Randomized Controlled Trial of Acupuncture for Dysmenorrhea

National Taiwan University Hospital22 enrolled

Overview

Since there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese Medicine.

There were abundant clinical experiences and medical records for dysmenorrhea in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices. The purpose of our study is to create the evidence of effect on dysmenorrhea by acupuncture. The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: pain score (Visual Analogue Scale), quality of life (SF-36, Taiwan version), overall improvement in dysmenorrhea, adverse effects from treatment, requirements for additional medication, restriction of daily life activities, absence from work or school.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dysmenorrhea

Interventions

acupuncturePROCEDURE

acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months

usual carePROCEDURE

usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Eligibility

Sex: FEMALEMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: * non-pregnant women who are at least 13 years old * the one who meet any one of the following two criteria: 1.suffering from dysmenorrhea in recent 3 menstrual periods; 2.dysmenorrhea with poor response to non-steroid anti-inflammation drugs Exclusion Criteria: * intrauterine device-related dysmenorrhea * history of alcohol or drug abuser * women who are pregnant, as determined by a urine pregnancy test * history of adverse reaction to acupuncture * received herb or acupuncture therapy within one month prior to enrollment * poor compliance to investigator's advice

Locations (1)

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan

Outcomes

Primary Outcomes

visual analogue scale of pain

Time frame: every 2 months

Secondary Outcomes

score of questionnaire of quality of life (SF-36)

Time frame: every 2 months

amount of additional medication

Time frame: every 2 months

degree of restriction of daily life activities

Time frame: every 2 months

degree of absence from work or school

Time frame: every 2 months

overall improvement in dysmenorrhea

Time frame: end of acupuncture treatment

safety evaluation (adverse events)

Time frame: every week

score of questionnaire of dysmenorrhea-related symptoms

Time frame: every 2 months

Data from ClinicalTrials.gov

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