Journal of General Internal Medicine

, Volume 21, Issue 7, pp 671–677

Primary care clinicians treat patients with medically unexplained symptoms

A randomized controlled trial
  • Robert C. Smith
  • Judith S. Lyles
  • Joseph C. Gardiner
  • Corina Sirbu
  • Annemarie Hodges
  • Clare Collins
  • Francesca C. Dwamena
  • Catherine Lein
  • C. William Given
  • Barbara Given
  • John Goddeeris
Original Articles


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.

Key words

medically unexplained symptoms somatization mental health in primary care provider-patient relationship satisfaction patient-centered 


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Copyright information

© Society of General Internal Medicine 2006

Authors and Affiliations

  • Robert C. Smith
    • 1
  • Judith S. Lyles
    • 1
  • Joseph C. Gardiner
    • 2
  • Corina Sirbu
    • 2
  • Annemarie Hodges
    • 1
  • Clare Collins
    • 3
  • Francesca C. Dwamena
    • 1
  • Catherine Lein
    • 3
  • C. William Given
    • 4
  • Barbara Given
    • 3
  • John Goddeeris
    • 5
  1. 1.Department of MedicineMichigan State UniversityEast LansingUSA
  2. 2.Department of EpidemiologyMichigan State UniversityEast LansingUSA
  3. 3.College of NursingMichigan State UniversityEast LansingUSA
  4. 4.Department of Family PracticeMichigan State UniversityEast LansingUSA
  5. 5.Department of EconomicsMichigan State UniversityEast LansingUSA
  6. 6.B312 Clinical CenterEast Lansing

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