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Pain in irritable bowel syndrome: Does anything really help?
BouSaba, J, Sannaa, W, Camilleri, M
Neurogastroenterology and motility. 2022;(1):e14305
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Abstract
Pain relief remains a significant challenge in the management of irritable bowel syndrome (IBS): "Does anything really help relieve the pain in patients with IBS?". Interventions aimed at pain relief in patients with IBS include diet, probiotics or antibiotics, antidepressants, antispasmodics, and drugs targeting specific gastrointestinal receptors such as opioid or histamine receptors. In the systematic review and meta-analysis published in this journal, Lambarth et al. examined the literature on the role of oral and parenteral anti-neuropathic agents in the management of pain in patients with IBS. This review article appraises their assessment of the efficacy of the anti-neuropathic agents amitriptyline, pregabalin, gabapentin, and duloxetine in the relief of abdominal pain or discomfort, and impact on overall IBS severity and quality of life. This commentary provides an update of current evidence on the efficacy of the dietary and pharmacological treatments that are available or in development, as well psychological and cognitive behavioral therapy for pain in IBS. Advances in recent years augur well for efficacious treatments that may expand the therapeutic arsenal for pain in IBS.
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Narrative review: Risk of eating disorders and nutritional deficiencies with dietary therapies for irritable bowel syndrome.
Simons, M, Taft, TH, Doerfler, B, Ruddy, JS, Bollipo, S, Nightingale, S, Siau, K, van Tilburg, MAL
Neurogastroenterology and motility. 2022;(1):e14188
Abstract
BACKGROUND AND AIMS Dietary treatments are growing in popularity as interventions for chronic digestive conditions. Patients with irritable bowel syndrome (IBS) often change their eating behaviors to mitigate symptoms. This can occur under the direction of their physician, a dietitian, or be self-directed. Poorly implemented and monitored diet treatments occur frequently with considerable risks for negative consequences. We aim to review the literature related to dietary treatments and risks associated with nutritional deficiencies and disordered eating. METHODS Searches were conducted from June to December 2020 on PubMed, MEDLINE, EMBASE, DARE and the Cochrane Database of Systematic Reviews using relevant keywords based on the Patient, Intervention, Comparator and Outcome (PICO) format. Studies included both adult and pediatric populations. Results are synthesized into a narrative review. RESULTS While dietary approaches are efficacious in many research studies, their translation to clinical practice has been less clear. Patients with IBS are at risk for nutritional deficiencies, disordered eating, increased anxiety, and decreases in quality of life in both adult and pediatric groups. CONCLUSIONS Physicians prescribing dietary treatment for IBS should be aware of nutritional and psychological risks and implement mitigation measures. These include using a combination of brief, validated questionnaires and clinical history, and collaboration with registered dietitians and/or psychologists. Recommendations for clinical decisions are provided.
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Pharmacological treatments of Chinese herbal medicine for irritable bowel syndrome in adults: A network meta-analysis of randomized controlled trials.
Wu, YB, Dai, YK, Zhang, L, Pan, HG, Chen, WJ, Li, RL, Hu, L
PloS one. 2021;(8):e0255665
Abstract
INTRODUCTION Plenty of clinical studies have suggested the value of Chinese herbal medicine (CHM) for patients with irritable bowel syndrome (IBS), but their efficacy and safety have not been systematically concluded yet. This article aimed to compare and rank the therapeutic effect and safety of CHM with routine pharmacotherapies and placebo in the treatment of IBS. METHODS Randomized controlled trials regarding CHM to treat IBS were searched in six databases from inception to Jan 31, 2020. A network meta-analysis was conducted to analyze the data of included publications. The quality assessment was assessed by Cochrane Handbook and GRADEpro software. The risk ratio was calculated for dichotomous outcomes while the standardized mean difference was used for continuous variables with 95% credible intervals. A Funnel plot was performed to evaluate publication bias. The surface under the cumulative ranking curve was conducted to rank the included interventions. Data were analyzed with STATA 15.0 and Review Manager 5.3. RESULT 3194 records were searched, and 28 eligible trials involving 3323 patients ere identified. Compared with conventional therapies and placebo, Jianpi-Chushi therapy showed significant improvement in adequate relief and IBS symptom severity scale; Shugan-Jianpi therapy showed the best efficacy in relieving the abdominal pain and abdominal distension; Wenshen-Jianpi therapy had a better effect on avoiding adverse effects and improving stool character. CONCLUSION This study confirmed that CHM could be beneficial for patients with IBS in relieving their clinical symptoms and should be recommended as alternative therapies. The quality of evidence in this study based on the GRADE system was "low".
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Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2).
Chey, WD, Lembo, AJ, Yang, Y, Rosenbaum, DP
The American journal of gastroenterology. 2021;(6):1294-1303
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Abstract
INTRODUCTION Tenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3. This phase 3 trial assessed the long-term efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). METHODS In this randomized double-blind study (ClinicalTrials.gov identifier: NCT02686138), patients with IBS-C received tenapanor 50 mg b.i.d. or placebo b.i.d. for 26 weeks. The primary endpoint was the proportion of patients who had a reduction of ≥30.0% in average weekly worst abdominal pain and an increase of ≥1 weekly complete spontaneous bowel movement from baseline, both in the same week, for ≥6 of the first 12 treatment weeks (6/12-week combined responder). RESULTS Of the 620 randomized patients with IBS-C, 593 (95.6%) were included in the intention-to-treat analysis set (tenapanor: n = 293; placebo: n = 300) and 481 patients (77.6%) completed the 26-week treatment period. In the intention-to-treat analysis set (mean age: 45.4 years; 82.1% women), a significantly greater proportion of patients treated with tenapanor were 6/12-week combined responders than those treated with placebo (36.5% vs 23.7%; P < 0.001). Abdominal symptoms and global symptoms of IBS were significantly improved with tenapanor compared with placebo. Diarrhea, the most common adverse event, was typically transient and mild to moderate in severity. Diarrhea led to study drug discontinuation for 19 (6.5%) and 2 patients (0.7%) receiving tenapanor and placebo, respectively. DISCUSSION Tenapanor 50 mg b.i.d. improved IBS-C symptoms over 26 weeks and was generally well tolerated, offering a potential new long-term treatment option for patients with IBS-C (see Visual abstract, Supplementary Digital Content 1, http://links.lww.com/AJG/B797).
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Nopal fiber (Opuntia ficus-indica) improves symptoms in irritable bowel syndrome in the short term: a randomized controlled trial.
Remes-Troche, JM, Taboada-Liceaga, H, Gill, S, Amieva-Balmori, M, Rossi, M, Hernández-Ramírez, G, García-Mazcorro, JF, Whelan, K
Neurogastroenterology and motility. 2021;(2):e13986
Abstract
BACKGROUND Clinical guidelines provide limited and conflicting recommendations regarding dietary fiber supplementation in irritable bowel syndrome (IBS). Nopal (Opuntia ficus-indica) is a cactus plant fiber containing both insoluble and soluble fibers that may have therapeutic potential in IBS. Our aim was to evaluate the dose-response effect of extracted nopal fiber powder on symptoms in IBS. METHODS We performed a 4-arm, double-blind, parallel, randomized controlled trial in 60 patients fulfilling Rome IV criteria for IBS. Patients were randomized and blindly allocated to receive either nopal fiber (10, 20, or 30 g/day) or placebo (30 g/day dextrose) for one week and to keep their usual diet. Symptom severity (Global Symptom Question, IBS-SSS, Gastrointestinal Symptom Rating Scale), stool frequency and consistency (Bristol Stool Form Scale), breath hydrogen response, and stool short-chain fatty acids (SCFA) were measured at baseline and follow-up. KEY RESULTS Significantly more patients reported adequate relief of symptoms after 20 g/day (87%, p = 0.008) and 30 g/day (80%, p = 0.025) of nopal fiber compared to placebo (33%). More patients receiving 20 g/day nopal fiber (67%) had a > 50% reduction in IBS-SSS compared to placebo (20%, p = 0.027), whereas the 30 g/day dose induced more loose stools (p = 0.027). Response rates were similar among IBS subtypes. There were no differences in breath hydrogen or stool SCFA between groups. CONCLUSIONS AND INFERENCES Nopal fiber supplementation at doses of 20 and 30 g/day was associated with short-term improvement in IBS symptoms, warranting a fully powered clinical trial of longer duration with symptomatic, physiological, and microbiological endpoints.
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[Treatment of IBS with Lactobacillus plantarum 299v: Therapeutic success increases with length of treatment - real-life data of a non-interventional study in Germany].
Krammer, H, Storr, M, Madisch, A, Riffel, J
Zeitschrift fur Gastroenterologie. 2021;(2):125-134
Abstract
INTRODUCTION The treatment of irritable bowel syndrome (IBS) in clinical practice is frequently challenging. Modulation of the intestinal microbiome as a treatment option is becoming more and more important. The effectiveness of a bacterial strain, Lactobacillus plantarum 299v (LP299V), was previously investigated in placebo-controlled clinical trials in patients with IBS over 4 weeks. The aims of the present non-interventional study were therefore to investigate tolerability and effectiveness of LP299V under everyday conditions and to gain information on long-term treatment. METHODS Data on tolerability and effectiveness of LP299V (1 capsule/day; 1 × 1010 CFU) were prospectively collected in 25 centers in 221 patients with IBS. The maximal treatment duration was 12 weeks. The survey was carried out using symptom diaries and medical assessments. Changes in frequency and severity of symptoms were compared to baseline and defined the primary endpoint. RESULTS During the 12-week treatment, a significant and continuous reduction of overall symptom score (p < 0.05) was observed. In addition, a significant reduction of severity (S) and frequency (H) of individual symptoms, such as abdominal pain (S: - 67 %, H: - 51 %), flatulence (S: - 61 %, H: - 63 %), diarrhea (S: - 70 %, H: - 32 %) and constipation (S: - 79 %, H: - 6 %) was observed. Urgency and feeling of incomplete evacuation were significantly decreased (p < 0.001). Additionally, quality of life increased significantly (mental well-being: + 110 %, influence on everyday life: -67 %, p < 0.01). Self-assessment identified that long-term treatment with LP299V was tolerated well by 94 % of patients. CONCLUSION In real life, LP299V significantly alleviates the global symptoms of IBS in patients. In order to achieve the maximum effect, long-term use of LP299V (as here 12 weeks) appears to be indicated and is well tolerated.
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Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant].
Gupta, AK, Maity, C
Medicine. 2021;(3):e23641
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Abstract
GOALS To evaluate safety and efficacy of Bacillus coagulans LBSC [DSM17654] in irritable bowel syndrome (IBS) through a prospective, interventional, randomized, double-blind, and placebo-controlled, CONSORT compliant clinical trial. BACKGROUND Bacteriotherapy shows promising impact on alleviating clinical conditions of IBS and associated functional gastrointestinal disorders. B coagulans LBSC is a genetically and phenotypically safe probiotic strain used in this study to study its impact on ameliorating IBS symptoms and improving quality of life. METHODS In this interventional, randomized, double-blind, placebo-controlled clinical study, total 40 subjects (18-65 years) were screened through Rome IV criteria and randomized into 2 groups, that is, interventional and placebo arm (n = 20/arm). Similar dosages were received by both the arm, that is, placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. Study completed with per protocol subjects (n = 38) and results were considered to evaluate the primary and secondary endpoints. RESULTS Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety. Maximum of "no symptoms" cases and mild to moderate gastrointestinal symptoms along with improved stool consistency were from interventional arm tested following IBS severity scoring system and Bristol stool form scale. Upper gastrointestinal endoscopy revealed no clinical difference of gastrointestinal mucosa between both the arms. B coagulans LBSC was well tolerated with no serious adverse events. CONCLUSIONS B coagulans LBSC was safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life evaluated.
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Combination of a Probiotic and an Antispasmodic Increases Quality of Life and Reduces Symptoms in Patients with Irritable Bowel Syndrome: A Pilot Study.
Barraza-Ortiz, DA, Pérez-López, N, Medina-López, VM, Minero-Alfaro, JI, Zamarripa-Dorsey, F, Fernández-Martínez, NDC, Llorente-Ramón, A, Ramos-Aguilar, GA
Digestive diseases (Basel, Switzerland). 2021;(3):294-300
Abstract
BACKGROUND Probiotics and antispasmodics have been tested extensively in the management of symptoms of irritable bowel syndrome (IBS), but they have rarely been evaluated in combination. The objective of this pilot study was to assess the efficacy of treatment with the probiotic formulation i3.1 (Lactobacillus plantarum CECT7484 and CECT7485 and Pediococcus acidilactici CECT7483), with or without the addition of the antispasmodic alverine/simethicone, in improving IBS-related quality of life (QoL) and reducing abdominal pain and diarrhea in patients with IBS. METHODS This was a randomized, placebo-controlled clinical trial with 3 parallel arms (probiotic, probiotic plus antispasmodic, and placebo). Patients with IBS (N = 55) were recruited at the Gastroenterology Department of the Juárez Hospital (México City). QoL was assessed with the IBS-QoL questionnaire, abdominal pain with a visual analog scale, and stool consistency with the Bristol scale. RESULTS The IBS-QoL rate of response (ITT analysis) was 50.0% for patients in the group with probiotic alone, 68.4% in the group with probiotic plus antispasmodic, and 16.7% in the group with placebo after 6 weeks of treatment (p = 0.005). Response to abdominal pain was reported by 38.9% of patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p = 0.035). Regarding stool consistency, a response to treatment was reported by 44.4% of patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p = 0.032). CONCLUSION The results are consistent with previous studies on the use of the i3.1 probiotic formulation for the management of symptoms in IBS patients, and the addition of an antispasmodic improves its observed effects.
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Nutrition in Patients with Lactose Malabsorption, Celiac Disease, and Related Disorders.
Alkalay, MJ
Nutrients. 2021;(1)
Abstract
Lactose malabsorption (LM), celiac disease (CD), non-celiac gluten sensitivity (NCGS), and irritable bowel syndrome (IBS) are conditions associated with food triggers, improvement after withdrawal, treatment with dietary restriction, and subsequent nutritional detriments. LM occurs when there is incomplete hydrolysis of lactose due to lactase deficiency and frequently produces abdominal symptoms; therefore, it can cause lactose intolerance (LI). A lactose-restricted diet is frequently recommended, although it can potentially lead to nutrient deficiencies. Furthermore, lactose is an essential component of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) and is subsequently associated with intolerance to these compounds, especially in IBS. LM commonly presents in CD. Nutritional deficits are common in CD and can continue even on a gluten-free diet (GFD). Conditions triggered by gluten are known as gluten-related disorders (GRDs), including CD, wheat allergy, and NCGS. IBS can also be associated with a gluten sensitivity. A GFD is the treatment for CD, GRDs, and gluten sensitive IBS, although compliance with this restricted diet can be difficult. Strict dietary therapies can have a negative effect on quality of life. This review aims to provide an overview of the difficult nutritional elements of these disorders, which are critical for medical providers to recognize when managing these patients.
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The fragility of randomized placebo-controlled trials for irritable bowel syndrome.
Williams, MO, Sedarous, M, Dennis, B, Dlamini, V, Nwaiwu, O, Nguyen, L, Okafor, PN
Neurogastroenterology and motility. 2021;(8):e14166
Abstract
BACKGROUND The fragility index (FI) represents the number of participants whose status in a trial would have to change from a non-event (not experiencing the primary endpoint) to an event (experiencing the primary endpoint) in order to turn a statistically significant result into a non-significant result. We sought to evaluate the fragility indices of irritable bowel syndrome [IBS-mixed (IBS-M), IBS-constipation (IBS-C), & IBS-diarrhea (IBS-D)] trials. METHODS Irritable bowel syndrome trials published in high-impact journals were identified from Medline. Trials had to be in adults, randomized, parallel-armed, with at least one statistically significant binary outcome, and an achieved primary endpoint of therapeutic efficacy. FI and correlation coefficients were calculated, and regression modeling used to identify predictors of a high FI. KEY RESULTS Twelve trials were analyzed with a median FI of 6 (range: 0-38). Median sample size in all trials was 366 (range: 44-856). Trial publication year (p = 0.71), journal impact factor (p = 0.52), duration of study (p = 0.12), and number need to treat [NNT] (p = 0.29) were not predictive of a high FI. While a lower p-value correlated with a higher FI (p = 0.039), no correlation was noted between FI and impact factor (R = -0.20, p = 0.52), trial publication year (R = 0.12, p = 0.71), duration of trial (R = -0.46, p = 0.13), NNT (R = -0.34, p = 0.29), and sample size (R = 0.23, p = 0.5). The highest FI was in a Ramosetron trial (FI = 30) for IBS-D. CONCLUSION & INFERENCES A median of six participants is needed to nullify results in the included IBS trials suggesting how easily statistical significance based on a threshold p-value may be overturned.