Acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression:Study protocol for a randomized controlled pilot trial
Pei Chen
Yue Liu
Haining Yuan
Di Wang
Xin Jin
Lei Zhang
Kaijuan Yan
Yumeng Guo
Jing Li
Fei Wang
Weishuang Sun
Yang Yang
摘要：Ojective:To explored the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and its mechanism from the aspect of the anti-infiammatory response.
Background:Bipolar disorder is a very common,often misdiagnosed mental disorder strongly associated with comorbidity,disability,and premature mortality.Bipolar depression(ie,depressive episode in bipolar disorder)is poorly responsive to available treatments.Acupuncture at back-shu points of five zang and Geshu(BL 17),a prescription from Dr.Leting Wang,is a popular therapy for depression in China.Its effectiveness and safety for bipolar depression are yet to be verified by clinical studies.
Methods:The study is a single-center,prospective,randomized controlled trial involving 72 patients diagnosed with bipolar depression.Participants will be randomized either to the study group or the control group in a 1:1 ratio.All participants will receive mood stabilizer therapy.In addition,the study group will receive acupuncture therapy at back-shu points of five zang and Geshu(BL 17),three times per week.The control group will orally take the antidepressant bupropion.Observation and intervention will last for 8 consecutive weeks.Outcome measurements include Hamilton Depression Rating Scale-17,Hamilton Anxiety Rating Scale,Clinical Global Impression Scale,Young Manic Rating Scale,Treatment Emergent Symptom Scale,serum levels of anti-infiammatory cytokines[interleukin-4(IL-40),IL-10,and transforming growth factor-β,pro-infiammatory cytokines(IL-1β,IL-6,and tumor necrosis factor-α),brain-derived neurotrophic factor,and C-reactive protein.Assessments will be conducted at baseline,first,second,fourth,and eighth weeks after randomization.Safety assessments will be performed throughout the study.
Discussion:The results of this study are expected to verify the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and explore its therapeutic mechanisms from the point of anti-infiammation.
机标关键词：depressionbipolarprotocoltrialpilotstudyacupunctureback-shu
论文发表日期：2024-03-30
页数：6( 21-26 )
英文信息