{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T22:43:41Z","timestamp":1792622621170,"version":"4.5.0"},"reference-count":555,"publisher":"National Institute for Health and Care Research","issue":"46","license":[{"start":{"date-parts":[[2020,9,1]],"date-time":"2020-09-01T00:00:00Z","timestamp":1598918400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["14\/26\/08"],"award-info":[{"award-number":["14\/26\/08"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>The term \u2018medically unexplained symptoms\u2019 is used to cover a wide range of persistent bodily complaints for which adequate examination and appropriate investigations do not reveal sufficiently explanatory structural or other specified pathologies. A wide range of interventions may be delivered to patients presenting with medically unexplained symptoms in primary care. Many of these therapies aim to change the behaviours of the individual who may have worsening symptoms.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>An evidence synthesis to determine the clinical effectiveness and cost-effectiveness of behavioural modification interventions for medically unexplained symptoms delivered in primary care settings was undertaken. Barriers to and facilitators of the effectiveness and acceptability of these interventions from the perspective of patients and service providers were evaluated through qualitative review and realist synthesis.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Data sources<\/jats:title><jats:p>Full search strategies were developed to identify relevant literature. Eleven electronic sources were searched. Eligibility criteria \u2013 for the review of clinical effectiveness, randomised controlled trials were sought. For the qualitative review, UK studies of any design were included. For the cost-effectiveness review, papers were restricted to UK studies reporting outcomes as quality-adjusted life-year gains. Clinical searches were conducted in November 2015 and December 2015, qualitative searches were conducted in July 2016 and economic searches were conducted in August 2016. The databases searched included MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and EMBASE. Updated searches were conducted in February 2019 and March 2019.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Participants<\/jats:title><jats:p>Adult participants meeting the criteria for medically unexplained symptoms, including somatoform disorders, chronic unexplained pain and functional somatic syndromes.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Interventions<\/jats:title><jats:p>Behavioural interventions were categorised into types. These included psychotherapies, exercise-based interventions, multimodal therapies (consisting of more than one intervention type), relaxation\/stretching\/social support\/emotional support, guided self-help and general practitioner interventions, such as reattribution.<jats:italic>Evidence synthesis<\/jats:italic>: a network meta-analysis was conducted to allow a simultaneous comparison of all evaluated interventions in a single coherent analysis. Separate network meta-analyses were performed at three time points: end of treatment, short-term follow-up (&lt;\u20096 months since the end of treatment) and long-term follow-up (\u2265\u20096 months after the end of treatment). Outcomes included physical and psychological symptoms, physical functioning and impact of the illness on daily activities.<jats:italic>Economic evaluation<\/jats:italic>: within-trial estimates of cost-effectiveness were generated for the subset of studies where utility values (or quality-adjusted life-years) were reported or where these could be estimated by mapping from Short Form questionnaire-36 items or Short Form questionnaire-12 items outcomes.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Results<\/jats:title><jats:p>Fifty-nine studies involving 9077 patients were included in the clinical effectiveness review. There was a large degree of heterogeneity both between and within intervention types, and the networks were sparse across all outcomes. At the end of treatment, behavioural interventions showed some beneficial effects when compared with usual care, in particular for improvement of specific physical symptoms [(1) pain: high-intensity cognitive\u2013behavioural therapy (CBTHI) standardised mean difference (SMD) 0.54 [95% credible interval (CrI) 0.28 to 0.84], multimodal SMD 0.52 (95% CrI 0.19 to 0.89); and (2) fatigue: low-intensity cognitive\u2013behavioural therapy (CBTLI) SMD 0.72 (95% CrI 0.27 to 1.21), relaxation\/stretching\/social support\/emotional support SMD 0.87 (95% CrI 0.20 to 1.55), graded activity SMD 0.51 (95% CrI 0.14 to 0.93), multimodal SMD 0.52 (95% CrI 0.14 to 0.92)] and psychological outcomes [(1) anxiety CBTHI SMD 0.52 (95% CrI 0.06 to 0.96); (2) depression CBTHI SMD 0.80 (95% CrI 0.26 to 1.38); and (3) emotional distress other psychotherapy SMD 0.58 (95% CrI 0.05 to 1.13), relaxation\/stretching\/social support\/emotional support SMD 0.66 (95% CrI 0.18 to 1.28) and sport\/exercise SMD 0.49 (95% CrI 0.03 to 1.01)]. At short-term follow-up, behavioural interventions showed some beneficial effects for specific physical symptoms [(1) pain: CBTHI SMD 0.73 (95% CrI 0.10 to 1.39); (2) fatigue: CBTLI SMD 0.62 (95% CrI 0.11 to 1.14), relaxation\/stretching\/social support\/emotional support SMD 0.51 (95% CrI 0.06 to 1.00)] and psychological outcomes [(1) anxiety: CBTHI SMD 0.74 (95% CrI 0.14 to 1.34); (2) depression: CBTHI SMD 0.93 (95% CrI 0.37 to 1.52); and (3) emotional distress: relaxation\/stretching\/social support\/emotional support SMD 0.82 (95% CrI 0.02 to 1.65), multimodal SMD 0.43 (95% CrI 0.04 to 0.91)]. For physical functioning, only multimodal therapy showed beneficial effects: end-of-treatment SMD 0.33 (95% CrI 0.09 to 0.59); and short-term follow-up SMD 0.78 (95% CrI 0.23 to 1.40). For impact on daily activities, CBTHI was the only behavioural intervention to show beneficial effects [end-of-treatment SMD 1.30 (95% CrI 0.59 to 2.00); and short-term follow-up SMD 2.25 (95% CrI 1.34 to 3.16)]. Few effects remained at long-term follow-up. General practitioner interventions showed no significant beneficial effects for any outcome. No intervention group showed conclusive beneficial effects for measures of symptom load (somatisation). A large degree of heterogeneity was found across individual studies in the assessment of cost-effectiveness. Several studies suggested that the interventions produce fewer quality-adjusted life-years than usual care. For those interventions that generated quality-adjusted life-year gains, the mid-point incremental cost-effectiveness ratios (ICERs) ranged from \u00a31397 to \u00a3129,267, but, where the mid-point ICER fell below \u00a330,000, the exploratory assessment of uncertainty suggested that it may be above \u00a330,000.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Limitations<\/jats:title><jats:p>Sparse networks meant that it was not possible to conduct a metaregression to explain between-study differences in effects. Results were not consistent within intervention type, and there were considerable differences in characteristics between studies of the same type. There were moderate to high levels of statistical heterogeneity. Separate analyses were conducted for three time points and, therefore, analyses are not repeated-measures analyses and do not account for correlations between time points.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Conclusions<\/jats:title><jats:p>Behavioural interventions showed some beneficial effects for specific medically unexplained symptoms, but no one behavioural intervention was effective across all medically unexplained symptoms. There was little evidence that these interventions are effective for measures of symptom load (somatisation). General practitioner-led interventions were not shown to be effective. Considerable heterogeneity in interventions, populations and sparse networks mean that results should be interpreted with caution. The relationship between patient and service provider is perceived to play a key role in facilitating a successful intervention. Future research should focus on testing the therapeutic effects of the general practitioner\u2013patient relationship within trials of behavioural interventions, and explaining the observed between-study differences in effects within the same intervention type (e.g. with more detailed reporting of defined mechanisms of the interventions under study).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Study registration<\/jats:title><jats:p>This study is registered as PROSPERO CRD42015025520.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 24, No. 46. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta24460","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T11:20:27Z","timestamp":1601032827000},"page":"1-490","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":47,"title":["Behavioural modification interventions for medically unexplained symptoms in primary care: systematic reviews and economic evaluation"],"prefix":"10.3310","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5632-6021","authenticated-orcid":true,"given":"Joanna","family":"Leaviss","sequence":"first","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6609-4287","authenticated-orcid":true,"given":"Sarah","family":"Davis","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3568-7124","authenticated-orcid":true,"given":"Shijie","family":"Ren","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3326-9842","authenticated-orcid":true,"given":"Jean","family":"Hamilton","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Scope","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4808-3880","authenticated-orcid":true,"given":"Andrew","family":"Booth","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2449-2516","authenticated-orcid":true,"given":"Anthea","family":"Sutton","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4339-0577","authenticated-orcid":true,"given":"Glenys","family":"Parry","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4016-5857","authenticated-orcid":true,"given":"Marta","family":"Buszewicz","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Population Health, University College London Medical School, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2927-3446","authenticated-orcid":true,"given":"Rona","family":"Moss-Morris","sequence":"additional","affiliation":[{"name":"Department of Psychology, King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8193-5355","authenticated-orcid":true,"given":"Peter","family":"White","sequence":"additional","affiliation":[{"name":"Barts and The London School of Medicine and Dentistry, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2020,9]]},"reference":[{"key":"key20200924115942632_ref1-bib1","volume-title":"Guidance for Health Professionals on Medically Unexplained Symptoms \u2013 2011","author":"Chitnis","year":"2014"},{"key":"key20200924115942632_ref1-bib2","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1097\/01.nmd.0000152796.07788.b6","article-title":"Somatization revisited: diagnosis and perceived causes of common mental disorders","volume":"193","author":"Henningsen","year":"2005","journal-title":"J Nerv Ment Dis"},{"key":"key20200924115942632_ref1-bib3","doi-asserted-by":"publisher","first-page":"936","DOI":"10.1016\/S0140-6736(98)08320-2","article-title":"Functional somatic syndromes: one or many?","volume":"354","author":"Wessely","year":"1999","journal-title":"Lancet"},{"key":"key20200924115942632_ref1-bib4","doi-asserted-by":"publisher","first-page":"1449","DOI":"10.1136\/bmj.325.7378.1449","article-title":"What should we say to patients with symptoms unexplained by disease? 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