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A multicenter, randomized, double-blinded trial of pyridostigmine in postpolio syndrome

From the Departments of Neurology (Drs. Trojan and Cashman) and Physiotherapy (L. Finch), Montreal Neurological Institute and Hospital; the Randomized Clinical Trial Unit (Drs. Collet and Shapiro, and A. Robinson and T. Ducruet), Jewish General Hospital, Montreal; the Department of Epidemiology and Biostatistics (Drs. Collet and Shapiro), McGill University, Montreal, Quebec, Canada; the Department of Neurology (Dr. Jubelt), SUNY Health Science Center, Syracuse, NY; the Department of Neurology (Dr. Miller), California Pacific Medical Center, San Francisco, CA; the Department of Rehabilitation Medicine (Dr. Agre), University of Wisconsin–Madison; New England Medical Center (Drs. Munsat and Hollander), Tufts University, Boston, MA; Department of Neurology (Dr. Tandan), University of Vermont, Burlington, VT; and Medical and Regulatory Affairs (Dr. Granger), ICN Pharmaceuticals, Inc., Costa Mesa, CA.

Address correspondence and reprint requests to Dr. Daria A. Trojan, Montreal Neurological Institute and Hospital, 3801 University, Montreal, Quebec, Canada H3A 2B4, or to Dr. Neil R. Cashman, Center for Research in Neurodegenerative Disease, 6 Queens Park Crescent, Toronto, Ontario, Canada M5S 1A8.

BACKGROUND: Postpoliomyelitis syndrome (PPS) is likely due to degeneration and dysfunction of terminal axons of enlarged postpolio motor units. Age-related decline in growth hormone and insulin-like growth factor (IGF-I) may be a contributing factor. Neuromuscular junction abnormalities and decreased IGF-I levels may respond to the anticholinesterase pyridostigmine, with consequent improvement in strength, fatigue, and quality of life.

OBJECTIVES: To determine the effect of pyridostigmine in PPS on health-related quality of life, isometric muscle strength, fatigue, and serum IGF-I levels; and to assess the safety of pyridostigmine in PPS.

METHODS: The study was a multicenter, randomized, double-blinded, placebo-controlled trial of a 6-month course of pyridostigmine 60 mg three times per day in 126 PPS patients. The primary data analysis compared mean changes of outcomes between treatment and control groups at 6 months using an intention to treat approach. Secondary analyses included a comparison of outcomes at 6 and 10 weeks, and in compliant patients.

RESULTS: The study showed no significant differences in pyridostigmine and placebo-treated patients with regard to changes in quality of life, isometric strength, fatigue, and IGF-I serum levels at 6 months in the primary analysis and in compliant patients. There were no differences in outcomes at 6 and 10 weeks between groups. However, very weak muscles (1 to 25% predicted normal at baseline) were somewhat stronger (p = 0.10, 95% CI of difference -9.5 to 73.3%), and in compliant patients IGF-I was somewhat increased (p = 0.15, 95% CI of difference -6.4 to 44.8 ng/mL) at 6 months with the medication. Pyridostigmine was generally well tolerated.

CONCLUSIONS: This study showed no significant differences between pyridostigmine and placebo-treated PPS patients on measures of quality of life, isometric strength, fatigue, and serum IGF-I.

Key words: Poliomyelitis—Pyridostigmine—Quality of life—Strength—Insulin-like growth factor-I.

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