Current and future hormonal contraception in Italy: results from an Italian consensus expert meeting.

BACKGROUND: Hormonal pills are among the most widely contraceptive methods used by women, despite the possible onset of different adverse events. To minimize the risk of thrombosis-related adverse events, different formulations and doses have been investigated. Micronized estradiol (E2)/nomegestrol acetate (NOMAC) 24+4 is the first monophasic combined oral contraceptive pill containing natural E2, the same steroid produced by the granulosa cells of women ovaries. This combination presents an improved effect on hemostasis and metabolism compared to ethinyl-estradiol (EE)-based products and may be considered a good option to meet women's needs in a more physiological way. Despite the benefits of E2, its use is still not so common among combined oral contraceptives (COC). METHODS: Seventy-seven Italian gynecologists were involved and asked to answer a survey to investigate some aspects related to contraception. The results of the survey were discussed within the same gynecologists and a panel of experts during eight macro-regional meetings. RESULTS: The survey demonstrated that clinicians dedicate 40-60% of their time to contraception and confirmed the importance of the choice of the contraceptive pill, which is mostly prescribed for contraceptive purposes. Moreover, COC containing E2 is considered as the first choice in oral contraception and meets the features of an ideal pill. CONCLUSIONS: Italian gynecologists reported that E2-based pill presents benefits related to safety, good tolerability, and low adverse events, in particular, related to a reduced thromboembolic risk. Research market data highlight that the use of these types of COC should expand with respect to traditional compounds containing EE.

Infezioni virali in ginecologia: un problema risolto?

The aim of this observational study was to evaluate the effectiveness of a dietary integrator containing methionine, zinc, Echinacea angustifolia and E. purpurea, probiotics, and antioxidant factors (Immuno Gin) in the treatment of mild cervical dysplasia associated with human papillomavirus (HPV) infection. The study sample was 95 women (age range, 31-55 years) resident in various cities in Italy. Initial Pap test results showed abnormal changes in cervical cells described as atypical squamous cells of undetermined significance (ASC-US) and HPV infection in 23/95 women, 3 of which received the study product. Follow-up repeat Pap testing at 6 months returned normal test results in all 3. In 12 of the 20 women who did not receive treatment with the study product, the repeat Pap test at 6 months showed normal results, whereas persistence of lesions was observed in the other 8 women, with progression to low-grade squamous intraepithelial lesion (LSIL) in one case. Forty-five women presented initially with abnormal changes in cervical cells described as LSIL and HPV infection. Twenty received treatment with the study product; the repeat Pap test at 6 months showed normal results in 15 and no change in lesions in the other 5. Among the 25 women who did not receive treatment with the study product, the repeat Pap test at 6 months showed normal results in 13, whereas persistence of lesions was noted in the other 12, with progression to high-grade squamous intraepithelial lesion - moderate cervical intraepithelial lesion 2 (HSIL - CIN 2) in one case. Twenty-seven women with vulvoperineal condylomatosis received treatment with the study product, as described above, plus biophysical treatment of the lesions. At the 6-month follow-up assessment, no relapse of lesions occurred in 19, whereas relapse was noted in the other 8. Though the study sample is too small to draw statistically significant conclusions, the percentage of cases of lesion regression among the women treated with the study product was slightly higher than in those who did not receive treatment. Use of the study product may provide clinical benefit by stimulating immune defenses against HPV infection.

Efficacy and tolerability of a new chlorhexidine-based vaginal gel in vaginal infections.

OBJECTIVE: We evaluated the efficacy and tolerability of a new chlorhexidine-based bioadhesive vaginal gel (Clomirex) in women with vaginal infections. STUDY DESIGN AND SUBJECTS: A total of 90 nonpregnant women with vaginal infections of both bacterial (bacterial vaginosis: BV) or fungal (vaginal candidiasis VC) origin, were enrolled in the study: a randomised, controlled, 4-week, multicentre trial. Patients were randomly treated with either chlorhexidine 0.5% vaginal gel (CHX-VG), 2.5 g or with metronidazole vaginal tablets 500 mg (M) or clotrimazole (CL) vaginal cream, depending on aetiology of the infection, daily for 7 days (treatment phase) in a 2:1 ratio. A total of 45 women had a diagnosis of BV and 45 a diagnosis of VC. Sixty women were treated with CHX-VG, 15 with M and 15 with CL. All patients were followed for an additional 3 weeks without treatments (follow-up phase). For women with BV,clinical cure rate was defined as the disappearance of the following signs and symptoms: homogenous vaginal discharge; presence of >or= 2 or more clue cells at the wet mount microscopy; a vaginal pH > 4.7 and a positive whiff test. For women with VC, clinical cure rate was defined as a resolution of signs and symptoms plus absence of hyphae, pseudohyphae and blastospores on 10% KOH wet mount microscopy. Clinical cure rate was assessed at the end of the study (week 4) by an investigator unaware of the patient's treatment allocation. RESULTS: At week 4, in women with BV, 28 out of 30 (93%) women in the CHX-VG group were clinically cured in comparison with 11 out of 15 (74%) in the M group (p = 0.3). In women with VC, 26 out of 30 (86.6%) women in the CHX-VG group were clinically cured in comparison with 13 out of 15 (86%) in the CL group (p = 0.5). Tolerability was good and very good in 90% of the CHX-VG patients. Six women (10%) complained of a mild transient burning sensation after CHX-VG vaginal application. No serious adverse events were observed during the trial in all treated groups. No women presented with vaginal discharge after treatment.

Efficacy of the combination of 2 g oral tinidazole and acidic buffering vaginal gel in comparison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investigator-blinded, controlled trial.

OBJECTIVE: To evaluate the efficacy of tinidazole (T) (Trimonase, Mipharm, Italy) and an acidic vaginal gel (Miphil) (M) in comparison with vaginal clindamycin (CL) (Cleocin Pharmacia Upjohn) in BV. DESIGN: A multicentre, randomised, investigator-blinded, controlled trial. POPULATION AND METHODS: 64 women with BV were enrolled. Thirty-two were allocated to receive oral T 2g, single dose, and 32 were assigned to CL 2% for 7 consecutive days. After week 1, T group were treated with an acidic vaginal gel, 2g every 3 days, for additional 3 weeks, whereas CL group did not received any additional treatment. Patients were evaluated at week 1 and 4. Vaginal pH, the BV-blue test (Gryphus Diagnostics, USA) and the whiff test were performed at baseline and at week 4. MAIN OUTCOMES MEASURES: Clinical cure rate; normalisation of vaginal pH (pH<4.5); and laboratory cure rate (defined as a clinical cure rate and a negative results of BV-blue and whiff test). RESULTS: At baseline, vaginal pH values were (mean+/-S.D.) 5.4+/-0.7 and 5.3+/-0.5 in T and CL groups, respectively. Six patients (2 in T group and 4 in CL group) withdrew from the study due to side effects. At week 1, the clinical cure rates were 84% in both T and CL treated group (P=N.S.). At week 4, clinical cure rates were 94% in T+M group and 77% in CL group (P=N.S.). The laboratory cure rates were 81% in T+M group and 59% in CL group (P<0.04). Vaginal pH normalisation (i.e. pH <4.5) was achieved in 78% and in 38% of T+M and CL groups, respectively (P<0.0007). CONCLUSIONS: In the short term, 2g single oral dose tinidazole was at least as effective as 7-day of vaginal clindamycin. The sequential treatment of tinidazole and acidic vaginal gel was superior to vaginal clindamycin in lowering vaginal pH and achieving a higher laboratory tests normalization rate at 1-month follow-up.