Scientific evidence,rather than uncontrolled case studies should be the basis for patient management

The case study and review article by Mill and colleagues published in this volume of Therapeutic Advances in Drug Safety reaches a potentially dangerous conclusion that puts patient belief ahead of scientific evidence. The authors report on a case study in which the patient was convinced that they require a lactose-free preparation. The authors present a very admirable review of the research literature that demonstrated that lactose-intolerant individuals can easily tolerate the small amounts of lactose found as an excipient in pharmaceutical preparations.^1–3 In fact, the level of tolerance is likely 30-fold higher than the highest amount of lactose found in a single capsule (12 g of tolerance versus 400 mg). ⁴ Mill and colleagues consider that the nocebo effect (the worsening of symptoms following the administration of a placebo, in this case the small amount of lactose found in the pharmaceutical) might be at work.

The premise that the physician should respect the nocebo effect and what is most likely false belief is problematic for several reasons. First and foremost, there may be underlying causes of symptoms that require alternative treatment. Ignoring these underlying causes is both unethical and dangerous. Second, supporting an industry of lactose-free pharmaceuticals when the science shows that lactose-containing products do not cause symptoms of intolerance is a costly disservice to patient care. Montalto’s and Suarez’s excellent blinded work need to be promoted and repeated. Shaukat and colleagues have published a classic systematic review that clearly demonstrates tolerance to low doses of lactose. Uncontrolled case studies should not be the basis for patient management. Let’s not further a myth most likely based on nocebo effects and promote the development of unnecessary formulations that add cost and are no more effective than traditional approaches.