Chinese Herbal Formula Restores Menstruation in Early Menopause Trial

A carefully controlled clinical trial from Guangzhou, China, has reported that a traditional Chinese herbal formula may help women with primary ovarian insufficiency recover their menstrual periods, a result that is drawing attention because the condition has long been considered largely irreversible with existing medicine. The study, published in BMC Complementary Medicine and Therapies, tested a formula known as Huyang yangkun, abbreviated HYYK, against a placebo in a randomized, double-blind design, the gold standard structure for separating a real treatment effect from expectation and chance. For a field where patients often cycle through hormone pills with limited hope of restoring ovarian activity, the findings offer a rare signal of biological change rather than mere symptom relief.

Primary ovarian insufficiency, often called POI, describes a loss of normal ovarian function before the age of forty. It affects a small but significant fraction of women of reproductive age and carries consequences far beyond missed periods. Women with POI frequently experience infertility, irregular or absent menstruation, and elevated long-term risks of osteoporosis and cardiovascular disease because their ovaries stop producing normal levels of estrogen earlier than expected. The standard medical response is hormone replacement therapy, which supplies the missing estrogen and progesterone from outside the body. HRT can relieve hot flushes, protect bone density, and mimic a monthly bleed, but it does not restart the ovaries themselves. It is essentially a substitute, not a repair, and many patients and clinicians have searched for approaches that might do more.

The trial behind the new report was conducted between September 2017 and May 2019 at the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, with ethics approval from the hospital’s committee and written informed consent from every participant. Seventy-two women with POI were enrolled and randomly assigned in a two-to-one ratio: forty-eight received the HYYK formula and twenty-four received an identical-looking placebo. Neither the participants nor the researchers assessing outcomes knew who received which treatment, a double-blind arrangement that guards against bias in reporting and measurement. The treatment period lasted twelve weeks, and the study was prospectively registered at the Chinese Clinical Trial Registry before recruitment began, a practice that helps prevent selective reporting of outcomes after the fact.

The primary question the investigators asked was simple and clinically meaningful: did women on the herbal formula resume menstruation more often than women on placebo? The answer, according to the published results, was yes. The HYYK group experienced significantly more menstrual cycles over the treatment period, with a statistical significance value of P equal to 0.027, and showed greater efficiency of menstrual resumption, with P equal to 0.006. In practical terms, women taking the herbal formula were more likely to see their periods return during the three-month course of the trial than women taking the placebo, and the difference was unlikely to be explained by random variation alone.

Perhaps the most intriguing findings concerned the ovaries themselves. Using transvaginal ultrasound, the researchers counted antral follicles, the small resting follicles visible on the ovarian surface, and dominant follicles, the larger structures that are actively growing toward potential ovulation. After just four weeks of treatment, the HYYK group had a higher number of dominant follicles, with P equal to 0.037, and a higher total follicle count, with P equal to 0.017. By twelve weeks, the antral follicle count was also significantly higher in the treatment group, with P equal to 0.004, along with total follicles at P equal to 0.011. These are measures of follicular development, the biological raw material of ovarian function, and their improvement suggests the formula may be doing something at the level of the ovary rather than simply producing withdrawal bleeds driven by external hormones.

Not every measured outcome moved in the same direction, and the researchers were candid about that. Serum levels of the key reproductive hormones, follicle-stimulating hormone, estradiol, and anti-Müllerian hormone, did not differ significantly between the two groups at the end of the trial. FSH is typically elevated in POI because the pituitary gland works harder to stimulate unresponsive ovaries, while AMH is a marker of the remaining follicle pool, so the absence of hormonal shifts tempers the interpretation of the follicle counts. It is possible that twelve weeks was too short a window for the endocrine system to recalibrate, or that the formula acts on follicle growth through local ovarian pathways that precede measurable changes in circulating hormones. The authors’ conclusion, that the formula is effective in restoring cycles and promoting follicular development, rests on the menstrual and ultrasound outcomes rather than on blood chemistry.

Symptom relief provided a third line of evidence. Participants completed the Menopause Rating Scale, a validated questionnaire covering the physical and psychological complaints that accompany estrogen loss. Scores improved in the HYYK group, with statistically significant benefits in two specific domains: hot flushes, with P equal to 0.044, and heart discomfort, with P equal to 0.037. Hot flushes are the most recognizable signature of estrogen decline and one of the main reasons women seek treatment, so a measurable reduction on a standardized scale is clinically relevant. The improvement in perceived heart discomfort, a common menopausal complaint, adds to the picture of broader symptomatic benefit, although self-reported scales always carry some subjectivity even when administered blindly.

Safety was a central concern for any trial involving an herbal preparation, since multi-ingredient formulas can carry risks of interactions, contamination, or liver toxicity that single-molecule drugs do not. In this study, no severe adverse effects were reported in either group, which the authors present as evidence that the formula was well tolerated over the twelve-week treatment period. The trial was designed and reported according to the CONSORT guidelines for Chinese herbal medicine formulas, a specialized extension of the standard randomized trial checklist that requires transparent documentation of the formula’s composition, quality control, and intervention details. That level of methodological rigor matters, because complementary medicine trials have historically been criticized for vague descriptions of what patients actually ingested.

The scientific context makes the result notable but also demands caution. Researchers worldwide have experimented with approaches intended to wake dormant follicles in POI, including in vitro activation of ovarian tissue, platelet-rich plasma injection, and mesenchymal stem cell therapies, all of which remain experimental and resource-intensive. A standardized oral herbal formula, if its effects were replicated, would represent a far more accessible option. However, this was a single-center trial with seventy-two participants, and the two-to-one randomization left a relatively small placebo group of twenty-four women. The hormonal markers did not confirm ovarian recovery, and longer follow-up will be needed to know whether resumed cycles persist, whether ovulation occurs, and whether fertility outcomes improve. The authors declare no competing interests, and the work was funded by institutional and national research grants in China, including support from Guangdong Provincial Hospital of Chinese Medicine and the National Natural Science Foundation of China.

For now, the trial stands as one of the more rigorous tests of a Chinese herbal formula in this patient population, and its combination of menstrual, ultrasound, and symptom outcomes gives clinicians concrete endpoints to examine in future studies. Larger, multi-center, placebo-controlled trials with extended follow-up and fertility endpoints would be the natural next step before any change to clinical practice. Women with primary ovarian insufficiency, a diagnosis that often arrives as a shock in a woman’s twenties or thirties, have few options that address the underlying condition rather than its consequences. The Huyang yangkun trial does not overturn that reality, but it provides credible early evidence that a carefully studied herbal intervention may nudge dormant ovarian machinery back toward activity, and it demonstrates how traditional medicine can be interrogated with the same double-blind, registered, CONSORT-compliant methods used to evaluate any modern drug.

Subject of Research: A randomized double-blind placebo-controlled trial of the Chinese herbal formula Huyang yangkun for restoring menstruation in women with primary ovarian insufficiency.

Article Title: Efficacy and safety of chinese herbal medicine for menstrual resumption in women with primary ovarian insufficiency: a randomized double-blind placebo-controlled trial

Article References: Liu, J., Wen, Z., Li, Y., Wen, M., Nie, G., Feng, D., Cheng, F., Du, Q., Huang, J., Liang, X., & Yang, H. (2026). Efficacy and safety of chinese herbal medicine for menstrual resumption in women with primary ovarian insufficiency: a randomized double-blind placebo-controlled trial. BMC Complementary Medicine and Therapies. https://doi.org/10.1186/s12906-026-05515-y

Image Credits: AI Generated

DOI: 10.1186/s12906-026-05515-y

Keywords: primary ovarian insufficiency, Chinese herbal medicine, Huyang yangkun formula, menstrual resumption, randomized controlled trial, antral follicle count, hormone replacement therapy, menopause symptoms, follicular development, placebo-controlled trial, reproductive endocrinology, traditional Chinese medicine