Clinical Question: Does a care recommendation letter improve outcomes for patients with somatization disorder?
Setting: Outpatient (primary care)
Study Design: Randomized controlled trial (nonblinded)
Synopsis: Somatizing patients have many unexplained symptoms; evaluation of these symptoms consumes significant health care resources and is frustrating for the patient and the physician. In this study, 2,902 consecutive primary care patients were screened for the presence of at least three unexplained physical symptoms with an 11-item questionnaire derived from the Diagnostic and Statistical Manual of Mental Disorders, 3d ed., rev. (DSM-III-R) criteria for somatization disorder.
A more detailed face-to-face interview was used to classify the patients (based on DSM-III-R criteria) into somatoform disorder (13 or more lifetime unexplained physical symptoms; n = 88), abridged somatization disorder (at least four unexplained lifetime physical symptoms in men or six in women; n = 183), or multisomatoform disorder (three or more current unexplained symptoms from a list of 15 in a patient with a two-year history of somatization; n = 111). The diagnostic classifications of somatoform disorder, abridged somatization disorder, and multisomatoform disorder were not mutually exclusive; 188 patients (6.4 percent) of the 2,902 patients were classified in at least one of these groups. Thus, on a typical day of outpatient care seeing 24 patients, a physician might see one or two of these patients, so this classification has face validity.
The 188 patients were randomized to have their primary care physician receive a care recommendation letter immediately following the evaluation or after 12 months. The study was not blinded, and details are not given about allocation concealment. The functional status of patients was evaluated at baseline, 12 months, and 24 months. The letter notified the physician of the diagnosis and provided reassuring information regarding prognosis. The letter also recommended having brief regularly scheduled appointments; avoiding urgent appointments; looking closely for signs of disease rather than taking symptoms at face value; avoiding hospitalization, surgery, or diagnostic procedures unless indicated; and viewing the symptoms as part of an unconscious process rather than telling the patient that the problem is “all in your head.” A limitation of this study is that 20 percent of patients were lost to follow-up at one year, and 40 percent were lost at two years.
In general, the groups were demographically similar, although emotional function was slightly worse in patients lost to follow-up at two years. The authors found that physical function declined in a statistically and clinical significant manner in the untreated group during the first 12 months, but not in the intervention group. In the second 12 months, the initially untreated group regained their former level of physical function after the intervention. No effect on mental health function was evident. The cost of the intervention and its effect on resource use were not provided.
Bottom Line: A letter notifying physicians of patients in their practice who have been diagnosed with somatization disorder and recommending a strategy for caring for these patients can lead to clinically meaningful gains in patients' physical function compared with patients whose physicans do not receive such letters. (Level of Evidence: 1b)