Abstract
BackgroundDysmenorrhea is a common menstrual complaint among adolescent girls and women of reproductive age. The treatment of dysmenorrhea is typically selected from multidisciplinary options, including complementary and alternative medicine such as acupuncture and moxibustion. However, there are few published randomized controlled trials concerning moxibustion treatment for dysmenorrhea. This trial aims to investigate the efficacy and safety of moxibustion for primary dysmenorrhea, and to identify the optimal time of moxibustion treatment for primary dysmenorrhea.Methods/DesignThis protocol is for a randomized controlled trial in which the assessor and statistician will be blinded. A total of 222 eligible patients with dysmenorrhea will be randomly assigned to three groups in a 1:1:1 ratio as treatment group A (treated before menstruation onset), treatment group B (treated at the onset of menstruation), or control group C (waiting list group). The participants assigned to the treatment groups will receive suspended moxibustion treatment at Sanyinjiao (SP6) and Guanyuan (CV4), while the waiting list group will not receive moxibustion treatment until the completion of the study. The trial period will consist of three baseline menstrual cycles, three menstrual cycles of treatment, and three menstrual cycles in the follow-up period. The primary outcome will be measured by changes in the Cox Menstrual Symptom Scale and the secondary outcomes will be measured using the Visual Analogue Scale, Cox Retrospective Symptom Scale, diary entries, the Self-rating Depression Scale, and the Self-rating Anxiety Scale. The safety of moxibustion will be assessed at every visit.DiscussionThis trial aims to assess the effectiveness and safety of moxibustion for primary dysmenorrhea, as well as to determine whether the optimal time of treatment for primary dysmenorrhea in clinical practice is before or after the onset of menstrual pain.Trial registrationChinese Clinical Trial Register: ChiCTR-TRC-14004627, registered on 9 May 2014.
Highlights
Dysmenorrhea is a common menstrual complaint among adolescent girls and women of reproductive age
The form of moxibustion used in this trial will be suspended moxibustion treatment
When suspended moxibustion is applied to acupoints, the patient will have non-local or non-superficial heat sensation, such as penetrating heat, expanding heat, and transmitting heat, as DeQi appears
Summary
This proposed trial is a randomized, controlled clinical trial with separation of the practitioner, assessor, and statistician. One limitation of this study is the possibility of a high risk of bias regarding blinding, as the waiting list group will be used as a control instead of a group receiving a sham procedure Another limitation is that as moxibustion treatment will begin five to seven days before menstruation or at the onset of pain, the treatment may interfere with the menstrual period; treatment may cause menstruation to occur one or two days sooner or later than the usual cycle. It will be of great significance for clinical practice to identify an optimal moxibustion treatment time for PD.
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