摘要
Objective:This study is conducted to determine effects of manual acupuncture(MA)in patients with a diagnosis of major depressive disorder(MDD)and comorbid insomnia.Methods:A total of 67 participants who met the inclusion criteria were randomly enrolled in a two-arm randomized,placebo controlled,patients-blind trial and allocated to a real-MA group(patients=34)and a sham-MA group(patients=33).Patients in the real-MA group were treated on‘Five-shen acupoints’,including Sishencong(四神聪EX-HN 1),Shenting(神庭GV 24),Shendao(神道GV 11),bilateral Benshen(本神GB 13),and bilateral Shenmen(神门HT 7).Though being punctured on the same acupoints,patients in the sham-MA group were treated by a placebo acupuncture approach(Streitberger Placeboneedle).Each group received corresponding interventions every other day,three times a week for total eight weeks.Both polysomnography(PSG)and testing of serum biological markers such as neuropeptide Y(NPY)and substance P(SP)were performed at pre-and post-treatment.Additionally,the global scores of Pittsburgh sleep quality index(PSQI)and the global scores of 17-items Hamilton Depression Rating Scale(HAMD17)were used for assessing the subjective sleep and emotion experience of patients,respectively.Meanwhile,adverse effects were monitored and recorded.Results:After eight-week treatment,the global scores of PSQI and global scores of HAMD17 declined significantly(both P<0.05)in the real-MA group but not in the sham-MA group(both P>0.05).According to the parameters of PSG,striking decline were observed in sleep latency(SL)and wake after sleep onset(WASO)and striking climb were observed in total sleep time(TST)and sleep efficiency(SE)in the real-MA group after treatment(P<0.05,respectively)but not in the sham-MA group(P>0.05,respectively).Additionally,there were no significant differences in awakening times(ATs)and rapid eyes movement sleep latency(REM-SL)in both two groups after treatment(both P>0.05).Meanwhile,the expression of NPY increased significantly and the expression of SP decreased significantly in the real-MA group after interventions(both P<0.05)while those indicators only slightly fluctuated in the sham-MA group(P>0.05).No serious adverse event was reported in either real-or sham-MA group.Conclusion:(1)MA may be a potential alternative therapy for improving MDD and comorbid insomnia(particularly in extending total sleep time and shortening wake-up duration and sleep latency)via upregulating the expression of NPY and downregulating the expression of SP;more importantly,this efficacy of acupuncture can not be replaced by sham-acupuncture acting on the same acupoints with the same treatment frequency.(2)There is insufficient evidence to prove that MA can effectively reduce the number of arousals.
基金
Supported by TCM Science and Technology Innovation Project of Shanghai Health and Family Planning Commission:Mobile internet-based guidance platform of‘Preventive Treatment of Insomnia’(chronic disease management)(No.ZYKC20161016)
Special Project for Clinical Research,Shanghai Municipal Health Commission(No.20174Y0009).