Samuel W. Chey, MPH1, William D. Chey, MD, FACG1, Kenya Jackson, BS2, Shanti Eswaran, MD3; 1University of Michigan Health System, Ann Arbor, MI; 2Atlanta VA Healthcare System, Decatur, GA; 3University of Michigan, Ann Arbor, MI
Introduction: Patients with chronic constipation (CC) are increasingly seeking natural treatments. Psyllium and prunes are proven treatments for CC. Asian studies suggest that kiwi may also benefit CC symptoms. We report a randomized, comparative effectiveness trial evaluating kiwifruit, psyllium, and prunes in US CC patients. Methods: Adults with CC at a US medical center were randomized to 3 natural treatments. Eligible patients had ≤3 complete spontaneous bowel movements (CSBMs) per week. After a 2-week baseline screening period, eligible patients were randomized to green kiwifruit (2/day, Zespri), prunes (100g/day, Kirkland), or psyllium (12g/day, Proctor & Gamble) for 4 weeks. The primary endpoint was the proportion of patients in each group reporting an increase of ≥1 CSBM per week compared to baseline for at least 2 of 4 treatment weeks. Key secondary outcomes included stool frequency, stool consistency (Bristol Stool Form Scale), and straining (0-10 scale) assessed daily and overall treatment satisfaction (Y/N) evaluated after treatment. Standard statistical methods were utilized (Chi-Square, ANOVA, paired t-tests) and a p< .05 was considered significant. Adverse events were collected using open-ended questions after treatment. Results: 79 CC patients (mean age=42.7 yrs, 87% female, 77% white) were randomized. Complete data was available for 75 patients (kiwi 29, prunes 24, psyllium 22). Demographics were similar between groups. For the primary endpoint, proportions of CSBM responders were similar for the treatments. For secondary outcomes comparing treatment weeks 3&4 to baseline, there was a significant increase in weekly CSBM rate with all 3 treatments (p≤.003); Stool consistency significantly improved with kiwi (p=.01) and prunes (p=.049); Straining significantly improved with kiwi (p=.003), prunes (p< .001), and psyllium (p=.04). Adverse events (AEs) were most common with psyllium and least common with kiwi. At the end of treatment, a smaller proportion of patients were dissatisfied with kiwi compared to prunes or psyllium (p=.02). Discussion: Kiwifruit, prunes, and psyllium improve constipation symptoms in CC patients. Kiwifruit was associated with the lowest rate of adverse events and dissatisfaction with therapy. These results confirm the benefits of prunes & psyllium and offer the first US data for green kiwifruit as an effective and well-tolerated treatment for CC patients.
Figure 1. Primary outcome with satisfaction/dissatisfaction reports by group
Table 1. Secondary outcomes by group at baseline screening and treatment weeks 3&4
Table 2. Adverse events reported by ≥5% of the study population by group
Disclosures: Samuel Chey indicated no relevant financial relationships. William Chey: Abbvie – Consultant. Alnylam – Consultant. American College of Gastroenterology – Advisory Committee/Board Member. ANMS – Advisory Committee/Board Member. BioAmerica – Consultant, Grant/Research Support. Commonwealth Diagnostics International – Grant/Research Support. GI On Demand – Advisory Committee/Board Member, Stockholder/Ownership Interest (excluding diversified mutual funds). IFFGD – Advisory Committee/Board Member. IM Health – Consultant. Ironwood – Consultant. Modify Health – Consultant, Stockholder/Ownership Interest (excluding diversified mutual funds). Phathom – Consultant. QOL Medical – Consultant, Grant/Research Support. ROME Foundation – Advisory Committee/Board Member. Salix – Consultant, Grant/Research Support. Takeda – Consultant. Urovant – Consultant, Grant/Research Support. Zespri – Grant/Research Support. Kenya Jackson indicated no relevant financial relationships. Shanti Eswaran indicated no relevant financial relationships.