Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database.

The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality is not based on research data. We assessed suicides, suicide attempts, and depressive symptom reduction in studies of 7 new antidepressants using the Food and Drug Administration database. Among 19,639 participating patients, 34 committed suicide (0.8% per year), and 130 attempted suicide (2.9% per year). Rates of suicide and attempted suicide did not differ significantly among the placebo- and drug-treated groups. Annual rates of suicide and attempted suicide were 0.4% and 2.7% with placebo, 0.7% and 3.4% with active comparators, and 0.8% and 2.8% with investigational antidepressants, respectively. Symptom reduction was 40.7% with investigational drugs (n = 4,510), 41.7% with active comparators (n = 1,416), and 30.9% with placebo (n = 2,805). These data may help inform discussions about the use of placebo in antidepressant clinical trials.

Primary Hodgkin's disease of the esophagus.

A 30-year-old man with progressive dysphagia and pain on alcohol ingestion was shown to have a mass lesion confined to the esophageal wall. The mass proved to be Hodgkin's disease. It was treated by surgical excision and radiotherapy and the patient remains well, five years after onset. While Hodgkin's disease presenting in the esophagus is rare, it warrants inclusion in the differential diagnosis of esophageal mass lesions.

Cimetidine hepatitis.

This case of an adult with cimetidine-induced hepatitis is presented. An etiologic role for the drug was strongly suggested when the patient developed transient hepatic dysfunction after two reexposures to cimetidine, which reverted promptly on withdrawal of the drug. The temporal relation between the administration of the drug and the development of hepatic dysfunction suggests that it is a hypersensitivity type of reaction.

Intestinal tuberculosis: experience at a Canadian teaching institution.

Thirteen cases of inflammatory bowel disease suspected to be intestinal tuberculosis are analyzed. In nine, the diagnosis was established from such criteria as caseation necrosis, positive acid-fast stains or cultures of the diseased tissue. In four others, enteric tuberculosis remained a diagnostic possibility as judged by the following criteria: coexistence of the bowel lesion with established tuberculosis elsewhere, a clear response to antituberculous chemotherapy, or typical features on roentgenographic, surgical or histologic examination. The patients with intestinal tuberculosis were not necessarily recent immigrants or poor, nor did they have coexistent active pulmonary disease. Although most exhibited classic features of intestinal tuberculosis, the diagnosis was rarely considered at first. A greater awareness of the entity is needed to avoid confusion between intestinal tuberculosis and Crohn's disease.

Parkinsonism and the gut.

Digestive symptoms are frequent in parkinsonism and occasionally dominate the picture of the disease. Symptoms seem to flow from skeletal-muscular and visceral effects of the central lesion.