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非劣效性设计临床试验是一类检验试验组治疗手段是否不劣于对照组治疗手段的随机对照临床试验。本文简要介绍非劣效性设计临床试验的基本概念、设计要点及其与等效性和优效性设计临床试验的差异，并通过具体案例解读，帮助读者全面了解、实施和评价非劣效性设计方法。 【Abstract】 A noninferiority design clinical trial is a type of randomized controlled clinical trials that examines whether the treatment of the experimental group is not inferior to the treatment of the control group. This paper introduces the basic concept, design points,comparison with equivalence and superiority trials, and case analysis to help readers fully understand, implement and evaluate noninferiority design clinical trials.

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Background: Many people with refugee backgrounds suffer from trauma-related complex social and psychological problems, and compliance with standard psychological treatment tends to be low. More culturally adaptable treatment options seem to be needed. Objective: We aimed to investigate whether the music therapy method: 'trauma-focused music and imagery' (tr-MI), characterized by a particular focus on arousal and affect regulation, would be equally effective as the standard psychological talk therapies for ameliorating trauma symptoms in Danish refugees. Methods: A pragmatic, noninferiority, parallel, randomized controlled trial with six-month follow-up was carried out at three clinics for refugees in the public mental health services of the Psychiatry (DK). Seventy-four adults diagnosed with posttraumatic stress disorder (PTSD) were allocated to either music therapy sessions (tr-MI, N = 39) or psychological treatment as usual (TAU, N = 35). Western classical music, new age music, and music from the participants' own national culture were used to generate inner imagery, following a phased treatment protocol. Homework entailed listening to music. The primary outcome was the measurement of trauma symptoms by the Harvard Trauma Questionnaire, section IV (HTQ-IV); secondary measures were somatoform and psychoform dissociation (DSS-20), SDQ-20), attachment (RAAS), and well-being (WHO-5). Treatment effects reflected by primary and secondary measures were estimated using linear mixed models. Results: Tr-MI was noninferior to TAU (mean difference at follow-up HTQ-IV: 0.14, CI (−0.10; 0.38), with a − 0.3 noninferiority margin). A high dropout rate of 40% occurred in the TAU group, compared to 5% in the music therapy group. Secondary measures generated small to medium effect sizes in both groups, with significant medium effect sizes for well-being and psychoform dissociation at follow-up in tr-MI. Conclusions: Tr-MI is an innovative form of psychological treatment in refugee mental health services. Trials comparing music therapy to standardized therapy are needed to substantiate the evidence base for tr-MI therapy. Music therapy was shown to be no less effective than standard psychological treatment regarding the decrease of posttraumatic stress disorder symptoms in a randomized clinical trial with 74 adult traumatized refugees. Good retainment and significant changes in well-being and dissociation during six-month follow-up were found in music therapy. [ABSTRACT FROM AUTHOR]