Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia.

OBJECTIVE: Non-surgical therapies are needed to reduce the rate of progression of low-grade cervical intraepithelial neoplasia (CIN 1) to high grade CIN (CIN 2/3). The aim of this study was to assess the efficacy and safety of hexaminolevulinate (HAL) photodynamic therapy (PDT) in the treatment of patients with CIN 1. STUDY DESIGN: This phase IIa prospective double-blind study randomized patients with CIN 1 into three groups: HAL vaginal suppository, placebo vaginal suppository or follow-up only. Patients in the first two groups received HAL or placebo suppositories 5 hours before illumination with 50 J/cm(2) red coherent light (633 nm) using a special light catheter. All patients had a follow up including colposcopy, cytology and human papilloma virus (HPV) testing 3 and 6 months and additional biopsy 6 months after PDT. The main outcome measure was efficacy, defined as complete histologic remission 6 months after PDT. Secondary outcomes were histologic remission 3 months and HPV eradication 6 months after first PDT. RESULTS: Seventy patients were randomized: 47 to HAL, 12 to placebo, 11 to follow up only. After 6 months CIN lesions had cleared in 57% of patients in the HAL-PDT group compared to 25% in the combined control group (per protocol population, P = 0.04). Twenty-six patients (37%) reported 44 adverse events (AEs), of which 40 were mild or moderate. Nineteen treatment-related AEs were reported by 15 patients (32%) in the HAL PDT group, one in the placebo PDT group (8%), and none in the follow-up group. The most common adverse events were local discomfort including mild pain/cramping (11) and leucorrhoea (2). CONCLUSION: HAL PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with CIN 1.

Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers.

OBJECTIVES: To evaluate healthcare providers' (HCPs') knowledge, attitudes and beliefs regarding intrauterine contraception (IUC). STUDY DESIGN: HCPs in eight European countries and Canada who saw at least 20 women per month for contraception completed an online questionnaire. Responses were evaluated by country. RESULTS: In total, 1103 HCPs completed the survey: 633 obstetrician-gynecologists, 335 general practitioners and 135 family planning clinicians (physician, midwife or nurse). When respondents in different countries were asked to report their three main barriers to considering IUC, predominant concerns were nulliparity (34-69%) and pelvic inflammatory disease (PID; 14-83%) for women in general, and insertion difficulty (25-83%), PID (17-83%), insertion pain (7-60%) and infertility (6-55%) for nulliparous women. In addition, 4-59% of HCPs reported that they never proactively include IUC in contraceptive counseling for a nulliparous woman, regardless of her age. Furthermore, only 30-61% of respondents correctly identified that, in the World Health Organization medical eligibility criteria for IUC, nulliparity is category 2 (benefits outweigh risks). CONCLUSIONS: HCPs in Europe and Canada have clear gaps in their knowledge regarding IUC and misplaced concerns persist, particularly regarding use of IUC in nulliparous women; the predominant misconceptions are about PID, insertion difficulty and insertion pain. Further education on the evidence is needed so that IUC is recognized as being suitable for young and nulliparous women and is included in contraceptive counseling.