Evaluation of Benefit and Tolerability of IQP‐CL‐101 (Xanthofen) in the Symptomatic Improvement of Irritable Bowel Syndrome: A Double‐Blinded, Randomised, Placebo‐Controlled Clinical Trial

Abstract

Irritable bowel syndrome (IBS) is a functional bowel disorder of unknown aetiology. There is currently no known cure, and pharmacological interventions are usually targeting symptomatic relief, where natural and herbal remedies also play a role. This study aimed to evaluate the benefit and tolerability of IQP‐CL‐101 in symptomatic IBS relief. A double‐blinded, randomised, placebo‐controlled trial was conducted over 8 weeks. A total of 99 subjects fulfilling ROME‐III criteria for IBS were randomised into two groups, given either two IQP‐CL‐101 softgels or matching placebo twice daily before main meals. The primary endpoint was the difference in change of IBS Symptom Severity Score (IBS‐SSS) after an 8‐week intake of IQP‐CL‐101 compared to placebo. After 8 weeks, subjects on IQP‐CL‐101 showed a significant reduction in IBS‐SSS (113.0 ± 64.9‐point reduction) compared to subjects on placebo (38.7 ± 64.5‐point reduction) (p < 0.001). A significant improvement could be seen as early as 4 weeks. No serious adverse events were reported throughout. IQP‐CL‐101 can be considered beneficial in the improvement of IBS symptom severity, regardless of IBS type, and therefore able to improve quality of life in patients suffering from abdominal pain and discomfort. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

What phytotherapy needs: Evidence‐based guidelines for better clinical practice

“…Good‐quality clinical trials represent the key research tool for advancing medical knowledge and patient care (Figure ). For example, the double‐blind, randomised, placebo‐controlled trial reported by Alt et al fulfils the quality criteria for clinical trials and allows conclusions to be drawn from a good level of EBM (Alt, Chong, Teng, & Uebelhack, ). In this study, the authors correctly randomised the participants, and inclusion/exclusion criteria were clearly defined.…”

“…on irritable bowel syndrome. The results showed significant reduction in severity of symptoms, with consequent improvement in patient quality of life (Alt et al, ). This high‐quality study clearly contributes to our understanding of whether an analysed phytotherapy can be an effective treatment strategy.…”

A Meta-Analysis of the Clinical Use of Curcumin for Irritable Bowel Syndrome (IBS)

“…With regard to the possible side effects of curcumin use, human trials assessing its safety and toxicity have found it to be safe, with occasional reports of slight giddiness, nausea, and diarrhoea [ 42 ]. Encouragingly, no adverse events were also reported in any of the trials reviewed in this study [ 24 , 25 , 26 , 28 ]. However, at higher doses, curcumin may interact with some medications, such as anticoagulants [ 43 ].…”

“…Overall, random-effects meta-analysis based on three studies and 326 subjects found curcumin to have beneficial but not statistically significant effects on IBS symptoms. Of the five clinical trials reviewed, three reported positive and significant effects for curcumin-containing products [ 24 , 26 , 28 ], while two [ 25 , 27 ] found no significant effects compared to placebo and advised against monotherapy with curcumin. It is important to note that in the study by Brinkhaus et al [ 25 ], diagnosis of IBS was not based on the established Rome Criteria [ 29 ], but rather an intensive clinical examination ruling out other organic causes.…”

“…Second, inter-study variability in terms of curcumin formulation (even combined with peppermint oil, a known antispasmodic [ 44 ], in one study [ 26 ]) and the diagnosis of IBS likely contributed to the overall heterogeneity of the meta-analysis, and could have affected the reliability of current findings. Furthermore, curcumin was mixed with at least one other therapeutic or potentially therapeutic material in two of the trials analysed [ 26 , 28 ], hence, it is difficult to quantify a curcumin-attributable SMD and determine whether the therapeutic benefits observed in these two studies were due to curcumin. More robust clinical trials involving a standardized curcumin preparation and larger sample sizes are warranted.…”