General lack of use of placebo in prophylactic, randomised, controlled trials in adult XXXX . A systematic review.

@entity1 @entity2704 @entity10 @entity922
BACKGROUND: The Clinical Trials Subcommittee of the International @entity10 Society (IHS) recommends that a placebo arm is included in comparative @entity922 ( @entity922 ) of multiple prophylactic drugs due to the highly variable placebo response in @entity2704 prophylaxis studies. The use of placebo control in such trials has not been systematically assessed. METHODS: We performed a systematic review of all comparative @entity922 of prophylactic drug treatment of @entity2704 published in English from 2002 to 2014. PubMed was searched using the Cochrane Highly Sensitive Search Strategy for identifying reports of @entity922 . RESULTS: A placebo arm was used in <10% (three of 31) of prophylactic @entity922 in @entity2704 . In only 7.1% (two of 28) of the comparative @entity922 without placebo was one drug superior to another drug. Thus in 26 @entity922 , including one study requiring more than 75,000 @entity1 days, no difference was identified across treatment arms and conclusions regarding drug superiority could not be drawn. CONCLUSIONS: The majority of comparative, prophylactic @entity2704 @entity922 do not include a placebo arm. Failure to include a placebo arm may result in failure to demonstrate efficacy of potentially effective @entity2704 -prophylactic agents. In order to benefit current and future @entity1 , the current strong tendency to omit placebo-controls in these @entity922 should be replaced by adherence to the guidelines of the IHS.
