Clinical trial NCT01116453: Randomized Controlled Trial of Acupuncture for Dysmenorrhea
Official title: Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Keywords: dysmenorrhea
acupuncture
randomized controlled trial
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale of pain
timeFrame: every 2 months
Secondary outcomes:
measure: score of questionnaire of quality of life (SF-36)
timeFrame: every 2 months
measure: amount of additional medication
timeFrame: every 2 months
measure: degree of restriction of daily life activities
timeFrame: every 2 months
measure: degree of absence from work or school
timeFrame: every 2 months
measure: overall improvement in dysmenorrhea
timeFrame: end of acupuncture treatment
measure: safety evaluation (adverse events)
timeFrame: every week
measure: score of questionnaire of dysmenorrhea-related symptoms
timeFrame: every 2 months
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Chien-Hsun Huang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.