| Objective:1. To summarize the principles of acupuncture treatment and acupoint selection through investigating existing literatures and to investigate the efficacy of acupuncture for treatment of perimenopausal insomnia by performing meta-analysis and systematic review.2. To evaluate the clinical efficacy and safety of acupuncture for treatment of perimenopausal insomnia and patients quality of life by conducting randomized clinical trials (CRT).Methods:1. literature review:Electronic searches were conducted through the following main domestic databases:CNKI、WF、VIP、CBM from inception to December 2014 and the data retrieved were analyzed regarding the principles of acupuncture treatment and acupoint selection. From such basis, the included literatures were analyzed by titles, abstracts and full text to be categorized as clinical studies having pure acupuncture as the treatment group, and Chinese herbal medicine or western medicine as the control group. They were then evaluated by meta-analysis of systematic review.2. Clinical study:90 patients were randomized into 3 groups:acupuncture group(acupuncture+ acupoint intradermal needle), pseudo-acupuncture group (pseudo-acupuncture+ wangbuliuxing seed compression) and non-acupoint intradermal acupuncture group(non-acupoint intradermal acupuncture+wangbuliuxing seed compression). All groups were administered acupuncture treatment 3 times per week, with each administration separated≥24 hours; acupoint intradermal needle and wangbuliuxing seed compression were administered 2 times a week, with each administration separated≥72hours; a sequential 4 weeks of administrations were considered as one cycle of treatment, and a total of 2 cycles of treatments were conducted for each group, with one-month follow-up period. The short and mid-term effects of using acupuncture combined with acupoint intradermal needle for treatment of perimenopausal insomnia were evaluated by the PSQI scale、Modified Kupperman score and MENQOL scale at 4 time points:start of treatment,4 weeks after treatment,8 weeks after treatment and end of one-month follow up period. The data of acupuncture group along with that of the other two control groups (pseudo-acupuncture group and non-acupoint intradermal acupuncture group) were analyzed using rank sum test, ANOVA, Post Hoc tests, analysis of variance of repeated measures by SPSS 18.0 to investigate their differences in efficacy of treating perimenopausal insomnia.Results:1. literature reviewA total of 550 literatures were retrieved and after scanning the titles, abstracts and full texts,76 literatures documenting acupoints in clinical studies were adopted. The acupoints were analyzed in terms of their usage frequencies. The top ten are as follows:sanyinjiao, shenmen, baihui, shenshu, taichong, taixi, neiguan, xinshu, pishu, and zusanli. From the 76 literatures, 18 clinical control trials were then scanned and included, among them,5 trials had Chinese medicine as control,11 trials had western medicine as control, a total of 1434 patients were included for study. Among the 16 trials,14 reported the effective rates,1282 patients were included. Among these trials, 10 studies having acupuncture and moxibustion compared with western medicine, the heterogeneity test indicated (P=0.0008, I2=68%), thus random effect model was used, the result showed:[RR=1.20,95%CI(1.06,1.35), P=0.003], indicating acupuncture and moxibustion might have better efficacy than western medicine. In the 2 studies having acupuncture compared with Chinese herbal medicine, the heterogeneity test indicated (P=0.36, I2=0%), thus fixed effect model was used, the result revealed:[MD=-4.23,95%CI(-5.13,-3.34), P＜0.00001], indicating acupuncture and moxibustion group might be more effective in improving PSQI than Chinese herbal medicine group.2 studies reported results of AIS scale,184 patients were included, the heterogeneity test indicated (P=0.87, I2=0%), thus random effect model was used, the result showed: [MD=-2.26,95%CI(-3.00,-1.52), P＜0001], indicating acupuncture and moxibustion group might have better efficacy in improving AIS value than western medicine.2. Clinical studiesBaseline characteristics, PSQI, Kupperman and MENQOL for the three groups had no significant difference (P> 0.05) before treatment, they were comparable.(1)PSQI① Intragroup comparison:the scores of PSQI scale of treatment group at the four observation points are (16.8 ±1.16,12.63±1.45,11.33±2.25,11.23 ±1.25). When the later three points compared to the first point, the statistical significance was not observed (P=0.000, P=0.000, P=0.000). The scores of PSQI scale of sham acupuncture group at the four Observation points are (16.37± 1.92,15.3±2.58,15.27±3.25,15.06±2.83). When the later three points compared to the first point, the statistical significance was not observed (P=0.000, P=0.000, P=0.000). The scores of PSQI scale of non acupoint shallowly puncture group at the four Observation points are (17.2±1.32,14.83 ±1.97,14.17±2.42,14.37±1.79). When the later three points compared to the first point, the statistical significance was not observed (P=0.000, P=0.000, P=0.000).② Comparison among groups:At the later three observation points, the differences between the treatment group and the sham acupuncture group were statistical significant (P=0.000, P=0.000, P=0.000). At the later three observation points, the differences between the treatment group and t non acupoint shallowly puncture group were statistical significant (P=0.000, P=0.000, P=0.000). At the later three observation points, the differences between the sham acupuncture group and the non acupoint shallowly puncture group showed no statistical significance (P=0.38,P=0.115, P=0.197).(2)MENQOL①Intragroup comparison:the scores of MENQOL scale of treatment group at the four Observation points are (85.27±15.36,59.77±13.3,41.83±9.93, 48.17±11.67), When the later three points compared to the first point, the statistical significance was observed (P=0.000, P=0.000,P=0.000). The scores of MENQOL scale of sham acupuncture group at the four Observation points are (85.37±19.67,65.3±16.53,56.77±14.83,60.23±13.27). When the later three points compared to the first point, the statistical significance was observed (P=0.000, P=0.000,P=.000). The scores of MENQOL scale of non acupoint shallowly puncture group at the four Observation points are (82.57+22.75、 65.07±17.72、54.1±15.24、57.27±14.33). When the later three points compared to the first point, the statistical significance was observed (P=0.000, P=0.000,P=.000).② Comparison among groups:At the second observation point, the differences between the treatment group and the sham acupuncture group was not statistical significant (P=0.183). At the later two observation points, the differences between the treatment group and the sham acupuncture group were statistical significant (P=0.000, P=0.001). At the second observation point, the differences between the treatment group and non acupoint shallowly puncture group was not statistical significant (P=0.202). At the later two observation points, the differences between the treatment group and the sham acupuncture group were statistical significant(P=0.001, P=0.009). At the later three observation points, the differences between the sham acupuncture group and the non acupoint shallowly puncture group showed no statistical significance (P=0.955, P=0.448,P=0.384).(3) Modified Kupperman scale① Intragroup comparison:the scores of Modified Kupperman scale of treatment group at the four Observation points are (16.8±1.16,12.63±1.45, 11.33±2.25,11.23±1.25). When the later three points compared to the first point, the statistical significance was observed (P=0.000, P=0.000, P=0.000). The scores of Modified Kupperman scale of sham acupuncture group at the four Observation points are (22.73±4.83,21.3±4.58,21.27±4.17,21.33 ±4.25). When the later three points compared to the first point, the statistical significance was not observed (P=0.216,P=206, P=0.227). The scores of Modified Kupperman scale of non acupoint shallowly puncture group at the four Observation points are (22.5±4.1,18.67.3±3.74,18.2±3.93, 17.37±4). When the later three points compared to the first point, the statistical significance was observed (P=0.000, P=0.000, P=0.000).② comparison among groups:At the later three observation points, the differences between the treatment group and the sham acupuncture group were statistical significant (P=0.000, P=0.00, P=0.00). At the second and thrid observation points, the differences between the treatment group and t non acupoint shallowly puncture group showed no statistical significance (P=0.148, P=0.066). At the last observation point, the differences between the treatment group and t non acupoint shallowly puncture group showed statistical significance (P=0.026). At the later three observation points, the differences between the sham acupuncture group and the non acupoint shallowly puncture group were statistical significant (P=0.014,P=0.003,P=0.000).(4) Effective rate comparisonAt the forth week of therpy, the effective rate of the treatment group was 83.33%, and that value was 50% in the sham acupuncture group and 66.67% in the non acupoint shallowly puncture group. The comparison results of effective rate among the three groups were statistically significant (P＜0.0167). At the eighth month of therpy, the effective rate of the treatment group was 93.33%, and that value was 46.67% in the sham acupuncture group and 60.00% in the non acupoint shallowly puncture group. The comparison results of effective rate among the three groups were statistically significant (P<0.0167). At the first month of follow-up, the effective rate of the treatment group was 90.00%, and that value was 26.67% in the sham acupuncture group and 43.33% in the non acupoint shallowly puncture group. The comparison results of effective rate among the three groups were statistically significant (P＜0.0167).(6)The adverse effectNo incidence of adverse reaction was found during the study. Conclusion:1.Literature review:Following the basic principle of treating the fundamental cause of disease, the methods of "locating acupoints along the meridians" and "locating acupoints in relation to diseased areas" were adopted. The most commonly used acupoints included:sanyinjiao, shenmen, baihui, shenshu, taichong, taixi, neiguan, xinshu, pishu, and zusanli. Results of meta-analysis revealed that certain advantages were demonstrated by acupuncture in treating perimenopausal insomnia over western medicine or Chinese herbal medicine, however, more RCT s of good quality should be expected to give sound support.2. Clinical studyThe clinical study showed that the group using acupuncture combined with acupoint intradermal needle exerted relatively better clinical effects on relieving insomnia and improving quality of life for women during perimenopausal period. |
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