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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
| |
| Usual Care | Active Comparator | usual care followed by delayed acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale of pain | every 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| score of questionnaire of quality of life (SF-36) | every 2 months | |
| amount of additional medication | every 2 months | |
| degree of restriction of daily life activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Hsun Huang, MD, MSc | National Taiwan University Hospital, Yun-Lin Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Yun-Lin Branch | Douliu | 640 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18226614 | Background | 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. |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| usual care | Procedure | usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months |
|
|
| every 2 months |
| degree of absence from work or school | every 2 months |
| overall improvement in dysmenorrhea | end of acupuncture treatment |
| safety evaluation (adverse events) | every week |
| score of questionnaire of dysmenorrhea-related symptoms | every 2 months |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |