PMID- 33345689 OWN - NLM STAT- MEDLINE DCOM- 20220119 LR - 20220123 IS - 1461-7285 (Electronic) IS - 0269-8811 (Linking) VI - 35 IP - 5 DP - 2021 May TI - A comparison of MDMA-assisted psychotherapy to non-assisted psychotherapy in treatment-resistant PTSD: A systematic review and meta-analysis. PG - 501-511 LID - 10.1177/0269881120965915 [doi] AB - RATIONALE: Novel, evidence-based treatments are required for treatment-resistant post-traumatic stress disorder (PTSD). 3,4-Methylenedioxymethamphetamine (MDMA) has beneficially augmented psychotherapy in several small clinical trials. OBJECTIVE: To review the use of MDMA-assisted psychotherapy in treatment-resistant PTSD. METHODS: Systematic searches of four databases were conducted from inception to February 2020. A meta-analysis was performed on trials which were double-blinded, randomised, and compared MDMA-assisted psychotherapy to psychotherapy and placebo. The primary outcomes were the differences in Clinician Administered PTSD Scale (CAPS-IV) score and Beck's Depression Inventory (BDI). Secondary outcome measures included neurocognitive and physical adverse effects, at the time, and within 7 days of intervention. RESULTS: Four randomised controlled trials (RCTs) met inclusion criteria. When compared to active placebo, intervention groups taking 75 mg (MD -46.90; 95% (confidence intervals) CI -58.78, -35.02), 125 mg (MD -20.98; 95% CI -34.35, -7.61) but not 100 mg (MD -12.90; 95% CI -36.09, 10.29) of MDMA with psychotherapy, had significant decreases in CAPS-IV scores, as did the inactive placebo arm (MD -33.20; 95% CI -40.53, -25.87). A significant decrease in BDI when compared to active placebo (MD -10.80; 95% CI -20.39, -1.21) was only observed at 75 mg. Compared to placebo, participants reported significantly more episodes of low mood, nausea and jaw-clenching during sessions and lack of appetite after 7 days. CONCLUSION: These results demonstrate potential therapeutic benefit with minimal physical and neurocognitive risk for the use of MDMA-assisted psychotherapy in TR-PTSD, despite little effect on Beck's Depression Inventory. Better powered RCTs are required to investigate further. INTERNATIONAL PROSPECTIVE REGISTER OF SYSTEMATIC REVIEWS: CRD42019109132 available online at www.crd.york.ac.uk/prospero. FAU - Illingworth, Benjamin Jg AU - Illingworth BJ AUID- ORCID: 0000-0002-7990-2634 AD - Peterborough City Hospital, North West Anglia NHS Foundation Trust, Peterborough, UK. FAU - Lewis, Declan J AU - Lewis DJ AD - University College London Medical School, London, UK. FAU - Lambarth, Andrew T AU - Lambarth AT AD - North Middlesex Hospital, North Middlesex University Hospital NHS Trust, London, UK. FAU - Stocking, Kate AU - Stocking K AD - Centre for Biostatistics, The University of Manchester, Manchester, UK. FAU - Duffy, James Mn AU - Duffy JM AD - Institute for Women's Health, University College London, London, UK. AD - The Fetal Medicine Research Institute, King's College Hospital NHS Foundation Trust, London, UK. FAU - Jelen, Luke A AU - Jelen LA AUID- ORCID: 0000-0001-6398-5239 AD - Centre for Affective Disorders, King's College London, London, UK. FAU - Rucker, James J AU - Rucker JJ AUID- ORCID: 0000-0003-4647-8088 AD - Centre for Affective Disorders, King's College London, London, UK. LA - eng GR - CS-2017-17-007/DH_/Department of Health/United Kingdom PT - Comparative Study PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20201220 PL - United States TA - J Psychopharmacol JT - Journal of psychopharmacology (Oxford, England) JID - 8907828 RN - 0 (Hallucinogens) RN - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine) SB - IM MH - Combined Modality Therapy MH - Hallucinogens/administration & dosage/adverse effects MH - Humans MH - N-Methyl-3,4-methylenedioxyamphetamine/*administration & dosage/adverse effects MH - Psychiatric Status Rating Scales MH - Psychotherapy/*methods MH - Randomized Controlled Trials as Topic MH - Stress Disorders, Post-Traumatic/physiopathology/*therapy MH - Treatment Outcome OTO - NOTNLM OT - 3,4-Methylenedioxymethamphetamine OT - MDMA OT - PTSD OT - novel therapies OT - post-traumatic stress disorder OT - psychotherapy OT - treatment-resistance EDAT- 2020/12/22 06:00 MHDA- 2022/01/20 06:00 CRDT- 2020/12/21 08:43 PHST- 2020/12/22 06:00 [pubmed] PHST- 2022/01/20 06:00 [medline] PHST- 2020/12/21 08:43 [entrez] AID - 10.1177/0269881120965915 [doi] PST - ppublish SO - J Psychopharmacol. 2021 May;35(5):501-511. doi: 10.1177/0269881120965915. Epub 2020 Dec 20.