Clinical efficacy of meridian differentiation acupuncture in the treatment of intractable insomnia based on objective data: a protocol for a multicentre, single-blind, randomised controlled trial

Abstract

Introduction: Insomnia, a prevalent sleep disorder, significantly impacts individuals' physical and mental well-being. Despite conventional treatments, some patients experience persistent insomnia. Acupuncture, a safe complementary therapy, has been demonstrated to be effective in treating insomnia. Meridian differentiation can enhance acupuncture efficacy by enabling individualised diagnosis. Previous clinical research has indicated that meridian differentiation acupuncture (MA), based on objective data, can notably enhance sleep quality in patients with intractable insomnia. However, small sample sizes and a lack of objective measures necessitate further investigation. Therefore, we plan to conduct a large-scale, multicentre clinical trial to validate its efficacy.

Methods: We propose a multicentre, single-blind, randomised, sham acupuncture (SA)-controlled trial involving 489 participants with intractable insomnia. Patients will be randomly assigned to three groups at a 1:1:1 ratio: the MA group, the conventional acupuncture group and the SA group. We will assess Pittsburgh Sleep Quality Index scores, actigraphy, sleep diary, Insomnia Traditional Chinese Medicine Symptom Scale scores, Hamilton Rating Scale for Anxiety scores and meridian imbalance values at baseline, after 2 weeks and 4 weeks of treatment, and at two follow-up periods (8 weeks and 12 weeks postbaseline). The intention-to-treat principle will be applied to analyse the data, observe differences between meridian differentiation acupuncture, CA and SA in improving outcomes related to intractable insomnia.

Ethics and dissemination: The study protocol has been approved by the Ethics Committee of the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine (2024HL-002) and the ethics committees of other participating institutions. Each participant must provide their written informed consent form before enrolling in this study, and consent can be withdrawn at any stage. On completion of the study, the results will be published in a journal or made available by contacting the corresponding author via email.

Trial registration number: This study protocol was registered in the Chinese Clinical Trial Registry on 22 April 2024 (ChiCTR2400083323).

Keywords: Acupuncture; COMPLEMENTARY MEDICINE; Randomized Controlled Trial; Sleep medicine.

Figure 1. 12 Jing-Well points positioning and testing sequence. Red numbers, the order in which Jing-Well points are detected. BL, Bladder Meridian; GB, Gallbladder Meridian; HT, Heart Meridian; KI, Kidney Meridian; LI, Large Intestine Meridian; LR, Liver Meridian; LU, Lung Meridian; PC, Pericardium Meridian; SI, Small Intestine Meridian; SP, Spleen Meridian; ST, Stomach Meridian; TE, Triple Energiser Meridian.

Figure 2. Location of acupuncture points. a,b,c,d: EX-HN 1. GV 20 and EX-HN 1 are fixed points. The Back-shu points are chosen according to the meridian imbalance. EX-HN, Extra point in common use-Head and neck; GV, Governor vessel; BL, Bladder Meridian; KI, Kidney Meridian; B-cun, Body cun.

Figure 3. Illustration of Park Sham Device. The blunt tip of sham acupuncture does not stick into the skin.

Figure 4. Participant recruitment and study flow diagram. CA, conventional acupuncture; HAM-A, Hamilton Rating Scale for Anxiety; I-TCMS, Insomnia Traditional Chinese Medicine Symptom Scale; MIV, meridian imbalance values; MA, meridian differentiation acupuncture; PQSI, Pittsburgh Sleep Quality Index; SA, sham acupuncture;