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Amyotrophic lateral sclerosis

Effects of acute intravenous and chronic subcutaneous administration of thyrotropin-releasing hormone in controlled trials

Departments of Neurology (Drs. Mitsumoto, Salgado, Negroski, Hanson, Salanga, Wilbourn, and Breuer) and Biostatistics and Epidemiology (Ms. Leatherman), The Cleveland Clinic Foundation, Cleveland, OH; and the Section of Endocrinology, Department of Medicine (Dr. Wilber), Louisiana State University Medical Center, New Orleans, LA.

We performed double-blind crossover trials to assess the effects of thyrotropin-releasing hormone (TRH) on amyotrophic lateral sclerosis patients. For acute intravenous trials, 500 mg TRH or placebo with norepinephrine was given at 1-week intervals (16 patients). CSF TRH concentration increased, and clinical side effects appeared with TRH. For chronic studies, 25 mg TRH and a saline placebo were given subcutaneously every day for 3 months (25 patients). CSF TRH level increased 29-fold after a single TRH injection, and mild transient side effects occurred. Vital signs, respiratory function, semiquantitative and quantitative neurologic function, muscle strength by manual and dynamometer testing, and EMG were studied. With daily TRH, 10 patients noted subjective improvement without objective evidence, and 10 patients complained of worsening of the disease with objective decline after TRH was stopped. Statistical analysis, however, showed no beneficial effects from either acute or chronic TRH trials.

Address correspondence and reprint requests to Dr. Mitsumoto, Neuromuscular Program, Department of Neurology, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44106.

The entire study was funded by The Cleveland Clinic Foundation (Research Program Committee). Abbott Laboratory supplied TRH.

Accepted for publication October 17, 1985.

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