Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial.
BACKGROUND
Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty.


METHODS
This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary.


RESULTS
152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (P<0.01). Three months after treatment, the effectiveness of moxibustion sustained and started to be superior to the drug's effect (-0.87, 95%CI -1.32 to -0.42, P<0.01). Secondary outcome analyses showed that moxibustion was as effective as drugs in alleviating menstrual pain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (P<0.05). No adverse events were reported in this trial.


CONCLUSIONS
Both moxibustion and conventional drug showed desirable merits in managing menstrual pain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians.


BACKGROUND
ClinialTrials.gov NCT01972906.
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Mingxiao
M
Yang
Pixian Hospital of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Xiangzhu
X
Chen
Rentong Clinics of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Linna
L
Bo
School of Chinese Medicine, The University of Hong Kong, Hong Kong.
Lixing
L
Lao
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Jiao
J
Chen
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Siyi
S
Yu
Pixian Hospital of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Zheng
Z
Yu
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Hongzhi
H
Tang
Medical Center and Hospital of Qionglai, Chengdu, Sichuan, China.
Ling
L
Yi
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Xi
X
Wu
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Jie
J
Yang
School of Acupuncture and moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Fanrong
F
Liang
D000328:Adult; D015415:Biomarkers; D004412:Dysmenorrhea / Q000097:blood / Q000150:complications*; D005260:Female; D006801:Humans; D009071:Moxibustion / Q000379:methods; D010146:Pain / Q000175:diagnosis / Q000209:etiology*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
D015415:Biomarkers