Acupuncture Combined with Chinese Medicine in the Treatment of Insomnia with Mixed Depression and Anxiety Disorder: A Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Ethnopharmacological relevanceAcupuncture and herbal medicine are common complementary and alternative treatments for clinical sleep disorders accompanied by depressive and anxious emotions. Prospective studies have indicated that both acupuncture and herbal medicine are effective for these patients, although there is a lack of verification through randomized double-blind placebo-controlled trials.Aim of the studyThis multicenter, randomized, double-blind, placebo-parallel controlled trial aims to evaluate the clinical efficacy and safety of acupuncture combined with the herbal medicine “Xuanyu Granules” for the treatment of “insomnia-depression-anxiety” syndrome.Materials and methodsA total of 244 eligible patients from four different medical centers in Shanghai will be randomly assigned to one of four groups: Group A (Xuan-Yu granule + acupuncture), Group B (Xuan-Yu granule + placebo acupuncture), Group C (placebo Xuan-Yu granule + acupuncture), and Group D (placebo Xuan-Yu granule + placebo acupuncture). Participants in all groups will receive 21 sessions of acupuncture treatments for eight consecutive weeks (three sessions per week for the first 6 weeks, two sessions for the next one week, and one session for the final one week). Subjects will be trained to take one packet of medication twice daily, in the morning and evening, throughout the 8-week intervention period.ResultsWe anticipate that participants in Group A (Xuan-Yu granule + acupuncture) will exhibit significant improvements in the “insomnia-depression-anxiety” syndrome compared to other groups. The primary outcomes will include ISI, HAMA, and HAMD-17 scores. Secondary outcomes will include the PSQI, sleep parameters recorded by physical activity monitors (Geneactiv, ActivInsights), and data from sleep diaries. Daily doses of sedative-hypnotic and antipsychotic medications will also be recorded in the diaries. Adverse effects will be assessed using the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline and at 2, 4, 6, and 8weeks post-treatment, as well as at a 16-week follow-up. Analyses will be conducted on the intention-to-treat (ITT) population, including all patients who receive at least one treatment.ConclusionsThe results of this clinical trial will provide evidence on the efficacy and safety of combined acupuncture and “Xuan-Yu granules” in the treatment of “insomnia-depression-anxiety” syndrome.