Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116453
• Other study ID #: 201002022R
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2010
• Last updated: March 5, 2013
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Procedure:
• acupuncture
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
• usual care
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yun-Lin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008 Feb;198(2):166.e1-8. doi: 10.1016/j.ajog.2007.07.041. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale of pain		every 2 months	No
Secondary	score of questionnaire of quality of life (SF-36)		every 2 months	No
Secondary	amount of additional medication		every 2 months	No
Secondary	degree of restriction of daily life activities		every 2 months	No
Secondary	degree of absence from work or school		every 2 months	No
Secondary	overall improvement in dysmenorrhea		end of acupuncture treatment	No
Secondary	safety evaluation (adverse events)		every week	Yes
Secondary	score of questionnaire of dysmenorrhea-related symptoms		every 2 months	No