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Primary care clinicians treat patients with medically unexplained symptoms: A randomized controlled trial

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Smith, Robert C., Lyles, Judith S., Gardiner, Joseph C., Sirbu, Corina, Hodges, Annemarie, Collins, Clare, Dwamena, Francesca C., Lein, Catherine, Given, C. William, Given, Barbara, Goddeeris, John·2006·Journal of General Internal Medicine

DOI 10.1111/j.1525-1497.2006.00460.xPMC PMC1924714

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Abstract

Objective There is no proven primary care treatment for patients with medically unexplained symptoms (MUS). We hypothesized that a long-term, multidimensional intervention by primary care providers would improve MUS patients' mental health.Design Clinical trial.Setting HMO in Lansing, MI.Participants Patients from 18 to 65 years old with 2 consecutive years of high utilization were identified as having MUS by a reliable chart rating procedure; 206 subjects were randomized and 200 completed the study.Intervention From May 2000 to January 2003, 4 primary care clinicians deployed a 12-month intervention consisting of cognitive-behavioral, pharmacological, and other treatment modalities. A behaviorally defined patient-centered method was used by clinicians to facilitate this treatment and the provider-patient relationship.Main outcome measure The primary endpoint was an improvement from baseline to 12 months of 4 or more points on the Mental Component Summary of the SF-36.Results Two hundred patients averaged 13.6 visits for the year preceding study. The average age was 47.7 years and 79.1% were females. Using intent to treat, 48 treatment and 34 control patients improved (odds ratio [OR]=1.92, 95% confidence interval [CI]: 1.08 to 3.40; P=.02). The relative benefit (relative "risk" for improving) was 1.47 (CI: 1.05 to 2.07), and the number needed to treat was 6.4 (95% CI: 0.89 to 11.89). The following baseline measures predicted improvement: severe mental dysfunction (P<.001), severe body pain (P=.039), nonsevere physical dysfunction (P=.003), and at least 16 years of education (P=.022); c-statistic=0.75.Conclusion The first multidimensional intervention by primary care clinicians led to clinically significant improvement in MUS patients.

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Authors: Smith, R. C., Lyles, J. S., Gardiner, J. C., Sirbu, C., Hodges, A., Collins, C., Dwamena, F. C., Lein, C., Given, C. W., Given, B., & Goddeeris, J.
Affiliations: Michigan State University (US)
Corresponding author: Smith, Robert C.
ORCID: Smith, Robert C.
Gardiner, Joseph C.
Collins, Clare
Given, C. William
Given, Barbara
Venue: Journal of General Internal Medicine
Publisher: Springer Science and Business Media LLC
Published: 2006-07
Volume: 21
Issue: 7
Pages: 671-677
ISSN: 0884-8734 (ISSN-L)
1525-1497
DOI: 10.1111/j.1525-1497.2006.00460.x
PMC: PMC1924714
OpenAlex: W1986905167
Cited by: 187
References: 34
Citations by year: 2026: 1 · 2025: 3 · 2024: 2 · 2023: 4 · 2022: 1 · 2021: 15 · 2020: 12 · 2019: 7 · 2018: 5 · 2017: 8 · 2016: 10 · 2015: 9 · 2014: 10 · 2013: 16 · 2012: 20
FWCI: 7.85
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of General Internal Medicine (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (5r01mh057099-03)
National Institute of Mental Health (MH 57099)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Psychosomatic Disorders and Their Treatments
Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
Social Sciences › Arts and Humanities › History and Philosophy of Science › Medicine, History, and Philosophy
Keywords: medically unexplained symptoms, primary care, multidimensional intervention, cognitive behavioral therapy, mental health, quality of life, SF-36, bodily pain, predictors of treatment response, provider-patient relationship
MeSH terms: Adult, Aged, Mental Disorders, Education, Medical, Continuing, Female, Health Maintenance Organizations, Humans, Male, Mental Health, Middle Aged, Pain, Physicians, Family, Treatment Outcome, Patient Selection

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Primary care clinicians treat patients with medically unexplained symptoms: A randomized controlled trial

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