A critical appraisal of the design of clinical trials which examined the effectiveness of various interventions in fibrositis was conducted. Therapeutic interventions included physical fitness, biofeedback, acupuncture, dothiepin, imipramine, cyclobenzaprine, S-adenosylmethionine and amitriptyline. The design and analysis of the randomized, controlled studies render their results reliable. Major areas for methodologic improvement in future trials were identified. Standardized, validated and reliable diagnostic and outcome criteria need to be established. Factors which could predict response need to be identified to enable the selection of the most appropriate patient population for inclusion in future studies. Finally, the incorporation of measures of patient function will result in more clinically meaningful outcome evaluation.