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An experimental double-blind study to evaluate the use of Euphrasia in preventing conjunctivitis
BritishHomoeopathicJournal January 1992, Vol. 81, pp. 22-24
An experimental double-blind study to evaluate the use of Euphrasia in preventing conjunctivitis RUPA MOKKAPATTI, MD
Abstract A double-blind study using Euphrasia 30c or placebo was carried out during an epidemic of viral conjunctivitis. Nine hundred and ninety-four subjects were available at follow-up, when 48 subjects in the group given Euphrasia and 43 subjects in the placebo group had signs and symptoms of conjunctivitis, a difference which was not statistically significant. The protocol by which Euphrasia was tried may be used without change to scientifically confirm the efficacy of a genus epidemicus. The concept of genus epidemicus lends itself well to experimental double-blind studies in homceopathy during epidemics.
KEY WORDS: Genus epidemicus; Conjunctivitis; Double-blind trial
Introduction A study was conducted in Hyderabad during an epidemic of viral conjunctivitis in August 1988 to study the efficacy of Euphrasia 30c in preventing the disease. Euphrasia 30c was chosen for this study because it was being widely prescribed in the lay press and commonly used on self-prescription for the prevention and treatment of conjunctivitis. Also, several practitioners reported satisfactory results with Euphrasia in the prevention of conjunctivitis.
junctivitis in the recent past, had taken homoeopathic prophylactics for conjunctivitis in the preceding fortnight, and whether other family members had been affected. The children were examined for conjunctivitis one week after the third dose. A scoring key to grade the severity of conjunctivitis, if present, was devised as under:
Symptom~sign (a) Burning/foreign body sensation in the eyes (b) Redness of the eyes (c) Swelling of the eyelids (d) Subconjunctival haemorrhages (e) Photophobia--along with (b) or (d) Other
Material and methods Day scholars aged 4-15 years studying in two schools in Hyderabad were given Euphrasia 30c or placebo on a double-blind basis. Informed consent was obtained from the concerned school authorities. The allotment of a subject to either group was done in a randomized manner within each class. About 1,30.0 students were included in the trial. Five to si~I~il'ls of Euphrasia or placebo were given orally on three successive days. At the first visit it was noted whether the child had had con-
Score 1 1 1 3 3 1
The results were analysed using the chisquare test. Results A total of 994 subjects were present for follow-up examination. Forty-eight of those who had received Euphrasia and 43 of those who had received placebo had signs and/or symptoms relating to conjunctivitis of varying severity. The
The HomeeopathyStudy Circle, Hyderabad.
22
Volume 81, Number 1, January1992
23
TABLE1. Results Number of subjects Group A
No. of subjectswho received a drug No. of subjectswho were available for follow-up No. of subjectswith ocular signs/symptoms Grade 1-2 Grade 3-5 Grade 6 and above Conjunctivitisreported but student not examined
(Euphr. 30)
GroupB (placebo)
658
648
495
499
48 24 20 4
43 14 22 7
15
9
incidence of mild symptoms was higher in the experimental group while severe conjunctivitis was seen more frequently in the placebo group (Table 1). These differences were, however, not significant on statistical analysis. No significant difference was seen after excluding subjects who had previously received homeeopathic prophylaxis or had conjunctivitis. The same applied to the number of those not affected despite the presence of one or more case of conjunctivitis in the family. Discussion
It is apparent that there is no significant difference in the incidence or severity of the disease in the experimental group compared to the control group. Prescribing on the genus epidemicus is an accepted method in homoeopathy. While the range of medicines that are tried will be determined by symptoms which are common to many medicines, the eventual choice will depend on proving the superior efficacy of a particular drug in that epidemic. A study involving 44 subjects, by the Central Council for Research in Homoeopathy (CCRH), using Euphrasia eye drops or sac. lac., found that all of 13 cases of conjunctivitis treated with the drug were relieved of symptoms, while only 13 of the 24 coo trols obtained reliefJ Nash writbs of an experience that followed reports by Dr C. W. Boyd of great success in preventing measles with Euphrasia (used because the prodromal symptoms and signs in measles affect the eyes): 'So I went for the next
epidemic in my vicinity with Euphrasia, and my failure was as marked as his success. It was not the remedy for my epidemic. But I hunted up my similimum. This time I succeeded too.'2 The possible reasons for our failure to demonstrate a significant benefit with Euphrasia 30c may be any of the following:
1 Euphrasia was the wrong choice for this epidemic. Other drugs that were found useful in the personal experience of some clinicians were: Argentum nitricum, Sulphur and
Merc. s o l . 2 The epidemic was on the wane at the time the study was conducted. Only 91 cases of 994 developed any symptoms or signs. Had a larger number been affected, benefits from the drug, if any, might have become apparent. 3 The demonstrated efficacy of Euphrasia in the CCRH study is in contrast to the findings of the present study. The different potency or route of administration, differences in population characteristics, and possible antigenic or other changes in the virus may have been responsible for the lack of response found in Hyderabad.
The findings of this study support the teachings that a genus epidemicus cannot be established from the pathological or symptomatic affinity of a drug, nor its usefulness in another epidemic of the 'same' disease. A decision is best made after gathering comprehensive clinical data from different sources. An important fact we realized during this experiment was that the concept of genus epidemicus to prevent disease lends itself well to double-blind research protocols. Such experiments would not involve the disadvantages faced by other methods of homeeopathic prescribing in such a framework. 3 More clinical trials following the accepted methodology should be conducted so that the role of homoeopathy may be clearly defined. Without such trials, and the proof afforded by these trials, homoeopathy will remain a mere philosophy in the eyes of modern science. On the other hand, proof (best obtained with controlled clinical trials) would raise very interesting questions relating to immunity and the
24
nature of matter. The possibilities are too important, and too fascinating, for such research to be neglected.
Acknowledgements We wish to express our gratitude to Dr Vidya, MS, for advice in devising a scoring key, and the staff and students of the JSPS
Address for correspondence D r R u p a Mokkapatti Department of Pharmacology University of Pittsburgh School of Medicine Pittsburgh PA 15263 USA
British Homceopathic Journal Government Homoeopathic Medical College for providing manpower and for their enthusiasm.
References 1 Central Council for Research in Hom~eopathy. Clinical Research in Epidemics. CCRH News 1989; 15: 3-4. 2 Nash EN. Leaders in Hom~eopathic Therapeutics, p 445. Calcutta: Roysingh & Co. 1970. 3 Fisher P. An experimental double-blind clinical trial method in homeeopathy. Br Horn J 1986; 75: 142-47.
An experimental double-blind study to evaluate the use of Euphrasia in preventing conjunctivitis RUPA MOKKAPATTI, MD
Abstract A double-blind study using Euphrasia 30c or placebo was carried out during an epidemic of viral conjunctivitis. Nine hundred and ninety-four subjects were available at follow-up, when 48 subjects in the group given Euphrasia and 43 subjects in the placebo group had signs and symptoms of conjunctivitis, a difference which was not statistically significant. The protocol by which Euphrasia was tried may be used without change to scientifically confirm the efficacy of a genus epidemicus. The concept of genus epidemicus lends itself well to experimental double-blind studies in homceopathy during epidemics.
KEY WORDS: Genus epidemicus; Conjunctivitis; Double-blind trial
Introduction A study was conducted in Hyderabad during an epidemic of viral conjunctivitis in August 1988 to study the efficacy of Euphrasia 30c in preventing the disease. Euphrasia 30c was chosen for this study because it was being widely prescribed in the lay press and commonly used on self-prescription for the prevention and treatment of conjunctivitis. Also, several practitioners reported satisfactory results with Euphrasia in the prevention of conjunctivitis.
junctivitis in the recent past, had taken homoeopathic prophylactics for conjunctivitis in the preceding fortnight, and whether other family members had been affected. The children were examined for conjunctivitis one week after the third dose. A scoring key to grade the severity of conjunctivitis, if present, was devised as under:
Symptom~sign (a) Burning/foreign body sensation in the eyes (b) Redness of the eyes (c) Swelling of the eyelids (d) Subconjunctival haemorrhages (e) Photophobia--along with (b) or (d) Other
Material and methods Day scholars aged 4-15 years studying in two schools in Hyderabad were given Euphrasia 30c or placebo on a double-blind basis. Informed consent was obtained from the concerned school authorities. The allotment of a subject to either group was done in a randomized manner within each class. About 1,30.0 students were included in the trial. Five to si~I~il'ls of Euphrasia or placebo were given orally on three successive days. At the first visit it was noted whether the child had had con-
Score 1 1 1 3 3 1
The results were analysed using the chisquare test. Results A total of 994 subjects were present for follow-up examination. Forty-eight of those who had received Euphrasia and 43 of those who had received placebo had signs and/or symptoms relating to conjunctivitis of varying severity. The
The HomeeopathyStudy Circle, Hyderabad.
22
Volume 81, Number 1, January1992
23
TABLE1. Results Number of subjects Group A
No. of subjectswho received a drug No. of subjectswho were available for follow-up No. of subjectswith ocular signs/symptoms Grade 1-2 Grade 3-5 Grade 6 and above Conjunctivitisreported but student not examined
(Euphr. 30)
GroupB (placebo)
658
648
495
499
48 24 20 4
43 14 22 7
15
9
incidence of mild symptoms was higher in the experimental group while severe conjunctivitis was seen more frequently in the placebo group (Table 1). These differences were, however, not significant on statistical analysis. No significant difference was seen after excluding subjects who had previously received homeeopathic prophylaxis or had conjunctivitis. The same applied to the number of those not affected despite the presence of one or more case of conjunctivitis in the family. Discussion
It is apparent that there is no significant difference in the incidence or severity of the disease in the experimental group compared to the control group. Prescribing on the genus epidemicus is an accepted method in homoeopathy. While the range of medicines that are tried will be determined by symptoms which are common to many medicines, the eventual choice will depend on proving the superior efficacy of a particular drug in that epidemic. A study involving 44 subjects, by the Central Council for Research in Homoeopathy (CCRH), using Euphrasia eye drops or sac. lac., found that all of 13 cases of conjunctivitis treated with the drug were relieved of symptoms, while only 13 of the 24 coo trols obtained reliefJ Nash writbs of an experience that followed reports by Dr C. W. Boyd of great success in preventing measles with Euphrasia (used because the prodromal symptoms and signs in measles affect the eyes): 'So I went for the next
epidemic in my vicinity with Euphrasia, and my failure was as marked as his success. It was not the remedy for my epidemic. But I hunted up my similimum. This time I succeeded too.'2 The possible reasons for our failure to demonstrate a significant benefit with Euphrasia 30c may be any of the following:
1 Euphrasia was the wrong choice for this epidemic. Other drugs that were found useful in the personal experience of some clinicians were: Argentum nitricum, Sulphur and
Merc. s o l . 2 The epidemic was on the wane at the time the study was conducted. Only 91 cases of 994 developed any symptoms or signs. Had a larger number been affected, benefits from the drug, if any, might have become apparent. 3 The demonstrated efficacy of Euphrasia in the CCRH study is in contrast to the findings of the present study. The different potency or route of administration, differences in population characteristics, and possible antigenic or other changes in the virus may have been responsible for the lack of response found in Hyderabad.
The findings of this study support the teachings that a genus epidemicus cannot be established from the pathological or symptomatic affinity of a drug, nor its usefulness in another epidemic of the 'same' disease. A decision is best made after gathering comprehensive clinical data from different sources. An important fact we realized during this experiment was that the concept of genus epidemicus to prevent disease lends itself well to double-blind research protocols. Such experiments would not involve the disadvantages faced by other methods of homeeopathic prescribing in such a framework. 3 More clinical trials following the accepted methodology should be conducted so that the role of homoeopathy may be clearly defined. Without such trials, and the proof afforded by these trials, homoeopathy will remain a mere philosophy in the eyes of modern science. On the other hand, proof (best obtained with controlled clinical trials) would raise very interesting questions relating to immunity and the
24
nature of matter. The possibilities are too important, and too fascinating, for such research to be neglected.
Acknowledgements We wish to express our gratitude to Dr Vidya, MS, for advice in devising a scoring key, and the staff and students of the JSPS
Address for correspondence D r R u p a Mokkapatti Department of Pharmacology University of Pittsburgh School of Medicine Pittsburgh PA 15263 USA
British Homceopathic Journal Government Homoeopathic Medical College for providing manpower and for their enthusiasm.
References 1 Central Council for Research in Hom~eopathy. Clinical Research in Epidemics. CCRH News 1989; 15: 3-4. 2 Nash EN. Leaders in Hom~eopathic Therapeutics, p 445. Calcutta: Roysingh & Co. 1970. 3 Fisher P. An experimental double-blind clinical trial method in homeeopathy. Br Horn J 1986; 75: 142-47.