| Objective:To evaluate clinical efficacy of electroacupuncture in the treatment of perimenopausal syndrome in comparison with the placebo acupuncture.Methods:This topic according to STRAW-10 "standard of the perimenopausal period", selected 60 cases of perimenopausal patients as the research objects. All patients were from outpatient department of Traditional Chinese Medicine of Guangdong Province and randomly divided into electroacupuncture group and sham acupuncture group according to the proportion of 1:1.Both groups select acupoints named Tianshu, Guan Yuan, uterus and Sanyinjiao. All these acupoints are located according to PRC National Standard in 2006 (GB/T 12346-2006) (Names and Locations of Acupoints) and fixed with foam pad while patients were undergoing needle stimulation.Electroacupuncture group:Needles of 75 mm were used at Tianshu, needles of 50 mm were used at uterus and Guanyuan and reach the parietal peritoneum. Needles of 40mm were used at Sanyinjiao and insert into 25 mm. Utilizing twiring, lifting and thrusting techniques until patients feel acupoints local soreness. Then needles handle of bilateral uterine and Tianshu acupoints were connected to electric acupuncture apparatus respectively and transversely. Dilatational wave, frequency of 10/50Hz and current of 0.5-1.0 mA were chosen as electroacupuncture parameters while patients feel comfortable.Sham acupuncture group:Blunt Needles of 40 mm were used at all acupoints. It is need that blunt needles just reach the skin without perforation and any acupuncture manipulation. Then needles handle of bilateral uterine and Tianshu acupoints were connected to electric acupuncture apparatus respectively and transversely. Dilatational wave, frequency of OHz and current of 0 mA were chosen as electroacupuncture parameters.Both groups recerved treatment three times a week for eight weeks with interval of each treatment at least 24 hours. At the time points of before treatment, treatment week four, treatment week eight, one month after treatment and three months after treatment, hot flashes record, menopause symptoms rating scale (MRS) and perimenopausal quality of life, scale (MENQOL) were adopted for evaluation of effectiveness. Side effects were recorded during the study.The data were analyzed by SPSS18.0 software package. The measurement data chose paired t-test when making comparison within group and two independent samples t-test or t’-test according to homogeneity of variance when making comparison between groups. And Chi square test helped to analyze enumeration data while rank sum test for ranked data. All statistical tests were two-sided as the inspection level is 3=0.05.Results1.60 cases were brought into the study including two shedding cases in ham acupuncture group. The shedding rate is 3.33%.2. Comparison of baseline:There were no significant differences in age, weight, course of disease, hot lashes score, MRS score, MENQOL score, education level, occupation, staging of menopause and therapy process between two groups before treatment suggesting that the baseline levels of two groups is comparable(P>0.05).3.Hot flashes score3.1 Changes of hot flashes scoreHot flashes score of electroacupuncture before treatment,treatment week four, treatment week eight, one month after treatment and three months after treatment were (12.27±9.51), (6.22±5.01), (3.74±4.65), (4.04±4.89), (4.42 ± 4.72), while sham group were (13.70±9.90), (11.04±7.86), (9.56±7.84), (9.03±6.86), (9.07±6.79)3.2 Comparison within groupElectroacupuncture group:The differences were statistically significant as hot flashes score of treatment week four, treatment week eight,one month after treatment and three months after treatment comparied to before treatment (P=0.000,0.000,0.000,0.000).It is suggesting that electro-acupuncture can reduce the frequency and severity of hot flashes.Sham acupuncture group:After fourth weeks of treatment, treatment for eighth weeks,1 months after the end of treatment,3 months after the end of treatment compared with before treatment, the differences were statistically significant as hot flashes score of treatment week four, treatment week eight, one month after treatment and three months after treatment comparied to before treatment (P=000,0.000,0.000,0.000). It is also suggesting that sham acupuncture can reduce the frequency and severity of hot flashes.3.3 Comparison between groupsThere were statistically significant of differences between two groups at time points treatment week four, treatment week eight,1 month after the end of treatment,3 months after the end of treatment compared to before treatment (P=0.008,0.000,0.000,0.000). It is suggesting that electroacupuncture is better than sham acupuncture in reducing the frequency and severity of hot flashes.4. MRS score4.1 Changes of MRS scoreMRS score of electroacupuncture before treatment, treatment week four, treatment week eight, one month after treatment and three months after treatment were(26.93±8.63), (15.00±5.48), (8.30±3.76), (9.33±3.54), (9.03 ±3.44), while sham group were(25.00±8.58), (17.68±7.42), (13.11±6.71)、 (14.04±6.57), (13.75±6.58).4.2 Comparison within groupElectroacupuncture group:The differences were statistically significant as MRS score of treatment week four, treatment week eight, one month after treatment and three months after treatment comparied to before treatment (P=000,0.000,0.000,0.000). It is suggesting that electro-acupuncture can relieve clinical symptoms of menopausal syndrome. Sham acupuncture group:The differences were statistically significant as MRS score of treatment week four, treatment week eight, one month after treatment and three months after treatment comparied to before treatment (P=0.000,0.000,0.000,0.000). It is suggesting that sham acupuncture can also relieve clinical symptoms of menopausal syndrome.4.3 Comparison between groupsThere was on statistically significant of differences of MRS score between two groups at time points treatment week four compared to before treatment which suggesting therapeutic effect of electroacupuncture is equal to sham acupuncture(P=0.127). While there were statistically significant of differences at time points treatment week eight,1 month after the end of treatment,3 months after the end of treatment compared to before treatment (P=0.002,0.002,0.002). It is suggesting that electroacupuncture is better than sham acupuncture in relieving clinical symptoms of menopausal syndrome as course of treatment extend.5.MENQOL score5.1 Changes of MENQOL scoreMENQOL score of electroacupuncture before treatment, treatment week four,treatment week eight,one month after treatment and three months after treatment were (85.07±15.19), (57.90±13.38), (40.83±10.03), (45.90± 11.65), (63.44±47.17), while sham group were (84.37±20.22), (65.64±16.98), (57.79±14.81), (60.11±13.68), (60.11±13.36).5.2 Comparison within groupElectroacupuncture group:The differences were statistically significant as MENQOL score of treatment week four, treatment week eight, one month after treatment and three months after treatment comparied to before treatment(P=0.000,0.000,0.000,0.000).It is suggesting that electro-acupuncture can improve the quality of life of perimenopausal patients.Sham acupuncture group:The differences were statistically significant as MENQOL score of treatment week four, treatment week eight,one month after treatment and three months after treatment comparied to before treatment(P=0.000,0.000,0.000,0.000). It is also suggesting that sham acupuncture can improve the quality of life of perimenopausal patients.5.3 Comparison between groupsThere was on statistically significant of differences of MENQOL score between two groups at time points treatment week four compared to before treatment which suggesting therapeutic effect of electroacupuncture is equal to sham acupuncture(P=0.058). While there were statistically significant of differences at time points treatment week eight,1 month after the end of treatment,3 months after the end of treatment compared to before treatment (P=000,0.000,0.000). It is suggesting that electroacupuncture is better than sham acupuncture in improving the quality of life of perimenopausal patients as course of treatment extend.6. Evaluation of curative effect6.1 Evaluation of curative effect of MRSAt time point of treatment week four, significant efficiency and efficiency of electroacupuncture group(36.67%,60%)were higher than those in sham group(7.10%,57.1%). At treatment week eighth, the cure rate and significant efficiency of electroacupuncture group(36.67%,60%)were higher than those in sham group(7.10%,42.9%). At 1 months after the end of treatment, cure rate and significant efficiency of electroacupuncture group(26.67%,53.33%)were higher than those sham group(3.60%,42.9%) and significant efficiency of the electroacupuncture group(53.33%)was higher than sham group(9.60%). Cure rate and significant efficiency of electroacupuncture group(30%,60%)were higher than those in sham group(7.1%,39.3%) at 3 months after the end of treatment. All showed there were significant difference between two groups by using MRS (P=0.048,0.001,0.000,0.000).Above all, the short-term curative effect and treatment of effect persistent of electroacupunture were better than sham acupuncture group in relieving clinical symptoms of menopausal syndrome.6.2 Evaluation of curative effect of MENQOL At time point of treatment week four, significant efficiency and efficiency of electroacupuncture group(3.33%,80%)were higher than those in sham group(0%,25%). At treatment week eighth, significant efficiency of electroacupuncture group(60%) was higher than that of sham group(3.60%) and effective rate (40%) was lower than that of sham group (60.7%). At 1 months after the end of treatment, the significant efficiency(33.33%) of the electro-acupuncture was higher than sham group(0%) while the efficiency of electro-acupuncture group(66.67%) was slightly lower than sham group(71.4%). The significant efficiency and of efficiency of electroacupuncture group (26.67%,73.33%) is higher than sham group(0%,53.6%) at 3 months after the end of treatment.To sum up, at time point of treatment week four and 3 months after the end of treatment the differences were not statistically significant (P= 0.000,0.001). But it showed statistically significant at time point of treatment week eight and 1 months after the end of treatment (P= 0.066,0.703).So the efficacy of electroacupuncture in improving the quality of life of patients with menopausal syndrome is better than sham acupuncture at treatment week four and 3 months after treatment. But it is equal to sham acupuncture at treatment week eight and lmonths after treatment.7. No side effects occur during process.Conclusion:Both electroacupuncture and sham acupuncture can relieve clinical symptoms of menopausal syndrome and improve the quality of life of patients with menopausal syndrome. But the efficacy of electroacupuncture is better than sham acupuncture. |
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