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Primary care clinicians treat patients with medically unexplained symptoms

A randomized controlled trial

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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 and Affiliations

  1. Department of Medicine, Michigan State University, East Lansing, MI, USA

    Robert C. Smith MD, ScM, Judith S. Lyles PhD, Annemarie Hodges MA & Francesca C. Dwamena MD

  2. Department of Epidemiology, Michigan State University, East Lansing, MI, USA

    Joseph C. Gardiner PhD & Corina Sirbu PhD

  3. College of Nursing, Michigan State University, East Lansing, MI, USA

    Clare Collins RN, PhD, Catherine Lein RN, FNP & Barbara Given PhD

  4. Department of Family Practice, Michigan State University, East Lansing, MI, USA

    C. William Given PhD

  5. Department of Economics, Michigan State University, East Lansing, MI, USA

    John Goddeeris PhD

Authors
  1. Robert C. Smith MD, ScM
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  2. Judith S. Lyles PhD
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  3. Joseph C. Gardiner PhD
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  4. Corina Sirbu PhD
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  5. Annemarie Hodges MA
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  6. Clare Collins RN, PhD
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  7. Francesca C. Dwamena MD
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  8. Catherine Lein RN, FNP
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  9. C. William Given PhD
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  10. Barbara Given PhD
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  11. John Goddeeris PhD
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Corresponding author

Correspondence to Robert C. Smith MD, ScM.

Additional information

Supported by NIMH grant MH 57099. Orally presented as a research abstract at the annual meetings of the Society of General Internal Medicine (May 2004), the American Academy on Physician and Patient Research Forum (October 2004), and the Academy of Psychosomatic Medicine (November 2004).

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Smith, R.C., Lyles, J.S., Gardiner, J.C. et al. Primary care clinicians treat patients with medically unexplained symptoms. J Gen Intern Med 21, 671–677 (2006). https://doi.org/10.1111/j.1525-1497.2006.00460.x

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  • DOI: https://doi.org/10.1111/j.1525-1497.2006.00460.x

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