The randomised controlled trial is one of the simplest but most powerful tools of research. In essence, it is a study in which people are allocated at random to receive one of several clinical interventions.

Prof B. M. Hegde, in his article (Where the prescription looks like the laundry list, Open Page, December 4, 2010), is highly critical of modern science's reliance on randomised controlled trials (RCTs) in clinical medicine. He says “it is just statistical science and does not meet the strict standards of either science or technology.” Thus he decries all prescriptions based on RCTs. But he does not say what scientific method that meets strict standards of science and technology should be used.

Prof. Hegde also claims that Ayurveda and homoeopathy have more scientific basis than modern medicine. But he never volunteers to disclose how he came to this conclusion. It may be remembered that as recently as February 2010 the U.K. Government Parliamentary Committee concluded that homoeopathy has only a placebo effect and recommended withdrawal of all state funding.

The randomised controlled trial is one of the simplest but most powerful tools of research. In essence, it is a study in which people are allocated at random to receive one of several clinical interventions.

RCTs are “the most powerful tool in modern clinical research,” mainly because randomising patients to receive or not receive the intervention ensures that, on average, all other possible causes are equal between the two groups. Thus, any significant difference between the groups in the outcome can be attributed to the intervention and not to some other unidentified factor.

RCTs are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost-effectiveness of a treatment.

The first RCT reported was in 1948 in British Medical Journal which proved that streptomycin injection is much more effective than bed rest in tuberculosis. Since then hundreds of RCTs have changed the clinical practice in all fields of medicine.

Many RCTs found that treatment used till then based on observational data was wrong and harmful. The practice of giving dexamethsone for cerebral malaria and lignocaine for heart attack was stopped as they were proved harmful in RCTs.

Use of medicines to control blood pressure, blood sugar and cholesterol was found to decrease mortality and morbidity in many trials. It was RCTs and meta-analysis of RCTs which helped us know the bad effects rofecoxib and rosiglitazone, which resulted in the withdrawal of those drugs from the market.

However, RCTs are not a panacea to all clinical questions. In many situations, RCTs are not feasible, necessary, appropriate, or even sufficient to help solve important problems.

RCTs can be vulnerable to multiple types of bias at all stages. These include bias in design, publication bias, time lag bias and incomplete reporting. Researchers are very well aware of these and are trying to eliminate the biases.

It is true that many of the well-publicised RCTs are designed by pharama companies for their own benefits. This is because of the huge expenses required for conducting such trials. This is not a drawback of RCTs but a problem of commercialisation of medical science. If the state is ready to fund properly designed clinical trials, this problem can be solved.

As of now, there is no better scientific method than RCTs to find out whether a treatment modality is better or not. So why should we throw the baby out if the bathwater is dirty?

(The writer is consultant in internal medicine, Welcare Hospital, Palakkad, Kerala. His email id is: drnmarun00@yahoo.co.in)

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