Treatment of Vulvovaginal Atrophy with Fractional CO2 Laser: Evaluating Real-World Data.

Objective: We aimed to evaluate real-world data for the use of fractional CO2 laser therapy for treating symptoms of vulvovaginal atrophy (VVA). Background: VVA is widespread and can reduce the patients' quality of life. There is a lack of data regarding its therapy with laser, especially for daily practice (i.e., real-world data). Methods: Thirty-six patients were treated in a single medical center. They consisted of pre- and postmenopausal women and received three fractional CO2 laser therapy treatments with 3-6 weeks between each treatment. Each patient financed the treatment privately. The symptoms pain, pruritus, dyspareunia, burning, dryness, and dysuria were recorded with a visual analog scale (1-10) before the first, second, and third laser treatment. The data were examined retrospectively. Results: Pain was reduced from a mean of 2.5 points (minimum 0, maximum 9 points) to 1.1 (minimum 0, maximum 8 points) before the third laser treatment. Pruritus showed a mean score of 3.8 (minimum 0, maximum 10 points). This decreased to 1.4 (minimum 0, maximum 8 points). Dyspareunia scored a mean of 6.8 (minimum 0, maximum 10 points). After two laser therapies, the score was 3.3 (minimum 0, maximum 8 points). Burning showed 4.2 points (minimum 0, maximum 10 points). Having experienced two laser therapy sessions, the patients scored 1.5 (minimum 0, maximum 9 points) points. The severity of dryness dropped from 6.5 (minimum 0, maximum 10 points) to 3.3 (minimum 0, maximum 9 points). Dysuria was stated with 1.8 points (minimum 0, maximum 10 points) before the first and 0.5 points (minimum 0, maximum 6 points) before the third laser therapy. All changes showed statistical significance (p < 0.002). Conclusions: This real-world data propose fractional CO2 laser to reduce VVA-associated genital discomfort, thus being a valuable therapy option for pre- and postmenopausal women.

Sleep Quality Improves During Treatment With Bryophyllum pinnatum: An Observational Study on Cancer Patients.

HYPOTHESIS: Cancer patients frequently suffer from poor sleep quality. Bryophyllum pinnatum is a herbal medication used in anthroposophic medicine, which has been shown to be associated with improvements in sleep quality during pregnancy with only few and minor or moderate side-effects reported. In this study, the sleep quality of cancer patients during treatment with B pinnatum was investigated. STUDY DESIGN: In this prospective, observational study, cancer patients suffering from sleep problems were treated with B pinnatum (350 mg tablets, corresponding to 50% of leaf pressed juice [Weleda AG, Arlesheim, Switzerland], dosage at physician's consideration, but most frequently 2 tablets with evening meal and 2 before going to bed). METHODS: Sleep quality (Pittsburgh Sleep Quality Index [PSQI]), daily sleepiness (Epworth Sleeping Scale [ESS]), and fatigue (Fatigue Severity Scale [FSS]) were assessed at the beginning of the treatment and after 3 weeks. Possible adverse drug reactions perceived by the patients during the treatment were recorded. From the 28 recruited patients, 20 completed both questionnaires and were considered in the present analysis. Data are expressed as mean ± standard deviation. RESULTS: Patients were 61 ± 10.4 years old and the majority were female (17 out of 20). During treatment with B pinnatum, the PSQI decreased from 12.2 ± 3.62 to 9.1 ± 3.61 (P < .01), and ESS changed from 8.4 ± 3.18 to 7.1 ± 3.98 (P < .05). There was no change in FSS. The treatment was well tolerated by the majority of patients, with only 6 patients reporting discomfort that might have been caused by B pinnatum (fatigue n = 3, dry throat n = 1, agitation n = 1, difficult digestion n = 1). No serious adverse drug reactions were detected. CONCLUSION: B pinnatum may be a suitable treatment for sleep problems of cancer patients. Controlled, randomized clinical trials of the use of B pinnatum in sleep disorders are urgently needed.

Efficacy of black cohosh (Cimicifuga racemosa) medicines for treatment of menopausal symptoms - comments on major statements of the Cochrane Collaboration report 2012 "black cohosh (Cimicifuga spp.) for menopausal symptoms (review)".

Menopausal symptoms management with high-quality plant extracts from Actaea (Cimicifuga. racemosa rootstock is well-established. Efficacy and safety are supported by research and clinical trials since several decades and backed up by official monographs. However, the recent published Cochrane review on black cohosh neglects major evidence for beneficial effects. The authors' negative conclusions are questionable and call for reply and clarification. Our careful reconsideration of all appropriate placebo-controlled clinical studies reveals a standardized mean difference of 0.385 in favor of black cohosh (p < 0.0001).

Bone pain reduction in patients with metastatic breast cancer treated with ibandronate-results from a post-marketing surveillance study.

BACKGROUND: Pain relief is an important treatment goal for breast cancer patients with metastatic bone disease and treatment should be associated with a low rate of side effects. This interim analysis of a prospective non-interventional study documents the efficacy and safety of the amino-bisphosphonate ibandronate in the treatment of metastatic bone disease under real-life conditions. PATIENTS AND METHODS: For up to 24 weeks 913 breast cancer patients received IV infusions of 6 mg ibandronate every 3-4 weeks or 50 mg of oral ibandronate once daily. Efficacy variables included pain severity, analgesic use, and skeletal-related events; the major safety parameter was renal function, assessed by serum creatinine levels. Subgroup analyses were performed according to pretreatment with bisphosphonates (none, ibandronate, or other bisphosphonates). RESULTS: At baseline, patients with ibandronate pretreatment tended to have lower mean pain scores and lower serum creatinine levels than those pre-treated with other bisphosphonates. Over the observation period, analgesic use did not increase. Among the 712 patients reporting pain at baseline, 70% achieved an improvement in pain severity during treatment with ibandronate, and there was no evidence to suggest relevant differences in mean pain reductions with IV or oral administration of ibandronate or according to prior bisphosphonate treatment. Skeletal-related events were rare (7%). Changes in serum creatinine levels during ibandronate treatment were small and both formulations of ibandronate were rated as well tolerated by physicians and patients. CONCLUSIONS: Data from this non-interventional study confirm the analgesic efficacy and safety profile of IV and oral ibandronate under real-life conditions.

The impact of breast cancer awareness and socioeconomic status on willingness to receive breast cancer prevention drugs.

PURPOSE: To find associations between knowledge about risk factors for breast cancer and the socioeconomic status of healthy women, as well as their attitude toward taking chemopreventive drugs. PATIENTS AND METHODS: Between April and September 1999, 7135 healthy women completed questionnaires providing information about their willingness to take chemopreventive drugs. Items in the questionnaire included the sources of the information they had, their estimates of the population and personal lifetime risk, and risk factors for breast cancer. RESULTS: A total of 6597 questionnaires were evaluable. The responders' median age was 44. Fifty-five percent of the women were willing to consider receiving chemopreventive drugs to lower their risk for breast cancer. Participants who estimated the population risk as being very high were more disposed to receive chemoprevention (65.3%), as were women who estimated their own breast cancer risk as being high (74.1%). A family history of breast cancer only had a low impact on willingness to receive chemoprevention. Women with a family history of breast cancer were willing to take chemopreventive agents in 57.2% of cases. The multivariate analysis showed that knowing about risk factors and having a lower educational level were factors positively correlated with willingness to consider chemoprevention. CONCLUSION: These findings emphasize the role of estimations of the risk of breast cancer for patients considering whether to accept chemoprevention treatment. To date, only a few modern models of risk estimation have been evaluated in relation to chemoprevention. There is a need for better integration of professional risk estimations into clinical practice.

Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO.

BACKGROUND: The combination of carboplatin and paclitaxel is the standard of care for the treatment of ovarian cancer, yet rates of recurrence and death remain high. We performed a prospective randomized phase III study to examine whether sequential administration of topotecan can improve the efficacy of carboplatin and paclitaxel in first-line treatment of advanced epithelial ovarian cancer. METHODS: A total of 1308 patients with previously untreated ovarian cancer (International Federation of Gynecology and Obstetrics stages IIB-IV) were randomly assigned to receive six cycles of paclitaxel and carboplatin followed by either four cycles of topotecan (TC-Top; 658 patients) or surveillance (TC; 650 patients) on a 3-week per cycle schedule. The primary endpoint was overall survival, and secondary endpoints were progression-free survival, response rate, toxicity, and quality of life. Time-to-event data were analyzed using the Kaplan-Meier method, and a stratified log-rank test was used to compare distributions between treatment groups. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using a Cox proportional hazards model. Categorical data were compared using a stratified Cochran-Mantel-Haenszel test. All statistical tests were two-sided. RESULTS: Median progression-free survival was 18.2 months in the TC-Top arm versus 18.5 months in the TC arm (stratum-adjusted HR = 0.97 [95% CI = 0.85 to 1.10]; P = .688). Median overall survival was 43.1 months for the TC-Top arm versus 44.5 months for the TC arm (stratum-adjusted HR = 1.01 [95% CI = 0.86 to 1.18]; P = .885). At 3 years, overall survival in both arms was 57% (58.5% in the TC arm and 55.7% in the TC-Top arm). Compared with patients in the TC arm, patients in the TC-Top arm had more grade 3-4 hematologic toxic effects (requiring more supportive care) and more grade 3-4 infections (5.1% versus 2.7%; P = .034) but did not have a statistically significant increase in febrile neutropenia (3.3% versus 3.1%; P = .80). Among patients who had measurable disease (TC, n = 147; TC-Top, n = 145), overall (i.e., complete or partial) response was 69.0% (95% CI = 61.4% to 76.5%) in the TC-Top arm and 76.2% (95% CI = 69.3% to 83.1%) in the TC arm (P = .166). CONCLUSIONS: The sequential addition of topotecan to carboplatin-paclitaxel did not result in superior overall response or progression-free or overall survival. Therefore, this regimen is not recommended as standard of care treatment for ovarian cancer.