Objective:The aim of this trial is to evaluate efficacy and safety of acupuncture in the treatment of hot flashes in perimenopausal women.Methods:The study was a single-site,pragmatic,randomized control trial.A total of 72 perimenopausal patients with hot flashes were randomly divided into treatment group and control group with the ratio 1:1.The treatment group received acupuncture,applying the following points:Baihui（GV20）,Shenting（GV24）,Yintang（GV29）,Qihai（CV6）,Zhongwan（CV12）,Guanyuan（CV4）,Yinxi（HT6）,Taixi（KI3）,Fuliu（KI7）,Sanyinjiao（SP6）.Every treatment session lasted 30 minutes,twice per week for six weeks.The control group was given only health education during the observation period and the one-month follow-up,but were offered the same six-week treatment program after the observation period had been completed.The changes in frequency and severity of hot flashes,and Menopause-Specific Quality of Life questionnaire（MenQoL）were observed and recorded at baseline,week three,week six and after follow-up period.Moreover,any adverse event was recorded and paid sustained attention until it had been resolved properly.Results:At the end of treatment,a total of 66 patients had finished the last assessment,dropout rate was 8.3%,and the number of patients that at the start were randomly assigned the groups（72 women）were included to ITT analysis.At baseline there was no statistically significant difference between the groups in age,income,educational level,or other general information,the degree and frequency of hot flashes,or the MenQoL total scores;or separately vasomotor,psychosocial,physical or sexual scores（P＞0.05）.Primary outcome:Concerning frequency of hot flashes,there was no significant difference between the two groups at week three（P＞0.05）,but compared to the waitlist group,the acupuncture group had a significantly reduced frequency in hot flashes at week six and 10（both P＜0.05）.Compared to baseline,the acupuncture group showed an obvious descending trend in the frequency of hot flashes already at week three（P＜0.05）,and with a continued significant difference both at week six and 10（both P＜0.05）.However,the waitlist group had no statistical difference in the hot flash frequency at week three,six or 10 compared to baseline（all P＞0.05）.Concerning severity of hot flashes,there was no significant difference between the two groups at week 3（P＞0.05）,but compared to the waitlist group,there was a reduction for the acupuncture group at week six and 10（both P＜0.05）.Compared to baseline,the acupuncture group showed an obvious descending trend in the severity of hot flashes at week three（P＜0.05）,with sustained significant reduction in severity at week six and week 10（both P＜0.05）.However,in the waitlist group there was no statistical difference in severity at week three,six or 10 compared to baseline（all P＞0.05）.Secondary outcomes:Men-QoL total score:Compared to waitlist group,the acupuncture group showed significant improvement at week six（P＜0.05）.Compared to baseline,there was also significant statistical difference for the acupuncture group at week six and week 10（both P＜0.05）.Men-QoL vasomotor score:Compared to waitlist group,there was significant improvement in the acupuncture group at week six（P＜0.05）.Compared to baseline,there was significant statistical difference at week six and 10（both P＜0.05）,but there was no statistical difference in the waitlist group at the same time point（all P＞0.05）.Men-QoL psychosocial score:Compared to the waitlist group,the acupuncture group showed significant improvement at week six and 10（both P＜0.05）.Also compared to baseline,the acupuncture group showed significant improvement at week six and week 10（both P＜0.05）.However,there was no statistical difference in the waitlist group at neither week six nor week 10 compared to baseline（all P＞0.05）.Men-QoL physical score:Compared to the waitlist group,the acupuncture group showed significant statistical progress at week six and week 10（both P＜0.05）.Compared to baseline,there was significant statistical difference in acupuncture group at week six and week 10（both P＜0.05）.However,there was no statistical difference in waitlist group at neither week six nor week 10（all P＞0.05）.Men-QoL sexual score:There was no statistical difference between the two groups,or between the baseline and other time points（all P＞0.05）.Conclusion:1."Regulating and Unblocking Conception and Governing Meridians"acupuncture therapy can effectively reduce the frequency and severity of hot flashes in perimenopausal women.2."Regulating and Unblocking Conception and Governing Meridians" acupuncture therapy can improve the quality of life of perimenopausal women,considering the significant decline in their Men-QoL total scores,as well as in psychosocial,physical and vasomotor scores individually.3."Regulating and Unblocking Conception and Governing Meridians" acupuncture therapy has no evident advantage in sexual function score among perimenopausal women.4."Regulating and Unblocking Conception and Governing Meridians" acupuncture therapy is a safe treatment method with almost no adverse events occurring.