One issue for prune intake that should be raised is its tendency to cause diarrhea and flatulence ( 11, 12). Collectively, our study underlies that it is important to improve stool shape in ≤4 weeks, but that quality of life determination should take place after at least 8 weeks. Previous studies focusing on constipation and prune intake have limited evaluation to study periods ≤4 weeks ( 4, 5). Importantly, the persistence of BSFS 4 was reported to be significantly correlated with the quality of life ( 10). Although a previous study has also shown a significant increase in the mean BSFS after prune intake in chronic constipation ( 4, 5), it has not focused on alteration of each BSFS score. Notably, BSFS 1 (hard stool) rates significantly decreased after 3 weeks, whereas BSFS 4 (normal stool) rates significantly increased after 7 weeks of prune juice intake compared with placebo (Figure (Figure1). Detailed methods are provided in Methods (see Supplementary Digital Content, ). The severity of AEs or laboratory abnormalities was evaluated according to the definition by the Common Terminology Criteria for Adverse Events, version 5.0 ( 9) ( number, University hospital Medical Information Network Identify Document: 000041384). Laboratory parameters were assessed by blood and urine tests at baseline and in the postintake period. Subjects reported any adverse events (AEs) during the study period. GSRS was measured at baseline, 4 weeks, and 8 weeks after starting intake. Stool consistency was recorded at each bowel movement and analyzed as the rate of each score in every week throughout the study period. Stool consistency by BSFS ( 7) and subjective complaints by the Gastrointestinal Symptom Rating Scale (GSRS) ( 8) were assessed for constipation improvement. The placebo is designed to match the flavor, color, and taste of prune juice (see Table 1, Supplementary Digital Content, ). Subjects were randomly assigned to the prune juice group or placebo group and consumed 54 g of each test food in a day for 8 weeks. The criterion for chronic constipation was defined according to Rome IV as fewer than 3 bowel movements per week and/or hard stool defined by the Bristol Stool Form Scale (BSFS) 1 or 2, for the past 3 months, with symptom onset at least 6 months earlier ( 6). This study included subjects aged 20–75 years who presented symptoms of treatment-naive chronic constipation. Written informed consent was obtained from all subjects before their enrollment into this study. This study was conducted in accordance with the Declaration of Helsinki with the approval of the institutional review boards of the Miura Clinic (approval number: R2001) and Tokyo Medical University (approval number: T2021-0243).
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