title: Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy.
abstract: BACKGROUND
  Psychopharmacology and psychotherapy are the two main therapies in mental health. It is common practice to consider adverse events (AEs) of medications, but it's not clear this occurs with psychotherapy.
  
  
  OBJECTIVE
  This study investigates the frequency with which reports of AEs occur in clinical trials using either psychopharmacology alone, psychotherapy alone, or combined approaches.
  
  
  METHODS
  Forty-five articles of randomized trials published in high-impact journals were chosen from a Medline search, and separated into three groups of 15 articles: pharmacotherapy alone (M), psychotherapy alone (T) and combined studies that looked at the effect of both a psychotherapeutic (CT) and psychopharmacologic (CM) intervention. Criteria for what defines an AE were established and the papers were rated for mentions of AEs in papers as a whole and by each section.
  
  
  RESULTS
  The χ(2)-analysis of AE mentions showed significant differences between the four study conditions in terms of each paper as a whole (χ(2):10.1,p<0.018), and by section. Medication (M+CM) and psychotherapy papers (T+CT) were then combined into two groups to compare the odds that one was more likely to mention AEs than the other. Bivariate logistic regression yielded statistically significant odds ratios ranging from 9.33 to 20.99, with medications being far more likely to mention AEs.
  
  
  CONCLUSIONS
  We believe the difference in reports of AEs mirrors the attitudes researchers and providers. It's critical to consider, and standardize the definition of, AEs in psychotherapy, and imperative to identify and address potential AEs in psychotherapy research.
authors.affiliation: Columbia University/New York State Psychiatric Institute, 1051 Riverside Drive, Unit 66, New York, NY 10032. Electronic address: bvaughan05@gmail.com.
authors.forename: Barney
authors.initials: B
authors.lastname: Vaughan
authors.affiliation: Mount Sinai Beth Israel Medical Center, New York, NY.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Goldstein
authors.affiliation: Mount Sinai Beth Israel Medical Center, New York, NY.
authors.forename: Maria
authors.initials: M
authors.lastname: Alikakos
authors.affiliation: Mount Sinai Beth Israel Medical Center, New York, NY.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Cohen
authors.affiliation: Mount Sinai Beth Israel Medical Center, New York, NY.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Serby
mesh_terms: D003131:Combined Modality Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011613:Psychotherapy; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D011619:Psychotropic Drugs