Evaluating the efficacy of a combination therapy.
Standard multiple comparison techniques do not adequately address the situation in which one must demonstrate a combination therapy's superiority to both of its components. This paper proposes several alternative tests to deal with this situation, and evaluates the tests with a Monte Carlo sampling experiment that compares the actual with the nominal significance levels of the tests. Data from a clinical trial that compares the efficacy of a combination analgesic/muscle relaxant to its components and placebo in the treatment of low back pain and spasm illustrate the tests.
D000639:Amitriptyline / Q000031:analogs & derivatives / Q000627:therapeutic use; D000700:Analgesics / Q000627:therapeutic use; D001416:Back Pain / Q000188:drug therapy; D001699:Biometry / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods; D004061:Diflunisal / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D009010:Monte Carlo Method; D009125:Muscle Relaxants, Central / Q000627:therapeutic use; D011897:Random Allocation
D000700:Analgesics; D004338:Drug Combinations; D009125:Muscle Relaxants, Central; D000639:Amitriptyline; C004704:cyclobenzaprine; D004061:Diflunisal