Effectiveness Study of Moxibustion on Pain Relief in Primary Dysmenorrhea: Study Protocol of a Randomized Controlled Trial

Yang, Jie; Chen, Jiao; Lao, Lixing; Yang, Mingxiao; Chen, Jianping; Bo, Linna; Tang, Hua; Yi, Ling; Zheng, Hui; Wu, Xi; Liang, Fanrong

doi:10.1155/2014/434978

Cited by 11 publications

(9 citation statements)

References 16 publications

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“…The authors confirmed that all ongoing and related trials for this intervention were registered. Study protocol of this study was published online[ 6 ]( S2 File ).…”

Section: Methodsmentioning

confidence: 99%

“…Primary dysmenorrhea typically begins before and is relieved soon after the onset of menstruation. The incidence of primary dysmenorrhea ranges from 45% to 72% of all menstruating women; however, among adolescent girls it can be as high as 93%[ 6 ]. In Modern medicine, it is believed that the excessive production and release of endometrial prostaglandin (PG) during menstruation may significantly induce uterine hypercontractility, reduce uterine blood flow, and trigger hypersensitive pain fibers[ 7 ].…”

Section: Introductionmentioning

confidence: 99%

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

Yang

Chen²,

Bo³

et al. 2017

PLoS ONE

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BackgroundThough moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty.MethodsThis 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.Results152 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.ConclusionsBoth 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 registrationClinialTrials.gov NCT01972906

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“…The authors confirmed that all ongoing and related trials for this intervention were registered. Study protocol of this study was published online[ 6 ]( S2 File ).…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Yang

Chen²,

Bo³

et al. 2017

PLoS ONE

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“…Primary dysmenorrhea is a main gynecological disorder in the absence of significant pathological changes which prevails in adolescent girls in the first 2-3 years after menarche or in young women who have not given birth [1]. e prevalence of primary dysmenorrhea in menstruating women is ranged between 45% and 72% [2,3]. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the first recommendation to temporarily relieve pain, which are often ineffective or slow-acting [4], and at the same time adverse effects are reported such as indigestion, headache, and drowsiness, [5].…”

Section: Introductionmentioning

confidence: 99%

Effect of an Acupuncture Technique of Penetrating through Zhibian (BL54) to Shuidao (ST28) with Long Needle for Pain Relief in Patients with Primary Dysmenorrhea: A Randomized Controlled Trial

Wang

Cao

Jin

et al. 2019

Pain Research and Management

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Background. Primary dysmenorrhea (PD) is the commonest gynecological disorder in young women of reproductive age, and there is not always satisfactory relief of pain treated by common medications. Therefore, acupuncture has been used as an alternative therapy to relieve the symptoms of PD. In clinical practice, a penetrating method of acupuncture with long needle has been shown to be particularly effective for improving primary dysmenorrhea. This study was conducted to evaluate the effectiveness of this technique for pain relief in patients with primary dysmenorrhea as compared with a conventional pain medication. Methods. The present study is a perspective, randomized, ibuprofen-controlled trial. Sixty-two eligible participants were randomly assigned in a 1 : 1 ratio to receive either acupuncture treatment or ibuprofen administration. The treatment lasted for three menstrual cycles for both groups. The primary outcome was the intensity of menstrual pain measured by using the visual analogue scale at the completion of treatment. Secondary outcomes included the severity of symptoms associated with menstrual pain, responder rate, and safety of acupuncture treatment. The clinical outcomes were measured on each menstrual cycle at baseline, treatment course (3 cycles), and follow-up period. Results. Sixty-four patients of primary dysmenorrhea were recruited, and 62 subjects were included in the final analysis. At trial completion, acupuncture was shown to be associated with a significantly lower pain intensity and decreased symptom severity of primary dysmenorrhea as compared with ibuprofen (p<0.05). A significantly higher responder rate was found in the acupuncture group as compared with the control group (p<0.05). No serious adverse events were reported by patients in either group. Conclusions. The penetrating method of acupuncture with long needle may be an effective and safe therapy for pain relief in patients with primary dysmenorrhea. This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17012621).

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“…Primary dysmenorrhea (PD) is prevalent among adolescent girls and women of reproductive age [ 1 ]. The incidence of PD ranges from 45% to 72% of all menstruating women; moreover, among adolescent girls it can be as high as 93% [ 2 , 3 ]. Its symptoms vary but typically include dull, throbbing and cramping pain in the lower abdomen during menstruation [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial

Wen

Xia

et al. 2018

Trials

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BackgroundPrimary dysmenorrhea (PD), is one of main gynecological complaints in women of child-bearing age. Common medications for PD do not always achieve satisfactory outcome of pain relief. Hence, both health professionals and patients are seeking help from complementary and alternative medicine. The acupoint herbal plaster (AHP), which appears to be a safe and effective way to alleviate menstrual pain, as well as to improve other PD-related symptoms. Despite similar clinical studies for this condition in the past, no high-quality methodology-based clinical trial has been reported to date. The current study aims to assess the efficacy of the AHP compared with the acupoint placebo plaster (APP) and being placed on a waiting-list control group in patients with primary dysmenorrhea.Methods/designThis study is a randomized, single-center, placebo-controlled clinical trial. A total of 180 women with PD will be included and randomly allocated to the AHP, APP and waiting-list (WL) groups in a 1:1:1 ratio. Patients in the AHP group will be provided with herbal plasters (Shaofuzhuyu decoction) on various acupoints: Shenque (CV8), Guanyuan (CV4), Qihai (CV5), Ciliao (BL32) and Zigong (EX-CA1). Women in the APP group will receive placebo plasters on the same acupoints, and no intervention will be given to the WL group until completion of the study. The primary outcome will be pain intensity reduction measured by a Visual Analog Scale (VAS), with other outcome measurements including the Cox Menstrual Symptom Scale (CMSS), the 12-Item Short Form Health Survey (SF-12) and the Participant Global Impression of Change (PGIC). All assessments will be performed at baseline, each menstrual cycle during the treatment course and the follow-up course. Any adverse events will be recorded throughout the study.DiscussionThis is the first study to compare the changes in menstrual pain after three different interventions: the active intervention (AHP), the placebo intervention (APP), and a period of no intervention (WL). This three-arm randomized controlled trial (RCT) aims to investigate the relative contributions of the specific (AHP vs. APP) and non-specific (APP vs. WL) effects to the overall clinical effects of the active AHP on women with PDM. The scientific and rigorous methodology design of this trial should gather good evidence to assess the curative effects and safety of the AHP on PD. Moreover, the results of this study may provide evidence-based references for the treatment of menstrual pain in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-TRC-16008701. Registered on 22 July 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2682-8) contains supplementary material, which is available to authorized users.

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Effectiveness Study of Moxibustion on Pain Relief in Primary Dysmenorrhea: Study Protocol of a Randomized Controlled Trial

Cited by 11 publications

References 16 publications

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

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

Effect of an Acupuncture Technique of Penetrating through Zhibian (BL54) to Shuidao (ST28) with Long Needle for Pain Relief in Patients with Primary Dysmenorrhea: A Randomized Controlled Trial

Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial

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