Improvement in quality-of-life measures and stimulation of weight gain after treatment with megestrol acetate oral suspension in geriatric cachexia: results of a double-blind, placebo-controlled study.

BACKGROUND: Weight loss among older patients is a severe problem, associated with an increased incidence of infections, decubiti, and death. Megestrol acetate (MA) causes weight gain in cachectic cancer and AIDS patients, but its effects in older cachectic patients are unknown. OBJECTIVE: To compare the effects of MA oral suspension (O.S.), 800 mg/day, versus placebo on weight in geriatric nursing home patients with weight loss or low body weight. DESIGN: Twelve-week, randomized, double-blind, placebo-controlled trial with a 13-week follow-up period. SETTING: Veterans Administration Medical Center (VMAC) nursing home. PATIENTS: Nursing home patients with weight loss of > or =5% of usual body weight over the past 3 months, or body weight 20% below their ideal body weight. INTERVENTIONS: Patients were randomly assigned to receive placebo or MA 800 mg/day for 12 weeks and were then followed for 13 weeks off treatment. MEASUREMENTS: Primary outcome was measured by weight and appetite change. Secondary outcome measures included sense of well-being, enjoyment of life, change in depression scale, laboratory nutrition parameters, energy intake counts, body composition, and adverse events. RESULTS: At 12 weeks there were no significant differences in weight gain between treatment groups, whereas MA-treated patients reported significantly greater improvement in appetite, enjoyment of life, and well-being. Body composition was not statistically different between the two groups. At Week 25 (3 months after treatment), 61.9% of MA-treated patients had gained > or =1.82 kg (4 lbs) compared to 21.7% of placebo patients. CONCLUSIONS: In geriatric patients with weight loss or low body weight MA improves appetite and well-being after 12 weeks of treatment. During the 3 months of MA treatment, there was no statistically significant weight gain (> or =4 lbs). Three months after treatment, weight gain (> or =4 lbs) was significantly increased in MA-treated patients.