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In the prune juice group, the rates of hard and lumpy stools (BSFS 1 or 2) were significantly decreased from baseline and were significantly lower than the placebo group after 3 weeks ( Figure 1). There were no significant differences in baseline characteristics ( Table 1) including age, sex, body mass index, dietary habits, BSFS score ( Figure 1), and bowel symptoms ( Table 2) between the groups. RESULTSĪ total of 84 subjects were enrolled and included in the intention-to-treat analysis (see Figure 1, Supplementary Digital Content, ). 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.
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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). We aimed to evaluate the effects of prune juice consumption on stool consistency and subjective complaints of constipation symptoms in Japanese subjects with chronic constipation. Among natural foods, prune potentially exerts an ameliorating effect on constipation ( 4,5), but little data are available on the effectiveness in chronic constipation subjects or on side effects such as abdominal discomfort or diarrhea symptoms.
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Instead of drug treatment, there has been increasing recognition of natural food treatment, which is beneficial in its safety and prevalence ( 3).
MICROSOFT WORD ENDNOTE NUMBERING PROBLEM ANDROID
All 1800-number Accessibility Accessories Activity Monitor Adware Airdrop Airplay Airpods Alarms Alerts Android Apple Id Apple-id are a wide variety of laxatives available for chronic constipation treatment, but they have several problems, including side effects and insufficient efficacy ( 1,2).