Abstract
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).
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Acknowledgement
We extend our sincere thanks to acupuncturists and gynecologists from Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, and the participation of Sichuan University Infirmary.
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Ling YK and Tu HY contributed to trial design and supervised the whole process. Wang Y majorly participated in enrollment. Zhang HR and Yang T participated in clinical treatment. Zhang HR wrote the manuscript. Ling YK and Tu HY revised the manuscript. Zhao GY and Xia SL contributed to data analysis. All the authors have read, revised and approved the final manuscript for publication.
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The authors declare that they have no competing interests.
Supported by Traditional Chinese Medicine Administration of Sichuan Province (No. 2018KF013), Health Commission of Sichuan Province (No. 2000IF10) and Self-determined Project of Sichuan University (No. 2016CDDY-S19-SCU)
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Zhang, Hr., Tu, Hy., Wang, Y. et al. Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea: A Randomized Controlled Pilot Trial. Chin. J. Integr. Med. 27, 578–584 (2021). https://doi.org/10.1007/s11655-021-3287-8
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DOI: https://doi.org/10.1007/s11655-021-3287-8