Elix’s Second IRB Approved Independent Clinical Study - Cycle Balance and Daily Harmony for Polycystic Ovary Syndrome (PCOS)

At Elix, we are dedicated to addressing the gender disparities in healthcare by advancing medical research and providing access to holistic care via online health coaching and 100% organic Chinese herbal medicine formulas that deliver clinical results.

Combating Medical Misogyny Through Research

Historically, women's health issues have been marginalized, with only 4% of US healthcare R&D efforts targeting these concerns. It wasn’t until 1993 that the NIH required women and minorities to be included in all federally funded clinical research, and it took until 2016 for the NIH to mandate that biological sex differences be considered in study designs. 

Women were intentionally excluded due to their natural hormone fluctuations and the statistical variances this brought to research. In fact, women were considered “little men” in research leading to them being overmedicated. A great example of this is Ambien, where women were prescribed the same dose as men and were found to have a higher risk of impairment the next day since their body didn’t clear the drug as fast. Now women are given a lower dose. 

Shockingly, PCOS research receives less than 1% of the funding that has been allocated to erectile dysfunction research. 

The Hidden Struggle of PCOS: Why Diagnosis Is Often Delayed

One of the difficulties of navigating PCOS is actually getting the correct diagnosis. The average time to be diagnosed with PCOS is typically around 2 to 5 years. 

This delay is often due to the complexity of the condition, its wide range of symptoms, and the lack of standardized diagnostic criteria across healthcare providers. Some providers dismiss a PCOS diagnosis if the patient isn’t presenting with “cysts” on their ultrasound, or if their periods are not irregular. 

With 70% of those with PCOS remaining undiagnosed or misdiagnosed due to medical misogyny, we see this research as a critical step forward in supporting women's health journeys and to support them in advocating for themselves while navigating the healthcare system.

Why PCOS Was Chosen for Our Second Clinical Study: Key Insights and Impact

PCOS is a widespread hormonal disorder affecting 4% to 20% of women of reproductive age worldwide, yet there are no FDA-approved drugs specifically for its treatment. 

Current management options, like birth control, metformin, and spironolactone, are often prescribed off-label to manage symptoms and come with potential side effects. Given its prevalence and the lack of targeted treatments, PCOS was a natural choice for our second independent clinical study following our 2021 research on Cycle Balance for primary dysmenorrhea, where 90% of participants saw an overall improvement in 15 PMS and menstrual symptoms.

Due to the lack of timely diagnosis and effective treatments for most chronic gynecological conditions many of our community members report using Cycle Balance successfully to support the symptoms associated with chronic conditions like PCOS, endometriosis, adenomyosis, fibroids, and premenstrual dysphoric disorder (PMDD). Cycle Balance can be used alongside conventional western biomedicine treatments, as it doesn’t have to be an either-or situation.    

PCOS Symptoms and Causes: How Hormonal Imbalances, Metabolic Issues, and Irregular Periods Affect Diagnosis

PCOS is a complex and stubborn condition linked to imbalances in the endocrine and metabolic systems, manifesting in a variety of symptoms that can make diagnosis challenging. 

Common signs include androgen dominance (leading to acne and unwanted hair growth), metabolic issues (such as weight gain, cravings, fatigue, and insulin resistance), and menstrual irregularities (like infrequent cycles, mood swings, PMS symptoms, and cramps). These varied symptoms often result in delayed or misdiagnosis, further complicating treatment efforts.   

Elix PCOS Clinical Study: How Cycle Balance and Daily Harmony Support Menstrual Health, Skin, and Anxiety

This open-label, two-armed study examined the efficacy of Elix’s Cycle Balance and Daily Harmony formulas in improving menstrual health, skin condition, and anxiety levels in individuals diagnosed with PCOS. Symptoms assessed include: 

• Cycle regularity 
• Cramps
• Bloating 
• Mood swings
• Anxiety 
• Overall mental wellbeing 
• Cravings 
• Acne 
• Weight gain 
• Unwanted hair growth 
• Overall PMS symptoms
• Overall PCOS symptoms  
• Ovulation 
• Mental clarity  
• Fatigue
• Sleep quality 

Participants were matched with their personalized Cycle Balance herbal formula based on their unique pattern diagnosis, determined through Elix’s free Online Health Assessment. These organic glycerin based herbal formulas, rooted in Traditional Chinese Medicine (TCM), are designed to address the underlying causes of symptoms by incorporating herbs known for their anti-inflammatory, antioxidant, hormone-modulating, and stress-relieving properties.

Seventy participants, aged 18-36, were divided into two groups: those using birth control (BC) and those not using it (no BC). Over a 24-week period, every 4 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.

A few sample questions include:

• During your most recent period, how severe were your cramps?
• During your most recent period, how many days did your PMS symptoms persist?
• Since your previous period, would you agree that Elix Cycle Balance and Daily Harmony have helped regulate your cycle?

In addition to symptom based questions, two validated questionnaires were utilized in this study to monitor changes in acne and mood:

• Acne Quality of Life (QoL)
• 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 were asked to take 2.5 mL each of their personalized Elix Cycle Balance formula and Elix’s Daily Harmony formula daily for a consecutive 6 month period. 

PCOS Treatment: How Cycle Balance and Daily Harmony Enhance Mood, Sleep, and Blood Sugar Regulation Over 6 Months 

Data was analyzed for each group (BC and no BC) as well as combined results. The study demonstrated that Cycle Balance and Daily Harmony can effectively improve several common life-interfering PCOS symptoms. More changes were noticed as the study period went on. 

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
• Overall health and wellbeing 

Overall, these results indicate a positive effect of the test formulas on the parameters surrounding cycle health over time. It’s important to note that many of these changes were seen by the end of the 6 month study, showing that herbal healing can take time and patience, but the results are well worth the wait. 

There’s a golden rule in TCM that for every year you have been dealing with a condition, it can take at least a month of treatment to see results. For people looking for herbal support for PCOS, it’s important to stick with it for at least 6 months. It may not be a quick fix, but it’s paving the way for long term wellness. 

Natural PCOS Treatment Without Birth Control: Elix Study Shows Better Cycle Regularity, Hormonal Balance, and PMS Relief

The results show that these two formulas are an especially effective natural alternative for those who cannot or do not want to take birth control to manage their PCOS symptoms. The data shows improvement in the three main areas PCOS affects:

• Androgen excess
• Metabolic health
• Menstrual health 

Of those not on birth control:

• 89.3% of participants agreed that Elix Cycle Balance and Daily Harmony have helped to regulate their cycle.
• 85.7% of participants agreed that they had fewer premenstrual and menstrual cramps after taking Elix Cycle Balance and Daily Harmony.
• 71.4% of participants agreed that taking Elix Cycle Balance and Daily Harmony had improved their hormonal acne/breakouts.
• 71.4% of participants agreed that they experienced fewer mood swings after taking Elix Cycle Balance and Daily Harmony.
• 71.4% of participants agreed that taking Elix Cycle Balance and Daily Harmony has improved their PCOS symptoms.

This is great news for those who have been managing PCOS with birth control but are wanting to transition off to focus on fertility or avoid the unwanted side effects of birth control. No need to fear the return of stubborn symptoms while stopping birth control, there is a data backed natural alternative in Elix.   

PCOS Clinical Study: Exploring the Impact of Natural Remedies on Hormonal Acne, Skin Health, and Redness

A subgroup of 20 participants from the no BC group who experience hormonal acne or frequent hormonal breakouts provided photos of their face 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. The parameters the dermatologist scored were improvements in acne, skin discoloration, skin health, and redness. A majority of participants saw improvements in these scores over the course of the study. 

PCOS Clinical Study: Herbal Treatments vs. Birth Control – Understanding Symptom Management and the Importance of Personalized Care

While this study showed promising results, particularly in participants not on birth control, it highlights an opportunity for further research. While the birth control group did experience improvements in specific symptoms including period predictability, cramp severity, and mood stability at certain points, the changes were not as big or sustainable as the no birth control group. Although the birth control group did see perceived improvements in sleep quality, unwanted hair growth, and premenstrual sensitivity to blood sugar showing evidence of possible improvements in the metabolic and hormonal causes of PCOS.  

A few possible explanations behind these differences include:

• The interplay between Elix and synthetic hormones in birth control might mask the actual efficacy of Elix formulas. 
• Birth control is working to manage symptoms, so these participants have less room to improve. 
• Those on birth control who are still looking for other solutions may be those with more severe disease or harder to treat disease.
• From a TCM point-of-view birth control can cause a lot of the same patterns of imbalance (like blood stasis and Liver Qi stagnation) that also lead to the symptoms associated with PCOS. 

Further investigation is needed to explore the interactions between Elix and synthetic hormones in birth control. The fluctuations in symptom improvement within the birth control group indicate that more research is needed to understand and optimize the combined use of these interventions for people using hormonal contraceptives. 

These findings are valuable as they highlight the need for personalized approaches to managing PCOS, particularly when considering herbal treatments alongside hormonal contraceptives. 

Clinically Proven PCOS Care: Herbal Remedies and Lifestyle Changes for Better Wellness

Our findings underscore the value of a holistic approach to managing PCOS, incorporating both herbal treatments and healthy lifestyle choices. While participants were asked not to change anything else about their lifestyle including their current treatment regimen over the 24 week study. Those that are associated with better lifestyle habits at baseline had more substantial outcomes. Participants who prioritized sleep, movement, a balanced diet, and stress management saw the most substantial benefits, aligning with TCM principles that emphasize the importance of daily habits in promoting wellness.

Elix’s Commitment to Education 

Centuries ago, Chinese medicine practitioners were only paid if their patients stayed healthy. Imagine living in a time where prevention and thriving wellness were the priority and focus. We want to spread the time-tested lifestyle wisdom that TCM has long known, which modern research is now validating. 

We have tons of great resources from TCM theory to recipes on our blog The Wisdom.

Here are a few favorites when it comes to creating healthy lifestyle rituals:

• How to make new rituals stick
• Sleep Tips
• Acupressure for Pain & Stress
• Breathwork

Elix’s TCM Health Coaching

Elix is not just focused on providing effective herbal remedies; we are also committed to education and support through our TCM Health Coaching program. Our expert team of licensed practitioners offer personalized guidance to enhance the healing journey, helping individuals incorporate TCM lifestyle practices that complement our formulas. It’s the small daily rituals that can make a big difference in the healing journey. 

Our TCM Health Coaches are available for consults at all phases of the Elix journey - to discuss how Elix formulas can help, check-in on progress, and share tips about the small TCM lifestyle changes that enhance the healing process. We want everyone to have access to expert support, Elix’s health coaching sessions are a fraction of the price of what practitioners charge in private practice. 

Elix’s Ongoing Commitment to Women’s Health

As a small, female-founded and mission-driven startup, we recognize the need for more comprehensive research. Since we don’t have the deep pockets of big pharma, this study is just the second step of our multi-year efforts to expand the scientific understanding of how TCM can support women’s health and chronic care. We plan to conduct additional clinical trials, including a randomized, double-blind, placebo-controlled study, to further validate our findings and contribute to the growing body of knowledge in this vital under-researched field.

Looking Ahead

Elix is dedicated to advancing research in women’s health and providing natural, effective solutions for managing the symptoms associated with PCOS and other hormonal imbalances. By combining TCM wisdom with modern scientific methods, we aim to empower women with more options for their wellness journeys and to foster a more inclusive, equitable healthcare landscape.

Take Elix’s free Online Health Assessment to determine your personalized Cycle Balance blend!

“It’s great to have a natural alternative that is safe and effective with clinical data behind it that I can offer my patients who do not want to be on birth control, or can’t tolerate it, to help with their symptoms related to PCOS.”

- Dr. Jessica Ritch, Minimally Invasive Gynecologist and Elix Medical Advisor. 

Sources

• ​​Closing the Sex Gap in Medical Research: CU Center Leads Way
• Polycystic ovary syndrome
• The Prevalence of Polycystic Ovary Syndrome: A Brief Systematic Review - PMC
• Polycystic Ovary Syndrome (PCOS) Blog | FDA
• Women’s Equality Day: Celebrate the Anniversary of the 19th Amendment by Becoming a Health Care Advocate
• Closing the women’s health gap | McKinsey
• Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline

This article was reviewed by Dr. Liem Le.

Dr. Liem Le is a Doctor of Chinese Medicine, Functional Medicine Practitioner, and Nutritionist Integrative Medicine Department at H. Lee Moffitt Cancer Center. He is a part of the teaching staff for the Masters program for the Functional Medicine and Human Nutrition program at University of Western States. Dr. Le is currently working on his fellowship in Integrative Medicine with the Academy of Integrative Health and Medicine via a scholarship from the White House to complete the initiative.