Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Patient experiences of therapy for borderline personality disorder: Commonalities and differences between dialectical behaviour therapy and mentalization-based therapy and relation to outcomes

OBJECTIVES: Dialectical behaviour therapy (DBT) and mentalization-based therapy (MBT) are widely used evidence-based psychological treatments for borderline personality disorder (BPD). The study aimed to establish evidence on common and unique, and helpful and unhelpful, treatment processes. DESIGN: Mixed-methods. METHODS: In-depth qualitative interview data on patient experiences during treatment were combined with quantitative outcome measures in 73 patients diagnosed with a personality disorder and receiving DBT or MBT. RESULTS: Across both DBT and MBT, accounts of learning not to react impulsively, learning to question one's thoughts and assumptions, learning to communicate more effectively, and exposure to painful emotions that may previously have been avoided were each associated with less baseline-adjusted self-harm at the end of treatment. Difficulties in interacting with other group members were more likely to be described by patients receiving MBT than DBT, whilst difficulties in the therapeutic relationship were equally common. Both of these types of difficult experience were associated with higher baseline-adjusted levels of BPD traits and emotional dysregulation, at the end of the 12-month study period. CONCLUSIONS: The findings identify novel evidence of common therapeutic processes across DBT and MBT that may help to reduce self-harm. The findings also highlight the potential iatrogenic effect of difficulties in the alliance with therapists or with other group members. This underscores the importance of listening to patients' voices about what they are finding difficult during therapy and working to address these relational challenges, so that the patient is able to progress and make best use of the treatment. PRACTITIONER POINTS: - Regardless of whether dialectical behaviour therapy or mentalization based therapy is used, helping service-users to learn not to react impulsively, to question their thoughts and assumptions, and to communicate more effectively, may be beneficial for reducing self-harm. - Across both types of therapy, exposure to painful emotions is a difficult experience for service-users, but may also be beneficial for reducing self-harm, if carefully managed. - Whilst service-users' experiences across both types of therapy have much in common, accounts of mentalization based therapy stand out in more often describing both helpful and unhelpful experiences of interactions with therapy group members. - Service-users across both types of therapy report the benefits of learning intrapersonal mentalization skills, whilst recipients of mentalization based therapy uniquely extend this to learning interpersonal mentalization. - Ruptures in the therapeutic alliance, and distressing interactions with group members, may be iatrogenic and must be carefully managed