Moxibustion for Primary Dysmenorrhea

Traditional Chinese Moxibustion for Primary Dysmenorrhea

Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized controlled trial. 152 participants will be included. Two arms: moxibustion treatment group and ibuprofen control group.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Device: moxibustion; Drug: Ibuprofen Sustained Release Capsules

Detailed Description

There is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due to low methodologic quality and small sample size. The investigators designed the random clinical trial to investigates the effectiveness of moxibustion in treating primary dysmenorrhea, the purpose of this study is to provide the research base of moxibustion efficacy. The investigators also examined the acceptability and any adverse effects associated with the use of moxibustion.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Affiliated Hospital of Chengdu University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Clinical diagnosis of Guidelines of Primary dysmenorrhea clinical by the Society of Obstetricians and Gynaecologists of Canada
• Menstrual cycle is regular (28±7) days
• Syndrome differentiation of Traditional Chinese Medicine: Congealing cold-damp and Qi-stagnation and blood stasis
• Mean value of ≥40mm during last 3 months
• Informed consent form must be signed by patient or lineal relative

Exclusion Criteria:

• Patients with secondary dysmenorrhea, which is caused by endometriosis, pelvic inflammation, myoma of uterus and so on
• Patients who are unconscious and psychotic
• Patients with serious primary illness or diseases of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on
• Patients take prostaglandin synthetase inhibitors (PGSI) 2 weeks before inclusion
• Pregnant women or women in lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxibustion treatment group; Apply traditional acupuncture to prevent the dysmenorrhea according to traditional Chinese medicine theory	Device: moxibustion; apply moxibustion according to traditional Chinese medicine
Active Comparator: Medicine control group; Ibuprofen Sustained Release Capsules will be penetrated for dysmenorrhea	Drug: Ibuprofen Sustained Release Capsules; apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle; Other Names: Fenbid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in menstrual pain intensity measured by VAS at 6 months	to assess the degree of dysmenorrhea	at baseline, 1st, 2nd, 3rd, 4th, 5th, 6th menstrual cycle after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory index-1	prostaglandin (PGF2a、PGE2)	at baseline, 4th menstrual cycle after inclusion
Cox Menstrual Symptom Scale Cox Menstrual Symptom Scale	to assess the change of symptom during menstrual cycle	1st, 2nd, 3rd, 4th, 5th, 6th, 7th menstrual cycle after inclusion
Laboratory Index-2	oxytocin	at baseline, 4 menstrual cycles after inclusion
Laboratory Index-3	β-endorphin	at baseline, 4 menstrual cycles after inclusion
Laboratory Index-4	plasma endothelin-1	at baseline, 4 menstrual cycles after inclucion
Laboratory Index-5	nitric oxide	at baseline, 4 menstrual cycles after inclusion
Laboratory Index-6	Plasma vascular pseudohemophilia factors	at baseline, 4 menstrual cycles after inclusion

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Yang M, Chen X, Bo L, Lao L, Chen J, Yu S, Yu Z, Tang H, Yi L, Wu X, Yang J, Liang F. Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial. PLoS One. 2017 Feb 7;12(2):e0170952. doi: 10.1371/journal.pone.0170952. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: primary dysmenorrhea; moxibustion
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 2011SZ0302