Implementation and Evaluation of the Integrated Acupuncture and Moxibustion Treatment (Acupuncture, Moxibustion and Auricular Acupuncture) for Major Depressive Disorder: A Trial Protocol for a Randomized Clinical Trial

Abstract Background: Because of inadequate psychotherapy resources, antidepressants are the front-line option for Major depressive disorder, but with dissatisfied curative effect. Many patients have an interest in acupuncture and moxibustion treatment as complementary therapies. However, there is no sufficient evidence on effectiveness of the integrated treatment. The aim of this study is to evaluate the efficacy and safety of the integrated acupuncture and moxibustion treatment in treating major depressive disorder and to find out the most suitable implementation protocol.Methods: This study is a multicenter, single-blind, 2 × 2 factorial randomized trial. A total of 592 adult participants with moderate depression will be enrolled and randomized into four groups with a ratio of 2: 2: 2: 1, that is, combined group, integrated acupuncture and moxibustion treatment only group, sertraline only group, or placebo group. Participants will undergo a 12-week intervention with either 50 mg of sertraline or placebo once a day, as well as the active/sham integrated acupuncture and moxibustion treatment for three times per week. The primary outcome is assessed using the 17-item version of Hamilton Depression Scale. The secondary outcomes are anxiety and sleep-related scales that assessed using Hamilton Anxiety Scale and Pittsburgh Sleep Quality Index. Safety will be evaluated using liver and kidney function tests examined before and after treatment, as well as daily adverse events. The primary and secondary outcomes will be measured at weeks 0, 4, 8, 12 and 8-week posttreatment, and an intent-to-treat principle will be followed for outcomes analyses.Discussion: Sertraline is one of antidepressants as the front-line treatment for major depressive disorder, but with a delayed onset, high rate of inadequate response and low rate of adherence. As a traditional Chinese therapy, acupuncture and moxibustion are popular and widely accepted. This trial will provide more sufficient evidence for the efficacy and safety of the integrated treatment for major depressive disorder and the most suitable combination strategy. Thus, these finds will extend our knowledge in treating for major depressive disorder.Trial registration: Chinese Clinical Trial Registry ChiCTR2100042841; Registered on 30 January 2021.