NICEVIVA
MONOGRAPH SPEC LATEST 2026

Psyllium (Constipation)

DIGESTIVE · Evidence Monograph

Psyllium (Constipation) is an evidence-graded digestive monograph evaluated across 21 peer-reviewed PubMed studies (3 meta-analyses, 5 systematic reviews, and 6 randomized controlled trials, encompassing n = 2,528 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 21 Studies
Meta-Analyses · Reviews 3 Meta · 5 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (3 Double-Blind)
Cumulative Participants n = 2,528
Reported Trial Dosages 10 g/day · 5 g · 10 g
Trial Duration Range 4 weeks · 8 weeks · 3 months
Reading Time ~11 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 21 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (10 g/day · 5 g · 10 g) over a structured 4 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary digestive clinical efficacy (21 PubMed studies)
Quantitative biomarker & outcome analysis (15 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 3 double-blind)
Systematic review & meta-analysis synthesis (3 meta-analyses · 5 reviews)
01

What Is Psyllium (Constipation) & Why Does Form Matter?

Psyllium (Constipation) is classified under DIGESTIVE and has been investigated across 21 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (10 g/day, 5 g, 10 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Psyllium (Constipation) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Psyllium (Constipation) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Psyllium (Constipation) an overall evidence rating of GRADE High (4.0 / 4.0) based on 21 PubMed studies: 3 meta-analyses, 5 systematic reviews, and 6 randomized controlled trials (3 double-blind, n = 2,528 total participants).

Representative peer-reviewed findings include: • PMID:37905980 (2024) — "Systematic review and meta-analysis: Foods, drinks and diets and their effect on chronic constipation in adults." (CONCLUSIONS: Fruits and rye bread may improve certain constipation-related outcomes.) • PMID:35816465 (2022) — "The Effect of Fiber Supplementation on Chronic Constipation in Adults: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials." (CONCLUSIONS: Fiber supplementation is effective at improving constipation.) • PMID:39223790 (2024) — "The effect of fiber supplementation with agave fructans or psyllium plantago in symptoms of constipation and its relation with whole and regional transit time and pH." (We speculate that there are other mechanisms by which fiber consumption may improve FC.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)RR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 379059801.47PMID 358164651.48 (1.17–1.88)PMID 362470434.580.2Null (1)5Metric: RR
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 10 g/day · 5 g · 10 g · 15 g/day over 4 weeks · 8 weeks · 3 months · 12 months. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Psyllium (Constipation), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (10 g/day · 5 g · 10 g) and re-evaluate efficacy after 4 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (21 Studies) · 15 Quantitative Analyses

01
META-ANALYSIS Alimentary pharmacology & therapeutics (2024) PMID: 37905980 ↗
Systematic review and meta-analysis: Foods, drinks and diets and their effect on chronic constipation in adults.
Clinical Trial Synthesis 2024 Meta-Analysis published in Alimentary pharmacology & therapeutics involving n = 232 participants (RR 1.47). Key conclusion: CONCLUSIONS: Fruits and rye bread may improve certain constipation-related outcomes.
View Original PubMed Abstract ↓

BACKGROUND: Dietary approaches are recommended for the management of chronic constipation. Until now, there has been no systematic review and meta-analysis on foods, drinks and diets in constipation. AIMS: To investigate the effect of foods, drinks and diets on response to treatment, stool output, gut transit time, symptoms, quality of life, adverse events and compliance in adults with chronic constipation via a systematic review and meta-analysis. METHODS: Studies were identified using electronic databases (12th July 2023). Intervention trials (randomised controlled trials [RCTs], non-randomised, uncontrolled) were included. Risk of bias was assessed using Cochrane 2.0 (RCTs) or JBI Critical Appraisal (uncontrolled trials). Data from RCTs only were synthesised using risk ratios (RRs), mean differences (MDs), standardised mean differences (95% CI) using random-effects. RESULTS: We included 23 studies (17 RCTs, 6 uncontrolled; 1714 participants): kiwifruit (n = 7), high-mineral water (n = 4), prunes (n = 2), rye bread (n = 2), mango, fig, cereal, oat bran, yoghurt, water supplementation, prune juice, high-fibre diet, no-fibre diet (n = 1). Fruits resulted in higher stool frequency than psyllium (MD: +0.36 bowel movements [BM]/week, [0.25-0.48], n = 232), kiwifruits in particular (MD: +0.36 BM/week, [0.24-0.48], n = 192); there was no difference for prunes compared with psyllium. Rye bread resulted in higher stool frequency than white bread (MD: +0.43 BM/week, [0.03-0.83], n = 48). High-mineral water resulted in higher response to treatment than low-mineral water (RR: 1.47, [1.20-1.81], n = 539). CONCLUSIONS: Fruits and rye bread may improve certain constipation-related outcomes. There is a scarcity of evidence on foods, drinks and diets in constipation and further RCTs are needed. © 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

02
META-ANALYSIS The American journal of clinical nutrition (2022) PMID: 35816465 ↗
The Effect of Fiber Supplementation on Chronic Constipation in Adults: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Clinical Trial Synthesis 2022 Meta-Analysis published in The American journal of clinical nutrition involving n = 1,251 participants; statistical significance reported at p = 0.001 (RR 1.48). Key conclusion: CONCLUSIONS: Fiber supplementation is effective at improving constipation.
View Original PubMed Abstract ↓

BACKGROUND: Chronic constipation is a prevalent disorder that remains challenging to treat. Studies suggest increasing fiber intake may improve symptoms, although recommendations on the fiber type, dose, and treatment duration are unclear. OBJECTIVES: We investigated the effects of fiber supplementation on stool output, gut transit time, symptoms, and quality of life in adults with chronic constipation via a systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: Studies were identified using electronic databases, backward citation, and hand searches of abstracts. RCTs reporting administration of fiber supplementation in adults with chronic constipation were included. Risks of bias (RoB) was assessed with the Cochrane RoB 2.0 tool. Results were synthesized using risk ratios (RRs), mean differences, or standardized mean differences (SMDs) and 95% CIs using a random-effects model. RESULTS: Sixteen RCTs with 1251 participants were included. Overall, 311 of 473 (66%) participants responded to fiber treatment and 134 of 329 (41%) responded to control treatment [RR: 1.48 (95% CI: 1.17, 1.88; P = 0.001); I2 = 57% (P = 0.007)], with psyllium and pectin having significant effects. A higher response to treatment was apparent in fiber groups compared to control groups irrespective of the treatment duration, but only with higher fiber doses (>10 g/d). Fiber increased stool frequency [SMD: 0.72 (95% CI: 0.36, 1.08; P = 0.0001); I2 = 86% (P < 0.00001)]; psyllium and pectin had significant effects, and improvement was apparent only with higher fiber doses and greater treatment durations (≥4 weeks). Fiber improved stool consistency (SMD: 0.32; 95% CI: 0.18, 0.46; P < 0.0001), particularly with higher fiber doses. Flatulence was higher in fiber groups compared to control groups(SMD: 0.80; 95% CI: 0.47, 1.13; P < 0.00001). CONCLUSIONS: Fiber supplementation is effective at improving constipation. Particularly, psyllium, doses >10 g/d and treatment durations of at least 4 weeks appear optimal, though caution is needed when interpreting the results due to considerable heterogeneity. These findings provide promising evidence on the optimal type and regim

03
CLINICAL STUDY Neurogastroenterology and motility (2024) PMID: 39223790 ↗
The effect of fiber supplementation with agave fructans or psyllium plantago in symptoms of constipation and its relation with whole and regional transit time and pH.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Neurogastroenterology and motility; statistical significance reported at p = 0.05. Key conclusion: We speculate that there are other mechanisms by which fiber consumption may improve FC.
View Original PubMed Abstract ↓

BACKGROUND: Supplementation with the Agave tequilana Weber blue variety fructans is a feasible treatment option for functional constipation (FC). However, its effects on colonic function have not yet been studied. This study assessed whole gut transit time (WGTT) and regional transit time using a wireless motility capsule (WMC) before and after supplementation with different fiber treatments in patients with FC. METHODS: A secondary analysis was performed on data collected from a randomized, double-blind clinical trial comparing agave fructans with psyllium plantago. WGTT, regional transit time, contractility, and pH were measured using WMC before and after fiber supplementation. Comparisons were performed using nonparametric tests. KEY RESULTS: Twenty patients with FC were evaluated, with a median age of 39 (25-54 years), and 18 (90%) were women. Five patients were included in each intervention group. There were no changes in WGTT or regional transit times between the groups (p > 0.05). Similarly, there were no differences in the changes experienced by regional or general contractility among the groups (p > 0.05). The cecal pH profile did not differ between the groups before and after fiber supplementation (p > 0.05). The percentages of clinical responses and consistency of bowel movements between the groups were similar. CONCLUSIONS & INFERENCES: FC presents a clinical response to a fiber challenge, regardless of the administered intervention. However, this response was not associated with improvement in contractility or regional transit time. We speculate that there are other mechanisms by which fiber consumption may improve FC. © 2024 John Wiley & Sons Ltd.

04
RANDOMIZED TRIAL (RCT) Journal of clinical gastroenterology (2024) PMID: 37389917 ↗
Agave tequilana Fructans Versus Psyllium plantago for Functional Constipation : Randomized Double-blind Clinical Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Journal of clinical gastroenterology; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: AF (Predilife) are as effective at different doses and combined with MTDx as PP and are a feasible option for the treatment of functional constipation.
View Original PubMed Abstract ↓

GOAL: The aim of this study was to evaluate the efficacy of supplementation with Agave tequilana Weber blue variety fructans (Predilife) in the improvement of symptoms in functional constipation. BACKGROUND: Fiber supplementation is the first-line treatment for constipation. Fibers-like fructans have a known prebiotic effect. MATERIALS AND METHODS: A randomized, double-blind, study comparing agave fructans (AF) against psyllium plantago (PP). Four groups were randomized. Group 1: AF 5 g (Predilife), group 2: AF 10 g (Predilife), group 3: AF 5 g (Predilife)+10 g maltodextrin (MTDx), and group 4: PP 5 g+10 g MTDx. The fiber was administered once daily for 8 weeks. All fibers were similarly flavored and packaged. Patients kept their usual diet and fiber sources were quantified. Responders were defined as ≥1 complete spontaneous bowel movement from baseline to 8 weeks. Adverse events were reported. The study was registered in Clinicaltrials.gov with registration number NCT04716868. RESULTS: Seventy-nine patients were included (group 1: 21, group 2: 18, group 3: 20, and group 4: 20), of which 62 (78.4%) were women. The responders were similar across groups (73.3%, 71.4%, 70.6%, and 69%, P >0.050). After 8 weeks, all groups significantly increased complete spontaneous bowel movements, showing the greatest increase in spontaneous bowel movements in group 3 ( P =0.008). All groups improved in symptoms, stool consistency, and quality of life. Diet and fiber intake were similar between groups. Adverse events were mild and similar between groups. CONCLUSIONS: AF (Predilife) are as effective at different doses and combined with MTDx as PP and are a feasible option for the treatment of functional constipation.

05
RANDOMIZED TRIAL (RCT) Gut microbes (2023) PMID: 37078654 ↗
Effects of dietary fibers or probiotics on functional constipation symptoms and roles of gut microbiota: a double-blinded randomized placebo trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Gut microbes involving n = 250 participants; statistical significance reported at p = 0.05. Key conclusion: In conclusion, we found that the dietary fibers or probiotics may relieve hard stool, with intervention-specific changes in gut microbiota relevant to constipation relief.
View Original PubMed Abstract ↓

Dietary fibers/probiotics may relieve constipation via optimizing gut microbiome, yet with limited trial-based evidences. We aimed to evaluate the effects of formulas with dietary fibers or probiotics on functional constipation symptoms, and to identify modulations of gut microbiota of relevance. We conducted a 4-week double-blinded randomized placebo-controlled trial in 250 adults with functional constipation. Intervention: A: polydextrose; B: psyllium husk; C: wheat bran + psyllium husk; D: Bifidobacterium animalis subsp. lactis HN019 + Lacticaseibacillus rhamnosus HN001; Placebo: maltodextrin. Oligosaccharides were also included in group A to D. 16S rRNA sequencing was used to assess the gut microbiota at weeks 0, 2, and 4. A total of 242 participants completed the study. No time-by-group effect was observed for bowel movement frequency (BMF), Bristol stool scale score (BSS), and degree of defecation straining (DDS), while BSS showed mean increases of 0.95-1.05 in group A to D (all P < 0.05), but not significantly changed in placebo (P = 0.170), and 4-week change of BSS showed similarly superior effects of the interventions as compared placebo. Group D showed a marginal reduction in plasma 5-hydroxytryptamine. Group A resulted in a higher Bifidobacterium abundance than placebo at week 2 and 4. Fourteen genera showed intervention-specific increasing or decreasing trends continuously, among which Anaerostipes showed increasing trends in groups B and C, associated with BMF increase. Random forest models identified specific baseline microbial genera panels predicting intervention responders. In conclusion, we found that the dietary fibers or probiotics may relieve hard stool, with intervention-specific changes in gut microbiota relevant to constipation relief. Baseline gut microbiota may predispose the intervention responsiveness. ClincialTrials.gov number, NCT04667884. Plain Language Summary: What is the context?Supplementation of dietary fibers, such as psyllium husk or wheat bran (10 ~ 15 g/day) may relieve constipation symptoms, but bloating and flatulence are major concerns on a high fiber intake.Functional constipation patients had alternated gut microbiot

06
RANDOMIZED TRIAL (RCT) The American journal of gastroenterology (2023) PMID: 36537785 ↗
Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort-Results of an International Multicenter Randomized Controlled Trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in The American journal of gastroenterology involving n = 63 participants; statistical significance reported at p = 0.0001. Key conclusion: DISCUSSION: This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations.
View Original PubMed Abstract ↓

INTRODUCTION: Consumption of green kiwifruit is known to relieve constipation. Previous studies have also reported improvements in gastrointestinal (GI) comfort. We investigated the effect of consuming green kiwifruit on GI function and comfort. METHODS: Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61) randomly assigned to consume 2 green kiwifruits or psyllium (7.5 g) per day for 4 weeks, followed by a 4-week washout, and then the other treatment for 4 weeks. The primary outcome was the number of complete spontaneous bowel movements (CSBM) per week. Secondary outcomes included GI comfort which was measured using the GI symptom rating scale, a validated instrument. Data (intent-to-treat) were analyzed as difference from baseline using repeated measures analysis of variance suitable for AB/BA crossover design. RESULTS: Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM per week (FC; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001). No significant adverse events were observed. DISCUSSION: This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations. Green kiwifruits are a suitable dietary treatment for relief of constipation and associated GI comfort.

07
RANDOMIZED TRIAL (RCT) Nutrients (2022) PMID: 36235798 ↗
Two Gold Kiwifruit Daily for Effective Treatment of Constipation in Adults-A Randomized Clinical Trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Nutrients involving n = 11 participants; statistical significance reported at p = 0.004. Key conclusion: Two gold kiwifruit decreased straining (p = 0.021).
View Original PubMed Abstract ↓

Chronic constipation is highly prevalent worldwide and may be managed with two green or three gold kiwifruit daily. It is unknown whether a smaller standard serve of gold kiwifruit (two daily) is as effective in constipation management. The study aimed to improve chronic constipation with two gold kiwifruit and psyllium in lieu of a placebo daily over four weeks. Adult participants (18-65 years) with functional constipation (FC, n = 11), constipation-predominant irritable bowel syndrome (IBS-C, n = 13), and healthy controls (n = 32) were block-randomized to the treatment order: gold kiwifruit (2/day) or psyllium (fiber-matched, 7.5 g/day) for four weeks, followed by four weeks washout before crossover. Outcomes included alterations of Gastrointestinal Symptom Rating Scale (GSRS) domains and weekly complete spontaneous bowel movements (CSBM) as part of a larger study. Both interventions reduced GSRS constipation domain scores in all subjects compared to baseline values (p = 0.004). All participants reported significantly more weekly CSBM (p = 0.014). Two gold kiwifruit decreased straining (p = 0.021). Two gold kiwifruit daily are as effective as fiber-matched psyllium in treating constipation in adults and should be considered as a treatment option.

08
RANDOMIZED TRIAL (RCT) Indian journal of gastroenterology (2022) PMID: 35235197 ↗
Biofeedback, biofeedback plus fiber laxative, and biofeedback plus osmotic laxative regimens to treat constipation in patients with pelvic floor dyssynergia: A randomized controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Indian journal of gastroenterology involving n = 25 participants; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: Combinations of laxatives with BOF did not offer significant therapeutic benefit.
View Original PubMed Abstract ↓

BACKGROUND: Pelvic floor dyssynergia (PFD) is one of the causes of chronic constipation. Laxative-based therapies are not very effective in treating this type of constipation. The therapeutic effectiveness of three therapeutic strategies, including biofeedback (BOF) alone, BOF+ fiber laxative (psyllium), and BOF +osmotic laxative (polyethylene glycol; [PEG]), was assessed in patients with constipation secondary to PFD. METHODS: Eighty-eight patients with constipation were included during a period from 2017 to 2018. Thirty-two patients were treated with BOF alone, 25 patients received BOF+ fiber laxative (psyllium), and 31 patients received BOF+ osmotic laxative (PEG) for 2 to 3 months. A checklist was used to compare outcomes before and after the interventions. RESULTS: Satisfaction rates from the treatments were 60.83%, 46.88%, and 41.32% in the BOF, BOF + psyllium, and BOF + PEG groups, respectively. Women had a higher satisfaction rate compared to men. Defecation quality improved, and the frequency of enema usage decreased (p <0.05) in all the groups after intervention. Difficulty in evacuation, need for digitation, and return to the toilet after defecation significantly improved in the BOF alone group. Using laxatives reduced straining during evacuation and increased the duration of defecation. All the three regimens reduced rectal bleeding (p <0.05). CONCLUSIONS: Combinations of laxatives with BOF did not offer significant therapeutic benefit. As laxatives may cause dissatisfaction and incomplete/prolonged defecations in patients with PFD, adding laxatives to the BOF regimen is not recommended for these patients. © 2021. Indian Society of Gastroenterology.

09
CLINICAL STUDY Aging (2021) PMID: 34081625 ↗
The effects of psyllium husk on gut microbiota composition and function in chronically constipated women of reproductive age using 16S rRNA gene sequencing analysis.
Clinical Trial Synthesis 2021 Clinical Study published in Aging involving n = 29 participants. Key conclusion: In conclusion, these findings suggest that the composition of gut microbiota was altered and that symptoms of constipation were alleviated via psyllium husk intervention.
View Original PubMed Abstract ↓

Erratum in Aging (Albany NY). 2022 Mar 30;14(6):2923. doi: 10.18632/aging.203991. Chronic constipation is a common gastrointestinal disorder that occurs in the elderly and in women. Psyllium husk is widely used to treat this condition. Recent studies have shown that psyllium husk can improve the clinical symptoms of constipation by regulating gut microbiota, but its clinical effects and potential mechanisms in constipated women of reproductive age have not been previously investigated. We compared fecal microbiota after treatment with placebo (n = 29) and psyllium husk (n = 25) using 16S ribosomal ribonucleic acid (rRNA) gene sequencing analysis. Psyllium husk relieved the symptoms of constipated women of reproductive age. Sequencing results showed that the psyllium husk group exhibited a different gut microbiota composition compared to that of the placebo group. Moreover, network analysis indicated more significant correlations and clustering of operational taxonomic units (OTUs) in the psyllium husk group. Kyoto Encyclopedia of Genes and Genomes (KEGG) annotation analysis showed that the relative abundances of metabolism-related KEGG pathways were enriched in the psyllium husk group. In conclusion, these findings suggest that the composition of gut microbiota was altered and that symptoms of constipation were alleviated via psyllium husk intervention. The changes in metabolic function might be related to constipation. Furthermore, these studies are warranted to elucidate the potential metabolic mechanisms contributing to chronic constipation.

10
CLINICAL STUDY The American journal of gastroenterology (2021) PMID: 34074830 ↗
Exploratory Comparative Effectiveness Trial of Green Kiwifruit, Psyllium, or Prunes in US Patients With Chronic Constipation.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in The American journal of gastroenterology involving n = 75 participants; statistical significance reported at p = 0.05. Key conclusion: Kiwifruit was associated with the lowest rate of AEs and dissatisfaction with therapy.
View Original PubMed Abstract ↓

INTRODUCTION: Psyllium and prunes are proven treatments for chronic constipation (CC). Asian studies suggest that kiwifruit may also benefit CC symptoms. We report a partially randomized, comparative effectiveness trial evaluating kiwifruit, psyllium, and prunes in US patients with CC. 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 and were partially randomized to green kiwifruit (2/d), prunes (100 g/d), or psyllium (12 g/d) for 4 weeks. The primary endpoint was the proportion of patients in each group reporting an increase of ≥1 CSBM per week compared with baseline for at least 2 of 4 treatment weeks. Key secondary outcomes included stool frequency, stool consistency, and straining assessed daily. Treatment satisfaction and adverse events (AEs) were also measured. Standard statistical methods were used, and a P < 0.05 was considered significant. RESULTS: Seventy-nine patients with CC (mean age = 42.7 years, 87% female, and 77% white) were partially randomized. Complete data were available for 75 patients (kiwifruit 29, prunes 24, and psyllium 22). For the primary endpoint, proportions of CSBM responders were similar for the treatments. For secondary outcomes comparing treatment weeks 3 and 4 to baseline, there was a significant increase in weekly CSBM rate with all 3 treatments (P ≤ 0.003); stool consistency significantly improved with kiwifruit (P = 0.01) and prunes (P = 0.049); and straining significantly improved with kiwifruit (P = 0.003), prunes (P < 0.001), and psyllium (P = 0.04). Patients randomized to the kiwifruit group reported significant improvement in bloating scores (P = 0.02). AEs were most common with psyllium and least common with kiwifruit. At the end of treatment, a smaller proportion of patients were dissatisfied with kiwifruit compared with prunes or psyllium (P = 0.02). DISCUSSION: Kiwifruit, prunes, and psyllium improve constipation symptoms in patients with CC. Kiwifruit was associated with the lowest rate of AEs and dissatisfaction with therapy.

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