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The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials.

ABSTRACT: In response to questions regarding the scientific basis for mindfulness-based interventions (MBIs), we evaluated their empirical status by systematically reviewing meta-analyses of randomized controlled trials (RCTs). We searched six databases for effect sizes based on four or more trials that did not combine passive and active controls. Heterogeneity, moderators, tests of publication bias, risk of bias, and adverse effects were also extracted. Representative effect sizes based on the largest number of studies were identified across a wide range of populations, problems, interventions, comparisons, and outcomes (PICOS). A total of 160 effect sizes were reported in 44 meta-analyses (k = 336 RCTs, N = 30,483 participants). MBIs showed superiority to passive controls across most PICOS (ds = 0.10-0.89). Effects were typically smaller and less often statistically significant compared with active controls. MBIs were similar or superior to specific active controls and evidence-based treatments. Heterogeneity was typically moderate. Few consistent moderators were found. Results were generally robust to publication bias, although other important sources of bias were identified. Reporting of adverse effects was inconsistent. Statistical power may be lacking in meta-analyses, particularly for comparisons with active controls. Because MBIs show promise across some PICOS, future RCTs and meta-analyses should build on identified strengths and limitations of this literature.

SUBMITTER: Goldberg SB

PROVIDER: S-EPMC8364929 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Objective To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses.Design Meta-epidemiological study.Data sources Cochrane Database of Systematic Reviews (CDSR) and PubMed.Eligibility criteria for study selection Reviews published in the CDSR with sex-treatment subgroup analyses in the forest plots, using data from randomized controlled trials.Data extraction Information on the study design and sex subgroup data were extracted from reviews and forest plots that met inclusion criteria. For each statistically significant sex-treatment interaction, the potential for biological plausibility and clinical significance was considered.Results Among the 41 reviews with relevant data, there were 109 separate treatment-outcome analyses ("topics"). Among the 109 topics, eight (7%) had a statistically significant sex-treatment interaction. The 109 topics included 311 randomized controlled trials (162 with both sexes, 46 with males only, 103 with females only). Of the 162 individual randomized controlled trials that included both sexes, 15 (9%) had a statistically significant sex-treatment interaction. Of four topics where the first published randomized controlled trial had a statistically significant sex-treatment interaction, no meta-analyses that included other randomized controlled trials retained the statistical significance and no meta-analyses showed statistical significance when data from the first published randomized controlled trial were excluded. Of the eight statistically significant sex-treatment interactions from the overall analyses, only three were discussed by the CDSR reviewers for a potential impact on different clinical management for males compared with females. None of these topics had a sex-treatment interaction that influenced treatment recommendations in recent guidelines. UpToDate, an online physician-authored clinical decision support resource, suggested differential management of men and women for one of these sex-treatment interactions.Conclusion Statistically significant sex-treatment interactions are only slightly more frequent than what would be expected by chance and there is little evidence of subsequent corroboration or clinical relevance of sex-treatment interactions.

Project description:BackgroundHypertension and prehypertension have been widely recognized as the main contributors of global mortality. Evidence shows mindfulness-based interventions may reduce blood pressure and improve mental health. However, the effect of mindfulness-based interventions on blood pressure and mental health has not been fully understood.MethodsPotential studies published before May 24th 2023 were identified by searching Embase, Ovid Emcare, PsycINFO, CINAHL, Web of Science, Cochrane, PubMed, China National Knowledge Infrastructure, Wanfang database, and VIP China Science. Additionally, two grey databases were searched: Mednar, WorldWideScience.org. The risk of bias in the included studies was assessed using the Cochrane Risk of Bias Assessment tool. The random-effects meta-analyses were conducted using Review Man 5.4 software and the key outcomes are presented as mean difference or standard mean difference and the 95% confidential interval.ResultsSearches returned 802 studies in total, of which 12 were included (N = 715). The duration of interventions was 8 weeks in 10 trials and 6 weeks in one trial. Pooled effect sizes indicated reductions in systolic blood pressure (MD = - 9.12, 95% CI [- 12.18, - 6.05], p < 0.001), diastolic blood pressure (MD = - 5.66, 95% CI [- 8.88, - 2.43], p < 0.001), anxiety (SMD = - 4.10; 95% CI [- 6.49, - 1.71], p < 0.001), depression (SMD = - 1.70, 95%CI [- 2.95, - 0.44], p < 0.001) and perceived stress (SMD = - 5.91, 95%CI [- 8.74, - 3.09], p < 0.001) at post-intervention. The findings from subgroup analyses are favorable for mindfulness-based interventions regardless of gender and baseline blood pressure with regard to BP reduction, with a more profound effect observed in participants with higher pre-intervention blood pressure.ConclusionsThe results provide evidence for the positive role of mindfulness-based interventions in hypertension management. More large randomized control trials with sufficient statistical power and long-term follow-up are needed.Trial registrationThe protocol had been registered with Prospero on October 2nd 2021 (registration NO. CRD42021282504 ).

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The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials.

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