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Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women - a multicenter randomized clinical trial.

TrialsยทDecember 2008ยทKun-Hyung Kim, Kyung-Won Kang, Hee-Jung Jung et al.
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Key Finding

This protocol aims to evaluate whether Traditional Korean Acupuncture combined with usual care is more effective than usual care alone in reducing hot flush scores in perimenopausal and postmenopausal women over 4-8 weeks.

What This Means For You

This study examines whether traditional Korean acupuncture can help reduce hot flushes in women going through or past menopause. Hot flushes are the most common symptom during menopause and can significantly impact quality of life, affecting sleep, work, and daily activities. While hormone replacement therapy (HRT) is considered the most effective conventional treatment, many women seek alternatives due to concerns about side effects associated with HRT.

Researchers in Korea designed a multi-center trial comparing two groups of menopausal women experiencing significant hot flushes. One group received their usual care plus acupuncture treatments three times weekly for four weeks (12 total sessions), while the control group continued with usual care alone. Participants were followed for an additional month after treatment ended. To qualify for the study, women needed to have a hot flush score of at least 10 per day and could not be taking HRT or other medications affecting hot flushes.

The study measured changes in hot flush scores and used the Menopause Rating Scale to assess quality of life. Researchers also examined whether acupuncture affected daytime versus nighttime hot flushes differently and considered participants' expectations about treatment.

As this is a study protocol, final results are not yet available. However, the research aims to provide evidence on whether acupuncture is an effective alternative for managing menopausal hot flushes. If proven effective, acupuncture could offer women a treatment option with fewer side effects than conventional hormone therapy. Women interested in acupuncture for menopausal symptoms should seek treatment from a licensed, qualified acupuncture practitioner.

Clinical Notes for Practitioners

This multi-center randomized controlled trial protocol evaluates Traditional Korean Acupuncture (TKA) plus usual care versus usual care alone for perimenopausal and postmenopausal hot flushes. Inclusion criteria require documented daily average hot flush score โ‰ฅ10 for one week prior to screening, with exclusion of patients on HRT or other pharmaceutical interventions affecting vasomotor symptoms. The intervention group receives acupuncture three times weekly for four weeks (12 sessions total), with one-month post-treatment follow-up. Primary outcome measures change in hot flush score from baseline to weeks 4 and 8. Secondary outcomes include Menopause Rating Scale (MRS) scores, frequency and severity analysis of daytime versus nighttime hot flushes, MRS sub-domain analysis, and patient expectation effects. Sample size and effect size data are not provided in this protocol publication. The trial (ISRCTN49335612) aims to establish evidence-based efficacy of acupuncture as an alternative to HRT for climacteric vasomotor symptoms with minimal adverse effects.

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