
epidemicus
The selection of the homoeopathic medicine (genus
epidemicus) to be tried as prophylactic for the
chikungunya during the epidemic was done by the
standard method of determining the genus epidemicus
as per the instructions given by Hahnemann[4] in
his Organon of Medicine (§101-§102). A total of
205 patients, having fever and severe arthralgia, etc.,
from the area where laboratory confirmed cases
were detected during the epidemic were studied and
the totality of symptoms of the prevailing epidemic
was constructed [Table 1]. The symptoms were
repertorised using Kent’s[10] Repertory followed by
Synthesis Repertory in Radar version 7.1[11] and thus
the genus epidemicus i.e. Bryonia alba was selected
after common consensus of group of homoeopathic
experts, against the epidemic under reference.
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Nair, et al.: A preventive study on viral fever/chikungunya with genus epidemicus in India
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 162
Before being finalised, the salient symptoms of the
Bryonia alba was confirmed from the Homoeopathic
Materia Medica.[12,13] The medicine/control for the trial
were obtained from Sharada Boiron Laboratories (SBL),
Pvt. Ltd., Sahibabad.
Study population and procedure
The homoeopathic prophylactic trial was conducted
in Yeroor and Alappatu panchayats of Quilon district
and Arattupuzha panchayat of Alappuzha district
of Kerala. Voluntary Health workers (VHW) were
trained on the features of chikungunya, method
of administration of medicine and follow-up. A kit
containing information sheets, consent forms, survey
forms and medicine/placebo were distributed to
the VHW’s. They (VHW) screened the participants
through house visits for healthy state by enquiring
about their suffering with fever and arthralgia during
the said outbreak. Screened participants who were
declared healthy (absence of fever and arthralgia),
aged between 1 and 98 years and of both genders
were enrolled after obtaining written informed
consent. In case of minors, consent of the guardian
was taken. Group of families with population around
200 healthy individuals were considered as one
cluster. Accordingly estimated sample was divided
into 167 clusters and each cluster was kept under
observation of one VHW. The clusters were randomly
administered Bryonia alba/placebo. Out of these, 84
clusters received Bryonia alba and 83 clusters received
placebo. Computer-generated random numbers were
used to randomised the clusters and was sealed until
data analysis is completed.
Bryonia alba was distributed in 30C potency. The
participants were instructed to take three doses
(3 globules of size No. 30) per day for 3 days orally in
empty stomach. Similarly placebo was administered
to control group but the globules were impregnated
with unsuccused non-medicated alcohol. The
participants who were under trial were allowed to
repeat Bryonia alba 30 C/placebo after 15 days in the
same dosage schedule provided the prevalence of
the epidemic continued in the area. Follow-up visits
were made by the VHW’s on 8th, 15th, 22nd, 29th and
35th day. Any participant who suffered from fever and
arthralgia (characteristic symptoms of chikungunya)
during the follow-up period was considered as a
case of chikungunya.
Outcome measures
The main outcome measure was to assess number of
infected persons as per guidelines of European Centre
for Disease Prevention and Control[14] for probable case
of chikungunya at the end of 35 days of follow-up.
Sample size
The prevalence of chikungunya was estimated at the
initial stage of the epidemic which was 10/1000. To
achieve 90% power at level of significance (α) = 0.05
with a prevalence of 5/1000 in Bryonia alba 30C
group and 10/1000 in placebo the required sample
size was 6080 in each arm in a simple random
sampling. As cluster sampling was used in this trial
it was multiplied by a design effect of 2.5 with
additional load of non-response factor which led to
total sample sized of 34000 (17000 in each arm).
Statistical analysis
Since this trial used a cluster design, analysis was
done with the cluster as the unit. Comparison of rate
ratios was done by use of 95% confidence intervals
(CIs) of the rate ratios. All the healthy participants
were observed for a period of five weeks with a
weekly follow-up. Participants infected were not
considered for further observation in the study.
The event rate, standard error, standard deviation,
intervention effects, difference in event rate and 95%
CI of intervention and control group were estimated
following the cluster analysis methodology.[15]
Independent sample t-test was performed to analyze
the cluster level event rates. The P ≤ 0.05 was
considered to be significant.
RESULTS
The trial flow diagram is shown in Figure 1. Due
to non-compliance of nine VHW (Bryonia = 2;
Placebo = 7) data from these clusters could not be
Table 1: Symptoms observed during the
epidemic
• Pain in joints: worse from motion, during night
• Pain in extremities: worse from motion, during night
• Fever: morning, evening, before mid‑night, night with chill; fever
with chill; no perspiration
• Headache: forehead, temple; bursting, throbbing; worse from
motion, during night
• Coated tongue: white, yellow; dryness of tongue
• Dryness of mouth with: thirst; thirstlessness. Bitter taste in mouth
• Diminished appetite. Nausea
• Thirst: during chill, heat; for large quantity; at long interval; often
and extreme
• Complaint worse during motion; feels better while perspiring
• Pain sore, bruised
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Nair, et al.: A preventive study on viral fever/chikungunya with genus epidemicus in India
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 163
collected. The number of participants who were not
present during the house visit of VHW was similar in
both the groups (6.05% and 6.15%, respectively) and
therefore not considered for analysis. Prophylactic
outcome in intervention group (n = 19750) and
placebo group (n = 18749) were analysed.
The study groups were similarly distributed in terms
of demographic data (age, sex) at baseline [Table 2].
At the end of follow-ups it was observed that
12.78% (2525 out of 19750) healthy individuals,
administered with Bryonia alba 30 C, were presented
diagnosed as probable case of chikungunya, whereas it
was 15.79% (2919 out of 18749) in the placebo group.
Table 3 shows the number of person weeks
observation and rate ratio in all eligible participants
in both the intervention and control groups.
Independent t-test of clusters event rates between
the two groups showed significant statistical
difference (t-value = 2.19 and P = 0.03). The result
reflects a 19.76% relative risk reduction by Bryonia
alba 30C compared to placebo.
DISCUSSION
The results of this trial suggests the utility of
genus epidemicus i.e. Bryonia alba in preventing
chikungunya in the said epidemic. Bryonia alba
30C acted better than placebo. This argument is
appropriate in a situation, when the chikungunya
epidemic was prevalent, though there was
no laboratory confirmation of the cases. The
predictive power of clinical diagnosis will be
high during an epidemic because of increased
background of prevalence of disease. WHO[16] also
categorises such clinical cases, during an epidemic,
as probable cases of chikungunya. However,
it would be ideal to confirm those cases by
laboratory investigations, which could not be done
in this study due to resource constraints.
Table 3: Analysis of chikungunya incidence rates
Treatment
group
Control
group
Effect
estimates
Number of clusters 82 76
Total infected 2525 2919
Total person‑weeks 91472 84895
Analysis based on
cluster summaries
Overall rate 0.027 0.034
Mean of cluster rates 0.029 0.038
Rate ratio (95% CI) 0.76 (0.14 to 5.57)
Relative risk (95% CI) 0.80 (0.76 to 0.84)
Relative risk
reduction (%, 95% CI)
19.7 (15.4 to 23.8)
P value 0.03
CI: Condence interval
Table 2: Baseline details of participants
included in analysis
Treatment group
(Bryonia alba 30C)
Control group
(placebo)
Number of initially healthy
persons (n) considered in
analysis
19750 18749
Mean age (years) 32.3±18.9 32.3±18.4
Sex (male: Female) 9633:10117 9018:9731
Figure 1: Flow diagram of the progress through the phases of a cluster randomised trial
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Nair, et al.: A preventive study on viral fever/chikungunya with genus epidemicus in India
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 164
Rejikumar et al.[9] in their preventive study on
chikungunya selected Eupatorium perfoliatum as the
genus epidemicus whereas in this trial it was found
to be Bryonia alba. As stated by Hahnemann[4] that
in epidemic diseases the genus epidemicus may not
be same, it may vary in two different localities and
at two different phases/time of the same epidemic.
In their study they selected the genus epidemicus
by surveying the patients in two different areas
(Neyyattinkara and Vizhinjam) which were different
from the areas in this trial.
This study was cluster randomised, double-blind,
placebo-controlled, where both the groups were
similar in their characteristics which is not so in
Rejikumar’s[9] study and thus in our study bias is
minimized. Further their study was not randomised
and with unequal groups. The persons who had not
taken medicine due to any reason were considered
as control is not a true control group to be compared
and to give statistical rigour. The merit of our trial is
that the genus epidemicus was administered during
peak period of epidemic and follow up was continued
till there was decline in epidemicity of chikungunya
which covered almost all infected cases of the
prevailing epidemic whereas in Rejikumar’s study
the follow-up was only for 10 days. To add further,
the strength of our study is that a large number of
people of all age groups could be administered the
preventive and were followed till decline of epidemic.
Earlier prophylactic studies with homoeopathic
medicines showed mixed results. Mroninski et al.
who conducted a study with meningococcinum
involving 89,365 participants concluded statistically
significant results in favour of Homoeopathy. The trial
showed a protection against meningococcal disease
of 95% in 6 months and 91% in a year.[17] However,
this study had flaws similar to Rejikumar’s study like
randomisation, blinding and control group. In another
preventive study, Lathyrus sativus was found effective
in poliomyelitis.[3] In meningitis study the investigators
used meningococcinum isopathically, while in
poliomyelitis Lathyrus was given based on symptomatic
affinity irrespective of the symptoms prevailing
during the epidemic. Similarly a study by Nunes[18] in
prevention of dengue with homoeopathic combination
of Phosphorus 30C, Crotalus horridus 30 C and Eupatorium
perfoliatum 30C suggests positive results. The incidence
of the disease in the first 3 months of 2008 fell by
93% among covered population in comparison to the
corresponding period in 2007, whereas in the rest of
the State of Rio de Janeiro there was an increase of
128%. These medicines were predefined based on their
pathogenesis which is similar to dengue and dengue
haemorrhagic fever.
A systemic review of two randomised controlled
trials on the use of Oscillococcinum (nosode prepared
from autolysate of heart and liver of infected wild
duck, a vector for aviary influenza virus) as “specific
preventive” against flu-like syndromes, ignoring the
requirement of similitude between pathogenetic and
patients symptoms, showed no significant effect when
compared to placebo.[19] In an epidemic conjunctivitis
at Hyderabad, a RCT carried out to assess the
efficacy of Euphrasia officinalis 30CH, chosen on the
grounds of the epidemic genius of earlier outbreaks,
once again dismissing the symptomatic totality of the
ongoing epidemic showed insignificant results.[20]
Thus in the case of epidemics, which owing to the
virulence of their etiologic agents awaken symptoms
common to most susceptible individuals, individualised
remedies (genus epidemicus) must exhibit similitude of
the sets of symptoms shown by the patients affected
in the different stages or phases of each epidemic
outbreak which is followed in our trial for the selection
of genus epidemicus. The epistemological foundations
of Hahnemann’s Homoeopathy as preventive medicine
has also been vividly discussed by Teixeira[21] and the
same has been implemented in this trial which further
adds to the merit of this trial.
With emergence of viral epidemic diseases, where
the availability of vaccines is meager, costly or
no known effective treatments are available,
homoeopathic medicines as genus epidemicus can
be used as preventive to decrease the incidence at
particular epidemic.
CONCLUSIONS
Bryonia alba 30C as genus epidemicus was better than
placebo in decreasing the incidence of chikungunya
in Kerala. The efficacy of genus epidemicus needs to
be replicated in different epidemic settings.
ACKNOWLEDGMENTS
The authors acknowledge the contributions of the technical
officers of Central Research Institute for Homoeopathy,
Kottayam and Interns and students of A.N.S.S.
Homoeopathic Medical College, Kottayam who participated
in the preparation of medicines/control, conducting
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Nair, et al.: A preventive study on viral fever/chikungunya with genus epidemicus in India
Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 165
camps, distribution of the medicines and follow-up survey.
Government of Kerala, President and members of the three
panchayats for identification of areas of disease outbreak,
Kerala Voluntary Health Services Society, Kottayam,
Sameeksha, Arattupuzha, Deshabhimany Purusha Swayam
Sahaya Sangham, and A.K.G Purusha Swayam Sahaya
Sangham, Yeroor, for selection of voluntary health workers.
Staff of CCRH Headquarters for secretarial assistance.
Mr Rakesh Rana, Dr Richa Singhal, Statistical section,
Central Council for Research in Ayurveda and Siddha,
New Delhi, for re-analysis of the data and Dr C.M. Pandey,
Department of Biostatistics, Sanjay Gandhi Postgraduate
Institute of Medical Sciences, Lucknow for interpretation
of the analysis. A special thanks goes to Dr Anil Khurana,
Deputy Director (H) for his critical comments, which helped
us further to improve the manuscript.
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How to cite this article: Janardanan Nair KR, Gopinadhan S,
Sreedhara Kurup TN, Kumar BJ, Aggarwal A, Varanasi R, et al.
Homoeopathic Genus Epidemicus 'Bryonia alba' as a prophylactic
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Source of Support: Nil, Conict of Interest: None declared.
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