title: Drugs commonly associated with weight change: umbrella systematic review and meta-analysis (Protocol).
abstract: BACKGROUND
  Many drugs and treatments given to patients for various reasons affect their weight. This side effect is of great importance to patients and is also a concern for the treating physician because weight change may lead to the emergence or worsening of other health conditions.
  
  
  OBJECTIVE
  The aim of this study is to summarize the evidence about commonly prescribed drugs and their association with weight change.
  
  
  METHODS
  Umbrella systematic review and meta-analysis of randomized controlled trials.We will use an umbrella approach to identify eligible randomized controlled trials (RCTs). We will search for systematic reviews of RCTs that compare any of the drugs that have been associated with weight gain (obesogenic) or weight loss (leptogenic); these have been summarized by our experts' panel in a predefined list. Two reviewers will independently determine RCT eligibility. Disagreement will be solved by consensus and arbitrated by a third reviewer. We will extract descriptive, methodological, and efficacy data in duplicate. Our primary continuous outcomes will be weight loss or gain expressed as a mean difference (MD) for weight (kg) or BMI (kg/m2). We will calculate the MD considering the mean difference in weight or BMI between baseline and the last available follow-up in both study arms (drugs and placebo). Our primary dichotomous outcome, presented as a relative risk, will compare the ratio of the incidence of weight change in each trial arm. When possible, results will be pooled using classic random-effects meta-analyses and a summary estimate with 95% confidence interval will provided. We will use the I2 statistic and Cochran's Q test to assess heterogeneity. The risk of bias will be assessed using the Cochrane risk of bias tool. Publication bias, if appropriate, will be evaluated, as well as overall strength of the evidence.
  
  
  CONCLUSIONS
  This systematic review will offer the opportunity to generate a ranking of commonly prescribed drugs in terms of their effect on weight, allowing guideline developers and patient-physician dyad to choose between available therapies.
authors.affiliation: Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Domecq
authors.forename: Gabriela
authors.initials: G
authors.lastname: Prutsky
authors.forename: Zhen
authors.initials: Z
authors.lastname: Wang
authors.forename: Tarig
authors.initials: T
authors.lastname: Elraiyah
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Brito
authors.forename: Karen
authors.initials: K
authors.lastname: Mauck
authors.forename: Mohammed H
authors.initials: MH
authors.lastname: Lababidi
authors.forename: Aaron
authors.initials: A
authors.lastname: Leppin
authors.forename: Salman
authors.initials: S
authors.lastname: Fidahussein
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Prokop
authors.forename: Victor M
authors.initials: VM
authors.lastname: Montori
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Murad
mesh_terms: D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D006801:Humans; D015201:Meta-Analysis as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D000078202:Systematic Reviews as Topic; D015430:Weight Gain / Q000187:drug effects; D015431:Weight Loss / Q000187:drug effects