This page consists of a library of scientific materials, such as the reports of scientific tests, also called studies, that are relevant to your health. This page of our web site is intended to be educational in nature only.
Please keep in mind that it is important to read the text of the entire study report, although the Discussion, Results and Conclusions part of each study report and other publication will probably be of most interest to most viewers and readers. Finally, please remember the conclusions of the authors of each study may not be shared by all scientists or, possibly, by no other scientists. Often, there are opposing views of the benefit, including the extent of that benefit, of a particular ingredient or product.
THE NEW ENGLAND JOURNAL OF MEDICINE
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Title: A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention
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Background: Nonmelanoma skin cancers, such as basal-cell carcinoma and squamous-cell carcinoma, are common cancers that are caused principally by ultraviolet (UV) radiation. Nicotinamide (vitamin B3) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses.
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Objective: To determine if Nicotinamide (vitamin B3) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses.
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Methods: Randomly assigned participants in a 1:1 ratio to receive either 500 mg of nicotinamide (Insolar, Blackmores) twice daily or matched placebo. Randomization was performed centrally with stratification according to 5-year history of nonmelanoma skin cancer (<6 vs ≥6 nonmelanoma skin cancers), sex, and study site. Nicotinamide and placebo were administered in identical coated tablets. Participants received either nicotinamide or placebo for 12 months, and adherence was monitored by two of the authors who counted the remaining tablets at each visit through 12 months.
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Results: Among high-risk patients, nicotinamide was associated with a lower rate of new nonmelanoma skin cancers than was placebo and had an acceptable safety profile. Nicotinamide is widely accessible as an inexpensive over-the-counter vitamin supplement and presents a new opportunity for the chemoprevention of nonmelanoma skin cancers that is readily translatable into clinical practice.
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Conclusions: Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients.
View full publication – https://www.nejm.org/doi/full/10.1056/nejmoa1506197
THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY
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Title: Safety and Efficacy of Oral Polypodium leucotomos Extract in Healthy Adult Subjects
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Background: To determine the Safety and Efficacy of Oral Polypodium leucotomos Extract in Healthy Adult Subjects
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Objective: The objective of this study was to determine the safety of oral Polypodium leucotomos extract administered twice daily to healthy adults for 60 days and assess its ability to provide protection against exposure to ultraviolet radiation.
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Methods: Twenty subjects were randomized to receive 240mg of P. leucotomos extract or placebo twice daily at approximately 8AM and 2PM for two months. In addition, 10 subjects from each treatment group were randomized to undergo minimal erythema dose (MED) testing,19 consisting of three sessions of two-minute exposures to UV-B on an area of the buttocks that normally does not receive sun exposure.
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Results: After two months of treatment, there were no changes in any safety assessments. The subjects in the placebo group showed a greater likelihood of experiencing >1 episodes of sunburn (2 vs. 8 subjects; p=0.04) At Day 28, Polypodium leucotomos extract-treated subjects showed greater likelihood of an increased minimal erythema dose (8 vs. 1 subject; p=0.01) and greater likelihood of decreased ultraviolet-induced erythema intensity (10 subjects vs. 3 subjects; p<0.01).
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Conclusions: Polypodium leucotomos extract 240mg taken twice daily for 60 days was a safe and effective means for reducing the damaging effects of ultraviolet radiation. Based on the excellent safety profile of Polypodium leucotomos, additional studies using higher doses may be warranted.
View full publication – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345929/
THE NATIONAL LIBRARY OF MEDICINE
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Title: Oral Nicotinamide Prevents Common Skin Cancers in High-Risk Patients, Reduces Costs
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Background: As the aging population continues to grow, basal- and squamous-cell carcinomas will become even more common than they currently are. The investigators are from Australia, which has extremely high rates of sun-induced skin cancers. A previous phase 2 study by this group showed that nicotinamide reduced the number of new actinic keratoses in Australian patients with sun-damaged skin.
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Objective: To determine if oral Nicotinamide prevents common skin cancers in high-risk patients.
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Methods: The present study included 386 patients aged 30 to 91 years who had ≥2 nonmelanoma skin cancers over the past 5 years, and were therefore deemed high-risk. The patients were randomized to oral nicotinamide 500 mg twice daily or to placebo for 12 months.
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Results: The vitamin B3 supplement called nicotinamide—cut the rate of new squamous-cell and basal-cell skin cancers by 23% compared with placebo after 1 year among patients at high risk for skin cancer. Nicotinamide also reduced the risk for developing actinic keratosis, a common precancer of the skin.
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Conclusions: Nicotinamide is the form of vitamin B3 that should be taken for prevention—not other forms of vitamin B, such as niacin.
