A prospective, randomized, double-blind, placebo-controlled study of orbital radiotherapy for Graves' ophthalmopathy.

CONTEXT: Although widely used for more than 85 years, the efficacy of radiotherapy for Graves' ophthalmopathy (GO) has not been established convincingly. OBJECTIVE: To evaluate the efficacy of radiotherapy for GO. DESIGN: Prospective, randomized, internally controlled, double-blind clinical trial in a tertiary care academic medical center. PARTICIPANTS: The patients were ethnically diverse males and females over age 30 seen in a referral practice. The patients had moderate, symptomatic Graves' ophthalmopathy (mean clinical activity score, 6.2) but no optic neuropathy, diabetes, recent steroid treatment, previous decompression, or muscle surgery. Forty-two of 53 consecutive patients were enrolled after giving informed consent and fulfilling study entry criteria. Eleven eligible patients declined to participate because of inconvenience, desire for alternative therapy, or concern about radiation. INTERVENTION: One randomly selected orbit was treated with 20 Gy of external beam therapy; sham therapy was given to the other side. Six months later, the therapies were reversed. MAIN OUTCOME MEASURES: Every 3 months for 1 year, we measured the volume of extraocular muscle and fat, proptosis, range of extraocular muscle motion, area of diplopia fields, and lid fissure width. Effective treatment for GO will modify one or more of these parameters. RESULTS: No clinically or statistically significant difference between the treated and untreated orbit was observed in any of the main outcome measures at 6 months. At 12 months, muscle volume and proptosis improved slightly more in the orbit that was treated first. CONCLUSIONS: In this group of patients, representative of those for whom radiotherapy is frequently recommended, we were unable to demonstrate any beneficial therapeutic effect. The slight improvement noted in both orbits at 12 months may be the result of natural remission or of radiotherapy, but the changes are of marginal clinical significance.

Incidence of anemia in older people: an epidemiologic study in a well defined population.

OBJECTIVE: To assess the incidence and clinical spectrum of anemia among older people. DESIGN: Inception cohort assembled and followed by medical records linkage until death or last clinical contact through January 1994. SETTING: Population-based study in Olmsted County, Minnesota. PARTICIPANTS: All 618 Olmsted County men and women aged 65 years or more with anemia by World Health Organization criteria that was first recognized in 1986. MEASUREMENTS: Age- and sex-adjusted incidence rates, corrected for prevalent anemia, and survival estimates using the Kaplan-Meier method, with calculation of standardized mortality ratios for specific causes of death. RESULTS: The corrected annual incidence of anemia rose with age, and rates were higher in men (90.3 per 1000; 95% CI, 79.2-101.4) than women (69.1 per 1000; 95% CI, 62.3-75.8). In 465 cases (75%), anemia was detected in conjunction with a hospitalization, but admission was due to anemia in only 57 instances. Half of the cases were caused by blood loss, two-thirds of these as a result of surgery. The cause of anemia was uncertain in 102 cases (16%). One-third of the patients were transfused with a median of 3 units each. Overall survival was worse than expected but was better among those with anemia caused by blood loss. Mortality attributable to malignancy, mental disorders, circulatory and respiratory diseases, ill-defined conditions, and injuries was significantly increased among these older patients with anemia. CONCLUSIONS: The incidence of anemia among older people is 4 to 6 times greater than that suspected clinically, rises with age, and is higher in men than in women. The apparent cause in half the cases is blood loss. Even mild anemia is associated with reduced survival, especially during the first year, but this could relate to underlying comorbid conditions.

Long-term follow-up of patients treated surgically for medically intractable epilepsy: results in 291 patients treated at Mayo Clinic Rochester between July 1972 and March 1985.

To assess the long-term outcome in patients who underwent surgical treatment of intractable epilepsy, we retrospectively reviewed the medical records of 291 consecutive Mayo patients treated between July 1972 and March 1985. We also evaluated the responses to a follow-up mailed questionnaire or telephone interview completed in 1992. Of the 291 patients, 245 (94% of the 261 patients known to be alive at the time of the survey) responded to the follow-up questioning. Information on the patients' neurologic status (including frequency of seizures, use of antiepileptic drugs, and self-reported assessment of functional capacity) and their overall satisfaction with the operative procedure and postoperative outcome were evaluated. Two hundred ninety patients survived the operation and were dismissed from the hospital. Of the 245 patients who responded to the follow-up survey, 41% and 58% had been free of seizures since surgical treatment and for 3 years preceding the follow-up survey, respectively. In addition, of the respondent cohort, 36% were successfully weaned off all antiepileptic drugs. Patients reported improvement in their daily functional capacity and quality of life after surgical treatment. For example, in comparison with the preoperative assessment, the patients' ability to obtain a driver's license was significantly increased, and seizure-related driving accidents, falls, and bodily injury significantly decreased. Furthermore, on the basis of current knowledge of the operation and its outcome, 85% reported that they would repeat the operative procedure. Thus, surgical treatment of intractable epilepsy is an effective option that is met with patient satisfaction.