Despite the first case of PCOS diagnosed in 1935 and affecting up to 20% of women of reproductive age, there’s still no FDA-approved treatment for PCOS in conventional medicine.1-3 Instead of addressing the root causes, conventional treatments often rely on symptom management through off-label prescriptions of hormonal contraceptives, metformin, and spironolactone.4 This piecemeal approach leaves millions without comprehensive care – and up to 70% of those affected either undiagnosed or misdiagnosed.5
The Holistic Answer to PCOS
As Chinese medicine practitioners, we know that TCM offers a unique, holistic approach to PCOS – one that treats the condition at its root through personalized, pattern-based diagnosis. This opens up enormous opportunities for our profession to fill the gap and help patients who are frustrated with their limited options in conventional medicine.
A New Clinical Study
Seeking to bring a science-meets-holistic approach to healing, a new independent clinical study has validated what we as acupuncturists already know to be true: personalized, pattern diagnosis-driven Chinese herbal treatment is highly effective for PCOS (as noted in Iris Lee’s August AT article: “A TCM Understanding of PCOS and PCOS-Friendly Herbal Formulas - Pt. 1”).
The recently completed clinical study, pending publication of full results,6 which separated participants into birth control (BC) and no birth control (No BC) groups, revealed that herbal treatment not only regulated menstrual cycles, but also improved overall PCOS symptoms and increased ovulation rates. Considering PCOS is a leading cause of infertility, cycle regulation and improved ovulation are key.
Since birth control is the primary conventional treatment for PCOS, but many people either cannot tolerate its side effects or are unable to take it, finding clinically proven alternatives is crucial.
This six-month study highlights the cumulative healing power of herbs, demonstrating that real progress takes time and patience, while also proving that TCM is well-positioned to meet the unmet needs of those with PCOS. As practitioners, this is our chance to lead the way in providing patients with personalized, effective solutions rooted in centuries of tradition and now backed by additional clinical data.
Study Design
This open-label, two-armed study examined the efficacy of two organic herbal formulas on improving the common menstrual symptoms associated with PCOS. The first formula was customized based on the participant’s pattern diagnosis, determined through a proprietary online health assessment, and targeted menstrual imbalances. The second was a modified version of Xiao Yao San with added adaptogens like ling zhi (reishi) and huang qi (astragalus) to help strengthen the body’s response to stress.
Seventy participants, ages 18-36, were divided into two arms: BC and no BC. Over a 24-week period, every four weeks participants answered a series of questions using a validated menstrual health questionnaire about their perception of their menstrual cycle and symptoms, providing comprehensive data on the impact of the herbal formulas. In addition, two validated questionnaires were utilized to monitor changes in acne and mood: Acne Quality of Life (QoL) and Generalized Anxiety Disorder Questionnaire (GAD-7).
Participants were asked to not change anything else about their lifestyle, including their current treatment regimen, over the 24-week study. They took 2.5 mL each of their formulas daily for a consecutive six-month period.
Key Participant Insights
Here is some information about the participants in this study (combined BC + No BC arms):
Table 1: Participant Insights
| Ethnicity | Combined BC + No BC |
| White | 71.10% |
| Asian | 8.70% |
| Hispanic or Latino | 11.59% |
| Black or African MERICAN | 8.70% |
| How PCOS was diagnosed | Combined BC + No BC |
| Ultrasound | 43.62% |
| Blood Test | 31.91% |
| Pelvic Exam | 11.70% |
| I was diagnosed solely based on my symptoms | 12.77% |
| When diagnosed with PCOS | Combined BC + No BC |
| 0-5 years ago | 41.43% |
| 6-10 years ago | 38.57% |
| Over 10 years ago | 20.00% |
| %Yes | Combined BC + No BC |
| Have you seen your doctor in the past year about your PCOS condition? | 85.71% |
| Do you consider yourself to have a sedentary lifestyle? A sedentary lifestyle refers to a way living characterized by minimal physical activity or exercise and a significant amount of time spent in activities that involved sitting or lying down. | 24.29% |
| Do you consider yourself to have chronic poor sleep health? Chronic poor sleep health refers to an ongoing pattern of inadequate or unsatisfactory sleep over an extended period. This may include people who work night shifts. | 44.29% |
| Do you have a poor diet? This is defined as a diet that is high in sugar and/or junk food. | 14.29% |
| Do you consider yourself to have chronic stress or anxiety? | 68.57% |
| What method have you been using to track your cycle recently? | Combined BC + No BC |
| Via period tracker app | 44.29% |
| Via calendar app | 27.14% |
| Via memory app | 2.86% |
| I don't currently track my cycle | 24.29% |
| Other | 1.43% |
Study Findings
Data was analyzed for each arm, as well as combined results. The study demonstrated that these formulas combined, one personalized through an online health assessment and the other a modified Xiao Yao San, can effectively improve several common life-interfering PCOS symptoms, especially for the No BC cohort. Findings suggest TCM is an especially effective natural alternative for those who cannot or do not want to take birth control to manage their PCOS symptoms.
Over the 24-week period, participants reported a perceived improvement in cycle regulation, bloating, fatigue, mood swings, anxiety, sleep quality, premenstrual and menstrual cramps, hormonal acne/breakouts, brain fog + focus, mental clarity, weight gain, unwanted facial / body hair, fluid retention, overall PMS symptoms, overall PCOS symptoms, and overall health and well-being.
Summary of No BC Arm Data
Here is a summary of raw data from the No BC arm and their perception of changes in symptoms commonly associated with PCOS at the end of the 24-week study, based on responses to the question, “Would you agree that your formulas have helped [the following]?:
Table 2: No BC Arm Perceptions
This chart shows the raw data from the No BC arm and their perception of changes in symptoms commonly associated with PCOS.
| Questions | %Yes (No BC) | ||
| Week 4 | Week 12 | Week 24 | |
| Since your previous period, would you agree that your formulas have helped regulate your cycle? | 69.7% | 79.3% | 89.3% |
| In the past four weeks, would you agree that your formulas have helped to decrease bloating? | 51.5% | 55.2% | 71.4% |
| In the past four weeks, would you agree that your formulas have increased your energy and reduced your fatigue? | 51.5% | 58.6% | 60.7% |
| In the past four weeks, would you agree that you experienced fewer mood swings? | 51.5% | 62.1% | 71.4% |
| In the past four weeks, would you agree that your anxiety has improved? | 51.5% | 55.2% | 60.7% |
| In the past four weeks, would you agree that you have bad better quality sleep? | 36.4% | 55.2% | 60.7% |
| In the past four weeks, would you agree that you had fewer premenstrual and menstrual cramps? | 60.6% | 55.2% | 85.7% |
| In the past four weeks, would you agree that taking your formulas has improved your hormonal acne/breakouts? | 24.2% | 44.8% | 71.4% |
| In the past four weeks, would you agree that you have had less fluid retention? | 75.8% | 79.3% | 67.9% |
| In the past four weeks, would you agree that you have experienced less weight gain? | 45.5% | 51.7% | 67.9% |
| In the past four weeks, would you agree that you have had better mental clarity? | 45.5% | 55.2% | 71.4% |
| In the past four weeks, would you agree that you have experienced less brain fog? | 45.5% | 62.1% | 67.9% |
| In the past four weeks, would you agree that you have had better focus? | 45.5% | 58.6% | 64.3% |
| In the past 4 weeks, would you agree that taking your formulas has improved your PMS symptoms? | 69.7% | 75.9% | 82.1% |
| In the past four weeks, would you agree that taking your formulas has improved your PCOS symptoms? | 57.6% | 62.1% | 71.4% |
Acne + Skin Health
A subgroup of 20 participants from the No BC group who experience hormonal acne provided photos of their faces throughout the study. A board-certified dermatologist graded these photos, comparing photos taken at weeks 12, 20, and 24 to the baseline week 0 photo. A majority of participants reported an improvement in acne, skin discoloration, skin health, and redness.
Proven Care for PCOS
This study suggests that Chinese herbs can be a viable alternative (or addition) to conventional PCOS treatment. With more research in this field to scientifically validate herbal treatments, TCM can become the go-to modality for chronic disease care.
References
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