Fabiano A Gomes1, Raphael O Cerqueira2, Yena Lee3, Rodrigo B Mansur3, Flavio Kapczinski4, Roger S McIntyre3, Lakshmi N Yatham5, Michael Berk6, Roumen Milev7, Elisa Brietzke8. 1. Neurobiology of Mood Disorders Laboratory, Centre for Neuroscience Studies (CNS), Queen's University, 76 Stuart St., Burr 4., Kingston, ON, Canada; Kingston Health Sciences Centre-KGH Site, Kingston, ON, Canada; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada. Electronic address: fabiano.alvesgomes@queensu.ca. 2. Department of Psychiatry, Federal University of Sao Paulo (Unifesp), Sao Paulo, SP, Brazil. 3. Mood Disorders Psychopharmacology Unit (MDPU), Toronto Western Hospital, University Health Network (UHN), Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada. 4. Department of Psychiatry and Behavioural Neurosciences and Neuroscience Graduate Program, McMaster University, Hamilton, ON, Canada; Instituto Nacional de Ciência e Tecnologia Translacional em Medicina (INCT-TM), Porto Alegre, RS, Brazil; Bipolar Disorder Program, Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Department of Psychiatry, Graduate Program in Psychiatry and Behavioral Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil. 5. Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada. 6. Deakin University, IMPACT - The Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia; Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, Florey Institute for Neuroscience and Mental Health and the Department of Psychiatry, The University of Melbourne, Melbourne, Australia. 7. Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada; Centre for Neuroscience Studies, Queen's University, Kingston, Canada; Providence Care Hospital, Kingston, Canada. 8. Neurobiology of Mood Disorders Laboratory, Centre for Neuroscience Studies (CNS), Queen's University, 76 Stuart St., Burr 4., Kingston, ON, Canada; Kingston Health Sciences Centre-KGH Site, Kingston, ON, Canada; Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.
Abstract
BACKGROUND: Clinical practice guidelines (CPG) are an important tool for implementation of evidence-based clinical care. Despite clinical trials showing lack of efficacy of some agents in bipolar disorder (BD), they are still frequently prescribed in clinical practice. The objective of this study was to systematically review the CPG recommendations on pharmacological interventions with evidence against their use due to lack of efficacy data and/or due to serious safety concerns. METHODS: A systematic literature search identified 29 guidelines published by national and international organizations during the 1994-2020 period. Information was extracted regarding how the recommendations framed non-use of treatments in particular clinical situations as well as the actual recommendation in the guideline. RESULTS: Twenty-three guidelines (79%) mentioned at least one non-recommended treatment. The terms used to qualify recommendations varied amongst guidelines and included: "not recommended" "no recommendation" and "negative evidence". Lamotrigine, topiramate and gabapentin were commonly cited as non-recommended treatments for mania and most CPG did not recommend monotherapy with antidepressants, aripiprazole, risperidone, and ziprasidone for treatment of acute bipolar depression. Most guidelines made recommendations about lack of efficacy data or potential harm in treatments for BD but there is a significant variation in the way this information is conveyed to the reader. LIMITATIONS: Non-recommended treatments were based on their use for BD episodes or maintenance but specific medications may benefit patients when treating comorbid conditions. CONCLUSIONS: The absence of a uniform language and recommendations in current guidelines may be an additional complicating factor in the implementation of evidence-based treatments in BD.
BACKGROUND: Clinical practice guidelines (CPG) are an important tool for implementation of evidence-based clinical care. Despite clinical trials showing lack of efficacy of some agents in bipolar disorder (BD), they are still frequently prescribed in clinical practice. The objective of this study was to systematically review the CPG recommendations on pharmacological interventions with evidence against their use due to lack of efficacy data and/or due to serious safety concerns. METHODS: A systematic literature search identified 29 guidelines published by national and international organizations during the 1994-2020 period. Information was extracted regarding how the recommendations framed non-use of treatments in particular clinical situations as well as the actual recommendation in the guideline. RESULTS: Twenty-three guidelines (79%) mentioned at least one non-recommended treatment. The terms used to qualify recommendations varied amongst guidelines and included: "not recommended" "no recommendation" and "negative evidence". Lamotrigine, topiramate and gabapentin were commonly cited as non-recommended treatments for mania and most CPG did not recommend monotherapy with antidepressants, aripiprazole, risperidone, and ziprasidone for treatment of acute bipolar depression. Most guidelines made recommendations about lack of efficacy data or potential harm in treatments for BD but there is a significant variation in the way this information is conveyed to the reader. LIMITATIONS: Non-recommended treatments were based on their use for BD episodes or maintenance but specific medications may benefit patients when treating comorbid conditions. CONCLUSIONS: The absence of a uniform language and recommendations in current guidelines may be an additional complicating factor in the implementation of evidence-based treatments in BD.