| Objective1.Looking for evidence of acupuncture treatment on menopause symptoms through previous literature.2. To evaluate the effect of acupuncture treatment on symdrome clusters of menopause transition through clinical randomized controlled, single blind study.Methods1. Systematic review of literatureIn order to evaluate the clinical curative effect of acupuncture on menopause symptom, we search the abroad literatures between January 1999 and December 2015 about acupuncture treatment for menopause symptoms. Database include Medline/PubMed, Web of Science, the Cochrane Central Register of Controlled Trials. NoteExpress 3.0.2 was used to manage the literatures. Futher research was done to assess the quality of the literatures which met the inclusion criteria.2. Clinical researthVolunteers were recruited in the acupuncture and gynecology department of Guangdong Hospital of Traditional Chinese Medical. A total of 90 patients of menopausal transition period conforming to the inclusion criteria were randomly divided into acupoint acupuncture group, acupoint shallow acupuncture group, and acupoint sham acupuncture group. The selected acupoints were Guan yuan, uterus, Tianshu, Sanyinjiao (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 specially-made HuaTuo brand nested acupuncture needles (specially-made by Suzhou Medical Supplies Co., Ltd.) were applied for experiment.Acupoint acupuncture group:patients were enjoined to empty their bladders before acupuncture. Under supine position, local skin of the acupoint was routinely disinfected, and then viscous supporting rings were fixed on the acupoints. Needles of 3 cun were used at Tianshu, needles of 2 cun were used at uterus and Guan yuan to pierce through the supporting ring and reach the parietal peritoneum. The standard of reaching parietal peritoneum is that the patient feels clench pain at acupuncture local and the healer feels resistance force in hand. No special operation was performed at Tianshu and uterine; needle twirling, lifting and thrusting of small amplitude was performed for three times at Guan yuan. At bilateral Sanyinjiao, a 1.5 cun needle was applied to pierce through the fixed pad thrust in for 1 cun, 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.Acupoint shallow acupuncture group:under supine position, local skin of acupoint was routinely disinfected, and then viscous supporting ring was fixed on the acupoints. At bilateral Guan yuan, uterus, Tianshu and Sanyinjiao, 1.5-cun nested acupuncture needles were used to thrust into the skin (2mm). Uniform needle twirling, lifting and thrusting were performed 3 times at each acupoint without targeting to achieve the desired sensation.Sham acupuncture group:under supine position, local skin of acupoint was routinely disinfected, and then viscous supporting ring was fixed on the acupoints. At bilateral Guan yuan, uterus, Tianshu and Sanyinjiao,1 cun blunt needles were used to thrust the supporting rings and reach the skin. Uniform needle twirling, lifting and thrusting were performed 3 times at each acupoint but the skin was not pierced. Target of achieving the desired sensation was not necessary. All the three groups received treatment three times a week for eight weeks with interval of each treatment>24h. At the time points of before treatment, treatment Week 4, the end of the treatment (treatment Week 8), one month after treatment and three months after treatment, average 24-hour hot flashes record, menopause symptoms rating scale (MRS) and perimenopausal quality of life scale (MENQOL) were adopted for evaluation of effectiveness; VAS scale and acupuncture sensory scale (C-MASS) were applied to evaluate the deceiving effect of blind placebo needle as well as the desired sensation; safety assessment was conducted in combination with the recorded adverse reactions. Descriptive analysis of variance analysis, chi-square test, analysis of variance and repeated measurement data were analyzed by SPSS 18.0 software.Results1.The evaluation of literature systemAccording to retrieval strategy and data collection method, collected 106 relevant literature, used the note express 3.0.2 literature manager to delete 50 repeat references; After reading the title and abstract, deleted 39 references; Remaining 17, after reading the full article,7 references were deleted. Eventually,10 references met eligibility criteria. Sum to 801 patients. Language of The publications is English.Six studies were included for hot flashes frequency, heterogeneity test(P>0.10, I2<50%) suggested that fixed effects model would be used. the difference between two groups was significant(P<0.05), [WMD=-0.39,95%CI (-0.56,-0.23]. The efficacy of treatment group is better than that of control group.Six studies were included for hot flashes severity. Fixed effects model would be used. the difference between two groups was significant(P<0.05), [WMD=-0.55,95%CI (-0.72,-0.38]. The efficacy of treatment group is better than that of control group.Four studies were included for MRS. Heterogeneity test (P＜0.10, I2>50%) suggested that two groups are heterogeneous. Random effects model would be used. The difference between two groups was significant(P<0.05), [WMD=-8.52,95%CI (-13.83,-3.21]. The efficacy of treatment group is better than that of control group.MENQOL scale includes four domains, they are vasomotor, psychosocial, physical, and sexual. Every factor include 2 trials. Fixed effects model would be used. Physical domain score is [WMD=-0.32,95%CI(-0.93,0.30)], psychosocial domain score is [WMD=0.03,95%CI (-0.48,0.43)], sexual domain score is [WMD=0.35,95% CI (-0.41,1.12)], vasomotor domain score is [WMD=0.01,95%CI (-0.71,0.74)], the difference between the two groups was no significant (P>0.05).2. Clinieal Researeh(1)baseline informationThe difference in terms of age, occupy, weight, course, clinical diagnosis, whether treating or not before among three groups was no significant (P >0.05). The differences of an average of 24 hours hot flashes scores, MRS scale, MENQOL scale before treatment were not statistically significant (P>0.05). And, the difference of FSH, LH and E2 were also not statistically significant (P>0.05). Baseline level could be considered the same among three groups. (2) MRS①Total scores:Compare the MRS 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 fourth week point, the score of acupuncture group was 1.12+0.19, superficial acupuncture group was 1.16±0.15, sham needle group was 1.21± 0.18. Comparing acupuncture group and superficial acupuncture group, there was no statistically significant differences (P=0.389); Comparing acupuncture group and sham needle group, there was statistically significant differences (P=0.048);While there was no difference between superficial acupuncture group and sham needle group (P=0.246)At the eighth week point, the score of acupuncture group was0.80±0.28, superficial acupuncture group was 1.01±0.20, sham needle group was 1.08± 0.24. Comparing acupuncture group and superficial acupuncture group, the difference was statistically significant (P=0.001); Comparing acupuncture group and sham needle group, there was statistically significant differences (P=0.000);While there was no difference between superficial acupuncture group and sham needle group (P=0.295)The first month after treatment, the score of acupuncture group was 0.90±0.20, superficial acupuncture group was 1.02±0.18 and sham needle group was 1.13±0.21. Comparing acupuncture group and superficial acupuncture group, the difference was statistically significant (P=0.015); Comparing acupuncture group and sham needle group, there was statistically significant differences (P=0.000);Difference was also significant between superficial acupuncture group and sham needle group (P=0.045)The third month after treatment, the score of acupuncture group was 0.88±0.22, superficial acupuncture group was 1.03±0.19 and sham needle group was 1.12±0.20. Comparing acupuncture group and superficial acupuncture group, the difference was statistically significant (P=0.004); Comparing acupuncture group and sham needle group, there was statistically significant differences (P=0.000);Difference was no significant between superficial acupuncture group and sham needle group (P=0.045)②Domains:Compare the domain score of MRS at each time point of the three groups with that of before the treatment, the differences were statistically significant (P＜0.05).At the fourth week point, Three domains score of acupuncture group were 6.41±2.98,4.38±1.93,3.72±1.96, superficial acupuncture group was 7.00± 2.77,4.73±2.18,3.70±1.82, sham needle group was 7.59±3.43,6.30±2.71,4.26 ±2.36. There were no significant differences comparing acupuncture group and superficial acupuncture group (Pvalue were 0.464,0.554,0.964 respectively); Comparing acupuncture group and sham needle group, there was statistically significant differences in physical domain (P=.007); Comparing superficial acupuncture group and sham needle group, there was statistically significant differences only in physical domain (P=0.012)At the eighth week point, Three domains score of acupuncture group were 3.24±1.98、2.38±1.42、1.86±1.33, superficial acupuncture group were 4.87 ±1.59、3.53±2.18、2.83±1.6, sham needle group were 5.74±2.63、4.41±2.15、 3.30±2.00. There were significant differences comparing acupuncture group and superficial acupuncture group in three domains (P value were 0.04、0.025、 0.029, respectively); Comparing acupuncture group and sham needle group, there was statistically significant differences in three domains (Pvalue were 0.000、 0.000、0.002, respectively); Comparing superficial acupuncture group and sham needle group, there were no statistically significant differences (Pvalue were 0.118,0.094,0.303, respectively)After the firth month, Three domains score of acupuncture group were 3.38 ± 1.95,3.00 ±0.93,2.28 ± 1.25, superficial acupuncture group were 4.63 ± 1.81,4.00 ± 1.82,2.60±1.40, sham needle group were 6.30±2.92,4.59 ± 1.93,3.85±2.03.There were significant differences comparing acupuncture group and superficial acupuncture group both in psychiatry and physical domains ((Pvalue were 0.036,0.020, respectively); Comparing acupuncture group and sham needle group, there was statistically significant differences in three domains (P value were 0.000,0.000,0.000, respectively); Comparing superficial acupuncture group and sham needle group, there were statistically significant differences both in psychological and urogenital domains (Pvalue were 0.007,0.004, respectively)After the third month, Three domains score of acupuncture group were 3.76 ±1.83,2.45 ±1.21,2.21 ±1.11, superficial acupuncture group were 4.83± 2.04,3.90±1.90,3.07 ± 1.82, sham needle group were5.93±2.29,4.63 ± 1.94,3.96 ±2.313. There were significant differences comparing acupuncture group and superficial acupuncture group both in psychiatry and physical domains (Pvalue were 0.048,0.002, respectively); Comparing acupuncture group and sham needle group, there was statistically significant differences in three domains (P value were 0.000,0.000,0.000, respectively); Comparing superficial acupuncture group and sham needle group, there were no statistically significant differences (P value were 0.048,0.113,0.064, respectively)(3) The average 24 hours of hot flashes scoreCompare the hot flashes 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 fourth week point, the score of three groups were5.72±4.76,7.73 ±4.76 and 11.19±7.91 respectively. there was no statistically significant differences (P=0.197) between acupuncture group and superficial acupuncture group; There were statistically significant differences (P=0.001,0.030) comparing acupuncture group and superficial acupuncture group and sham needle group.At the eighth weeks point, the score of three groups were3.29±4.33, 5.96±4.04, and 9.84±7.78 respectively. No difference was found between acupuncture group and superficial acupuncture group; Difference was statistically significant between acupuncture group and sham needle group (P=0.000), also between superficial acupuncture group and sham needle group (P=0.010).The first month after treatment, scores were 3.51±4.25,5.77±4.07 and 9.25±6.82. No difference was found comparing acupuncture group and sham needle group (P=0.095), there was statistically significant differences (P=0.000);Difference was also significant between superficial acupuncture group and sham needle group (P=0.013)The third month after treatment, scores of three groups were 3.90±4.05, 5.82±4.12 and 9.23±6.82, Comparing acupuncture group and superficial acupuncture group, no statistical difference was found (P=0.153); Comparing acupuncture group and sham needle group, there was statistically significant differences (P=0.000), also the same between superficial acupuncture group and sham needle group (P=0.014). (4)MENQOL①Total score:Compare the MENQOL scores at each time point of the three groups with that of before treatment, Differences were statistically significant (P＜0.05).At the fourth week point, the score of three groups were58.52±12.80,61.47 ±17.41 and 65.15±16.81, respectively, there were no statistically significant differences between acupuncture group and superficial acupuncture group, acupuncture group and superficial acupuncture group, and superficial acupuncture group and sham needle group (P values were 0.476,0.120,0.382 respectively)At the eighth weeks point, the score of three groups were40.76+ 8.84,50.17±14.37and 57.85±15.08 respectively. Difference was found between acupuncture group and superficial acupuncture group (P=0.007), the same as acupuncture group and sham needle group(P=0.000)and also superficial acupuncture group and sham needle group (P=0.029)The first month after treatment, scores were 46.03±11.35,55.83±14.92, and 59.85±13.67. There was sinificant difference comparing acupuncture group with superficial acupuncture group (P=0.000); Comparing acupuncture group and sham needle group there was also statistically significant differences (P=0.000);No difference was found significantly between superficial acupuncture group and sham needle group (P=0.262).The third month after treatment, scores of three groups were47.24 ±11.71,54.53±13.72 and 60.59±13.28, Comparing acupuncture group and superficial acupuncture group, there was statistical difference (P=0.033); Comparing acupuncture group and sham needle group, there was statistically significant differences(P=0.000); No difference was found between superficial acupuncture group and sham needle group (P=0.081) (5) Serum sex hormone①FSH:The scores of three group before and after treatment were 1.35±0.48 and 1.39±0.42,1.44±0.37 and 1.33±0.46,1.57±0.40 and 1.32±0.65. All of them had no statistical difference comparing treatment before with end of treatment.At the end of treatment, the score of acupuncture group was 1.39±0.42, superficial acupuncture group was 1.33±0.46, sham needle group was 1.32± 0.65. No statistical differences were found among them (P values were 0.676,0.617,0.926).②LH:The scores of three group before and after treatment were 1.35±0.48 and 1.39±0.42,1.44±0.37 and 1.33±0.46,1.57±0.40 and 1.32±0.65. There was no statistical difference comparing score of treatment before with that of end of treatment in acupuncture group. Differences were statistically significant in superficial acupuncture group and sham needle groupAt the end of treatment, the score of acupuncture group was 24.69±23.63, superficial acupuncture group was 18.96±17.45, sham needle group was 20.37 ±18.43. No statistical differences were found among them (P values were 0.285,0.615,0.584).③E2:The scores of three group before and after treatment were 266.05±525.56 and 198.50±180.57,301.87±585.95 and 225.12±339.38,165.39±220.51 and 328.05±591.34. All of them had no statistical difference comparing treatment before with end of treatment.At the end of treatment, the score of acupuncture group was 198.50 ± 180.57, superficial acupuncture group was 225.12±339.38, sham needle group was 328.05±591.34. No statistical differences were found among them (Pvalues were 0.799、0.230、0.336)(6)Blindness of sham needleComparing VAS scores among three groups at the fourth and eighth point, there were statistical differences(Pvalues were 0.64 and 0.30)。 As to the needle type, there was also statistical difference (Pvalues were 0.19 and 0.07).(7)C-MMASSAt the twelfth and twenty-fourth times, comparing acupuncture group with sham needle group and superficial acupuncture group, there were significantly statistical difference at soreness, deep pressure, heaviness, fullness, tingling, numbness, dull pain, warmth and throbbing(P<0.05)(8)Total effective rateEffective rate was evaluated by comparing of acupuncture group with that of superficial acupuncture group and sham needle group at four time points. The rate were respectively 82.75%,53.33% and 40.74% at the fourth week treatment,86.20%,70.00% and 51.85% at the end of treatment,86.20%,66.67% and 59.26% at 1 month after treatment,79.31%,56.66% and 44.44% at 3 month after treatment. All of them had statistical differences (P<0.05).Conclusion1. Literature through the system evaluation, consider that acupuncture is curative to improve the symptoms of menopause, compared with acupoint sham acupuncture group or without any interference.2. The clinical trials showed that in acupuncture group, average 24 hours hot flashes integral, MRS scale, three dimension score, MENQOL scale score and four dimensions of patients of menopausal transition were reduced, effectively improved patients menopause symptoms and quality of life of patients; in serum sex hormones aspect, acupoint acupuncture group is similar with the control group.3. This clinical trial design has good blind deceiving effect with the comfort blind method. |
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