There are some drugs for which the formulation used is global. In such situations evidence of limited efficacy is traditionally acceptable. In case of probiotics the effect on patients is dependent on the formulation used. Some have desired effect while others do not. One of the formulations marketed in our setting was sensitive to all antibiotics tested. Information on product strain is very poorly described in the inserts of the marketed formulations. Probiotics do not offer additional benefit in infants who are breast fed. Additionally, the bacterial flora in Indians is very different. Because the efficacy of probiotics is dependent on the formulation and host factors it is rationale to invest in randomized controlled trials to gather evidence of benefit. We have to be clear in our messages to pharma companies because they generate the drugs. These companies are also aware that not all information required to make judgment is readily available when they market the drugs. Physicians have great responsibility in preserving this balance to ensure that medical practice is based on evidence. If this is not the case with many other formulations we have not been sufficiently alert. With all humility this should not be the argument for greater laxity.

Shinjini Bhatnagar,
Division of Gastroenterology,
Hepatology & Nutrition,
Department of Pediatrics,
All India Institute of Medical Sciences,
New Delhi 110 029, India.
E-mail: [email protected]