during the second phase of the study. Given the concomitant and continued increase in terminal hairs, this may indicate transition from vellus to terminal hair over time. Though overall shedding decreased significantly over 12 months, the most remarkable decrease was seen in the initial 6 months, indicating a possible return to healthy shedding patterns by 6 months of use and subsequent maintenance with continued therapy.
During the open-label phase of the study, subjects previously treated with placebo showed improvements in hair growth when placebo group transitioned to daily intake of the supplement. More precisely, they achieved significant increases in all hair counts and a significant decrease in shedding, as well as significant improvement in blinded investigator global hair and quality assessments. In contrast, while previously on placebo during the first phase, these subjects had a significant decrease in vellus hair counts, while showing no significant changes in terminal and total hair counts, or shedding.16 Although a decrease in vellus hairs could point to a transition of vellus to terminal hairs, it could also indicate progressive change in hair during menopause normally marked by relative androgen dominance and miniaturization.10,12 In the case of the placebo group in the initial phase of the study, the lack of concomitant increase in terminal hairs at the time suggested a progressive decline without intervention. It is known that androgens, particularly DHT, trigger miniaturization within genetically predisposed follicles, and that without intervention, miniaturization and hair loss tend to be progressive.2,10,13 Interestingly, after switching to the nutraceutical, these subjects showed a pattern of improvement similar to those of the active group in Phase I of study. Notably, significant increase in all hair counts, including vellus, as well as a significant decrease in shedding. Based on both groups' initial 6 months of use, we can corroborate early results and efficacy of therapy and suggest a predictable pattern of improvement with daily use of the nutraceutical.
It is worth noting that for many patients enrolled in the study, the open-label phase coincided with the COVID-19 pandemic. Although no subject reported any symptoms or was diagnosed with COVID-19 during the study, it is very possible that subjects' hair might have been affected as a result of physical and emotional stress, and potentially impacting outcomes.19-21 This could explain, at least in part, why the improvement in the placebo group that transitioned to active therapy was not as compelling as those initially seen in the active group during Phase I, and why the active group on continued therapy had stabilized in some parameters over the second 6-months of the study. Nevertheless, the results still showed significant and progressive improvements with 12 months of use, underscoring the observation that although the most dramatic improvements are seen within 3-6 months, hair growth and quality continuously increase over time, which speaks to continuity of care. Furthermore, a significant improvement from continued use was seen in women at different stages of menopausal transition, where we would otherwise expect a decline in hair health without intervention, as was witnessed in the placebo group during the first phase of the study until they were switched to the nutraceutical.
While the full etiology of female hair loss remains to be elucidated, we understand that multiple factors play a role.4 The currently studied supplement is formulated with standardized nutraceuticals that have shown multimodal biological activity against multiple molecular factors of hair loss and more specifically, additional targets of hair thinning in women going through and beyond the menopausal transition.16 These mechanisms and ingredients are detailed in previous publications15,16,22 and briefly described here. The stress-adaptogen ashwagandha has been shown to improve symptoms of stress and lower elevated cortisol in stressed adults,23 providing an option to address increased psychoemotional stress as a factor in hair thinning for menopausal women. Saw palmetto, which has shown efficacy for hair loss and is well known for its anti-androgenic and DHT-inhibiting properties, was optimized in this formulation to address relative androgen dominance in menopausal women.24-26 Maca root is likewise considered adaptogenic, exerting a positive effect on the balance of endogenous sex hormones, cortisol, and DHT through its numerous constituents and has been shown to improve menopausal symptoms.27-30 Other key ingredients like curcumin, astaxanthin, and the tocotrienol/tocopherol complex are well known for their clinical anti-inflammatory, immunomodulatory and antioxidant properties.15,31,32
Combinations of these and other ingredients have shown clinical efficacy in addressing symptoms of hair thinning in both menopausal and non-menopausal women.16,22 Additional benefits of the supplement reported in the current study included improvement in menopause symptoms such as hot flashes, sleep, and sexual problems, irritability, and mental and physical exhaustion. This may reflect the clinically studied properties of the individual ingredients discussed above.
Quality of life is significantly affected during the menopausal transition, while the emotional toll of associated symptoms including hair loss is high.33,19,34 Throughout the study, quality of life measures such as self-esteem, feelings of embarrassment, and self-consciousness were shown to improve. This may be due to the properties of the nutraceutical significantly increasing hair growth and quality parameters or because of improvement in menopausal symptoms or both. Whilst there is a paucity of research on women going through menopause, it is important to consider clinical examination of options to better optimize management of symptoms during this time. To our knowledge, this is the first prospective study showing clinical efficacy of a nutraceutical hair supplement over 12 months, specifically
During the open-label phase of the study, subjects previously treated with placebo showed improvements in hair growth when placebo group transitioned to daily intake of the supplement. More precisely, they achieved significant increases in all hair counts and a significant decrease in shedding, as well as significant improvement in blinded investigator global hair and quality assessments. In contrast, while previously on placebo during the first phase, these subjects had a significant decrease in vellus hair counts, while showing no significant changes in terminal and total hair counts, or shedding.16 Although a decrease in vellus hairs could point to a transition of vellus to terminal hairs, it could also indicate progressive change in hair during menopause normally marked by relative androgen dominance and miniaturization.10,12 In the case of the placebo group in the initial phase of the study, the lack of concomitant increase in terminal hairs at the time suggested a progressive decline without intervention. It is known that androgens, particularly DHT, trigger miniaturization within genetically predisposed follicles, and that without intervention, miniaturization and hair loss tend to be progressive.2,10,13 Interestingly, after switching to the nutraceutical, these subjects showed a pattern of improvement similar to those of the active group in Phase I of study. Notably, significant increase in all hair counts, including vellus, as well as a significant decrease in shedding. Based on both groups' initial 6 months of use, we can corroborate early results and efficacy of therapy and suggest a predictable pattern of improvement with daily use of the nutraceutical.
It is worth noting that for many patients enrolled in the study, the open-label phase coincided with the COVID-19 pandemic. Although no subject reported any symptoms or was diagnosed with COVID-19 during the study, it is very possible that subjects' hair might have been affected as a result of physical and emotional stress, and potentially impacting outcomes.19-21 This could explain, at least in part, why the improvement in the placebo group that transitioned to active therapy was not as compelling as those initially seen in the active group during Phase I, and why the active group on continued therapy had stabilized in some parameters over the second 6-months of the study. Nevertheless, the results still showed significant and progressive improvements with 12 months of use, underscoring the observation that although the most dramatic improvements are seen within 3-6 months, hair growth and quality continuously increase over time, which speaks to continuity of care. Furthermore, a significant improvement from continued use was seen in women at different stages of menopausal transition, where we would otherwise expect a decline in hair health without intervention, as was witnessed in the placebo group during the first phase of the study until they were switched to the nutraceutical.
While the full etiology of female hair loss remains to be elucidated, we understand that multiple factors play a role.4 The currently studied supplement is formulated with standardized nutraceuticals that have shown multimodal biological activity against multiple molecular factors of hair loss and more specifically, additional targets of hair thinning in women going through and beyond the menopausal transition.16 These mechanisms and ingredients are detailed in previous publications15,16,22 and briefly described here. The stress-adaptogen ashwagandha has been shown to improve symptoms of stress and lower elevated cortisol in stressed adults,23 providing an option to address increased psychoemotional stress as a factor in hair thinning for menopausal women. Saw palmetto, which has shown efficacy for hair loss and is well known for its anti-androgenic and DHT-inhibiting properties, was optimized in this formulation to address relative androgen dominance in menopausal women.24-26 Maca root is likewise considered adaptogenic, exerting a positive effect on the balance of endogenous sex hormones, cortisol, and DHT through its numerous constituents and has been shown to improve menopausal symptoms.27-30 Other key ingredients like curcumin, astaxanthin, and the tocotrienol/tocopherol complex are well known for their clinical anti-inflammatory, immunomodulatory and antioxidant properties.15,31,32
Combinations of these and other ingredients have shown clinical efficacy in addressing symptoms of hair thinning in both menopausal and non-menopausal women.16,22 Additional benefits of the supplement reported in the current study included improvement in menopause symptoms such as hot flashes, sleep, and sexual problems, irritability, and mental and physical exhaustion. This may reflect the clinically studied properties of the individual ingredients discussed above.
Quality of life is significantly affected during the menopausal transition, while the emotional toll of associated symptoms including hair loss is high.33,19,34 Throughout the study, quality of life measures such as self-esteem, feelings of embarrassment, and self-consciousness were shown to improve. This may be due to the properties of the nutraceutical significantly increasing hair growth and quality parameters or because of improvement in menopausal symptoms or both. Whilst there is a paucity of research on women going through menopause, it is important to consider clinical examination of options to better optimize management of symptoms during this time. To our knowledge, this is the first prospective study showing clinical efficacy of a nutraceutical hair supplement over 12 months, specifically
