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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 489 participants or records.
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