PURPOSE: To test the safety and efficacy of acupuncture in reducing hot flashes in men with advanced prostate cancer (CaP) undergoing androgen deprivation therapy. METHODS: A single-arm, pilot study was undertaken to ...PURPOSE: To test the safety and efficacy of acupuncture in reducing hot flashes in men with advanced prostate cancer (CaP) undergoing androgen deprivation therapy. METHODS: A single-arm, pilot study was undertaken to evaluate acupuncture treatment for hot flashes experienced by CaP patients undergoing hormonal therapy. Sixteen advanced CaP patients undergoing androgen deprivation therapy (ADT) received standardized full body and auricular acupunc-ture 1x/week for 14 weeks. Patients were evaluated at 0, 7, 14, and an additional 14-wk follow-up (F/U) (28-wks). Safety was measured by monitoring for adverse events over the treatment period. Serum testosterone was measured at 0 and 14-wks. Quality of life (QOL) was measured by the hormone domain of the Expanded Prostate Index Composite (EPIC), at the 0, 7, 14, and 28-wks and patient reported hot flash frequency was assessed weekly. Safety endpoints were serum testosterone and analysis of adverse events. Efficacy endpoints were scores on the EPIC and the number of pa-tient reported hot flashes. RESULTS: 17 patients were enrolled and 15 completed the trial. Of 15 evaluable patients the median age was 68 ± 8.19. Serum analysis demonstrated no change in testosterone at baseline 9.5 ng/ml ± 8.9 vs. end-point 14 ± 8.78 (p = 0.101). No adverse events were reported. Data analysis of the EPIC demonstrated a trend toward improvement after 7 wks and a significant improvement following 14 wks of acupuncture (p = 0.01). Analysis of patient reported frequency showed a significant reduction in the number of hot flashes at 7-wk (6, p = 0.04), 14-wk (2.6, p = 0.001), and 28-wk F/U (3.2, p = 0.01) as compared to baseline 9.57 ± 3.98. CONCLUSIONS: The administration of acupuncture in men with advanced CaP appears to significantly decrease the frequency of hot flashes. No serious ad-verse events were noted and serum testosterone levels were unchanged from baseline suggesting that the mechanism of action of acupuncture for hot flash amelioration is not via increase in testosterone.展开更多
Objective: It has been suggested that pantothenic acid may have antibacterial and skin softening activity. The aim of this study was to explore the feasibility, tolerability, safety and preliminary efficacy of oral ad...Objective: It has been suggested that pantothenic acid may have antibacterial and skin softening activity. The aim of this study was to explore the feasibility, tolerability, safety and preliminary efficacy of oral administration of a dietary supplement containing pantothenic acid in healthy human males and females with mild to moderate facial acne vulgaris. Methods: An open-label, single arm study of healthy adults who had been previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were asked to take the study agent, a dietary supplement containing pantothenic acid, for eight weeks. The primary endpoint of the study was to assess the feasibility of oral administration of the study agent in subjects over an eight week period. Safety and tolerability were measured utilizing the assessment of adverse events by the National Cancer Institute’s Common Criteria for Adverse Event Reporting. Secondary endpoints measuring the efficacy of an oral panthothetic acid dietary supplement for the treatment of mild to moderate facial acne utilized changes in the extent of global facial skin blemishes, assessment of quality of life utilizing the Dermatology Life Quality Index (DLQI) and analysis of questions about the subject's beliefs and attitudes towards skin care and lifestyle. Results: Eleven subjects were enrolled and ten completed the study (90.9%). There were no reported adverse events. Of the 10 evaluable subjects, the average age (mean ± SD) was 31.8 ± 8. Analysis of the global number of skin blemishes demonstrated a significant mean reduction in lesion count following the use of the study agent at week 8 (endpoint) (11.18 ± 6.38, p = 0.02) compared to the average number of baseline blemishes (20.45 ± 10.44). DLQI scores were significantly lower at week 8 vs. baseline (p = 0.0194). Conclusions: The results from this study indicated that the administration of a pantothenic based dietary supplement in healthy human adults with mild to moderate acne vulgaris is feasible, safe and well tolerated. Secondary analysis shows that administration of the study agent significantly reduced global facial blemishes. Further randomized, placebo-controlled trials are warranted.展开更多
文摘PURPOSE: To test the safety and efficacy of acupuncture in reducing hot flashes in men with advanced prostate cancer (CaP) undergoing androgen deprivation therapy. METHODS: A single-arm, pilot study was undertaken to evaluate acupuncture treatment for hot flashes experienced by CaP patients undergoing hormonal therapy. Sixteen advanced CaP patients undergoing androgen deprivation therapy (ADT) received standardized full body and auricular acupunc-ture 1x/week for 14 weeks. Patients were evaluated at 0, 7, 14, and an additional 14-wk follow-up (F/U) (28-wks). Safety was measured by monitoring for adverse events over the treatment period. Serum testosterone was measured at 0 and 14-wks. Quality of life (QOL) was measured by the hormone domain of the Expanded Prostate Index Composite (EPIC), at the 0, 7, 14, and 28-wks and patient reported hot flash frequency was assessed weekly. Safety endpoints were serum testosterone and analysis of adverse events. Efficacy endpoints were scores on the EPIC and the number of pa-tient reported hot flashes. RESULTS: 17 patients were enrolled and 15 completed the trial. Of 15 evaluable patients the median age was 68 ± 8.19. Serum analysis demonstrated no change in testosterone at baseline 9.5 ng/ml ± 8.9 vs. end-point 14 ± 8.78 (p = 0.101). No adverse events were reported. Data analysis of the EPIC demonstrated a trend toward improvement after 7 wks and a significant improvement following 14 wks of acupuncture (p = 0.01). Analysis of patient reported frequency showed a significant reduction in the number of hot flashes at 7-wk (6, p = 0.04), 14-wk (2.6, p = 0.001), and 28-wk F/U (3.2, p = 0.01) as compared to baseline 9.57 ± 3.98. CONCLUSIONS: The administration of acupuncture in men with advanced CaP appears to significantly decrease the frequency of hot flashes. No serious ad-verse events were noted and serum testosterone levels were unchanged from baseline suggesting that the mechanism of action of acupuncture for hot flash amelioration is not via increase in testosterone.
文摘Objective: It has been suggested that pantothenic acid may have antibacterial and skin softening activity. The aim of this study was to explore the feasibility, tolerability, safety and preliminary efficacy of oral administration of a dietary supplement containing pantothenic acid in healthy human males and females with mild to moderate facial acne vulgaris. Methods: An open-label, single arm study of healthy adults who had been previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were asked to take the study agent, a dietary supplement containing pantothenic acid, for eight weeks. The primary endpoint of the study was to assess the feasibility of oral administration of the study agent in subjects over an eight week period. Safety and tolerability were measured utilizing the assessment of adverse events by the National Cancer Institute’s Common Criteria for Adverse Event Reporting. Secondary endpoints measuring the efficacy of an oral panthothetic acid dietary supplement for the treatment of mild to moderate facial acne utilized changes in the extent of global facial skin blemishes, assessment of quality of life utilizing the Dermatology Life Quality Index (DLQI) and analysis of questions about the subject's beliefs and attitudes towards skin care and lifestyle. Results: Eleven subjects were enrolled and ten completed the study (90.9%). There were no reported adverse events. Of the 10 evaluable subjects, the average age (mean ± SD) was 31.8 ± 8. Analysis of the global number of skin blemishes demonstrated a significant mean reduction in lesion count following the use of the study agent at week 8 (endpoint) (11.18 ± 6.38, p = 0.02) compared to the average number of baseline blemishes (20.45 ± 10.44). DLQI scores were significantly lower at week 8 vs. baseline (p = 0.0194). Conclusions: The results from this study indicated that the administration of a pantothenic based dietary supplement in healthy human adults with mild to moderate acne vulgaris is feasible, safe and well tolerated. Secondary analysis shows that administration of the study agent significantly reduced global facial blemishes. Further randomized, placebo-controlled trials are warranted.
