| ObjectiveTo assess the clinical therapeutic efficacy and safety of soothing-liver and regulating-mentality acupuncture treatment on patients with comorbid depression and insomnia, and to explore the relationship between Deqi factor and the clinical efficacy, in order to provides reliable evidence for acupuncture treatment of depression comorbid insomnia.MethodsVolunteers were recruited in the acupuncture and psychological department of Guangdong Hospital of Traditional Chinese Medicine.In this randomized controlled trial, a total of 83 volunteers that conforming to the inclusion criteria are randomly assigned to one of two groups, and there were 50 cases in the treatment group and 33 cases in the control group. The treatment group receive soothing-liver and regulating-mentality acupuncture treatment, while the control group receive sham-acupuncture.The treatment group, patients will receive normal needle acupuncture on 12 acupoints, including Baihui(DU20), Yintang(EX-HN3),Hegu(LI14), Taichong(LR30), Anmian(Extra), Shenmen(H7), Sanyinjiao(sp6) and intradermal needle acupuncture on Xinshu(BL15) and Ganshu(BL18), or Hunmen(BL47) and Shentang(BL44) in turn. After groovy disinfection, the needle penetrated the skin sufficiently to reach the required depth, then manipulate the needles to elicit de qi. Ratain the needles for 30 min, with gently manipulation the needles 2 or 3 times until de qi. After 30 min, remove the needles and insert the intradermal needle into the acupoints by a forceps, secure by adhesive plaster, and retained for 2 to 3 days.The control group, patients will receive superficial (≤3mm) acupuncture on non-acupoints(lcm away from the real acupoints used in the treatment group), and using the wangbuliuxing seed instead of the intradermal needle.Course of treatment for both groups was 10 weeks, volunteers receive treatment 2 times a week(each administration separated over 72 hours).All enrolled patients received at least 16 times of treatment.Evaluate the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton depression rating scale(HAMD), Self-Rating Depression Scale (SDS) before treatment,5 weeks and 10 weeks after the treatment and the end of 4weeks follow up period, and evaluate the C-MMASS after the first treatment,5 weeks and 10 weeks after the treatment.Statistical analysis was carried out using SPSS software (version 19; IBM Corporation, Armonk, NY, USA). Means and standard deviations were used for continuous data and frequencies and percentages for categorical data. For the normally distributed continuous data, t-tests were conducted to compare means. For categorical data, chi-square analyses were conducted. Any significant imbalances among the groups were reported using student t-tests or chi-squares when appropriate. Correlation analysis used Spearman correlation analysis.Results1. A total of 83 patients were included in the study,79 subjects completed the study. The treatment group included 50 cases of subjects,2 of them dropped out, the drop out rate was 4%; The control group included 33 cases of subjects, 2 of them dropped out, the drop out rate was 6.06%.2. Before treatment, the treatment group and the control group had no statistical significance (P> 0.05) in age, gender, ethnic, educational level, course of depression and insomnia, PSQI, ISI, HAMD and SDS score, suggesting that two groups had comparability at baseline.3. PSQI scoreThe total score of PSQI was reduced in both groups after treatment. Comparisons of intra-group, the treatment group showed the significant difference in 5 weeks and 10 weeks after the treatment and the end of 4 weeks follow up period compared with before treatment (P=0.000,0.000,0.000, P<0.01). In the control group, the PSQI score of the later 3 observation points compare with the baseline, statistical difference was observed (P=0.010,0.000,0.000, P<0.05).5 weeks after the treatment compared with the end of the treatment, the PSQI sore of treatment group had no significant difference (P=0.215, P>0.05). while the control group had significant difference (P=0.215, P>0.05). Comparisons between two groups, the PSQI score at 5 weeks after treatment, the difference between two groups showed no statistical significance (P=0.809, P>0.05).At the end of the treatment and 4 weeks follow up had significant difference (P=0.037,0.005, P<0.05).4. ISI scoreThe total score of ISI was reduced in both groups after treatment. At 5 weeks and 10 weeks after the treatment and the end of 4 weeks follow up period compared with pre-treatment, the treatment group (P=0.000,0.000,0.000) and the control group (P=0.000,0.000,0.000) both showed the most significant difference (P<0.01). Compare the ISI score at the end of the treatment and at 4 weeks follow up, both groups increased, but the statistical significance was not observed in the treatment group (P=0.856,P>0.05), while the control group showed the significant difference (P=0.007, P<0.05). Comparisons between two groups, the ISI score at 5 weeks after treatment, the difference between two groups showed no statistical significance (P=0.302, P>0.05). At the end of the treatment and 4 weeks follow up, the difference between two groups shows statistical significance (P=0.016,0.006, P<0.05).5. HAMD scoreThe total score of HAMD was reduced in both groups after treatment. At 5 weeks and 10 weeks after the treatment and the end of 4 weeks follow up period compared with pre-treatment, the treatment group (P=0.000,0.000,0.000) and the control group (P=0.001,0.000,0.000) both showed the most significant difference (P<0.01). Comparisons between two groups, the HAMD score at 5 weeks after treatment, the end of the treatment and 4 weeks follow up, the difference between two groups shows most statistical significance (P=0.005,0.000,0.000, P<0.01).6. SDS scoreThe total score of SDS was reduced in both groups after treatment. At 5 weeks and 10 weeks after the treatment and the end of 4 weeks follow up period compared with pre-treatment, the treatment group (P=0.000,0.000,0.000) and the control group (P=0.000,0.000,0.000) both showed the most significant difference (P<0.01).4 weeks following up compared with the end of the treatment, the PSQI sore of both groups had increased, the treatment group had no significant difference (P=0.125, P>0.05), while the control group had significant difference (P=0.002, P>0.05). Comparisons between two groups, the SDS score at 5 weeks after treatment, the difference between two groups showed no statistical significance (P=0.481,P>0.05). At the end of the treatment and 4 weeks follow up, the difference between two groups shows statistical significance (P=0.012,0.020, P<0.05).7. Effective rateAt the end of the treatment, the total effective rate of the treatment group was 60.5%, and the control group was 25.8%. in the treatment group, clinically cured rate (12.5%), markedly effective rate (4.2%), effective rate (43.8%), it’s higher than the control group (3.2%、0%、22.6%), the difference shows most statistical significance (P=0.002, P<0.01).After 4 weeks follow up, in the treatment group, clinically cured rate, markedly effective rate and effective rate was (8.3%、6.3%、39.6%), it’s higher than the control group (0%、3.2%、9.7%), the difference shows most statistical significance (P=0.000, P<0.01).8. C-MMASS scoreSpearman rank correlation analysis was used to determine the relation between the PSQI subtraction mark rate and the C-MMASS score. Correlation analysis showed that the correlation coefficient was 0.528, which was positively and significantly correlated with each other (P=0.000,P<0.05).9. Adverse eventsThere is no adverse events records during the study.Conclusion1.The soothing-liver and regulating-mentality acupuncture therapy could improve the sleeping quality and depressive symptoms of patients with comorbid depression and insomnia, with better effects than non-acupoints superficial acupuncture therapy, and more durable effect than non-acupoints superficial acupuncture therapy on improving sleep quality.2. There are some relationship between the Deqi sensation and the efficacy of the soothing-liver and regulating-mentality acupuncture therapy on the improvement of sleep quality in patients with comorbid depression and insomnia. |
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