Equivalence and Non-inferiority Trials of CAM.

Edzard Ernst

doi:10.1093/ecam/neh001

Abstract

Equivalence and Non-inferiority Trials of CAM.

Highlights

For several reasons, the value of placebo-controlled trials has often been disputed () in complementary/alternative medicine (CAM) (1)
non-inferiority trial (NIT) test the hypothesis that one therapy is not worse than another, while equivalence trial (ET) are aimed at finding out whether one treatment is neither better nor worse than another
In CAM, as in many other areas of medicine, it is often relevant to ask, is therapy X as good as therapy Y? For instance, in palliative cancer care it may be much more relevant to know whether massage therapy yields the same benefit in terms of quality of life as does aromatherapy, compared to determining whether massage is different from a placebo intervention

Summary

Introduction

The value of placebo-controlled trials has often been disputed () in complementary/alternative medicine (CAM) (1). Two such options that potentially still retain major design features (namely blinding and randomization to a comparator treatment) of rigorous clinical trials are the non-inferiority trial (NIT) and the equivalence trial (ET). NITs test the hypothesis that one therapy is not worse than another, while ETs are aimed at finding out whether one treatment is neither better nor worse than another.

Results

Conclusion