Once placebo group subjects were switched to the active supplement and compared to when they were taking placebo, all hair counts increased significantly from day 180 to day 360: the mean terminal hair count increased by 4.3% (P<0.005), the mean total hair count increased by 5% (P<0.001), and the mean vellus count increased significantly by 11.6% (P<0.05; Figure 4). Furthermore, the mean change in total hair shed count significantly decreased from day 180 to Day 360 (-12.7) translating into a 39% decrease in shedding (P<0.0001). Blinded investigator Global Hair Growth improvement and Global Hair Quality Improvement scores increased significantly by 30% and 40%, respectively, across the 6-month evaluation period (for each, P<0.05).
Long-term Subjective Assessments
Hair Satisfaction Questionnaire
Chi-Square evaluations were conducted to evaluate the significance of the difference between the proportion of ‘Satisfied’ Subject Hair Satisfaction Ratings among subjects who took the active supplement for 12 continuous months. At day 0, not a single subject reported being ‘Satisfied’ with her hair; however, there was a significant increase in ‘Satisfied’ Hair Ratings across and between all evaluation periods for subjects who took the active supplement for 12 continuous months, culminating in 85% of subjects being ‘Satisfied’ with their hair (for each, P<0.05).
Hair Quality Self-assessment
Overall hair quality self-assessments agreed with the objective findings. From baseline until the end of the study, most subjects reported overall increased hair growth (81%), increased volume (84%), increased scalp coverage (78%), and increased amount of new hair (81%).
Women's Hair Loss Quality of Life Questionnaire
In general, items on the Women's Hair Loss Quality of Life Questionnaire showed positive changes from baseline until the end of the study. Notably, there was a ≥30% increased improvement for 'Feeling Embarrassed', 'Avoiding Social Gatherings', and 'Fearing Being the Center of Attention'. There was a ≥20% increase in improvement for 'Self-esteem', 'Being Self-Conscious', and 'Feeling Unattractive'.
Menopause Rating Scale Questionnaire
Almost all perimenopausal subjects (93%) reported experiencing baseline menopausal symptoms on the Lifestyle Questionnaire. Menopausal symptoms were notably more prevalent during the perimenopausal phase and progressively diminished for women in the menopausal (64%) and post-menopausal (23%) phases. The most frequently reported menopause symptom was hot flashes (61%) and most subjects reported symptom frequency as sporadic but a few experienced symptoms as often as 4 to 5 times weekly.
Subjects who reported experiencing menopausal symptoms at baseline and received the active supplement reported improvements and reductions in the severity of their menopausal symptoms throughout the 12-month period. Most symptoms that were rated as 'severe' or 'very severe' at baseline were either 'moderate', 'mild', or 'none' by day 360, including 'hot flashes', 'sleep problems', and 'depressive mood'. Furthermore, the symptoms of 'sexual problems,' 'irritability' and 'anxiety' showed a 44% improvement by ≥1-point in severity between day 0 and day 360. The most notable improvement occurred for 'physical and mental exhaustion' with a 56% improvement in severity.
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), during the first phase of the study. No adverse events were reported during Phase II.
Long-term Subjective Assessments
Hair Satisfaction Questionnaire
Chi-Square evaluations were conducted to evaluate the significance of the difference between the proportion of ‘Satisfied’ Subject Hair Satisfaction Ratings among subjects who took the active supplement for 12 continuous months. At day 0, not a single subject reported being ‘Satisfied’ with her hair; however, there was a significant increase in ‘Satisfied’ Hair Ratings across and between all evaluation periods for subjects who took the active supplement for 12 continuous months, culminating in 85% of subjects being ‘Satisfied’ with their hair (for each, P<0.05).
Hair Quality Self-assessment
Overall hair quality self-assessments agreed with the objective findings. From baseline until the end of the study, most subjects reported overall increased hair growth (81%), increased volume (84%), increased scalp coverage (78%), and increased amount of new hair (81%).
Women's Hair Loss Quality of Life Questionnaire
In general, items on the Women's Hair Loss Quality of Life Questionnaire showed positive changes from baseline until the end of the study. Notably, there was a ≥30% increased improvement for 'Feeling Embarrassed', 'Avoiding Social Gatherings', and 'Fearing Being the Center of Attention'. There was a ≥20% increase in improvement for 'Self-esteem', 'Being Self-Conscious', and 'Feeling Unattractive'.
Menopause Rating Scale Questionnaire
Almost all perimenopausal subjects (93%) reported experiencing baseline menopausal symptoms on the Lifestyle Questionnaire. Menopausal symptoms were notably more prevalent during the perimenopausal phase and progressively diminished for women in the menopausal (64%) and post-menopausal (23%) phases. The most frequently reported menopause symptom was hot flashes (61%) and most subjects reported symptom frequency as sporadic but a few experienced symptoms as often as 4 to 5 times weekly.
Subjects who reported experiencing menopausal symptoms at baseline and received the active supplement reported improvements and reductions in the severity of their menopausal symptoms throughout the 12-month period. Most symptoms that were rated as 'severe' or 'very severe' at baseline were either 'moderate', 'mild', or 'none' by day 360, including 'hot flashes', 'sleep problems', and 'depressive mood'. Furthermore, the symptoms of 'sexual problems,' 'irritability' and 'anxiety' showed a 44% improvement by ≥1-point in severity between day 0 and day 360. The most notable improvement occurred for 'physical and mental exhaustion' with a 56% improvement in severity.
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), during the first phase of the study. No adverse events were reported during Phase II.
DISCUSSION
This was a 12-month study to evaluate the efficacy and safety of a nutraceutical to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair. During the first 6-month double-blind, placebocontrolled phase of this study, women receiving the active supplement daily achieved significant improvements in hair growth and quality compared to placebo.16 In fact, this active group showed significant increases in the number of terminal and vellus hairs, significantly reduced shedding, as well as improved blinded physician and subjective assessments of hair growth and quality. The subsequent 6-month open-label extension phase assessed the continued long-term safety and efficacy of the nutraceutical for promoting hair growth and quality, and potential benefits on quality of life and menopausal symptoms, as well as to evaluate overall efficacy for subjects previously treated with placebo when switched to the active supplement.
After a total of 12 months of treatment with the nutraceutical, subjects achieved significant and progressive increases in the number of total and terminal hairs, improvement followed by subsequent stabilization of vellus hair growth and hair shedding. Blinded investigator global hair growth and quality assessments, as well as subjects' self-assessments for hair growth, quality, and satisfaction also showed progressive and significant improvement over the year-long duration of the study. More specifically, the number of total hairs continued to improve for 12 months, suggesting that a maximum increase may not have been reached; however, the total hair count increase was driven mainly by continued increase in terminal hairs throughout 12 months. While vellus hair saw a significant increase in the first 6 months of use, there was more of a stabilization in growth
After a total of 12 months of treatment with the nutraceutical, subjects achieved significant and progressive increases in the number of total and terminal hairs, improvement followed by subsequent stabilization of vellus hair growth and hair shedding. Blinded investigator global hair growth and quality assessments, as well as subjects' self-assessments for hair growth, quality, and satisfaction also showed progressive and significant improvement over the year-long duration of the study. More specifically, the number of total hairs continued to improve for 12 months, suggesting that a maximum increase may not have been reached; however, the total hair count increase was driven mainly by continued increase in terminal hairs throughout 12 months. While vellus hair saw a significant increase in the first 6 months of use, there was more of a stabilization in growth
