| Objective1. To explore the evidence of acupuncture treatment on sleep disorder in patients with mild to moderate depression through previous literature.2. To evaluate the effect of acupuncture treatment on sleep disorder in patients with mild to moderate depression through real world study.And eplore the factors which might influend the effectiveness of the treatment.Methods1. Systematic review and net-meta analysis of literatures In order to evaluate the clinical curative effect of acupuncture on sleep disorder in patients with depression, we searched the abroad literatures between January 1999 and December 2015. Database include Medline/PubMed, Web of Science, and Cochrane Central Register of Controlled Trials. NoteExpress was used to manage the literatures. Futher research was done to assess the quality of the literatures which met the inclusion criteria.2. Clinical studyVolunteers were recruited in the acupuncture department of Guangdong Hospital of Traditional Chinese Medical. A total of 90 patients of depression and insomnia conforming to the inclusion criteria were divided into acupuncture group (Group 1), medicine group(Group 2), and acupuncture and medicine group(Group 3) according to their will and the condition of their illnesses.(1) In Acupuncture comprehensive treatment group(Group 1),① Basic intervention:a) Needle acupuncture:Siguan, Baihui, and Yintang acupoints;b) Abdominal acupuncture:Acupoints related to guiding Qi back to its origin, and the two Huaroumen acupoints;c) Moxibustion:Sihua acupoint, direct moxibustion, two zhuangs/acupoints;d) Intradermal acupuncture:Bilateral Ganyu and Xinyu acupoints.② Additional individualized interventions in accordance with traditional Chinese medicine:a) Stagnation of liver-Qi:The same as the basic intervention with no additional intervention;b) Stagnated Qi transforming into fire:Added pricking method, bilateral Ganyu and Xinyu acupoints;c) Stagnation of phlegm-Qi:Added two zhuangs at Zhongwan acupoint for moxibustion and added Feiyu acupoint for intradermal acupuncture;d) Cardiosplenic asthenia:Added two zhuangs at Zhusanli acupoint for moxibustion and added Piyu acupoint for intradermal acupuncture;e) Heart-kidney imbalance:Added two zhuangs at each Yongquan acupoint for moxibustion (total of four zhuangs), and added Shenyu acupoint for intradermal acupuncture;f) Heart-gallbladder disorder:Added two zhuangs at each Zhuqiaoyin acupoint for moxibustion (total of four zhuangs), and added Danyu acupoint for intradermal acupuncture.The selected acupoints were Baihui, Yintang, Hegu, Taichong, Zhongwan, Xiawan, Qihai, Guanyuan (bilateral acupoints), and the acupoint location was confirmed according to PRC National Standard in 2006 (GB/T 12346-2006) (Names and Locations of Acupoints) and HuaTuo brand acupuncture needles (by Suzhou Medical Supplies Co., Ltd.) were applied for experiment. Before Needle acupuncture, patients were enjoined to empty their bladders and eat something before acupuncture treatment. Under supine position, local skin of the acupoint was routinely disinfected, and then viscous supporting rings were fixed on the acupoints. Needles of 2 cun(Φ 0.22mm*50mm) were used at Zhongwan, Xiawan, Qihai, Guanyuan to pierce and reach the parietal peritoneum. Needles of 1.5 cun(Φ 0.22mm*40mm) were used at Huaroumen. The standard of reaching parietal peritoneum is the patient feels clench pain locally and the healer feels resistance force in hands. Needles of 1 cun(Φ 0.30mm*25mm) were used at Baihui,Yintang, Hegu and Taichong. No special operation was performed at Yintang; needle twirling, lifting and thrusting of small amplitude was performed for three times at Baihui. At bilateral Hegu,Taichong, a 1 cun needle was applied to pierce, and needle twirling, lifting and thrusting of small amplitude was performed for three times to reach the effect of local bulging and obtain the desired sensation. In the process of needle retaining, the needle was manipulated with the neutral supplementation and draining method at each acupuncture point once every 10 minutes for three times.After the acupuncture needling, the patients who were in group 1 still receive the moxibustion, skin needling or sometime bleeding based on syndrome differentiation. Afterwards the patient rested for five minutes and moved forward with treatment if no discomfort was noted. The patient was positioned in the prone or sitting position. Universal oil was massaged around the Sihua acupoint and then a Moxa cone with a bottom diameter of 2 mm and height of 2 mm was attached to the acupoint and ignited at the tip with incense. When the local skin turned reddish and the patient felt a burning sensation, the moxa cone was replaced with a new cone, with two zhuangs per acupoint. After moxibustion, the universal oil was removed with cotton swabs. Next,1-2% iodophor was used to sanitize the bilateral Xinyu and Ganyu acupoints areas. The skin around the Yu acupoint area was held taut with one hand, and a needle held by a forceps at the tail was pierced intradermally into a Yu acupoint with the other hand. A plaster was placed under the needle tail and desensitization tape was used to cover the needle from its tail along the needle in the piercing direction to affix it to the skin. (2) Western medicine treatment group (Group 2)Paroxetine hydrochloride, a generally-accepted clinical medication to treat depression, was used for the patients in this group. The initial dosage was 20 mg per day. In total, the patients took the medication for two months.(3) Acupuncture-medicine group (Group 3)The patients in this group received both medicine and acupuncture treatments using the protocols described above.(4) courseFor the acupuncture group and acupuncture-medicine group received treatment, the above interventions were performed for 30～60 minutes each session, two times per week with an interval longer than 48 hours. Each patient received 8 weeks of treatment.(5) measuresAt the time points of before treatment, treatment Week 2, treatment Week 4, the end of the treatment (treatment Week 8), one month after treatment, Primary efficacy variables are Pittsburgh sleep quality index (PSQI), Hamilton depression rating scale (HAMD), secondary efficacy variables are SF-36 health survey, insomnia severity index (ISI), evaluation of patient compliance, safety and adverse effects.(6) data analysisThe data was analyzed by SPSS17.0 software. Measurement data (such as age, course of disease, the scores of measurement, and so on), between groups comparison using variance analysis [Kruskal Wallis], a repeated measurement data analysis of variance (ANOVA) based on multi point measurement data;attribute data uses the constituent ratio, expressed as a percentage, efficiency were compared by chi square test or Fisher exact probability method. The comparison between groups used chi square test (expressed by 2℃ table or 3℃ table). Statistical tests were two-sided test, the significant level difference is α=0.05.Results1. The results of systematic review and net-meta analysisAccording to retrieval strategy and data collection method, collected 1249 relevant literature, used the note express 3.0.2 literature manager to delete 259 repeat references; After reading the title and abstract, deleted 711 references; Remaining 52, after reading the full article,37 references were deleted. Eventually,15 references met eligibility criteria. Sum to 1120 patients. Language of The publications is Chinese.In the HAMD score, the differences among the acupuncute, comprehensive acupuncture and acupuncture-medicine were not statistically significant. The method of acupuncture-medicine maybe the priority.In the PSQI score, the differences among the acupuncute, comprehensive acupuncture and acupuncture-medicine were not statistically significant. The method of acupuncture-medicine combined maybe the priority.In the SDS score, the differences among the acupuncute, comprehensive acupuncture and acupuncture-medicine were not statistically significant. The method of acupuncture only maybe the priority.In the Asberg score, the differences among the acupuncute, comprehensive acupuncture and acupuncture-medicine were not statistically significant. The method of acupuncture only maybe the priority.2. Clinical study(1) Baseline informationThe difference in terms of age, occupation, course of illness,sex, whether treating or not before among three groups was no significant (P>0.05). The differences of an average of PSQI, HAMD, ISI and SF-36 scale were not statistically significant (P>0.05).Baseline level could be considered the same among three groups.(2)PSQI scoresComparing the PSQI scores at each time point of the three groups with that of before the treatment, the differences were statistically significant (P<0.05).At the second week point, there was statistically significant differences between the Group 1 and 3(P=0.001); there was statistically significant differences between the Group 2 and 3(P=0.0.004);While there was no difference between Group 1 and Group 2 (P=0.711).At the fourth week point, the score of Group 1 was 8.90±3.88, Group 2 was 8.13±4.48, Group 3 was 5.33±3.07. Comparing Group 1 and Group 3, there was statistically significant differences (P=0.001); Comparing Group 2 and Group 3, there was statistically significant differences (P=0.007);While there was no difference between Group 1 and Group 2 (P=0.45)At the eighth week point, the score of Group 1 was 8.13±4.48, Group 2 was 7.20±4.59, Group 3 was 6.83±3.09. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3,there was no difference (P =0.248,0.594,0.531).The one month after treatment, the score of Group 1 was 8.83±3.63, Group 2 was 9.90±4.85, Group 3 was 8.87±3.63. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =1.000,0.330,0.330) (3) HAMD scoresCompare the HAMD scores at each time point of the three groups with that of before the treatment, the differences were statistically significant (P<0.05).At the second week point, the score of Group 1 was 18.03±4.79, Group 2 was 17.53±4.74, Group 3 was 14.10±5.42. Comparing Group 1 and Group 3, there was statistically significant differences (P=0.003); Comparing Group 2 and Group 3, there was statistically significant differences (P=0.009);While there was no difference between Group 1 and Group 2 (P =0.699).At the fourth week point, the score of Group 1 was 14.30±5.44, Group 2 was 14.67±5.59, Group 3 was 11.83±5.91. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =0.095,0.056,0.802)At the eighth week point, the score of Group 1 was 12.03±5.78, Group 2 was 12.17±5.78, Group 3 was 10.47±6.24. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =0.294,0.255,0.929)The one month after treatment, the score of Group 1 was 12.37±5.21, Group 2 was 14.20±5.73, Group 3 was 10.90±6.27. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =0.327,0.029,0.221) (3)ISI scoresCompare the ISI scores at each time point of the three groups with that of before the treatment, the differences were statistically significant (P<0.05).At the second week point, the score of Group 1 was 17.40±5.34, Group 2 was 17.23±5.95, Group 3 was 13.06±4.71. Comparing Group 1 and Group 3, there was statistically significant differences (O=0.002); Comparing Group 2 and Group 3, there was statistically significant differences (P=0.003);While there was no difference between Group 1 and Group 2(P =0.000).At the fourth week point, the score of Group 1 was 11.26±5.65, Group 2 was 12.50±6.24, Group 3 was 7.50±3.73. Comparing Group 1 and Group 3, there was statistically significant differences (O=0.007); Comparing Group 2 and Group 3, there was statistically significant differences (P=0.000);While there was no difference between Group 1 and Group 2 (P =0.372)At the eighth week point, the score of Group 1 was 11.10±6.05, Group2 was 9.16±3.92, Group 3 was 9.96∧6.18. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =0.426,0.574,0.176)followed up for 1 month, the score of Group 1 was 11.36±4.27, Group 2 was 13.43±6.17, Group 3 was 11.96±4.68. Comparing Group 1 and Group 3, Group 1 and Group 2, Group 2 and Group 3, there was no difference (P =0.651,0.270,0.121). (4) SF-36 scoreGroup 1:PF, RP% BP, MH dimension at each time point, the difference was not statistically significant (P<0.05); GH, VT SF, RE dimension increased,the difference was not statistically significant (P> 0.05).Group 2:PF, RP, VT, MH dimension at each time point decreased, the difference was not statistically significant (P>0.05); BP, GH, RE dimension, SF dimension dimension at each time point increased, the difference was not statistically significant (P>0.05);.Group 3:The scores of 8 dimensions increased, and there was no significant difference between the 7 dimensions (P>0.05).At the second week point, Group 2 compared with Group 3, in the PF、RP、 BP、SF、MH dimensions, the difference is statistically significant (P<0.05, P=0.018,0.045,0.014,0.00,0.00); Group 1 compared with Group 3, in the SF, MH dimensions, the difference is statistically significant (P<0.05, P =0.00,0.00); Group 1 compared with Group 2, in the PF、MH dimensions, the difference is statistically significant (P<0.05, P=0.013,0.03).At the fouth week point, Group 2 compared with Group 3, in the PF, RP, GH、 VT, SF, MH dimensions, the difference is statistically significant (P<0.05, P=0.003,0.002,0.01,0.00,0.001,0.001); Group 1 compared with Group 3, in the RP、BP、GH、SF、MH dimensions, the difference is statistically significant (P<0.05, P=0.00,0.055,0.001,0.002,0.039), Group 1 compared with Group 2, in the VT dimension, the difference is statistically significant (P< 0.05, P=0.003);At the eighth week point, Group 2 compared with Group 3, in the PF, RP, GH, VT, SF, MH dimensions, the difference is statistically significant (P< 0.05, P=0.002,0.001,0.03,0.001,0.001,0.00); Group 1 compared with Group 3, in the RP、BP、GH、SF、MHdimensions, the difference is statistically significant (P<0.05, P=0.000,0.034,0.001,0.002,0.014), Group 1 compared with Group 2, in the VT dimension, the difference is statistically significant (P<0.05, P=0.001);followed up for 1 month, Group 2 compared with Group 3,in the PF, RP, GH, VT, SF, MH dimensions, the difference is statistically significant (P< 0.05, P=0.000,0.000,0.01,0.001,0.004,0.001); Group 1 compared with Group 3, in the PF, RP, BP, GH, SF, MH dimensions, the difference is statistically significant (P<0.05, P=0.037,0.000,0.003,0.000,0.004,0.014), Group 1 compared with Group 2, in the BP and VT dimension, the difference is statistically significant (P<0.05, P=0.040,0.001);(5) efficiencyAt the second week point, Group 1, Group 2, Group 3 PSQI efficiency were 66.7%,40%,70%. Group 3 and Group 2, the difference is statistically significant (P=0.03), the comparison between Group 1 and Group 2 is statistical significance (P=0.029). compared with Group 1 and Group 3, the difference was not statistically significant (P=0.55);At the fourth week point, the comparison showed no differences among the groups (P=0.86,0.24 and 0.17, respectively).After 8 weeks of treatment, the efficiency of Group 1, Group 2 and Group 3 was 83.9%,82.1%,87.1% respectively. The comparison showed no differences among the groups (P=0.86,0.17 and 0.12, respectively),followed up for 1 month, acupuncture group, western medicine group, acupuncture medicine group efficiency 70.1%,75.0% and 70.1%, respectively. The comparison showed no differences among the groups (P values were 0.96, 0.88 and 0.85).(6) SafetyThe adverse events were nausea, dry feeling of the mouth, dizziness, constipation,weak appetite, fatigue, and headache, restless. There was no significant difference in the incidence of adverse reactions among the groups.(7) sensitivity analysisEliminate the data of cases that the patients have taken the sedative hypnotic drugs, and compare with the result before, it is found that results are similar. The stability of result is good.(8) correlation analysisin the research, the level of education and combined disease showed a negative correlation (P<0.05/0.00), they maybe the factors that affect the effiency of treatment.Conclusion1. Literature through the system evaluation, consider that comprehasive acupuncture is curative to improve the symptoms of insomnia caused by depression, compared with medicine group or needling alone.2. The clinical trials shows that the three groups can effectively improved patients’insomnia symptoms, depressive symtoms and quality of life, and the effectiveness maybe the same. The adverse effects of the patients in Group 1 and 3 maybe was less than the patients in Group 2.3. Education and combined disease maybe the two influence factors which might influend the effectiveness of the treatment for the depression and insomnia. |
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