Protocols For ‘Verifying’ Homeopathy- How It Differs From ‘Clinical Trials’ Of Modern Medicine
Skeptics and critics always hope to corner homeopaths by raising the question ‘where is your reports of scientific clinical trials that prove homeopathy actually works’? According to them, ‘trial reports’ means reports of ‘controlled, double blinded trials’ conducted to ‘verify’ effectiveness of drugs similar to those they do for allopathic drugs. By ‘trials’, they mean giving a particular drug to a group of persons with a particular disease, with enough ‘controls’ kept on placebo, and study the effects produced by the drug. That is the way drugs of modern medicine are ‘verified’, and this protocol is considered to be inevitable part of studying drugs by ‘scientific method’. They expect homeopaths will find it difficult to cope with this demand.
In my opinion, homeopaths need not shy away. They have to take up this challenge, and prove homeopathy reallyworks. Of course, it should be proved by well designed ‘trials’ conducted within the frame work of what is known as ‘scientific methods’, under the supervision of scientists and impartial observers.
“A ‘blind’ or ‘blinded’ experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, thus invalidating the results. When evaluating the effectiveness of a medical drug, both the patients and the doctors who administer the drug may be kept in the dark about the dosage being applied in each case – to forestall any chance of a placebo effect, observer bias, or conscious deception. Blinding can be imposed on researchers, technicians, subjects, funders, or any combination of them. The opposite of a blind trial is an open trial. Blind experiments are an important tool of the scientific method, in many fields of research. The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject. This ‘blinding’ is to prevent biases, since if a physician knew which patient was getting the study treatment and which patient was getting the placebo, he/she might be tempted to give the (presumably helpful) study drug to a patient who could more easily benefit from it. In addition, a physician might give extra care to only the patients who receive the placebos to compensate for their ineffectiveness. A form of double-blind study called a “double-dummy” design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study. The use of a placebo in trials allows the researchers to isolate the effect of the study treatment from the placebo effect”
Fundamental difference between homeopathy and modern medicine is that ‘modern medicine’ uses ‘drug molecules’ as therapeutic agents, where as homeopathy uses ‘molecular imprints’ of drug molecules. This is a very important difference, indeed.
Allopathy designs their drug trials for studying the effects of a particular ‘drug’ substance on a particular ‘disease’, by administering it in a large group of individuals affected by the disease. It is a ‘drug/disease’ based approach. To avoid biases and subjectivity influencing the outcome from any corner, techniques of ‘blinding’ and ‘placebo’ are also utilized. They take utmost care to make such trials perfect and unbiased.
We have to examine how ‘blinded and controlled trials’ could to be adapted for designing protocols to verify homeopathy, taking into account the peculiarities of this therapeutic method, same time without ignoring the fundamental theme of ‘scientific method’
‘Drug/Disease’ approach cannot be applied to ‘verify’ homeopathy, which is based on ‘similimum/patient’ approach. You can never expect ‘individual-based’ homeopathic drugs to be proved using the protocols of testing drugs of ‘disease-based’ modern medicine. Asking to ‘prove’ homeopathic drugs using protocols of allopathic drugs is like trying to measure ‘length’ using units of ‘mass’.
Allopathic methods of ‘drug trials’ are applicable to ‘molecular forms’ of drugs only. But potentized homeopathic drugs, different from allopathic drugs, contain only molecular imprints, which can act only up on pathogenic molecules having specific configurational affinity. That means, they act only if indicated by similarity of symptoms. You cannot ignore this peculiarity in matters of active principles as well as mechanism of drug actions while designing ‘drug trials’ for homeopathy. In homeopathy, you cannot ‘verify’ action of a particular drug- you have to ‘verify’ action of ‘indicated drugs’ up on indicated individual patients, since different people with same disease may need different drugs.
I shall propose a protocol for conducting trials about homeopathy, adaptable to the peculiarities of this therapeutic system, and not conflicting the essence of scientific method. Trials should be conducted by genuine scientists, under the strict observation of an impartial panel of observers. Researchers should identify and select a fixed number of patients suffering from different acute and chronic diseases, and recruited as volunteers submitting themselves for the study. All physiological parameters should be measured, diagnostic tests should be conducted, and separate personal records prepared. A copy each of these individual case records should be duly signed by researchers, observers as well as the homeopath expected to treat the patients, and kept under joint safe custody of everyone involved, well sealed.
Homeopath should allowed to segregate 50 percent of volunteers as ‘controls’, and their details should be kept under joint custody well sealed. It should be ensured nobody except the homeopath knows who are the controls and who are not.
Homeopath should conduct detailed case taking of all volunteers, and select similimum for each patients. Controls also should be subjected to detailed case taking, so as not to cause any doubts to anybody. Names of drugs selected for each patient should be recorded by the homeopath, and false numbers should be assigned to each drug bottle. Bottles of rectified sprit should be kept separately for each ‘control’, and false number assigned to them also, in a random way so that they could not be identified by anybody. Records of rectified spirit, drug names, potencies and their false numbers also should be sealed and kept in joint custody.
Patients as well as controls should be given doses of drugs or rectified spirit from the numbered bottles. Nobody, except homeopath should know what are the exact contents of each bottle. Administration of drugs could be monitored by everybody involved. Homeopath should do follow up of all cases without giving any chances to guess who are the controls and who are real.
A team of impartial observers, not related with research team, should monitor the volunteers in regular ways, keep records of physiological parameters, and do clinical tests and keep their records.
Homeopath should be allowed to change drugs for any patient, if he thinks it is necessary. In that case also, he should use false numbering of drug bottles.
After a reasonable period, with the consent of homeopath, research team can stop trial in any volunteer, and open his secured records jointly and conduct verification and evaluation of results.
I think, the protocol of ‘verification’ described above satisfies the basic requirements of ‘blinded’ experiments of scientific method, as well as the special consideration homeopathy demands as an ‘individual-based’ therapeutic method.