Background: Patients with medically unexplained or functional somatic symptoms are common in primary care. Previous reviews have reported benefit from specialised interventions such as cognitive behavioural therapy and consultation letters, but there is a need for treatment models which can be applied within the primary care setting. Primary care studies of enhanced care, which includes techniques of reattribution or cognitive behavioural therapy, or both, have shown changes in healthcare professionals' attitudes and behaviour. However, studies of patient outcome have shown variable results and the value of enhanced care on patient outcome remains unclear.
Objectives: We aimed to assess the clinical effectiveness of enhanced care interventions for adults with functional somatic symptoms in primary care. The intervention should be delivered by professionals providing first contact care and be compared to treatment as usual. The review focused on patient outcomes only.
Search methods: We searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR-Studies and CCDANCTR-References) (all years to August 2012), together with Ovid searches (to September 2012) on MEDLINE (1950 - ), EMBASE (1980 - ) and PsycINFO (1806 - ). Earlier searches of the Database of Abstracts of Reviews of Effectiveness (DARE), CINAHL, PSYNDEX, SIGLE, and LILACS were conducted in April 2010, and the Cochrane Central Register of Controlled Trials (CENTRAL) in October 2009. No language restrictions were applied. Electronic searches were supplemented by handsearches of relevant conference proceedings (2004 to 2012), reference lists (2011) and contact with authors of included studies and experts in the field (2011).
Selection criteria: We limited our literature search to randomised controlled trials (RCTs), primary care, and adults with functional somatic symptoms. Subsequently we selected studies including all of the following: 1) a trial arm with treatment as usual; 2) an intervention using a structured treatment model which draws on explanations for symptoms in broad bio-psycho-social terms or encourages patients to develop additional strategies for dealing with their physical symptoms, or both; 3) delivery of the intervention by primary care professionals providing first contact care; and 4) assessment of patient outcome.
Data collection and analysis: Two authors independently screened identified study abstracts. Disagreements about trial selections were resolved by a third review author. Data from selected publications were independently extracted and risk of bias assessed by two of three authors, avoiding investigators reviewing their own studies. We contacted authors from included studies to obtain missing information. We used continuous outcomes converted to standardised mean differences (SMDs) and based analyses on changes from baseline to follow-up, adjusted for clustering.
Main results: We included seven studies from the literature search, but only six provided sufficient data for analyses. Included studies were European, cluster RCTs with adult participants seeing their usual doctor (in total 233 general practitioners and 1787 participants). Methodological quality was only moderate as studies had no blinding of healthcare professionals and several studies had a risk of recruitment and attrition bias. Studies were heterogeneous with regard to selection of patient populations and intensity of interventions. Outcomes relating to physical or general health (physical symptoms, quality of life) showed substantial heterogeneity between studies (I(2) > 70%) and post hoc analysis suggested that benefit was confined to more intensive interventions; thus we did not calculate a pooled effect. Outcomes relating to mental health showed less heterogeneity and we conducted meta-analyses, which found non-significant overall effect sizes with SMDs for changes at 6 to 24 months follow-up: mental health (3 studies) SMD -0.04 (95% CI -0.18 to 0.10), illness worry (3 studies) SMD 0.09 (95% CI -0.04 to 0.22), depression (4 studies) SMD 0.07 (95% CI -0.05 to 0.20) and anxiety (2 studies) SMD -0.07 (95% CI -0.38 to 0.25). Effects on sick leave could not be estimated. Three studies of patient satisfaction with care all showed positive but non-significant effects, and measures were too heterogeneous to allow meta-analysis. Results on healthcare utilisation were inconclusive. We analysed study discontinuation and found that both short term and long term discontinuation occurred more often in patients allocated to the intervention group, RR of 1.25 (95% CI 1.08 to 1.46) at 12 to 24 months.
Authors' conclusions: Current evidence does not answer the question whether enhanced care delivered by front line primary care professionals has an effect or not on the outcome of patients with functional somatic symptoms. Enhanced care may have an effect when delivered per protocol to well-defined groups of patients with functional disorders, but this needs further investigation. Attention should be paid to difficulties including limited consultation time, lack of skills, the need for a degree of diagnostic openness, and patient resistance towards psychosomatic attributions. There is some indication from this and other reviews that more intensive interventions are more successful in changing patient outcomes.