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Improvement of abdominal pain and bloating in relation to the Bristol Matrix. A scale that corresponds to stool consistency measured by the Bristol Stool Scale is shown. For IBS-C, improvement should be from left to right, whereas for IBS-D and IBS-M it should be from right to left.
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Background: Irritable Bowel Syndrome (IBS) is a disorder characterized by abdominal pain or discomfort associated with changes in bowel habit. Currently there are no objective outcome measures for evaluating the effectiveness of treatments for this disorder.
Aims: To determine the usefulness of a method of analysis that employs polar vectors to eva...
Context in source publication
Context 1
... bowel syndrome (IBS) is a functional gastrointesti- nal disorder characterized by abdominal pain or discomfort associated with changes in bowel habit. 1 Based on the pre- dominant bowel habit, it is classified into subtypes that, in accordance with the most recent Rome III 2 criteria, are IBS with diarrhea (IBS-D), constipation (IBS-C), mixed (IBS-M), and unsubtyped (IBS-U). 2 In the absence of a biological marker in IBS, diagnosis is based on the Rome III 1 clinical criteria that have been developed to classify functional gastrointestinal disorders (FGIDs) 2 ; but there are no objective outcome measures for evaluating the efficacy of treatments for this disor- der. Regulatory agencies have recently shown an interest in defining such objective outcome measures for the clinical trials that evaluate the medications presently being devel- oped for IBS. 3,4 The evaluation of pharmacologic efficacy must encompass several aspects, including the intensity of cardinal symptoms (abdominal pain and/or bloating) that can be evaluated with a visual analog scale (VAS), as well as changes in bowel habit (e.g. stool consistency that can be evaluated using the Bristol Stool Scale, or stool frequency that can be analyzed through symptom diaries). 3 The Bristol Stool Scale has been recommended by the Rome III committee. 1 It is a tool that enables bowel move- ments to be classified into seven categories, according to consistency: type 1, separate hard lumps, like nuts (hard to pass); type 2, sausage-shaped but lumpy; type 3, like a sausage but with cracks on the surface; type 4, like a sausage or snake, smooth and soft; type 5, soft blobs with clear- cut edges; type 6, fluffy pieces with ragged edges, a mushy stool; and type 7, watery, no solid pieces, entirely liquid. 1 A matrixial table or Bristol Matrix (BM) can be constructed by simultaneously recording the changes in consistency using the Bristol Stool Scale and measuring evacuation frequency. This matrix integrates the two variables (omnibus variable) and can serve as an efficacy measure for evaluating pharma- cologic treatments for IBS. Data from the BM can be graphed as a series of points or vectors in a two-dimensional space. In response to treatment effectiveness, improvement in stool frequency and consistency (type) recorded in the BM will be reflected as a movement of the vectors, and depending on the IBS subtype, this movement can be in the same or in opposite directions. For example, in patients with IBS-C, improvement means diminishing in evacuation consistency, going from a Bristol type 1 or 2 to a type 3 or higher, accom- panied by increased evacuation frequency (moving from left to right, Fig. 1). In contrast, in patients with IBS-D, clinical improvement implies bowel movements of a greater consis- tency, going from types 6 and 7 to type 5 or lower, with a reduction in evacuation frequency. Once the magnitude and direction of the vectorial movement is known (the degree of improvement), vectors can be transfered to a plane of polar coordinates that enables the treatment response in all the IBS subtypes to be observed at the same time. This method of analysis is based on the assumption that things are more easily understood if they can be visualized. The aim of this study was to determine the usefulness of the method of analysis employing polar vectors for evalu- ating IBS pharmacologic treatment efficacy. The data used were obtained in an open Phase IV study conducted on patients with active IBS who received 100 mg of pinaverium bromide + 300 mg of simethicone (PB + S) po bid over a four- week period. The hypothesis stated that this method is adequate for evaluating the efficacy of any IBS treatment, by determining stool consistency and frequency improve- ment through a BM that allows for the treatment response in the various IBS subtypes (IBS-D, IBS-C, IBS-M, IBS-U) to be ...
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Introduction
Irritable bowel syndrome (IBS) is a common gastrointestinal condition. Some studies have shown the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS). Weizmannia (Bacillus) coagulans LMG S-31876 has been marketed as a dietary ingredient, but to date, its efficacy in diarrhea-predominant irritable bowel syndrome (...
Background:
Probiotics are a promising solution for managing irritable bowel syndrome (IBS). Saccharomyces cerevisiae (S. cerevisiae) I-3856 has already demonstrated beneficial effects in IBS subjects, particularly in IBS with predominant constipation (IBS-C).
Aim:
To confirm the efficacy of S. cerevisiae I-3856 in the management of gastrointest...
The ability of the anticholinergic drug cimetropium bromide to maintain remission of irritable bowel syndrome (IBS) after remission was achieved with short-term crossover therapy with the anticholinergic drug prifinium bromide or with cimetropium was tested in a double-blind, placebo-controlled trial of three-months' duration. Thirty patients previ...
Citations
... Эффективность пинаверия бромида была оценена в клиническом испытании с участием 1677 пациентов с СРК, получавших данный спазмолитик в сочетании с симетиконом. В результате было отмечено улучшение частоты и консистенции стула у пациентов с СРК-З, СРК-Д и СРК-С, а также уменьшение болей и вздутия живота [25]. ...
Irritable bowel syndrome (IBS) is a common functional disease of the gastrointestinal tract, affecting a large number of adults worldwide, and leads to a significant decrease in the quality of life. IBS places a heavy burden on patients, most of whom are able-bodied population, as well as doctors and the healthcare system. The pathogenesis of this disease is multifactorial and includes the brain-intestine axis, disorders of the immune function of the mucous membrane, visceral hypersensitivity, changes in the motility of the gastrointestinal tract, changes in the microbial composition of the intestine. Based on the fact that changes in intestinal motility and visceral hypersensitivity are among the key factors in the pathogenesis of the disease, he use of antispasmodic drugs as part of complex therapy is justified. Mebeverin is a myotropic antispasmodic drug recommended for use in patients with IBS according to Rome IV Criteria, as well as clinical recommendations of the Russian Gastroenterological Association and the Association of Coloproctologists of Russia. According to available data, mebeverin has proven to be an effective and safe antispasmodic used to treat patients with IBS. The article presents a clinical case demonstrating the experience of effective use of the drug Mebespalin®. A patient with a diagnosis of IBS with a predominance of constipation is recommended to take an antispasmodic, as well as lifestyle modification – the addition of fiber-rich foods, sufficient drinking regime and increased physical activity. A week after the start of treatment, the patient noted an improvement in her condition – abdominal pain did not bother, the stool normalized.
... Клиническая эффективность пинаверия бромида также оценена у 1677 пациентов с СРК, получавших его в сочетании с симетиконом [46]. Результаты показали нормализацию частоты и постоянства стула у пациентов с СРК-З, СРК-Д и СРК-СМ; кроме того, значительно уменьшились интенсивность боли и вздутие живота. ...
Objective of the Review: To describe and compare some pharmacodynamic and pharmacokinetic parameters of antispasmodic drugs used in complex management of irritable bowel syndrome (IBS) in the Russian Federation. Key Points. IBS is a chronic recurrent disease associated with abdominal pain and bowel disorders. The key factors of IBS pathogenesis include intestinal motility disorders and visceral hypersensitivity. Both processes are controlled by endocrine and neural systems. In a target cell, voltage-operated calcium channels mediate neuronal signals for unstriped muscles to contract and for glands to start secreting. Antispasmodic drugs are a group of products that have been used for IBS management for decades. The review describes contemporary idea of molecular mechanisms to control contraction of GIT muscle cells and a comparison of antispasmodic drugs used in complex therapy of IBS in the Russian Federation. Their key pharmacodynamic and pharmacokinetic characteristics are discussed. Conclusion. The fundamental difference of mebeverine (Duspatalin) is its ability to normalise bowel motility in patients with IBS without the need in complete motility suppression. Also, its inability to block muscarinic receptors and stimulate opioid receptors is another advantage in improving the quality of life of patients. Keywords: pharmacodynamics, pharmacokinetics, antispasmodic drugs, therapy of irritable bowel syndrome, mebeverine.
... The effectiveness of 100 mg pinaverium bromide and 300 mg of simethicone (PB+S) as a combination therapy for IBS has previously been shown in a nationwide open-label 4-week clinical trial in Mexico. 33 In that study, PB+S improved abdominal pain and bloating in all IBS subtypes after 4 weeks of treatment. In addition, PB+S improved stool frequency and consistency in patients with all IBS subtypes. ...
... 34 Stool frequency was recorded in a diary that included the stool-type pictograms of the Bristol Scale, thus patients recorded each bowel movement according to the corresponding stool type, as previously reported. 33 To assess QoL, patients answered the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire at randomization and at the end of treatment (V0 and V3, respectively). The IBS-QOL is a self-administered questionnaire 35 that has been previously validated in Spanish-Mexico. ...
Goals:
We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS).
Background:
IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials.
Materials and methods:
IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores.
Results:
A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events.
Conclusions:
PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.
... Results of this meta-analysis have validated that RP could effectively improve the symptoms of this disorder [37][38][39]. However, M-TXYF may be more superior to RP in the reduction of symptom scores, with therapeutic gains over these RP of 17.6% and NNT = 5.7. ...
Objective
To systematically evaluate the efficacy and safety of Modified Tongxie Yaofang (M-TXYF) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Method
Electronic databases including PubMed, Springer Link, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), Wanfang, and Chinese Scientific Journals Database (VIP) were conducted from their inception through May 11, 2017 without language restrictions. Primary and secondary outcomes were estimated by 95% confidence intervals (CI). RevMan 5.3 and the Cochrane Collaboration’s risk of bias tool were analyzed for this meta-analysis.
Results
Twenty-three literatures with a total of 1972 patients were included for the meta-analysis. The overall risk of bias evaluation was low. The pooled odds ratio showed that M-TXYF was significantly superior to routine pharmacotherapies (RP) in clinical therapeutic efficacy (OR 4.04, 95% CI 3.09, 5.27, P < 0.00001, therapeutic gain = 17.6%, number needed to treat (NNT) = 5.7). Moreover, compared with RP, M-TXYF showed that it can significantly reduce the scores of abdominal pain (standardized mean difference (SMD) -1.27; 95% CI -1.99, -0.56; P = 0.0005), abdominal distention (SMD -0.37; 95% CI -0.73, -0.01; P = 0.09), diarrhea (SMD -1.10; 95% CI -1.95, -0.25; P = 0.01), and frequency of defecation (SMD -1.42; 95% CI -2.19, -0.65; P = 0.0003). The differences of the adverse events between experiment and control groups had no statistical significance.
Conclusion
This meta-analysis indicated that M-TXYF could be a promising Chinese herbal formula in treating IBS-D. However, considering the lack of higher quality of randomized controlled trials (RCTs), highly believable evidences should be required.
... For upper and lower gastrointestinal motility disorders whose motility changes are consistent with the same situation, such as the hypokinesis state of gastrointestinal tract when delayed gastric emptying FD appears simultaneously with IBS-C, or the hyperdynamic state of gastrointestinal tract when accelerating gastric emptying FD occurs with IBS-D, we can use gastrointestinal motility inhibitor or prokinetic drugs which have unidirection regulative function. For upper and lower gastrointestinal motility disorders whose motility changes are in inconsistency or paradoxical situation,, such as delayed gastric emptying FD combining with IBS-D, or accelerating gastric emptying FD combining with C-IBS, as well as FD combining with mixed type IBS (IBS-M), We recommend using gastrointestinal motility drugs which have bidirectional regulating function, such as trimebutine or pinaverium bromide[26][27][28][29]. Moreover, there are few drugs which have inhibitory effect both on stomach and intestine peristalsis, and their adverse reactions are frequently observed. ...
The overlap syndrome of functional dyspepsia and irritable bowel syndrome (FD-IBS) is very common and difficult to treat. There are many risk factors of FD-IBS. Mental illness of FD-IBS patients is more serious. Functional dyspep-sia and irritable bowel syndrome have some similarities in the aspects of pa-thophysiology, pathogenesis, and treatment. We should pay attention to two aspects of the treatment of overlap syndrome, one is simplifying medications, the other is using gastrointestinal motility drug with bidirectional regulative function when necessary. Traditional Chinese medicine in this respect shows some advantages. This review addresses the epidemiology, risk factors, clinical features, pathogenesis and management of FD-IBS.
... En el metaanálisis de Martínez Vázquez, esta misma combinación fue superior a +Model RGMX-303; No. of Pages 19 Consenso mexicano sobre el síndrome de intestino irritable 11 placebo en mejoría global de los síntomas 99 . La combinación de bromuro de pinaverio con dimeticona y de alverina con simeticona también ha sido superior a placebo en la mejoría de la distensión abdominal 99,104,105 . En el caso de trimebutina/simeticona no hay evidencia de que haya evaluado específicamente esta combinación para recomendar su uso. ...
Background: Since the publication in 2009 of the Guidelines on the Diagnosis and Treatment of Irritable Bowel Syndrome of the Asociación Mexicana de Gastroenterología (2009 Guidelines), there have been significant advances in our knowledge of the epidemiology, pathophysiology, diagnosis, and treatment of this disease.
Aims: To present a consensus review of the most current knowledge of IBS, updating the 2009 Guidelines by incorporating new internationally published scientific evidence, with a special interest in Mexican studies.
Methods: The PubMed literature from January 2009 to March 2015 was reviewed and complemented through a manual search. Articles in English and Spanish were included and preference was given to consensuses, guidelines, systematic reviews, and meta-analyses. Statements referring to the different aspects of the disease were formulated and voted upon by 24 gastroenterologists employing the Delphi method. Once a consensus on each statement was reached, the quality of evidence and strength of recommendation were determined through the GRADE system.
Results: Forty-eight statements were formulated, updating the information on IBS and adding the complementary data that did not appear in the 2009 Guidelines regarding the importance of exercise and diet, diagnostic strategies, and current therapy alternatives that were analyzed with more stringent scientific vigor or that emerged within the last 5 years.
Conclusions: We present herein a consensus review of the most relevant advances in the study of IBS, updating and complementing the 2009 Guidelines. Several studies conducted in Mexico were included.
... En el metaanálisis de Martínez Vázquez, esta misma combinación fue superior a +Model RGMX-303; No. of Pages 19 Consenso mexicano sobre el síndrome de intestino irritable 11 placebo en mejoría global de los síntomas 99 . La combinación de bromuro de pinaverio con dimeticona y de alverina con simeticona también ha sido superior a placebo en la mejoría de la distensión abdominal 99,104,105 . En el caso de trimebutina/simeticona no hay evidencia de que haya evaluado específicamente esta combinación para recomendar su uso. ...
Background:
Since the publication of the Asociacion Mexicana de Gastroenterología guidelines on the diagnosis and treatment of the irritable bowel syndrome (IBS) (2009 Guidelines), there have been significant advances on our knowledge on epidemiology, physiopathology, diagnosis and treatment of this disease.
Objectives:
To produce a consensus review of the state of the art on IBS, in order to bring the 2009 Guidelines up to date, incorporating new scientific evidence published worldwide with a special interest on Mexican publications.
Methods:
A PubMed literature review was performed from January 2009 to March 2015 and was complemented by a manual search. All publications in Spanish and English language were included, giving precedence to consensus, guidelines, systematic reviews and meta-analysis. Statements were generated in the different aspects of the disease and these were voted by 24 gastroenterologists using the Delphi method. Once agreed each statement, level of evidence was graded and strength of recommendation was given using the GRADE system.
Results:
Forty-eight statements were included in order to update IBS information and to complement the information not included in the 2009 Guidelines regarding the importance of exercise and diet, diagnostic strategies, and current therapy alternatives that were analyzed with more stringent scientific rigor or came to light during the last 5 years.
Conclusions:
We present a consensus review of the most relevant advances relative to IBS, which brings up to date and complement the 2009 Guidelines. Several studies produced in Mexico were included.
... Beneficial effects of pinaverium bromide treatment were also demonstrated by an open trial, in which 61 treated IBS patients experienced significantly reduced abdominal pain, improved stool consistency, reduced defecation straining and urgency, and decreased mucus in stool, with good drug tolerance and few side effects [87] . The clinical efficacy of pinaverium bromide was also evaluated using a statistical technique new to the fieldnamely, by employing polar vectors on data from a phase Ⅳ clinical trial with 1677 Rome Ⅲ IBS patients receiving pinaverium bromide combined with simethicone [88] . The results showed amelioration of stool frequency and consistency in IBS-C, IBS-D and IBS-M patients; furthermore, the intensity of abdominal pain and bloating was also significantly reduced. ...
Irritable bowel syndrome (IBS) is a long-lasting, relapsing disorder characterized by abdominal pain/discomfort and altered bowel habits. Intestinal motility impairment and visceral hypersensitivity are the key factors among its multifactorial pathogenesis, both of which require effective treatment. Voltage-gated calcium channels mediate smooth muscle contraction and endocrine secretion and play important roles in neuronal transmission. Antispasmodics are a group of drugs that have been used in the treatment of IBS for decades. Alverine citrate, a spasmolytic, decreases the sensitivity of smooth muscle contractile proteins to calcium, and it is a selective 5-HT1A receptor antagonist. Alverine, in combination with simethicone, has been demonstrated to effectively reduce abdominal pain and discomfort in a large placebo-controlled trial. Mebeverine is a musculotropic agent that potently blocks intestinal peristalsis. Non-placebo-controlled trials have shown positive effects of mebeverine in IBS regarding symptom control; nevertheless, in recent placebo-controlled studies, mebeverine did not exhibit superiority over placebo. Otilonium bromide is poorly absorbed from the GI tract, where it acts locally as an L-type calcium channel blocker, an antimuscarinic and a tachykinin NK2 receptor antagonist. Otilonium has effectively reduced pain and improved defecation alterations in placebo-controlled trials in IBS patients. Pinaverium bromide is also an L-type calcium channel blocker that acts locally in the GI tract. Pinaverium improves motility disorders and consequently reduces stool problems in IBS patients. Phloroglucinol and trimethylphloroglucinol are non-specific antispasmodics that reduced pain in IBS patients in a placebo-controlled trial. Antispasmodics have excellent safety profiles. T-type calcium channel blockers can abolish visceral hypersensitivity in animal models, which makes them potential candidates for the development of novel therapeutic agents in the treatment of IBS.
