The American journal of gastroenterology · 2025
Efficacy of 1 L Polyethylene Glycol Plus Ascorbic Acid With Linaclotide Versus Senna for Bowel Preparation: A Multicenter, Endoscopist-Blinded, Randomized Controlled Trial (Apple Trial).
СтатьяМногоцентровое исследованиеРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Maeda Natsumi, Higashimori Akira, Kabata Daijiro, Yamamoto Ikki, Yanagida Tsuyoshi, Kin Daiyu, Matsumoto Yuji, Nakata Rieko, Hashimoto Atsushi, Sawada Akinari, Maruyama Hirotsugu, Okamoto Junichi, Katsuno Takayuki, Nadatani Yuji, Ominami Masaki, Fukunaga Shusei, Morimoto Kenichi, Hosomi Shuhei, Tanaka Fumio, Nakatani Masami, Taira Koichi, Sasaki Eiji, Fukuda Takashi, Ota Keiko, Yoshida Hisako, Watanabe Toshio, Fujiwara Yasuhiro
Аннотация
INTRODUCTION: No bowel preparation (BP) for colonoscopy achieves optimal efficacy and tolerability. Combining polyethylene glycol plus ascorbic acid (PEG-Asc) with adjuvants has been explored to enhance cleansing efficacy and reduce the required volume. The aim of this study was to evaluate whether adding 0.5 mg linaclotide to 1 L PEG-Asc (1 L-PEG/AL) improves superior cleansing compared with adding 24 mg senna (1 L-PEG/AS), which we previously reported to be noninferior to the standard regimen of 2 L PEG-Asc.
METHODS: A multicenter, endoscopist-blinded, randomized controlled trial was conducted at 5 centers in Japan with outpatients scheduled for colonoscopy. The primary outcome was adequate BP, evaluated using the Boston Bowel Preparation Scale. Analyses were stratified based on low-risk and high-risk groups for inadequate BP.
RESULTS: Between April 2022 and April 2023, 1,464 patients were randomized to the 1L-PEG/AL (n = 731) or 1L-PEG/AS (n = 733). The 1L-PEG/AL demonstrated higher adequate BP rates (92% vs 86%, P = 0.001) compared with 1L-PEG/AS. Both groups experienced similar adverse events and expressed high willingness for repeat BP (83% vs 81%, P = 0.49). In high-risk patients (n = 892), 1L-PEG/AL had significantly higher adequate BP rates (94% vs 86%, P < 0.001), whereas rates were comparably high in low-risk patients (n = 539) (94% vs 94%, P = 0.66).
DISCUSSION: The linaclotide regimen was superior to the senna regimen reagrding BP efficacy without reducing tolerability. It can be a promising new option for BP, especially in patients at a high risk of inadequate BP.
METHODS: A multicenter, endoscopist-blinded, randomized controlled trial was conducted at 5 centers in Japan with outpatients scheduled for colonoscopy. The primary outcome was adequate BP, evaluated using the Boston Bowel Preparation Scale. Analyses were stratified based on low-risk and high-risk groups for inadequate BP.
RESULTS: Between April 2022 and April 2023, 1,464 patients were randomized to the 1L-PEG/AL (n = 731) or 1L-PEG/AS (n = 733). The 1L-PEG/AL demonstrated higher adequate BP rates (92% vs 86%, P = 0.001) compared with 1L-PEG/AS. Both groups experienced similar adverse events and expressed high willingness for repeat BP (83% vs 81%, P = 0.49). In high-risk patients (n = 892), 1L-PEG/AL had significantly higher adequate BP rates (94% vs 86%, P < 0.001), whereas rates were comparably high in low-risk patients (n = 539) (94% vs 94%, P = 0.66).
DISCUSSION: The linaclotide regimen was superior to the senna regimen reagrding BP efficacy without reducing tolerability. It can be a promising new option for BP, especially in patients at a high risk of inadequate BP.