Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs.2015
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Стандартизированные вмешательства на основе осознанности в здравоохранении: обзор систематических обзоров и метаанализов РКИ, 2015 г.
Сгенерированная сводка:
Из оставшихся 187 статей 146 были исключены на основании аннотации: 34 не были систематическими обзорами, 33 не были обзорами РКИ и 79 не включали MBCT или MBSR в качестве вмешательства.
Поиск РКИ, опубликованных после последнего включенного обзора, дал 9 результатов, которые указаны в конце раздела результатов, вместе с 7 РКИ, включенными в систематические обзоры, которые были исключены из нашего обзора.
Лесные участки демонстрируют существенные различия в пользу MBCT / MBSR. Три обзора, в которых сообщалось о SMD по нашим критериям результатов, были исключены из метаанализа, что позволило гарантировать, что количество РКИ с двойным подсчетом остается ниже 10% [, -,]. Метаанализ обзоров с депрессией исходов показал 3% двойного подсчета, тревогу 8,6%, стресс и качество жизни - 0% двойного подсчета, а физическое функционирование - 6%. Обзор РКИ по каждому результату метаанализа и более подробное описание результатов можно найти в дополнительных онлайн-материалах.
Качество жизни благоприятствовало MBSR по сравнению с программой санитарного просвещения, но не достигло статистической значимости по сравнению с контролем из списка ожидания [,]. MBSR также значительно улучшил качество жизни и депрессивные симптомы у пациентов с фибромиалгией [,]. В одном обзоре изучалось влияние MBSR и MBCT на психологические и физические исходы у 577 пациентов с сердечно-сосудистыми заболеваниями в 9 РКИ [,]. Депрессия, тревога и стресс показали значительные средние эффекты, а гипертония улучшилась со значительным smd 0,78. Два обзора включали 16 уникальных РКИ по MBSR и MBCT для различных хронических соматических заболеваний.
Эти обзоры были исключены из результатов метаанализа из-за слишком большого совпадения РКИ с другими обзорами в метаанализе.
Abstract:
Conclusion
The evidence supports the use of MBSR and MBCT to alleviate symptoms, both mental and physical, in the adjunct treatment of cancer, cardiovascular disease, chronic pain, depression, anxiety disorders and in prevention in healthy adults and children.,Although there is continued scepticism in the medical world towards MBSR and MBCT, the evidence indicates that MBSR and MBCT are associated with improvements in depressive symptoms, anxiety, stress, quality of life, and selected physical outcomes in the adjunct treatment of cancer, cardiovascular disease, chronic pain, chronic somatic diseases, depression, anxiety disorders, other mental disorders and in prevention in healthy adults and children.
Result
The search produced 187 reviews: 23 were included, covering 115 unique RCTs and 8,683 unique individuals with various conditions. Compared to wait list control and compared to treatment as usual, MBSR and MBCT significantly improved depressive symptoms (d=0.37; 95%CI 0.28 to 0.45, based on 5 reviews, N=2814), anxiety (d=0.49; 95%CI 0.37 to 0.61, based on 4 reviews, N=2525), stress (d=0.51; 95%CI 0.36 to 0.67, based on 2 reviews, N=1570), quality of life (d=0.39; 95%CI 0.08 to 0.70, based on 2 reviews, N=511) and physical functioning (d=0.27; 95%CI 0.12 to 0.42, based on 3 reviews, N=1015). Limitations include heterogeneity within patient categories, risk of publication bias and limited long-term follow-up in several studies.,A total of 299 potentially eligible articles were identified, retrieved, and screened for potential inclusion (see for the flowchart the ,). 112 reviews were duplicate records. From the remaining 187 articles, 146 were excluded based on the abstract: 34 were not systematic reviews, 33 were not reviews of RCTs and 79 did not have MBCT or MBSR as intervention. Five results were conference abstracts and not yet published. The full text of the remaining 36 articles was reviewed. Eight articles were excluded because the RCT results were not reported separately and five were excluded due to too much overlap in RCTs with other reviews. All excluded articles and the reason for their rejection are listed in supplementary ,. 23 reviews met our inclusion criteria and were reviewed by the first and second author. The search for RCTs published after the most recent included review gave 9 results, which are reported on at the end of the result section, together with 7 RCTs included in systematic reviews that were excluded from our review.,Characteristics of the study, patient population, intervention, control condition, and outcome measures of the 23 included reviews are shown in ,.,Syst = Systematic Review; Meta = Meta-analysis; MBSR = Mindfulness Based Stress Reduction; MBCT = Mindfulness Based Cognitive Therapy; TAU = treatment as usual; WL = waiting list; AT = Active Treatment,The results of the quality assessment are shown in ,. The inter-rater correlation was moderate (k = 0.48), and was influenced by structurally lower scoring of item 4 (search strategy reported) and item 9 (appropriate methods for combining results) by one reviewer due to different interpretation. The quality scores shown are those agreed upon after discussion. Nearly all reviews performed well on items related to the description of the objective, the literature search, and the study selection process (items 1–4). The list of included and excluded RCTs was not always complete (item 5). Although some reviews employed independent data extractors, many did not, and several were unclear about this item (item 6). Approximately half of the reviews assessed and presented the risk of bias of individual RCTs and the risk of publication bias (items 7 and 8). A meta-analysis of the individual RCTs was often not performed (item 9). In general, strengths and limitations were discussed, conclusions were supported by the data, and findings were interpreted independently of the funding source (items 10–12).,+ = yes;? = unclear;— = no; N/A = not applicable,The results of the reviewed RCT’s are summarized below, categorized by patient population (see also ,). 115 unique RCTs were included, with a combined total of 8683 participants. 3830 individuals had various somatic conditions; 4276 patients had various psychological problems and the remaining 577 subjects were recruited from the general population. Effect sizes used were Cohen’s d, Hedges g, Standard Mean Difference, Weighted Mean Difference (wmd), T-value, Odds Ratio, Hazard Ratio and Risk Ratio. Of note, most systematic reviews demonstrated a significant effect size.,Effect sizes reported as in reviews in different outcome measurements for the intergroup comparisons. Values are significant except when in parentheses. Smd = standard mean difference; OR = Odds Ratio; Wmd = weighted mean difference; HR = Hazard Ratio; RR = Risk Ratio. Interpretation: Cohen’s d, Hedges’g and smd: effect size 0–0.19 = no effect; 0.2–0.49 = small effect; 0.5–0.79 = medium effect; 0.8 and above = large effect. () = not significant. WL = compared to Wait list control; AT = compared to active treatment control,Also, 8 reviews were included in the meta-analysis based on reported intergroup smd’s of MBCT/MBSR and the pooled effect per outcome. Reviews that did not conduct a meta-analysis reporting in smd were excluded from our meta-analysis due to heterogeneity of effect size, but were only reviewed. The forest plots (,) demonstrate significant differences in favour of MBCT/MBSR. Three reviews that reported smd’s on our outcome measures were omitted from the meta-analyses which ensured that the number of double counted RCTs remained under 10% [,–,]. The meta-analysis on reviews with outcome depression had 3% double counting (1 out of 34 RCTs), anxiety 8.6% (3 out of 35 RCTs), both stress and quality of life had 0% double counting and physical functioning had 6% (1 out of 17 RCTs). An overview of the RCTs in each meta-analysis outcome and a more elaborate description of the results can be found in the online supplementary material (,).,The size of the marker per review indicates the size of the study population. The breadth of the line indicates the 95%CI. All values lower than 0 indicate a significant difference in favour of MBSR/MBCT. Values between 0 and -0.2 indicate negligible effect; between -0.2 and -0.5 small effect; between -0.5 and -0.8 medium effect and lower than -0.8 a large effect.,The search identified six systematic reviews covering 16 unique RCTs performed in 1668 unique cancer patients. 12 RCTs spread over two reviews were included in the meta-analysis, with one RCT duplication (8%). Most reviews found significant intergroup improvements in mental health but no significant results in physical health[,]. Significant improvements were demonstrated repeatedly in depressive symptoms, anxiety, stress, and quality of life [,,,–,]. Sleep quality did not change significantly; neither did body mass or fat consumption. A dose-response relationship was found between the number of minutes spent on meditating and improvement in total mood disturbance, and between the number of sessions attended and stress reduction [,], [,]. An association between the KIMS-subscale Observing [,] (a measure of mindfulness) and a decrease in anxiety, isolation and over-identification was also found.,For chronic pain patients we found three systematic reviews including 13 unique RCTs in 722 unique patients. One review containing 9 RCTs was included in the meta-analysis. Significant intergroup improvements were found in depressive symptoms, pain burden, and physical health, but neither in anxiety nor overall quality of life [,]. Pain intensity and pain disability decreased significantly and pain acceptance increased compared to wait list control but not when compared to a health education program. Self-efficacy showed no significant improvements. Quality of life favoured MBSR compared to the health education program but did not reach statistical significance when compared to wait list control [,]. MBSR also improved quality of life and depressive symptoms significantly in fibromyalgia patients [,].,One review looked at the effects of MBSR and MBCT on psychological and physical outcomes in 577 cardiovascular patients in 9 RCTs [,]. Depression, anxiety and stress showed significant medium effects (smd 0.35 to 0.50), and hypertension improved with a significant smd of 0.78.,Two reviews included 16 unique RCTs on MBSR and MBCT for various chronic somatic diseases (cancer, chronic pain, CVD, and fibromyalgia). In total 1331 unique patients were assessed. These reviews were excluded from the meta-analysis outcomes due to too much RCT overlap with other reviews in the meta-analysis. MBSR had a significant positive effect on depression symptoms, anxiety and psychological distress[,]. One of the reviews compared MBSR to MBCT for reducing symptom severity and found that MBCT was more effective, however no explanation was given[,].,Three systematic reviews of 17 unique RCTs with 1058 currently or recovered depressed patients were retrieved, none of which were included in the meta-analysis. The overall effect on depressive symptoms comparing MBCT with TAU was positive but not significant. However, in participants with 3 relapses or more, MBCT reduced depressive symptoms significantly between groups. Anxiety in bipolar patients was also reduced significantly[,]. The relapse rate decreased significantly in patients who had 3 depression episodes or more with a risk reduction of 43% compared to TAU[,]. Treatment in patients with 2 previous episodes, however, favoured TAU with a risk reduction of 49%. MBCT compared with antidepressants demonstrated a non-significant risk reduction of 20%[,].,A review of 13 RCTs with a total of 1244 patients with different anxiety disorders found a significant beneficial effect on anxiety [,]. Interestingly, RCTs conducted in Western countries showed bigger effects than those conducted in Eastern countries.,Four reviews assessed the effect of MBCT and MBSR among people with various mental disorders. 30 unique RCTs among 1974 unique participants were included. Two were included in the meta-analysis without overlap as one reported on depression [,], the other on anxiety[,]. Significant benefits were found in depressive symptoms, depression relapses and anxiety, and a significant increase in metacognitive awareness of negative thoughts and feelings was found. Relapse prevention was still significant at 1 year follow-up [,]. Not all RCTs, however, showed significant changes in relapse occurrence, and cognitive behavioural therapy was found to be superior to MBSR in reducing social anxiety [,]. In bipolar disorder, significant lower depression and anxiety scores were found. In schizophrenia there was significant intragroup improvement in clinical functioning and mindfulness of distressing thoughts and images; intergroup differences, however, did not reach significance [,]. In patients with a current anxiety or depression disorder, MBCT showed more effect than MBSR. Compared with WL and TAU there was a very large effect on symptom severity, however compared with active treatment this effect almost disappeared[,].,We included one review with heterogeneous populations, as excluding it would result in missing 18 unique RCTs [,]. Compared to meditation alone, MBSR had a positive effect on perceived stress, rumination and forgiveness. Compared to muscle relaxation in a study population of 31 inmates, however, MBSR caused no substantial differences in anger, egocentricity, stress reactivity or salivary cortisol. Mindfulness combined with light therapy diminished skin clearing rates of psoriasis patients significantly. There was no significant effect in treatment outcomes in a study with drug addicts. In a neuroimaging study of healthy employees a MBSR intervention produced increases in left-sided anterior cortical activation, which is associated with positive affect, and significant increase in influenza antibody titres.,Among healthy subjects, 5 RCT’s were performed in 247 students[,]. Anxiety decreased significantly compared to students that did not receive MBSR, and although depressive symptoms and stress also seemed to improve, this effect was analysed together with the effect of cognitive behavioural therapy, so the results could not be reported here.,One review assessed the effects of mindfulness in 330 children studied in two RCTs. Significant intergroup improvements were reported in anxiety, teacher-rated attention, social skills and objective measures of selective (visual) attention, but not in sustained attention. A study with adolescents under current or recent psychiatric outpatient care showed significant intergroup improvements in stress, anxiety, and several psychopathological symptoms. The study also found that more time spent in sitting meditation predicted improved functioning and a decline in depression and anxiety symptoms. A study including non-clinical 4–5 year olds indicated significant improvements in executive functioning on teacher ratings, but not on parent ratings [,].,Our search for individual RCTs not included in assessed systematic reviews resulted in 16 studies. Although some conclusions were not congruent with those in the reviews, overall the results supported use of the program. One RCT reports that currently non-depressed patients with one or two relapses benefit more from MBCT than patients with 3 or more relapses [,], whereas an included review [,] claimed the opposite. Note that both groups improved significantly in both studies, but results disagreed on which group improved more. Furthermore, the improvements in 39 Chinese chronic pain patients were not significant compared to active pain management [,] and no physical improvements were found in 86 elderly COPD patients [,].,Apart from these results, the other 13 RCTs demonstrated similar results as reported in the reviews: significant improvements in perceived stress, quality of life, symptom severity, anxiety and depression in patients with cancer [,], HIV [,], depression [,], mental disorders [,], ulcerative colitis [,], fibromyalgia [,], nonspecific chronic pain [,] [,], insomnia [,] and Parkinson [,], and in healthy participants [,–,].