Randomized Placebo-Controlled Trial of Psyllium Fiber in Functional Abdominal Pain Disorders in Children
Manjit Kaur1, Ujjal Poddar2, Anshu Srivastava1
1Department of Pediatric Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India.
Insights
Psyllium fiber significantly improved pain and quality of life in children with functional abdominal pain disorders (FAPD), including functional abdominal pain-not otherwise specified (FAP-NOS) and irritable bowel syndrome (IBS). Most children experienced sustained relief after treatment cessation.
Area of Science:
- Pediatric Gastroenterology
- Clinical Nutrition
- Evidence-Based Medicine
Background:
- Functional abdominal pain disorders (FAPD) are prevalent in children, with limited research on fiber's role, especially in functional abdominal pain-not otherwise specified (FAP-NOS).
- Heterogeneity in existing literature necessitates further investigation into effective treatments for pediatric FAPD.
Purpose of the Study:
- To assess the efficacy of psyllium fiber in managing pediatric FAPD, encompassing Irritable Bowel Syndrome (IBS) and FAP-NOS.
- To compare improvements in pain and quality of life (QoL) between psyllium fiber and placebo interventions.
Main Methods:
- A prospective randomized placebo-controlled trial involving 109 children (5-18 years) diagnosed with FAPD according to Rome IV criteria.
- Participants received either psyllium fiber or a placebo (maltodextrin) for 12 weeks, with pain and QoL assessed pre- and post-treatment.
- Pain was evaluated based on intensity, frequency, and duration, alongside QoL measures.
Main Results:
- Psyllium fiber significantly reduced pain intensity, frequency, and duration, and improved QoL compared to placebo (P < 0.001 for all).
- 86% of children in the psyllium group were responders ( >50% pain reduction) versus 60% in the placebo group (P = 0.001).
- Psyllium fiber use was the sole predictor of response (OR: 5.49), with 81% maintaining sustained relief post-treatment.
Conclusions:
- A 12-week psyllium fiber intervention effectively improves pain and quality of life in children with FAP-NOS and IBS.
- The majority of pediatric patients experience sustained pain relief after discontinuing psyllium fiber.
Background:
Functional abdominal pain disorders (FAPD) are common in children and there is heterogeneity in the available literature regarding the role of fibre in FAPD and none so-far in functional abdominal pain-not otherwise specified (FAP-NOS).
Aim:
The study aimed to evaluate the efficacy of psyllium fiber in pediatric FAPD including Irritable bowel syndrome (IBS) and FAP-NOS.
Methods:
In this prospective randomized placebo-controlled trial, children (5-18 years) diagnosed as FAPD based on Rome IV criteria were randomized to psyllium fiber or placebo (maltodextrin) for 12 weeks. Post-treatment improvement of pain and quality of life (QoL) from baseline was compared between the two groups. Pain assessment was done using the pain score table, which assessed duration, frequency, and intensity of pain.
Results:
The mean age of 109 children (FAP-NOS: 85%; psyllium fiber 57, placebo 52) was 11.8 ± 3.9 years (58% boys). There was a significant difference in pain improvement in terms of reduction in scores for intensity (5.5 vs. 3.2), frequency (6.0 vs. 3.2), duration (5.3 vs. 3.3), and QoL (4.4 vs. 2.3) between the psyllium and placebo group (P < 0.001 in all). Responders (> 50% reduction in pain) were seen in 86% of the psyllium as compared to 60% in the placebo group (P = 0.001). On multivariate analysis, use of psyllium fiber was the only factor predictive of response (OR: 5.49, 95% CI 2.05-14.72, P < 0.001). After discontinuation of psyllium fiber, 81% had sustained response over a mean follow-up of 6.7 ± 4.0 months.
Conclusions:
A 12-week trial of psyllium fiber improves pain in most and gives sustained relief in three-fourths of children with FAP-NOS and IBS.
Clinical Trial Registration:
Clinical Trial Registry of India ( CTRI/2023/08/056772; Website http://ctri.nic.in ).
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