Всемирная психиатрия. №2 2017

Повлиял ли рост ответов на плацебо на результаты клинических исследований антидепрессантов? Данные Управления по контролю качества пищевых продуктов и лекарственных средств США 1987-2013

Arif Khan1,2, Kaysee Fahl Mar1, Jim Faucett1, Shirin Khan Schilling1,3,Walter A. Brown4

Northwest Clinical Research Center, Bellevue, WA, USA; 2Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA; 3Department of Psychiatry, University of Connecticut, Hartford, CT, USA; 4Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA

Стр. 179-189

1620 просмотров

Опубликовано: 7 июня 2017

Аннотация / Abstract

Перевод: Рукавишников Г.В. (Санкт-Петербург), Шишорин Р.М. (Москва) Редактура: Чумаков Е.М. (Санкт-Петербург) Резюме Более пятнадцати лет назад было отмечено, что частота неудачных результатов клинических исследований антидепрессантов высока. Подобные негативные результаты исследований, как предполагалось, были связаны с растущей выраженностью ответов на плацебо. При этом данный феномен, как и его влияние на результаты более недавних исследований, остается предметом значительных споров. Для изучения этого вопроса мы рассмотрели обзоры Управленияпо контролю качества пищевых продуктов и лекарственных средств США (FDA) по шестнадцати антидепрессантам (85 исследований, 115 ветвей исследований, 23,109 пациентов), одобренных с 1987 по 2013 год. Мы рассчитали выраженность ответов на плацебо и антидепрессанты, различия в их эффективности, а также выраженность эффекта и степень успешности и сравнили их в течение времени. Предварительный анализ оценивал потенциальные изменения в дизайне исследований и их проведении со временем. Как ожидалось, выраженность ответов на плацебо неуклонно возрастала в течение последних 30 лет, увеличившись с 2000 года на 6,4% (r=0,46, p

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Вход / Регистрация

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