Abstract

Chronic constipation is a common symptom-based disorder that affects patient quality of life. Electrolyzed hydrogen-rich alkaline reduced water (EHARW) helps treat gastrointestinal disorders owing to its various bioactive properties. This single-arm, open-labelled study aimed to investigate the improvement of EHARW (pH 9.5; H2 ≈ 0.5 mg/L) in chronic constipation patients. Thirty patients with chronic constipation were enrolled after screening as intention-to-treat (ITT). During the intervention period, two patients dropped out, and 28 patients completed the study as per protocol (PP). The selected patients were instructed to drink EHARW (pH 9.5; H2 ≈ 0.5 mg/L) (20 mL/kg body weight/day) generated from a home medical device for four weeks. Complete spontaneous bowel movement (CSBM) frequency was measured as the primary outcome, and Bristol stool form, patient assessment of constipation–symptoms (PAC-SYM) score, and patient assessment of constipation–quality of life (PAC-QOL) score were measured as the secondary outcomes after the 4-week intervention compared to baseline. As a result of EHARW treatment, no adverse events were observed during the study period. Moreover, the frequency of CSBM/week (29.8%, p < 0.05) and Bristol stool form score (24.6%, p < 0.01) significantly increased compared to baseline. Finally, the overall and subscale scores of the PAC-SYM (58.0%) and PAC-QOL (54.2%) questionnaires significantly decreased (p < 0.001). These results suggest that daily ingestion of EHARW (pH 9.5; H2 ≈ 0.5 mg/L) can improve CSBM frequency as a primary outcome in chronic constipation patients. Likewise, EHARW (pH 9.5; H2 ≈ 0.5 mg/L) improved Bristol stool form score, symptoms and the quality of life as a secondary outcome in patients with chronic constipation through a home-based intervention.

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