Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea:A Randomized Controlled Pilot Trial

Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236).