Abstract
BackgroundHot flashes are the most frequent symptoms of the menopause, with 10–20% of all postmenopausal women reporting nearly intolerable occurrences. Although pharmacopuncture with hominis placenta extract is one of the new acupuncture therapies popular in East Asian medicine with a known efficacy in treating facial flushing, there has been little research on the efficacy and safety of this extract. This study, therefore, aims to evaluate the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) compared to injections of normal saline, in perimenopausal and postmenopausal women in Korea.Methods/designThis study is a randomized placebo-controlled single-blind multi-center parallel-design trial. In total, 128 perimenopausal or postmenopausal women who meet the inclusion criteria will be recruited. The treatment group will receive PLC pharmacopuncture twice a week, for a total of 18 sessions over 9 weeks. The control group will receive injections of normal saline at the same acupoints during the same period. The post-treatment follow-up assessment will occur 4 weeks after the participant has completed the treatment.DiscussionWe believe that this trial will provide evidence for the efficacy and safety of PLC pharmacopuncture as a treatment for hot flashes in perimenopausal and postmenopausal women.Trial registrationClinical Research Information Service (CRIS), Republic of Korea, ID: KCT0003533, Registered on 20 February 2019.
Highlights
Hot flashes are the most frequent symptoms of the menopause, with 10–20% of all postmenopausal women reporting nearly intolerable occurrences
We believe that this trial will provide evidence for the efficacy and safety of placenta extract (PLC) pharmacopuncture as a treatment for hot flashes in perimenopausal and postmenopausal women
Hot flashes affect their quality of life, and are usually the most common symptom, as they are experienced by 75% of women [1]
Summary
Hot flashes are the most frequent symptoms of the menopause, with 10–20% of all postmenopausal women reporting nearly intolerable occurrences. This study, aims to evaluate the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) compared to injections of normal saline, in perimenopausal and postmenopausal women in Korea. Women live more than a third of their lives in the perimenopausal or postmenopausal stage. Hot flashes affect their quality of life, and are usually the most common symptom, as they are experienced by 75% of women [1]. Hormone replacement therapy is the most effective and popular treatment for hot flashes [4, 5], it is not administered to many women due to its adverse side effects and potential risks [6]. Serotonin reuptake inhibitors are effective for hot flashes but are ineffective
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