Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial

Abstract

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.

Trial registration: ClinialTrials.gov NCT01972906.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Study flow chart.

This study is a randomized, drug-controlled, open-labeled clinical trial. 152 eligible patients were randomly assigned to either the moxibustion group or the drug-control group. After treatment for 3 months, menstrual pain intensity measured by VAS and menstrual intensity were assessed to evaluate the effectiveness of moxibustion for pain relief as compared with painkillers. Menstrual pain-associated serum markers/chemical compounds were tested as another secondary outcome. The follow-up lasted for 3 months after treatment.

Fig 2. Timeline of treatment and follow-up.

For both groups, the treatment course lasted for three months (M1-M3). After the completion of treatment, there’s a three-month follow-up period (M4-M6).

Fig 3. Pain intensity change at different time point.

By employing a 3-month moxibustion treatment, menstrual pain intensity and its related symptoms were significantly improved. In the treatment course (the 1st and 2nd month), drug overweighed moxibustion treatment in terms of controlling pain severity, but at the end of the 3-month treatment, the improvement in moxibustion group was not significantly different to the drug control group. Moreover, the effect of moxibustion sustained to 3 months after treatment.