Randomized Controlled Trial of Acupuncture for Dysmenorrhea

National Taiwan University

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Procedure: usual care; Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01116453

201002022R

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: Female

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Acupuncture

Experimental group

Treatment:

Procedure: acupuncture

Usual Care

Active Comparator group

Description:

usual care followed by delayed acupuncture

Treatment:

Procedure: usual care