Introduction

Menopause management remains a significant gap in women’s healthcare. Only one-third of OB/GYN residency programs offer formal menopause training, leaving many providers underprepared to address menopausal symptoms. (Allen 2023) This deficit is concerning given the prevalence of menopausal symptoms; 80% of women experience at least one symptom of menopause. (Vazirani 2024) 

While hormone therapy remains a cornerstone of menopause care, many women are exploring complementary and alternative therapies to support symptom management, either in conjunction with or independent of conventional treatment. (Johnson 2019)

Fullscript offers two distinct protocols for providers to use in supporting patients navigating menopause: Essential Menopause Support and Comprehensive Menopause Support. 

The Essential protocol focuses on foundational care for common menopausal symptoms (e.g., hot flashes, mood, and mild stress), particularly vasomotor symptoms such as hot flashes and night sweats. It includes evidence-based ingredients like black cohosh, chaste tree, rhubarb, ashwagandha, and saffron.

The Comprehensive protocol is designed for a more nuanced or multifaceted symptom picture. It incorporates additional ingredients to support weight management, hormonal balance, libido, sleep, bone health, and mood, providing broader support for whole person care. 

Providers can use these protocols individually or in combination to tailor care based on the range and complexity of symptoms they are looking to address.

Ingredients

Black Cohosh (Actaea racemosa)

Dosing: 40 mg per day, for at least eight weeks (Carroll 2006)(Castelo-Branco 2022) 

Supporting evidence:

• In a double-blind study in which 62 postmenopausal women were randomized to receive estrogen, black cohosh, or placebo, black cohosh was shown to be as effective as estrogen and superior to placebo in reducing hot flash symptoms. Additionally, black cohosh did not stimulate endometrial thickness, a potential side effect and concern of estrogen replacement therapy. (Wuttke 2003)
• A 2018 RCT compared the efficacy of black cohosh to evening primrose oil for 80 postmenopausal women with hot flashes. While both herbs effectively reduced hot flash severity by the end of the eight-week trial, the authors considered black cohosh superior because it also reduced the number of hot flashes women experienced. (Mehrpooya 2018) 
• A systematic review of 25 clinical studies in which 13,096 women were treated with a standardized black cohosh extract found that black cohosh was superior to placebo for treating menopausal symptoms, including hot flashes, night sweats, sleep disturbances, mood swings, anxiety, and depression. Furthermore, black cohosh appeared to have a good safety profile, without evidence of inducing liver toxicity or increasing hormone levels in breast or endometrial tissues. (Castelo-Branco 2020)
• A recently published meta-analysis of 22 RCTs involving 2,310 menopausal women found that black cohosh extract significantly improved overall menopausal symptoms, including common vasomotor and physical symptoms. (Sadahiro 2023)

Ashwagandha (Withania somnifera)

Dosing: 125–600 mg per day, for at least eight weeks (Akhgarjand 2022)(Pandit 2024)

Supporting evidence:

• A narrative review published in 2023 highlighted the health-promoting properties of ashwagandha, including its neuroprotective, sedative, and adaptogenic effects. (Mikulska 2023) These properties can be beneficial for menopausal women who are at increased risk of experiencing anxiety, depression, and sleep disturbances. (Bromberger 2013)(Zhang 2024)
• Higher levels of perceived stress are associated with increased severity of vasomotor and psychosocial menopausal symptoms. (Brimienė 2025) According to one study, women who were upset by a stressful event experienced 21% more vasomotor symptoms than those who were not coping with life stressors. (Arnot 2021)
• Multiple RCTs have demonstrated that ashwagandha effectively reduces symptoms of stress, anxiety, and depression. (Lopresti 2019)(Tandon 2020)(Pandit 2024) Although these studies have not explicitly focused on menopausal women, it’s possible that ashwagandha could be applied to this population to manage stress-related symptoms of menopause.

Saffron (Crocus sativus)

Dosing: 15 mg twice daily for at least six weeks (Kashani 2018)

Supporting evidence:

• Saffron has been shown to improve symptoms of anxiety and depression through its modulation of neurotransmitter and hormone levels, including dopamine, serotonin, and cortisol. (Pouchieu 2023)(Chauhan 2024) This aligns with the rationale for using selective serotonin reuptake inhibitors (SSRIs) as non-hormonal pharmaceutical therapies for managing vasomotor symptoms of menopause, as SSRIs also influence serotonin pathways involved in mood regulation and body temperature control. (Berendsen 2000)(Newhouser 2022)
• A meta-analysis of eight studies found that saffron outperformed a placebo and was just as effective as fluoxetine (an SSRI) to treat depression. (Khaksarian 2019)  Saffron can also be used safely alongside antidepressant medications to augment therapeutic outcomes in treating depression. (Marx 2019) 
• A double-blind, placebo-controlled RCT evaluated the efficacy of saffron in treating major depressive disorder associated with postmenopausal hot flashes in 60 women. Results demonstrated significant improvements in hot flash-related daily interference and depression scores in the saffron-treated group compared to those who received the placebo, with no difference in rates of adverse effects. (Kashani 2018) 
• A prospective, open, observational, multicenter study that assessed a nutritional product containing saffron—along with evening primrose oil, hop extract, tryptophan, and various vitamins—found significant reductions in hot flashes (48.15%), heart discomfort (33.3%), sleep disturbance (46.2%), musculoskeletal pain (27.8%), depressed mood (45%), irritability (47.6%), anxiety (44.4%), sexual dysfunction (30%), urinary symptoms (31.3%), and vaginal dryness (33.3%) among 156 menopausal women after just 12 weeks. (Palacios 2023) 

Chaste Tree Berry (Vitex agnus-castus)

Dosing: 20–40 mg standardized extract, once per day (Schellenberg 2001)(He 2009)

Supporting evidence:

• While Vitex agnus-castus (VAC) has been studied primarily for its effects on premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD), a systematic review highlights evidence supporting its role in alleviating menopausal symptoms. (van Die 2013)(van Die 2009)
• Hormonal fluctuations in luteinizing hormone (LH) and progesterone are associated with common menopausal symptoms, such as hot flashes, night sweats, mood changes, and sleep disturbances. (Spark 2012)(Joffe 2020)(McConnell 2021) VAC may help alleviate these symptoms by stabilizing hormonal fluctuations through its action on the hypothalamic-pituitary-gonadal axis. (Webster 2010)

In a double-blind RCT, 52 women aged 48–58 years old were randomly assigned to receive VAC or placebo for eight weeks. At the end of the trial, the women in the VAC group had significantly lower mean scores for total menopausal disorder, anxiety, and vasomotor dysfunction compared to the placebo group. There were no significant differences between somatic symptoms, depression, and sexual dysfunction between the two groups. (Naseri 2019)

Rhapontic Rhubarb (Rheum rhaponticum L)

Dosing: 4 mg daily, for three months to two years (Heger 2006)(Kaszkin-Bettag 2008)(Hasper 2009)

Supporting evidence:

• ERr 731®, a special extract from the roots of Rheum rhaponticum, has been extensively studied for its ability to alleviate menopausal symptoms via its estrogenic effects, particularly through the activation of estrogen receptor-beta. (Wober 2007)(Vollmer 2010) 
• A double-blind, placebo-controlled RCT demonstrated that ERr 731® significantly decreased the Menopause Rating Scale II (MRS II) total score and the severity of hot flushes in perimenopausal women compared to placebo. Additionally, the rhubarb extract improved menopause-specific quality of life and was well tolerated without significant adverse effects (including uterine abnormalities). (Heger 2006)
• A post-hoc evaluation of the study above found that ERr 731® led to statistically significant reductions in both the emotional and physical symptoms of anxiety, as measured by the Hamilton Anxiety Scale. Additionally, there was a positive correlation between the reduction in anxiety and a decrease in the number and severity of hot flashes. (Kaszkin-Bettag 2007)
• An observational study, conducted across 70 German gynecological practices and involving 363 menopausal women, concluded that daily supplementation with ERr 731® significantly reduced the MRS total score from 14.5 points at baseline to 6.5 points after six months. (Kaszkin-Bettag 2008)
• A two-year observational study followed 109 perimenopausal women (39 women receiving ERr 731® and 41 receiving a placebo) for 48 weeks. Afterward, 51 women continued in an additional 48-week observation period. At the end of the two years, positive clinical outcomes associated with daily ERr 731® supplementation included significant reductions in MRS II scores and a decrease in hot flushes, with women experiencing fewer than 1.4 hot flushes daily. (Hasper 2009)