Dysmenorrhea
Conditions
Keywords
dysmenorrhea, acupuncture, randomized controlled trial
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.
Interventions
PROCEDUREacupuncture
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
PROCEDUREusual care
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale of pain | every 2 months |
Secondary
| Measure | Time frame |
|---|---|
| amount of additional medication | every 2 months |
| degree of restriction of daily life activities | every 2 months |
| degree of absence from work or school | every 2 months |
| score of questionnaire of quality of life (SF-36) | every 2 months |
| safety evaluation (adverse events) | every week |
| score of questionnaire of dysmenorrhea-related symptoms | every 2 months |
| overall improvement in dysmenorrhea | end of acupuncture treatment |
Countries
Taiwan
Outcome results
None listed