Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c-PDT), using methyl aminolevulinate (MAL) cream. OBJECTIVES: To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK. MATERIALS AND METHODS: This 24-week randomized, controlled, investigator-blinded, multicentre, intra-individual efficacy (non-inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary end points for DL-PDT at week 12 were efficacy [non-inferiority regarding complete lesion response (mild AK)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire. RESULTS: At week 12, the complete lesion response rate with DL-PDT was non-inferior to c-PDT (89·2% vs. 92·8%, respectively; 95% confidence interval -6·8 to -0·3), confirmed by intention-to-treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the PDT session. For DL-PDT, subject-reported pain was significantly lower (0·8 vs. 5·7, respectively; P < 0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome. CONCLUSIONS: Daylight-mediated PDT was not inferior in efficacy to Metvix c-PDT (mild AK response rate), better tolerated, nearly painless and more convenient for patients.

Randomized trial of dietician counseling to try to prevent weight gain associated with breast cancer adjuvant chemotherapy.

This study was developed to test whether prospective dietician counseling could abrogate the unwanted weight gain seen among women receiving adjuvant chemotherapy for resected breast cancer. It was also designed to examine predictive factors for weight gain in an exploratory manner. Premenopausal women starting adjuvant chemotherapy for primary breast cancer were recruited for this trial. After appropriate stratification, they were randomized to a group which received monthly dietician counseling primarily aimed at weight maintenance versus a control group (whose attending physicians and nurses told them about possible weight gain but provided no formalized dietician counseling). One hundred and seven evaluable women were equally divided between the two protocol arms. The median weight changes 6 months after start of chemotherapy were gains of 2.0 kg in the dietician counseling group versus 3.5 kg in the control group. The median changes in average calorie consumption were reductions of 120 versus 46 cal/day on weekdays and 196 versus 20 cal/day on weekends for the counseling and control groups, respectively. Study data suggest that more weight was gained by patients with higher Quetelet's indices (p = 0.01) and patients who had been on a diet in the preceding 6 months (p = 0.02). Routine prospective dietician counseling aimed at weight maintenance appeared to produce small but statistically insignificant reductions in both calorie consumption and weight gain in this group of patients.

Ocular complications of PUVA therapy.

PUVA, the combination of psoralen and long wave ultraviolet radiation is widely used in the management of psoriasis, vitiligo and several other dermatological disorders. The potential for long term treatment to cause ocular damage remains to be determined and despite the large numbers of patients who have received PUVA treatment, development of cataract is exceedingly rare. This paper discusses cataract formation, reviews the literature concerning the ocular complications of PUVA therapy and proposes guidelines for ocular protection during photochemotherapy.