PRISM study: Comparison of a nystatin-neomycin-polymyxin B combination with miconazole for the empirical treatment of infectious vaginitis.

OBJECTIVE: An empirical treatment of infectious vaginitis is justified because of its multiple etiologies, the frequent uncertainty of clinical diagnosis and limits of microbiological analysis. Our aim was to comparatively investigate nystatin-neomycin-polymyxin B combination (NNP, Polygynax®) and miconazole. PATIENTS AND METHODS: In this European multicenter, double-blind PRISM trial, participating women presenting with infectious vaginitis were randomized to receive one vaginal capsule containing either NNP for 12 days or miconazole for 3 days followed by 9 days of placebo. RESULTS: The clinical success rate was higher in the NNP group (n=302) than the miconazole group (n=309), with a difference between groups close to statistical significance (91.1% vs. 86.7%, P=0.0906). The risk of treatment failure was 36% lower in the NNP group (odds ratio, 0.64; 95% confidence interval, 0.38-1.07). Vaginal burning on Day 2 and vaginal discharge on Day 4 were significantly less intense in the NNP group than in the miconazole group (39.1 vs. 42.3, P=0.031 and 34.6 vs. 37.6, P=0.031, respectively). Adverse drug reactions were reported by 1.2% and 2.1% of patients in the NNP and miconazole group respectively, with the ratio of adverse drug reactions relative to total adverse events significantly higher in the miconazole group (20.3% vs. 6.9%, P=0.022). CONCLUSION: The widespread use of NNP for several decades and its good efficacy and safety profile, as well as the frequent diagnostic uncertainties due to the various pathogens sustain the initiation of this broad-spectrum empirical treatment in infectious vaginitis.

Bactericidal activity of 3 cutaneous/mucosal antiseptic solutions in the presence of interfering substances: Improvement of the NF EN 13727 European Standard?

OBJECTIVE: There is no standard protocol for the evaluation of antiseptics used for skin and mucous membranes in the presence of interfering substances. Our objective was to suggest trial conditions adapted from the NF EN 13727 standard, for the evaluation of antiseptics used in gynecology and dermatology. METHODS: Three antiseptic solutions were tested in vitro: a chlorhexidine-benzalkonium (CB) combination, a hexamidine-chlorhexidine-chlorocresol (HCC) combination, and povidone iodine (P). The adaptation of trial conditions to the standard involved choosing dilutions, solvent, and interfering substances. The activity of solutions was assessed on the recommended strains at concentrations of 97% (pure solution), 50%, and 10% (diluted solution), and 1%. A logarithmic reduction ≥ 5 was expected after 60seconds of contact, to meet requirements of bactericidal activity. RESULTS: HCC did not present any bactericidal activity except on P. aeruginosa at a concentration of 97%. P was not bactericidal on E. hirae at any concentration and on S. aureus at 97%. CB had the most homogeneous bactericidal activity with a reduction>5 log on the 4 bacterial strains at concentrations of 97%, 50% and 10%. CONCLUSION: Adapting the NF EN 13727 standard allowed assessing the 3 tested solutions: only CB was bactericidal in dirty conditions. This study proved the possibility of validating antiseptic choice in vitro, in current practice conditions, for adjunctive treatment of skin and mucous membranes disorders, primarily of bacterial origin or with a potential of superinfection.

[The etiologic diversity of vaginitis]. / Diversité étiologique des vaginites.

OBJECTIVE: To establish the different etiologies of vaginitis and, especially, assess the distribution of responsible pathogens through a prospective study. PATIENTS AND METHODS: One hundred and sixty-nine women aged between 18 and 65 years (average age: 33.7 years old), consulting a physician for symptoms of vaginitis, were examined in 21 centers of gynaecology or infectious diseases. The clinical evaluation was completed by bacteriological sample that was tested for infections (including sexually transmitted infections (STIs)). RESULTS: One hundred and eighteen patients (69.8%) had one or several infectious etiologies distributed as follows: 79 (46.7%) candidiasis (3 of which were caused by non albicans Candida), 37 (21.9%) bacterial vaginitis and 16 (9.5%) bacterial vaginosis. To be noticed that there were 38 cases of mixed etiologies out of the 118 infectious etiologies (32.2%), 3 of them were STIs. DISCUSSION AND CONCLUSIONS: Although candidiasis was the most common etiology in this study, it only represented less than 1 out of every two patients. Among the infectious etiologies, 1 out of 3 women presented a bacterial or mixed vaginitis. The etiological diversity of vaginitis leads to consider broad-spectrum treatment as first-line therapy and to prescribe a microbiological analysis in case of failure.

[Sensitive skin in France: an epidemiological approach]. / Peaux sensibles en France: approche épidémiologique.

INTRODUCTION: Sensitive skin is a frequently evoked cosmetic disorder, but its prevalence in France is unknown. METHODS: Using a survey of a representative sample of the French population aged over 15 carried out by ISPSOS-Santé, we assessed the frequency of sensitive skin. We used the quota method (gender, age, occupation of the head of the family) and stratification by area and category of the agglomeration. RESULTS: One thousand and six persons were surveyed. The non-response rate was less than 1 p.cent. Fifty-two percent claimed they had sensitive or very sensitive skin. Women were predominantly concerned (59 vs. 44 p.cent, p<0.0001). There was no significant difference between the socio-professional categories. Twenty-eight p.cent of the population claiming their skin was very sensitive declared they had a concomitant dermatological disease, whereas 14 p.cent with sensitive skin, 7 p.cent with not very sensitive skin and 2 p.cent with normal skin declared likewise. Skin sensitivity was triggered by emotion, cold, heat or cosmetics. A quality-of-life assessment using the SF-12 scale showed significant alteration in the psychological dimension (but not physical) of the score for those with sensitive and very sensitive skin compared with the others, notably in the women (p<0.0001). DISCUSSION: This survey revealed a prevalence of sensitive skin in France equal to that found in England. It only measured the subjective feeling of sensitive skin experienced by those surveyed, since there was no clinical examination. The phenomenon appears frequent. Although women appeared to suffer more, a large proportion of men also suffered from sensitive skin.

Topical retinaldehyde with glycolic acid: study of tolerance and acceptability in association with anti-acne treatments in 1,709 patients.

BACKGROUND: Retinaldehyde (RAL), a key metabolite between vitamin A and retinoic acid, acts by modulating differentiation and proliferation of keratinocytes, which is of interest in acne lesions, mainly retentional lesions. Glycolic acid increases the exfoliation of corneocytes explaining its mild activity on retentional lesions. Thus, RAL and glycolic acid combined in the same product (Diacneal) have complementary activities which can be of interest for acne patients. The aim of this study was to evaluate the tolerance of Diacneal used by 1,709 acne patients in combination with their usual acne products except retinoids. RESULTS: This study demonstrated a very good tolerance of Diacneal when used with other acne treatments for 90 days. Complaints about side-effects were rare. Moreover, the significant decrease in both inflammatory and retentional lesions between day 0 and day 90 indicates that Diacneal could amplify the efficiency of other anti-acne products used at the same time by the patients. The subjective evaluation of the preparation's efficacy by investigators and patients was strongly favourable. CONCLUSION: These data show that a combination of RAL 0.1% and glycolic acid 6% may be used in association with other topical anti-acne treatments (benzoyl peroxide and topical antibiotics) with an excellent tolerance.

Gastrointestinal tolerability of ibuprofen compared with paracetamol and aspirin at over-the-counter doses.

This multicentre, randomized, investigator-blinded, parallel-group study compared the gastrointestinal (GI) tolerability of ibuprofen, paracetamol and aspirin at over-the-counter doses for common pain indications. Patients (of whom 8633 were evaluable) took either ibuprofen up to 1200 mg daily, or paracetamol or aspirin, each up to 3000 mg daily, for 1-7 days. The main outcome was the proportion of patients with GI adverse events. There were significantly more patients who suffered GI adverse events, principally abdominal pain, dyspepsia, nausea and diarrhoea, with aspirin (18.5%) than with ibuprofen (11.5%), but the difference between ibuprofen and paracetamol (13.1%) was not significant. Significantly more of those patients with a history of non-ulcer GI disease (n = 371) developed GI adverse events than did those with no such history; the incidence of GI adverse events in both groups was lowest with ibuprofen. More women than men experienced GI adverse events (15.5% versus 12.8%). The higher incidence of GI adverse events with aspirin was evident from the first day of treatment. In conclusion, the GI tolerability of ibuprofen, at over-the-counter doses of up to 1200 mg daily for up to 7 days, was at least as good as that of paracetamol and significantly better than that of aspirin.

Comparative tolerability of paracetamol, aspirin and ibuprofen for short-term analgesia in patients with musculoskeletal conditions: results in 4291 patients.

The aim of this blinded, randomised, multicentre study was to compare the tolerability of aspirin, paracetamol and ibuprofen in common pain resulting from musculoskeletal conditions (MSC) in general practice with patients with other non-MSC pain conditions. Patients took aspirin, paracetamol (both up to 3g daily) or ibuprofen (up to 1.2g daily) for up to 7 days. The main outcome was the rate of significant adverse events (SGAE). Four thousand two hundred and ninety one patients with MSC were evaluable (1436 aspirin, 1423 paracetamol, 1432 ibuprofen) and 4101 (95.5%) were per-protocol. A group of 4342 patients included for other (non-MSC) mild to moderate pain conditions was used for comparison. In the MSC group, SGAE were reported by 20.5% of patients with aspirin, 17.0% with paracetamol and 15.0% with ibuprofen. Ibuprofen was statistically equivalent to paracetamol and better tolerated than aspirin (p <0.0001). Ibuprofen was associated with fewer digestive system AE (4.4%) than aspirin (8.6%, p<0.0001) and paracetamol (6.5%, p <0.02). The non-MSC group showed similar intertreatment differences, but experienced fewer SGAE. No serious digestive events were observed with any of the three treatments in either group. These results show that in patients with mild to moderate pain resulting from MSC, ibuprofen given in OTC doses for 6 days is as well tolerated as paracetamol and better tolerated than aspirin.