HIV clinical trials · 2003
L-glutamine supplementation improves nelfinavir-associated diarrhea in HIV-infected individuals.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Huffman Fatma G, Walgren Melanie E
Аннотация
PURPOSE: To determine whether L-glutamine decreases the severity of nelfinavir-associated diarrhea in HIV-infected individuals. Other endpoints include the effect on quality of life, muscle-wasting syndrome, CD4 counts, and viral load.
METHOD: HIV-infected patients with nelfinavir-associated diarrhea for >1 month were randomized to receive L-glutamine 30 g/day or placebo for 10 days in a prospective, double-blind, crossover study. Diarrhea was measured on a scale ranging from grade 0 (no diarrhea) to grade 4 (severe diarrhea, > 7 stools/day). Quality of life was assessed by the Medical Outcome Study (MOS) HIV questionnaire.
RESULTS: Twenty-five participants completed the study. There was a significant difference between the L-glutamine and placebo arms on the mean grade of diarrhea (0.762 vs. 1.850, p <.01) when placebo was administered first. When L-glutamine was administered first, there was a significant crossover effect (p <.02), with similar mean grades of diarrhea in the two groups. There was also a significant difference between L-glutamine and placebo in the mean change in MOS scores from baseline (1.48 vs. -2.19, p <.017). There were no significant differences between treatment groups for the other endpoints.
CONCLUSIONS: In this population of HIV-positive participants, L-glutamine 30 g/day significantly (p <.01) reduced the severity of nelfinavir-associated diarrhea and produced improved quality of life compared with placebo.
METHOD: HIV-infected patients with nelfinavir-associated diarrhea for >1 month were randomized to receive L-glutamine 30 g/day or placebo for 10 days in a prospective, double-blind, crossover study. Diarrhea was measured on a scale ranging from grade 0 (no diarrhea) to grade 4 (severe diarrhea, > 7 stools/day). Quality of life was assessed by the Medical Outcome Study (MOS) HIV questionnaire.
RESULTS: Twenty-five participants completed the study. There was a significant difference between the L-glutamine and placebo arms on the mean grade of diarrhea (0.762 vs. 1.850, p <.01) when placebo was administered first. When L-glutamine was administered first, there was a significant crossover effect (p <.02), with similar mean grades of diarrhea in the two groups. There was also a significant difference between L-glutamine and placebo in the mean change in MOS scores from baseline (1.48 vs. -2.19, p <.017). There were no significant differences between treatment groups for the other endpoints.
CONCLUSIONS: In this population of HIV-positive participants, L-glutamine 30 g/day significantly (p <.01) reduced the severity of nelfinavir-associated diarrhea and produced improved quality of life compared with placebo.