Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients.

BACKGROUND: Immunosuppressed organ-transplant recipients have an increased incidence of, and mortality from, skin cancer. Nicotinamide (vitamin B3) enhances the repair of ultraviolet (UV) radiation-induced DNA damage, reduces the cutaneous immunosuppressive effects of UV radiation, and reduces the incidence of keratinocyte cancers (including squamous-cell and basal-cell carcinomas) and actinic keratoses among high-risk immunocompetent patients. Whether oral nicotinamide is useful for skin-cancer chemoprevention in organ-transplant recipients is unclear. METHODS: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, organ-transplant recipients who had had at least two keratinocyte cancers in the past 5 years to receive 500 mg of nicotinamide or placebo twice daily for 12 months. Participants were examined for skin lesions by dermatologists at 3-month intervals for 12 months. The primary end point was the number of new keratinocyte cancers during the 12-month intervention period. Secondary end points included the numbers of squamous-cell and basal-cell carcinomas during the 12-month intervention period, the number of actinic keratoses until 6 months after randomization, safety, and quality of life. RESULTS: A total of 158 participants were enrolled, with 79 assigned to the nicotinamide group and 79 to the placebo group. The trial was stopped early owing to poor recruitment. At 12 months, there were 207 new keratinocyte cancers in the nicotinamide group and 210 in the placebo group (rate ratio, 1.0; 95% confidence interval, 0.8 to 1.3; P = 0.96). No significant between-group differences in squamous-cell and basal-cell carcinoma counts, actinic keratosis counts, or quality-of-life scores were observed. Adverse events and changes in blood or urine laboratory variables were similar in the two groups. CONCLUSIONS: In this 12-month, placebo-controlled trial, oral nicotinamide therapy did not lead to lower numbers of keratinocyte cancers or actinic keratoses in immunosuppressed solid-organ transplant recipients. (Funded by the National Health and Medical Research Council; ONTRANS Australian New Zealand Clinical Trials Registry number, ACTRN12617000599370.).

Outcome Measurement Instruments for Provoked Vulvodynia: A Systematic Review.

OBJECTIVE: The objective of this study was to detail the outcome measurement instruments used in randomized control trials and observational studies investigating therapeutic interventions for provoked vulvodynia. MATERIALS AND METHODS: We searched Ovid Medline, Embase, Emcare, and PyschINFO libraries from database inception through April 2017. We included randomized control trials and observational studies of provoked vulvodynia that used instruments to measure the outcome of therapeutic interventions. RESULTS: A total of 2299 articles were retrieved and 25 were eligible for inclusion in accordance with the selection criteria. The included studies measured 26 different outcomes, using 110 outcome measurement instruments. Patient-reported outcomes were most commonly measured (144/166, 86%), followed by physician-reported outcomes (20/166, 12%). The most commonly measured outcomes were patient-reported psychological impact of disease (27/166, 16%), patient-reported improvement in dyspareunia (25/166, 15%), and patient-reported reduction in pain (24/166, 14%). The Pain Catastrophizing Scale, the Beck Depression Inventory, and the State Trait Anxiety Questionnaire were the most commonly used instruments to measure psychological impact.The most commonly measured clinician-rated outcome was an improvement in pain (17/166, 10%), which was most frequently assessed by the cotton swab test. Only 34 (31%) outcome measurement instruments were specific to vulvodynia (26/110, 23%) or sexual functioning (8/110, 7%). CONCLUSIONS: There is a wide range of outcome measurement instruments used in provoked vulvodynia studies, resulting in inconsistency of reporting and difficulty in comparing and combining findings for systemic review. There is a pressing need for the development of validated, reliable instruments and consensus on a core outcome set for further research purposes.