METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.
RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.
CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.
TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.
METHODS: A literature search was performed in 3 electronic databases for articles published before August 2018. Randomized clinical trials published in English that compared PP between machine-assisted agitation and syringe irrigation with needles as part of nonsurgical root canal treatment were included. Two authors were independently involved in the article selection process, data extraction, and assessment of the quality of included studies using the revised Cochrane risk of bias tool. The pooled effect estimates of the standardized mean difference (SMD) between machine-assisted agitation and syringe irrigation with needle was calculated by a random effects-modeled meta-analysis. A subgroup meta-analysis was performed. The quality of evidence was evaluated by the Grading of Recommendations, Assessment, Development and Evaluations approach.
RESULTS: Six studies were included for systematic review. Meta-analysis was performed using 3 studies and showed that machine-assisted agitation resulted in less PP compared with syringe irrigation with needle at 24 hours (SMD = -0.73; 95% confidence interval, -1.04 to -0.42; I2 = 30.6%) and 48 hours (SMD = -0.60; 95% CI, -0.85 to -0.35; I2 = 0%). The quality of evidence by Grading of Recommendations, Assessment, Development and Evaluations for the PP outcomes (24 hours and 48 hours) was graded as "moderate" quality.
CONCLUSIONS: Machine-assisted agitation reduced PP compared with syringe irrigation with needles in nonsurgical root canal treatment. Future clinical trials are needed to support the result of this review.