A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease.

TL;DR: Mindfulness interventions are effective in reducing stress and depression and improving quality of life and anxiety, but do not lead to significant improvements in the physical symptoms of IBD.

About: This article is published in Journal of Psychosomatic Research.The article was published on 2019-01-01 and is currently open access. It has received 41 citations till now. The article focuses on the topics: Mindfulness & Systematic review.

Summary

Background

• Mindfulness interventions are increasingly used as a part of integrated treatment in inflammatory bowel disease (IBD) but there are limited data and a lack of consensus regarding effectiveness.
• The authors conducted a systematic review and meta-analysis of relevant randomised controlled trials (RCTs).
• Rates of depression and anxiety in periods of remission are two to three times higher than in age matched individuals in the general population [4, 5].
• To their knowledge, there has been only one systematic review to date examining the efficacy and use of mindfulness interventions in IBD [17], published in 2015.
• This systematic review therefore addresses the evidence gap by exploring a wide range of mindfulness interventions and including papers published in languages other than English and German and conducted in individuals of any age.

Protocol and registration

• This systematic review was registered with PROSPERO , an international database of prospectively registered systematic reviews (CRD42017080632) [20].
• The authors followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines in designing this systematic review [21].
• Ethical approval was not required as all included primary data had been previously published with ethical approval.

Design of included studies

• Single-, double- or triple-blind RCTs were considered for inclusion.
• Studies published as abstracts were only included if the authors were contactable and further information provided to allow evaluation of study quality and main outcomes.
• Studies with a non RCT design and studies using non-validated outcome measures were excluded.
• Participants AC C EP TE D M AN U SC R IP T Patients of any age, including paediatric populations, with a diagnosis of IBD were included.
• The authors specified that the IBD diagnosis was based on established criteria, such as the Montreal classification system, including confirmation with ileocolonoscopy and biopsies of the affected tissues [20].

Interventions

• The authors adopted a broad definition of mindfulness interventions to include any therapy or program based on mindfulness principles and involving mindfulness practices.
• Interventions of interest included mindfulness-based programs, mindfulness-informed programs, adapted and shortened mindfulness interventions and yoga.
• Mindfulness-based programs included MBSR and MBCT which are evidencebased, 8-week-long manualised group programs taught in weekly 2-2,5 hours sessions encompassing multiple mindfulness components, homework exercises and usually a day of silent practice [14, 23-25].
• BBMW is an adapted program combining mindful movement, breathing practices, and meditation, delivered as a two-day workshop followed by six weekly sessions and monthly booster sessions [29].
• For the purposes of this review, the authors divided the interventions into yoga studies and mindfulness programs involving MBSR, MBCT, adapted mindfulness programs and mindfulness informed interventions.

Comparators and context

• Controls in the review included wait list, standard medical treatment or treatment as usual (TAU), and other evidence-based psychological interventions.
• Studies in any clinical setting were included.

Outcomes

• Studies examining IBD related psychological outcomes, quality of life and physical outcomes, assessed by validated screening tools were included.
• Psychological outcomes of interest included the following: rates of depression, anxiety and stress as assessed by validated screening tools such as Depression, Anxiety and Stress Scale (DASS), Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scale (HADS) and coping as measured by the Brief Cope Questionnaire (COPE).
• The authors extracted definitions of outcomes as reported in individual studies and recorded them in the data sheets in Covidence software [30] .

Sources of information

• The following databases were searched: MEDLINE, EMBASE, PsycINFO and CINAHL.
• These electronic databases searches were supplemented by searches of trial protocols and systematic reviews in the Cochrane Central Register of Controlled Trials , Australian and New Zealand Clinical Trials Register , WHO International Clinical Trials Registry Platform and the PROSPERO register of systematic reviews.
• The authors also scanned the reference and citation lists of included studies to improve literature coverage.
• The authors contacted the study authors for clarification and additional information when this was needed.
• The searches were re-run prior to review completion to ensure currency.

Search strategies

• The specific search strategies were created by a health clinical librarian with expertise in systematic review searching (KR).
• Literature search strategies were developed using controlled vocabulary and text words related to mindfulness and IBD.

Study records

• Data were managed by using EndNote and Covidence online software for conducting systematic reviews [30].
• Literature search results were uploaded to EndNote and Covidence.
• Data were extracted by one reviewer (TE) and checked for errors by a second (KR).
• The authors used RevMan software to create a PRISMA flow diagram following the completion of the screening and data extraction.
• Figure 1 shows the PRISMA diagram depicting the flow of studies through the systematic review.

Data selection and extraction

• Two reviewers worked independently through all stages of the review, including screening papers for eligibility, examining full-text versions of studies for eligibility and inclusion in meta-analysis (TE, KR).
• Any disagreements were resolved through discussion with the third author (SK) and reasons for decisions documented.

Risk of bias (quality) assessment

• The methodological quality of the included trials was assessed independently by two reviewers using the Cochrane Collaboration's Assessment of Risk of Bias Tool [32].
• The authors assessed risk of bias in the included studies against the six criteria from the Cochrane Risk of Bias Tool, including random sequence generation, allocation concealment, blinding of the participants and the outcome assessors, incomplete data reporting, selective data reporting and other bias .
• The authors used risk of bias tables embeded in Covidence and adapted them by creating additional criteria involving interventions’ fidelity, validity of the outcome measures, inclusion and exclusion criteria and similarity of participants’ baseline characteristics.
• The authors evaluated each of the criteria in the risk of bias tool as low, high or unclear risk of bias and provided decisions justification.
• The authors did not assess publication bias due to having insufficient number of studies included in the review.

Data synthesis

• The authors used statistical software RevMan 5.2, according to the guidelines referenced in the current version of the Cochrane Handbook for Systematic Reviews of Interventions [32].
• Because different instruments were used across studies, standardised mean differences were specified as the effect of interest.
• Results were presented by the two subgroups of AC C EP TE D M AN U SC R IP T mindfulness-based programs (MBPs) and yoga.
• Where possible, the authors conducted sensitivity analyses for study quality or type of control.
• If any meta-analysis included 10 or more studies, the authors planned to test for publication bias using funnel plot asymmetry, but only eight studies were included.

Results

• The authors identified 202 records and removed 37 duplicates .
• The authors excluded a further 154 after screening titles and abstracts of the remaining 165 records.
• The authors examined the remaining 11 articles for eligibility and excluded 3 of them, two because of being conference abstracts which were superseded by the full text articles and one because of not having the RCT design.
• The remaining 8 studies [34-41] were included in qualitative and quantitative analysis.
• Seven were full text articles and one was a conference abstract (Rowan 2017) which was assessed from the abstract content and by enlarging the reported graphs and then measuring and analysing the illustrated outcomes.

Study quality (Risk of Bias)

• Allocation concealment was not adequately described in 5 out of the 8 included studies.
• Due to the nature of the intervention, it was difficult to blind the participants as they were aware of their group allocation in studies with waitlist and TAU controls.
• There was also a significant proportion of studies with incomplete reporting with 6 studies having inadequate or incomplete data reporting.
• All the others used complete case or per protocol population analysis.
• Three out of eight studies described fidelity measures, both of the yoga studies and the MBCT study.

Participants’ characteristics

• All the participants were adults as no paediatric studies met the inclusion criteria.
• In all the studies, IBD was diagnosed with a combination of clinical, laboratory and endoscopic findings as per the widely accepted criteria.
• All studies enrolled individuals with quiescent IBD or IBD in remission and excluded individuals with significant mental health diagnoses.

Interventions Characteristics

• Two studies involved Mindfulness Based Programs (MBPs) , one MBSR [38] and one MBCT[42] , two of the studies used ACT, one MCT, one BBMW and two studies delivered yoga.
• Duration of therapy was between 6 and 12 weeks (Table 1).
• The shortest mindfulness intervention was BBMW with only 6 weeks duration, however it had an intensive two-day start and was followed by monthly booster sessions up till 26 weeks.
• The longest intervention was MCT of 16 weeks duration but with only 6 sessions delivering a similar “dose” of mindfulness practices to the other interventions.

Comparators’ characteristics

• All included studies had a parallel group allocation design.
• Control groups were wait list patients in five out of eight studies, one had a written self-care control group and two studies had active controls.
• In both studies with active controls, participants in the control group were receiving treatment that mimicked the amount of time and attention received by the treatment group but thought not to have significant therapeutic effect, referred to as attention placebo control [43].
• Outcomes characteristics and outcomes collection time points Seven of the eight included studies measured both psychological and biological outcomes and all studies measured psychological outcomes.
• For the purpose of this review, the authors classified post treatment outcomes collection point as a short-term follow-up which occurred 6-16 weeks post baseline, depending on the length of the intervention.

Psychological Outcomes Changes in Response to Mindfulness Interventions

• Eight studies were included in the meta-analysis, providing data for 251 participants who received mindfulness interventions and 249 waitlist, TAU or active controls (Table 1).
• Short-term psychological symptoms Outcome or Subgroup Studies Participants Standardised mean difference [95% CI], also known as Table 3.
• There was no significant difference in depression scores between people who received mindfulness and those in the control group in the short-term.
• These results were mirrored in the subgroup analyses of MBPs and yoga in the long-term but not the short-term .

Quality of Life Changes in Response to Mindfulness Interventions

• Three studies reported on the QoL outcome at each time-point but only two were common to both times.
• When the mindfulness and yoga interventions were combined in a single analysis, there was evidence for a statistically greater improvement in the long-term effect estimates , but not the short-term (Table 3).
• None of the results in the subgroup analyses reached statistical significance (Tables 3 and 4).

Physical Outcomes Changes in Response to Mindfulness Interventions

• There was limited information on physical disease outcomes, including systemic inflammatory markers (ESR/CRP), local inflammatory markers (FCP) and clinical disease activity.
• Only one MBP and one yoga study reported short term physical outcomes, both reporting non-significant results.
• Long-term physical outcomes were reported by two MBPs and one yoga study.

Discussion

• This review is the first systematic review to explore the efficacy of a broad range of mindfulness interventions in IBD while including all population ages and settings and posing no language or time and type of publication restrictions.
• Expanding the language only brought one additional study, published in Farsi, because the study conducted in Germany (Cramer 2017) and the study conducted in India (Sharma 2015) were both published in English.
• One of the yoga studies, Cramer et al, outperformed all other mindfulness interventions in depression, anxiety and stress scores changes both short and longterm and in stress scores long-term.
• Furthermore, the quality of individual studies has been affected by poor blinding of the outcome assessors, incomplete data reporting and a relative lack of fidelity measures.
• The review suggests the need for mindfulness interventions that are tailored for IBD which could improve participants’ engagement and potentially increase their effect via a doseresponse relationship.

Contributions

• Systematic review was conceived and designed by TE, SK and KR and critically revised by SK, MK, JB and KH.
• Drafting of the paper was completed by TE.

Declarations of interests

• None AC C EP TE D M AN U SC R IP T References 1. Kumar, V., C. Wijmenga, and R.J. Xavier, Genetics of immune-mediated disorders: from genomewide association to molecular mechanism.
• Hofmann, S.G., et al., The Effect of Mindfulness-Based Therapy on Anxiety and Depression: A Meta-Analytic Review.
• Journal of Consulting and Clinical Psychology, 2010.
• Berrill, J.W., et al., Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels.