title: Imperfect placebos are common in low back pain trials: a systematic review of the literature.
abstract: The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients' expectations showed that the placebo generated lower expectations than the experimental intervention. Taken together, these results demonstrate that imperfect placebos are common in low back pain trials; a result suggesting that many trials provide potentially biased estimates of treatment efficacy. This finding has implications for the interpretation of published trials and the design of future trials. Implementation of strategies to facilitate blinding and balance expectations in randomised groups need a higher priority in low back pain research.
authors.affiliation: Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, Missenden Rd, P.O. Box M201, Camperdown, NSW, 2050, Australia. lmachado@george.org.au
authors.forename: L A C
authors.initials: LA
authors.lastname: Machado
authors.forename: S J
authors.initials: SJ
authors.lastname: Kamper
authors.forename: R D
authors.initials: RD
authors.lastname: Herbert
authors.forename: C G
authors.initials: CG
authors.lastname: Maher
authors.forename: J H
authors.initials: JH
authors.lastname: McAuley
mesh_terms: D001416:Back Pain / Q000188:drug therapy*; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
chemical_list: D010919:Placebos