Effect of selenium intake on the prevention of cutaneous epithelial lesions in organ transplant recipients.

Organ graft recipients have a high rate of pre-malignant and malignant epithelial lesions. Selenium directly influences the number of Langer-hans cells. In several studies selenium has shown its role in preventing various carcinomas, it was worth investigating whether it could prevent skin cancer linked to human papilloma virus (HPV). A multicentre, randomised, placebo-controlled, parallel group study in 184 recent organ transplant recipients was undertaken. Patients were treated for 3 years with 200 mug/day selenium (91 patients) or a matching placebo (93 patients), and then monitored for 2 years. Occurrence rates of warts and various keratoses (main criterion) and of skin cancers (secondary criterion) were compared in the two groups, using Kaplan-Meyer analyses. There was no difference between the two groups for the main criterion (odds-ratio 1.09, p = 0.72) or the secondary criterion (odds-ratio 3.08; p = 0.15). When both arms were pooled, phenotype and age were not found to be discriminatory factors, whereas a previous history of an actinic keratosis significantly increased the risk of developing a skin cancer by 17.5%. Safety was good and similar in both groups. Selenium was not shown to prevent the occurrence of skin lesions linked to HPV. The occurrence of skin cancer was higher if there had been a previous actinic keratosis, highlighting the importance of early dermatological follow-up of the transplanted population. This was demonstrated by the high rate of epithelial lesions detected, which was more than twice the rate usually reported in the literature.

[Compliance with hormone replacement therapy in menopausal women: results of a two-year prospective French study comparing transdermal treatment with fixed oral combination therapy]. / Observance du traitement hormonal substitutif de la ménopause: résultats d'une étude prospective française de deux ans, comparant un traitement transdermique et une association fixe par voie orale.

OBJECTIVES: To evaluate rates of continuation with hormone replacement therapy (HRT) at 2 years in 2 cohorts of female patients, one of which was treated with a set combination of oral oestradiol valerate and medroxyprogesterone acetate and the other with percutaneous 17 beta-oestradiol gel combined with an oral progestogen selected by the prescribing doctor. PATIENTS AND METHODS: A prospective, randomised, open study, including 885 patients followed for 2 years whose 477 were in the oral HRT cohort and 408 were in the dermal cohort. Randomisation was done by group with prescription of the selected HRT for the cohort. The 2 treatment groups were compared using chi(2) tests and Fisher's exact test for qualitative variables, Student's t test or Wilcoxon's test for qualitative variables and Kaplan-Meier survival curves for continuation of HRT, with comparisons using the log-rank test. The prognostic value of baseline parameters on subsequent continuation of HRT was studied using the Cox model (Wald test, odds ratio). RESULTS; Among the 885 treated patients, 711 received the HRT assigned to their cohort (382 in the oral HRT cohort, 329 in the dermal HRT cohort). After 2 years, 77.9% of the patients in the oral HRT cohort and 73.4% of the patients in the dermal HRT cohort were continuing to take their prescribed HRT (P = 0. 076): 37.9% of patients in the oral HRT cohort and 20.2% of patients in the dermal HRT cohort (P < 0.001) continued taking their treatment without any modification. CONCLUSION: Although there was no significant difference in the level of compliance in the 2 groups, it is nonetheless worth noting that the HRT compliance with a sequential fixed estroprogestogen combination was, in this trial, at least equal to that with the free combination of a transdermal estrogen and a progestogen whose nature, dosage and sequence duration are selected by the prescriber. On the other hand, treatment modifications occurred more frequently in the cutaneous HRT group, which is logical as free combination affords to adapt the treatment to each patient.

Local spermicidal contraception: a comparative study of the acceptability and safety of a new pharmaceutical formulation of benzalkonium chloride, the vaginal capsule, with a reference formulation, the pessary.

OBJECTIVE: To evaluate comparatively the acceptability and safety of a new pharmaceutical form of benzalkonium chloride, the vaginal capsule, with the pessary form. METHODS: Eighty-nine women were randomized to receive either a benzalkonium chloride vaginal capsule or a benzalkonium chloride pessary prior to sexual intercourse according to an open cross-over design over a 2-month study period. RESULTS: The discomfort caused by delayed leakage or discharge was mild. The mean scores for subjective signs (burning, itching, vulvar pruritus) were also mild and were comparable for the two formulations. The capsule appeared to be slightly superior to the pessary regarding discomfort caused by immediate discharge or leakage, ease of use and acceptance by the woman's partner. Local safety was generally good. Adverse events consisted chiefly of vulvar pruritus and a vaginal or vulvar burning sensation, with a higher incidence being associated with the pessary than the capsule. All symptoms regressed spontaneously after the end of treatment. CONCLUSIONS: This study demonstrated good acceptability and good local safety for the benzalkonium chloride vaginal capsule. It is essential to take these parameters into consideration in the evaluation of any local spermicidal contraceptive, since they play a large part in compliance with, and thus in the efficacy of, the product under assessment.

Comparative three-month study of the efficacies of metformin and gliclazide in the treatment of NIDD.

In order to compare the effects of metformin and gliclazide on fasting serum insulin, 60 non-insulin dependent diabetics were included in a multi-centre study. Patients on a diabetic diet alone or a diabetic diet together with a sulphonylurea hypoglycaemic agent, with a fasting glucose greater than 1.4 g/l, on two measurements were included in the study. They were randomly allocated to two parallel groups and received either gliclazide or metformin. They were treated for three months and attended for consultation at one month and three months. The fasting serum insulin level decreased significantly in the group receiving metformin (26.2 +/- 3.2 mlU/L at entry versus 19.8 +/- 2.3 mlU/L after three months: less than 0.01), and increased in a non-significant way in the group receiving gliclazide (21.6 +/- 3 mlU/L versus 26.5 +/- 5 mlU/L after three months: NS). The difference between the two groups was significant (p less than 0.01). There was a comparable significant improvement in blood sugar levels during the three months in both patients receiving gliclazide and metformin. However, significant weight loss (p less than 0.05) occurred only in patients receiving metformin. There was an identical improvement in blood sugar control in both patients receiving gliclazide and metformin over the three months. On the other hand, fasting serum insulin levels decreased significantly in patients receiving metformin compared to gliclazide. The effect of metformin on serum insulin levels is probably due to its action on insulin resistance and its lack of effect on insulin secretion, in contrast to sulphonylurea hypoglycaemic agents like gliclazide.