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Efficacy of Oral Psyllium in Pediatric Irritable Bowel Syndrome: A Double-Blind Randomized Control Trial
Jagadeesh Menon1, Babu Ram Thapa1, Rajni Kumari2
1From the Division of Paediatric Gastroenterology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Insights
Psyllium husk effectively treats pediatric irritable bowel syndrome (IBS) in children. This randomized controlled trial showed significant symptom reduction and remission rates compared to placebo over four weeks.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Clinical Trials
Background:
- Pediatric irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disorder.
- Current therapeutic options for pediatric IBS show variable efficacy.
- Psyllium's effectiveness is established in adults, but data in children is lacking.
Purpose of the Study:
- To evaluate the efficacy of psyllium husk compared to placebo in pediatric IBS patients.
- To assess symptom severity and remission rates in children with IBS receiving psyllium.
Main Methods:
- A double-blind randomized controlled trial involving 81 children (43 psyllium, 38 placebo).
- Treatment duration was four weeks, with severity assessed using the IBS Severity Scoring Scale (IBS-SSS).
- Statistical analysis included chi-square and McNemar tests for categorical data.
Main Results:
- Significant reduction in median IBS-SSS scores in the psyllium group compared to placebo (P < 0.001).
- Remission rates (IBS-SSS < 75) were higher in the psyllium group (43.9%) versus placebo (9.7%) (P < 0.0001).
- Absolute risk reduction was 32% with a Number Needed to Treat (NNT) of 3.
Conclusions:
- Psyllium husk demonstrates short-term efficacy in treating pediatric IBS.
- The findings support psyllium as a therapeutic option for children with IBS.
- Further research may explore long-term effects and optimal dosing.
Objective:
Pediatric irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder with variable response to various therapeutic agents. Psyllium has been proven to be effective in adults; however, there is no study in children. The objective of this study is to evaluate the efficacy of psyllium husk as compared to placebo in pediatric IBS patients.
Methods:
In this double-blind randomized controlled trial, 43 children were assigned to psyllium arm (Group A) and 38 into placebo arm (Group B). Severity is assessed at baseline and after 4 weeks of treatment using IBS severity scoring scale (IBS-SSS) and classified into mild, moderate, and severe categories. Categorical data was compared with chi-square test and paired categorical variable was compared with McNemer test.
Results:
Mean ages (±SD; in years) of Groups A and B were 9.87 (2.7) and 9.82 (3.17), respectively, with median duration of illness of 12 months. At baseline, type, severity, and parameters (IBS-SSS) of IBS were equally distributed in 2 groups. There was a significant reduction in median interquartile range (IQR) of total IBS-SSS in psyllium versus placebo [75 (42.5-140) vs 225 (185-270); P < 0.001] at 4 weeks. Similarly 43.9% in Group A versus 9.7% in Group B attained remission [IBS-SSS < 75 ( P < 0.0001)]. The mean difference in IBS-SSS between Group A and Group B was -122.85 with risk ratio of 0.64 (95% CI; 0.42-0.83; P = 0.001) and absolute risk reduction of 32% (NNT = 3).
Conclusions:
Psyllium husk is effective for the therapy of pediatric IBS when compared with placebo in short term.
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