A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair

January 2021 | Volume 20 | Issue 1 | Original Article | 55 | Copyright © January 2021


Published online December 30, 2020

Glynis Ablon MD FAADa, Sophia Kogan MDb

aAblon Skin Institute and Research Center, Manhattan Beach, CA
bNutraceutical Wellness Inc., New York, NY

product to the scalp once or twice daily, and 91% feeling more comfortable taking a natural supplement. Seventy-six percent of active-treated subjects would recommend the product.

Safety
No unanticipated adverse events were reported. Adverse events occurred in three subjects, two in the active group (nausea, bloating, diarrhea) and one in the placebo group (nausea, headache).

DISCUSSION

The results of this six-month interim analyses showed that the administration of a novel oral supplement with patented Synergen Complex Plus® in perimenopausal, menopausal, and postmenopausal women with thinning hair was effective compared to placebo. Total hair counts, terminal hair counts, vellus hair counts, and shedding all significantly improved compared to placebo. These parameters were supported by significant and progressive visible clinical improvement in both hair growth and hair quality for the treatment group, as determined by a blinded investigator.

Subjects in the placebo group showed no significant improvements for the same hair parameters. In fact, vellus hairs were significantly decreased among subjects in the placebo group, which could indicate progressive change in hair during menopausal transition, normally marked by relative androgen dominance.7,11 It is known that androgens are converted to DHT via 5α-reductase at the follicle, where it shortens the anagen phase and causes miniaturization from terminal to vellus-like hairs in genetically predisposed follicles.6,7 Although a decrease in vellus hairs could also indicate the transition of those hairs to terminal ones, the concomitant lack of increase in terminal hairs for placebo subjects suggests otherwise. Miniaturization of follicles and hair loss tend to be progressive without intervention.2 These results suggest that progressive menopausal changes in hair may be reduced or at least delayed with intervention that specifically addresses hormonal changes in menopause.

While the full etiology of many types of hair loss remains elusive, research has shown that especially in women it is multi-factorial.4 Various molecular pathways and factors including DHT, aging, oxidative damage, inflammation, hormonal fluctuation, as well as stress mediators, play a significant role in compromising the hair follicle.4,9 Nutraceuticals providing multi-modal biological activity against these molecular and environmental factors therefore offer a unique therapeutic value. For example, standardized ashwagandha has anti-inflammatory, antitumor, stress-adaptogenic, antioxidant, and immunomodulatory activity15 and has demonstrated benefits in women with mild to moderate symptoms of menopausal syndrome.16 It was likewise shown to lower elevated cortisol levels in stressed adults.17 Standardized curcumin is a major component of turmeric with known anti-inflammatory and anti- oxidative effects, and was demonstrated to improve endothelial function in postmenopausal women.18 The biological and clinical activity of these ingredients has been previously detailed in a recent review by Farris et al.12 Moreover, these nutraceutical grade extracts along with other ingredients make up a similar formulation that was shown to significantly improve hair growth and quality compared to placebo in women with thinning hair.5

The currently studied formulation contains optimized dosages and added botanical ingredients, selected to address specific additional targets of hair thinning in women going through and beyond the menopausal transition. These targets include the relative hormonal shifts that occur in menopause. Paradoxically, most women that experience hair thinning in menopausal years have normal levels of androgens, but experience a decline in ovarian estrogens.11 Ultimately, the local balance of these hormones metabolized at the follicle influences hair growth by signaling a number of other hormones, transcription factors, growth factors, and cytokines.11 In addition to declining estrogen levels in relationship to androgens,11 other significant changes which affect the hair follicle specifically through and after menopause include: increased oxidative stress and inflammation,19 stress-related increases in cortisol,20,21 metabolic changes,22 and changes in nutritional status.23

One key ingredient is saw palmetto, which has shown efficacy in hair loss,24,25 and is known for its well-documented anti-androgenic and DHT-inhibiting26 properties. The dosage was optimized and increased in this formula. Maca root contains numerous constituents, including an alkaloid lipidiline, which exerts a positive effect on balance of endogenous sex hormones through its activity on 17β-hydroxysteroid dehydrogenase.27 Administration of maca has been shown to significantly improve menopausal symptoms.28 It also has adaptogenic effects, reducing stress-induced corticosterone levels,29 and targets DHT.30 Astaxanthin is an antioxidant 600-times more potent than vitamin C. It possesses anti-inflammatory and antioxidant properties, improving oxidative status overall and in aging skin.31,32 In the current study, the daily use of this blend of nutraceutical-grade extracts significantly increased the number of terminal and vellus hairs in perimenopausal, menopausal, and post-menopausal women. To our knowledge, this is the first prospective study showing clinical efficacy of a nutraceutical supplement in improving hair growth in women with thinning hair in menopausal transition.

A previous study evaluating an earlier formulation for women showed similar objective progressive improvements in hair growth and hair quality at 3 and 6-months.5 A significant percentage of subjects taking the supplement reported improvements in hair parameters, such as hair growth, thickness, and overall hair volume.5 The subjects in the current study also reported progressive improvements based on self-