Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trialReportar como inadecuado




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Trials

, 9:70

First Online: 03 December 2008Received: 08 October 2008Accepted: 03 December 2008DOI: 10.1186-1745-6215-9-70

Cite this article as: Kim, KH., Kang, KW., Jung, HJ. et al. Trials 2008 9: 70. doi:10.1186-1745-6215-9-70

Abstract

BackgroundHot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women-s lives. To date, conventional hormone replacement therapy HRT is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical CAM approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea.

We aim to evaluate the effectiveness of Traditional Korean Acupuncture TKA in conjunction with usual care, compared to usual care alone, on hot flushes in perimenopausal and postmenopausal women in Korea.

MethodsThis study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1 a documented daily average hot flush score ≥ 10 for one week prior to the screening visit 2 not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms.

While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture.

DiscussionThis trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and-or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale MRS, a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants- expectations of acupuncture treatment.

Trial registrationCurrent Controlled Trials ISRCTN49335612

AbbreviationsHRTHormone Replacement Therapy

CAMComplementary and Alternative Medicine

TKATraditional Korean Acupuncture

MRSMenopause Rating Scale

NIHNational Institutes of Health

RCTRandomized Controlled Trial

TSHThyroid Stimulating Hormone

FSHFollicle Stimulating Hormone

SSRISelective Serotonin Reuptake Inhibitor

OTCOver The Counter

TKMTraditional Korean Medicine

SMSShort Message Service

CRFCase Report Form.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-9-70 contains supplementary material, which is available to authorized users.

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Autor: Kun-Hyung Kim - Kyung-Won Kang - Hee-Jung Jung - Ji-Eun Park - So-Young Jung - Jun-Yong Choi - Sun-Mi Choi

Fuente: https://link.springer.com/







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