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To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial.

Trials·July 2019·Su-Ji Choi, Dong-Il Kim
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Key Finding

A randomized placebo-controlled trial was designed to evaluate whether PLC pharmacopuncture (hominis placenta extract injected at acupoints) is effective and safe for reducing hot flashes in perimenopausal and postmenopausal women, with results pending from 128 enrolled participants across 18 treatment sessions.

What This Means For You

Hot flashes are one of the most disruptive symptoms of menopause, affecting up to 20% of postmenopausal women so severely that they describe them as nearly unbearable. Researchers in Korea are exploring a promising acupuncture-based treatment that may offer relief without the side effects sometimes associated with hormone therapy.

The treatment being studied is called pharmacopuncture — a technique that combines traditional acupuncture with the injection of a therapeutic substance directly into acupuncture points. In this case, the substance is hominis placenta extract (PLC), a preparation derived from human placenta that has been used in East Asian medicine and has shown early promise in reducing facial flushing.

This clinical trial enrolled 128 perimenopausal and postmenopausal women in Korea. Participants were randomly assigned to receive either PLC pharmacopuncture or saline (saltwater) injections at the same acupuncture points — twice a week for nine weeks, totaling 18 sessions. Researchers then followed up with participants four weeks after treatment ended to assess lasting effects. Because neither the researchers administering assessments nor the participants knew which group received the active treatment, the study was designed to produce reliable, unbiased results.

While this article describes the study's design and protocol rather than its final results, the trial was carefully structured to build trustworthy evidence about whether PLC pharmacopuncture is both effective and safe for managing hot flashes. If results are positive, this could offer women a non-hormonal, acupuncture-based option for one of menopause's most challenging symptoms.

This research reflects a growing effort to validate traditional East Asian therapies through modern clinical standards — good news for patients interested in integrative approaches to menopausal care.

If you are considering acupuncture or pharmacopuncture for menopausal symptoms, consult a licensed and experienced acupuncture practitioner who can guide you safely.

Clinical Notes for Practitioners

This paper presents the protocol for a randomized, placebo-controlled, single-blind, multi-center parallel-design trial evaluating the efficacy and safety of pharmacopuncture with hominis placenta extract (PLC) for hot flashes in perimenopausal and postmenopausal women. A total of 128 participants are recruited and randomized to receive either PLC pharmacopuncture or normal saline injections at identical acupoints, administered twice weekly over 9 weeks (18 total sessions), with a 4-week post-treatment follow-up assessment. The control arm uses saline injection at the same points, providing a credible sham comparator. No efficacy or safety outcome data are reported, as this is a protocol publication. Primary endpoints and outcome measures are not explicitly detailed in the abstract. The clinical relevance lies in the structured effort to generate Level II evidence for a pharmacopuncture modality increasingly utilized in East Asian clinical practice for vasomotor symptoms. Practitioners should monitor publication of results from KCT0003533 for actionable clinical guidance.

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