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Background Practitioners who enhance how they express empathy and create positive expectations of benefit could improve patient outcomes. However, the evidence in this area has not been recently synthesised. Objective To estimate the effects of empathy and expectations interventions for any clinical condition. Design Systematic review and meta-analysis of randomised trials. Data source Six databases from inception to August 2017. Study selection Randomised trials of empathy or expectations interventions in any clinical setting with patients aged 12 years or older. Review methods Two reviewers independently screened citations, extracted data, assessed risk of bias and graded quality of evidence using GRADE. Random effects model was used for meta-analysis. Results We identified 28 eligible (n = 6017). In seven trials, empathic consultations improved pain, anxiety and satisfaction by a small amount (standardised mean difference −0.18 [95% confidence interval −0.32 to −0.03]). Twenty-two trials tested the effects of positive expectations. Eighteen of these (n = 2014) reported psychological outcomes (mostly pain) and showed a modest benefit (standardised mean difference −0.43 [95% confidence interval −0.65 to −0.21]); 11 (n = 1790) reported physical outcomes (including bronchial function/ length of hospital stay) and showed a small benefit (standardised mean difference −0.18 [95% confidence interval −0.32 to −0.05]). Within 11 trials (n = 2706) assessing harms, there was no evidence of adverse effects (odds ratio 1.04; 95% confidence interval 0.67 to 1.63). The risk of bias was low. The main limitations were difficulties in blinding and high heterogeneity for some comparisons. Conclusion Greater practitioner empathy or communication of positive messages can have small patient benefits for a range of clinical conditions, especially pain. Protocol registration Cochrane Database of Systematic Reviews (protocol) DOI: 10.1002/14651858.CD011934.pub2., FundingJH and AM were supported by the British Medical Association Dawkins and Strutt Award. PA was supported by the CLAHRC (The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health).QC 20180913