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. 2023 May 15:14:1181947.
doi: 10.3389/fpsyt.2023.1181947. eCollection 2023.

The efficacy and cerebral mechanism of intradermal acupuncture for major depressive disorder: a study protocol for a randomized controlled trial

Xiaoting Wu  1   2 , Mingqi Tu  1   2 , Nisang Chen  1   2 , Jiajia Yang  3 , Junyan Jin  1   2 , Siying Qu  1   2 , Sangsang Xiong  1   2 , Zhijian Cao  3 , Maosheng Xu  3 , Shuangyi Pei  2 , Hantong Hu  2 , Yinyan Ge  2 , Jianqiao Fang  2 , Xiaomei Shao  1   2
Affiliations

The efficacy and cerebral mechanism of intradermal acupuncture for major depressive disorder: a study protocol for a randomized controlled trial

Xiaoting Wu et al. Front Psychiatry. .

Abstract

Background: Major depressive disorder (MDD) has emerged as the fifth leading cause of years lived with disability, with a high prevalent, affecting nearly 4% of the global population. While available evidence suggests that intradermal acupuncture may enhance the effectiveness of antidepressants, whether its efficacy is a specific therapeutic effect or a placebo effect has not been reported. Moreover, the cerebral mechanism of intradermal acupuncture as a superficial acupuncture (usually subcutaneous needling to a depth of 1-2 mm) for MDD remains unclear.

Methods: A total of 120 participants with MDD will be enrolled and randomized to the waiting list group, sham intradermal acupuncture group and active intradermal acupuncture group. All 3 groups will receive a 6-week intervention and a 4-week follow-up. The primary outcome will be measured by the Hamilton Depression Rating Scale-17 and the secondary outcome measures will be the Self-Rating depression scale and Pittsburgh sleep quality index. Assessments will be conducted at baseline, 3 weeks, 6 weeks, and during the follow-up period. In addition, 20 eligible participants in each group will be randomly selected to undergo head magnetic resonance imaging before and after the intervention to explore the effects of intradermal acupuncture on brain activity in MDD patients.

Discussion: If the intradermal acupuncture is beneficial, it is promising to be included in the routine treatment of MDD.

Clinical trial registration: Clinicaltrials.gov, NCT05720637.

Keywords: cerebral mechanism; intradermal acupuncture; magnetic resonance imaging; magnetic resonance spectroscopy; major depressive disorder; selective serotonin reuptake inhibitors.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of this study.
Figure 2
Figure 2
Acupoints and locations. The locations of Neiguan (PC6), Shenmen (HT7), Sanyinjiao (SP6), and Taichong (LR3).
Figure 3
Figure 3
Active intradermal acupuncture (AIA) and sham intradermal acupuncture (SIA). (A) shows the AIA with an intradermal needle, while (B) shows the SIA with a thin silicone pad.
See this image and copyright information in PMC

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