Background: 3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD). Aims: This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated. Methods: Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification. Results: MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the ‘Outcomes’ study) by the same team with a similar population of people with AUD. Conclusions: This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.
With the fastest 10% of samples being reported within 35 minutes (haematology) and 1 hour 5 minutes (biochemistry) of request, our study showed that delays can be attributable to laboratory TAT. Given the limited ability to further improve laboratory processes, the solutions to improving TAT need to come from a collaborative and integrated approach that includes strategies before samples reach the laboratory and downstream review of results.
We report on differences in patient demographics in those men choosing to undergo radical prostatectomy in a UK center where there is no influence of robotic surgery and in those choosing radical prostatectomy in a US center where there is a strong robotic influence. Demographic and pathologic data were prospectively recorded in parallel for 78 consecutive men undergoing robot-assisted radical prostatectomy in a tertiary care academic US center and 69 consecutive men concurrently undergoing open radical prostatectomy in a similar UK center. Although average patient age was significantly younger in the US cohort (58.8 years, range 43.1-77.6 vs. 62.2 years, range 51.7-70.5; P = 0.002), the US cohort encompassed a wider age range and older patients than the UK cohort. Average preoperative prostate-specific antigen (PSA) was significantly lower in the US group (6.0, range 2.0-6.0 vs. 8.60, range 4.6-12.6; P < 0.01). Biopsy Gleason score, clinical stage, final pathology Gleason score, pathologic staging and positive margin rate were not significantly different between the two groups. Blood loss and transfusion rate were significantly lower in the US group. 16.7% of men in the US cohort had overall positive surgical margins compared to 29% in the UK group (P = 0.07). This data confirms our belief that patient age ranges are different in a setting influenced by robotic surgery. Although pathologic parameters were similar, the age distribution of robotic surgery patients was much wider, suggesting robotics attracts men previously reluctant to undergo surgery in the open setting or to pursue active surveillance protocols. Larger studies are needed to verify this finding.
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