The Clinical Study Of The Effect Of Lingnan Tianjiu Prescription 4 For Depression Insomnia

Objective1. To examine the effectiveness of acupuncture in the treatment for depression and related sleep disturbances;2. Randomized controlled clinical trials were adopted to evaluate the efficacy and safety of treating depression insomnia with Lingnan Tianjiu (crude herb moxibustion therapy) prescription No.4 through comparison with placebo and Lingnan Tianjiu prescription No.1, so as to inherit and expand the disease spectrum of Lingnan Tianjiu.Methods1. Data mining:The following databases were searched:CNKI, VIP, Wan Fang database, CBM, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and manual search the references of the relevant article by. We used odds ratio (OR) and standard mean differences for dichotomous outcomes and continuous outcomes respectively. Primary outcomes were improvement of depression and insomnia, measured by self-rating scales such as HAMD/SDS and PSQI.2. Clinical research:① The study period was from February 2014 to March 2015; the subjects were recruited mainly from the outpatient of the acupuncture and moxibustion department of Guangdong Provincial Hospital of TCM. ② Design of the clinical study:the study was the random controlled method, and 90 patients conformed to the diagnostic criteria were allocated as a ratio of 1:1:1 into three groups:Lingnan traditional Tianjiu prescription No.2 (treatment group), Lingnan traditional Tianjiu prescription No.1 (control group 1) and placebo group (control group 1). ③. Therapeutic regimen:the treatment group applied the Lingnan traditional Tianjiu prescription No.2, control group 1 applied the Lingnan traditional Tianjiu prescription No.1, and the control group 2 applied placebo. All the acupoints were selected from the following two groups of acupoints alternately, and each acupoint was selected on both sides:① Xin shu (both), Gan shu (both), Pi shu (both), Fei shu (both) and Shen shu (both);② Zhong wan, Xia wan, Qi hai, Guan yuan, Hua roumen (both), Ge shu (both) and Dan shu (both). The duration of each fixation was 2-3h and the acceptance was the maximum endurable heat pain of the patient. Treatments were provided twice a week for a total of eight times in four weeks (1 treatment course) and the interval of every two therapies was no less than 48 hours. ④. Efficacy evaluation:PHQ-9 scale and PSQI scale were adopted as the primary indexes of efficacy evaluation and SF-36 scale was adopted as the index of efficacy evaluation; adverse reactions and side effects occurred at any time during the study were recorded, and SPSS 20.0 statistical software was applied to build a database for statistical analysis.Results①Results of the systematic review and meta analysis:This review now contains data from 8 studies. Thirty trials with 549 participants are included. There was a high risk of bias in the majority of trials. There was evidence of a beneficial effect from acupuncture compared with control [OR 2.41,95%CI (1.31,4.42)].②Clinical study result:1. Baseline comparison:The differences of gender composition, education background and history of receiving acupuncture and moxibustion treatment, etc. in three groups were not statistically significant (P=0.84,0.67 and 0.23, respectively); differences of disease course, age and previous treatment time were not statistically significant (P=0.94,0.96 and 0.92, respectively). Score of PHQ-9 scale, score of PSQI scale and the baseline of the 8 measurement indexes in SF-36 in patients of three groups were equivalent (P=0.43,0.86 and 0.62, respectively), indicating that the two groups were consistent at baseline level with comparability.2. PHQ-9 scale score:Ⅰ. Comparison in the group:At the end of treatment, the scores of PHQ-9 scale of treatment group, control group 1 and control group 2 presented varying degrees of decrease (7.37 ± 2.477,8.67 ± 3.54,10.90 ± 4.7) compared to those before treatment, but statistical significance was not observed (P=0.773, P=0.122, P=0.122); at the first month of follow-up, the scores of PHQ-9 scale of treatment group, control group 1 and control group 2 presented varying degrees of decrease (9.30 ± 3.44,9.70 ± 3.90,11.13 ± 4.48) compared to those before treatment, but statistical significance was not observed (P=0.233, P=0.107, P=0.107).Ⅱ. comparison among groups:at the end of treatment course, the scores of treatment group, control group 1 decreased in comparison with that of control group 2 and the differences were statistically significant (P=0.178, P=0.000); the comparison of efficacy at other time points presented no statistical significance (P>0.05).(3)PSQI scale score:Ⅰ. Intragroup comparison:at the end of treatment, the scores of PSQI scale of treatment group, control group 1 and control group 2 presented varying degrees of decrease (10.23±2.79,10.73±2.45.12.71±3.29) compared to those before treatment, but statistical significance was not observed (P=0.014, P=0.00. P=0.00); at the first month of follow-up, the scores of PSQI scale of treatment group, and control group 1 presented varying degrees of decrease (10.49±2.6.11.31±3.14) compared to those before treatment, but statistical significance was not observed (P=0.011, P=0.107). At the first month of follow-up, the scores of PSQI scale of control group 2 presented varying degrees of decrease (13.27±3.79) compared to those before treatment, and the statistical significance was observed (P=0.003).II. comparison among groups:at the end of treatment course, the scores of treatment group, control group 1 decreased in comparison with that of control group 2 and the differences were statistically significant; the comparison of efficacy at other time points presented statistical significance (P=0.001、0.009). At the first month of follow-up, the scores of treatment group, control group 1 decreased in comparison with that of control group 2 and the differences were statistically significant (P=0.001、0.020).④　SF-36 scale score:comparison among groups:at the end of treatment course, the RP、BP、 VT、SF、RE、MH scores of treatment group, control group 1 decreased in comparison with that of control group 2 and the differences were statistically significant (P=0.05、0.03、0.00、0.06、0.06、0.02); at the end of treatment course, the PF、GH scores of treatment group, control group 1 increased in comparison with that of control group 2, but the differences were not statistically significant (P=0.15、0.14); At the first month of follow-up, the PF、RP、 BP、VT scores of treatment group, control group 1 increased in comparison with that of control group 2 and the differences were statistically significant (P＝0.09、0.08、0.05、0.00).⑤ Effective rate comparison:Ⅰ. PHQ-9 scale:At the end of treatment, the effective rate of the treatment group was 43%, and that value was 33.3% in the control group and 20% in the placebo group. The pairwise comparison results of effective rate among the three groups were statistically significant (P<0.05);Ⅱ. PSQI Scale:At the end of treatment, the effective rate of the treatment group was 56%, and that value was 60% in the control group and 23% in the placebo group. The pairwise comparison results of effective rate among the three groups were statistically significant (P<0.05).Conclusion1. The current evidence is likely to support or refute acupuncture for treating depression and related sleep disturbances. However the researches are in poor methodological quality and high levels of heterogeneity and publication bias. Larger high-quality clinical trials are required.2. Lingnan traditional Tianjiu prescription No.2 and Lingnan traditional Tianjiu prescription No.1 presented superior short-term curative effects to that of the placebo group in the evaluation adopting scores of PHQ-9 scale as measurement index, but the long-term efficacy remains uncertain.3. Both the intervention programs of Lingnan Tianjiu prescription No.2 and Tianjiusan can effectively improve sleep quality. However, Lingnan Tianjiu prescription No.2 (treatment group) presented more a significant decrease of PSQI score in comparison with that of the control group, indicating that the efficacy of the treatment group is more significant, and its long-term efficacy is superior to that of Lingnan Tianjiu prescription No.1 and the prescription of placebo.4 Lingnan Tianjiu prescription 4 is safe and effective to treatment of the insomnia and depression.