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A general practice study of the efficacy of Reglan in functional constipation
Abstract
Two hundred and one patients with functional constipation were entered into a single-blind, multicentre study. Patients were randomly allocated to one of two parallel groups, which determined whether they received either active Regulan (initial dose: one sachet, three times daily) or matching placebo. Patients were assessed clinically on entry to the study and after 14 days of treatment. Diary cards were completed daily by patients. Stool consistency was significantly improved (p < 0.001) in the group receiving active Regulan, with regard to both an increase in the number of formed bowel actions, and a decrease in the number of hard or pellet-like bowel actions. There was also a significant overall increase in the number of bowel actions in the Regulan group (p < 0.001) compared with the placebo group. A significant reduction in the severity of abdominal pain/discomfort (p = 0.035) and a decrease in straining on defaecation (p = 0.003) were reported by patients in the Regulan group at the second visit. There were seven withdrawals from the Regulan group and 11 from the placebo group. The low level of withdrawals and of spontaneous complaints indicates the safety of Regulan when used in the treatment of constipation. Assessments by the patients and investigator both showed a highly significant difference in efficacy of treatment in favour of Regulan (p < 0.001). In this study, Regulan has been shown to be an effective, safe and acceptable laxative.
... One completed but unpublished trial (NCT01847950) was confirmed to be eligible after contact with the principal investigator; however, the data could not be shared due to a confidentiality agreement (27). In total, 16 RCTs fulfilled the criteria for inclusion in the review, involving 1251 participants with chronic constipation (21,22,25,(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40). Table 2 displays the characteristics of the included studies. ...
... Severity of straining was reported in 4 studies including 489 participants (25,28,30,34). Fiber significantly improved (Figure 5). ...
... One study administering psyllium reported that 2 participants (18%) in the intervention group had abdominal pain, compared to none in the control group (28). Another study administering psyllium reported that 3 participants withdrew from the intervention group and 5 from the control group, for reasons related to the reported treatment side effects (30). A study administering wheat bran reported participant withdrawal due to "unbearable" abdominal pain (39). ...
Background
Chronic constipation is a prevalent disorder that remains challenging to treat. Studies suggest increasing fiber intake may improve symptoms, although recommendations on type, dose and duration are unclear.
Objective
To investigate the effect of fiber supplementation on stool output, gut transit time, symptoms and quality of life in adults with chronic constipation via a systematic review and meta-analysis of randomized controlled trials (RCTs).
Design
Studies were identified using electronic databases, backward citation and hand-searching abstracts. RCTs reporting administration of fiber supplementation in adults with chronic constipation were included. Risk of bias (RoB) was assessed with the Cochrane RoB 2.0 tool. Results were synthesized using risk ratios (RR), mean differences (MD) or standardized mean differences (SMD) and 95% confidence intervals (CI) using a random-effects model.
Results
Sixteen RCTs of 1,251 participants were included. Overall, 311/473 (66%) responded to fiber treatment and 134/329 (41%) to control (RR 1.48; 95% CI 1.17, 1.88; p = 0.001; I2 = 57%, p = 0.007), with psyllium and pectin having significant effects. A higher response to treatment was apparent irrespective of treatment duration, but only with higher fiber dose (>10 g/d). Fiber increased stool frequency (SMD 0.72; 95% CI 0.36, 1.08; p = 0.0001; I2 = 86%, p < 0.00001); psyllium and pectin had significant effects, and improvement was apparent only with higher fiber dose and greater treatment duration (≥4 weeks). Fiber improved stool consistency (SMD 0.32; 95% CI 0.18, 0.46; p < 0.0001), particularly with higher fiber dose. Flatulence was higher with fiber compared to control (SMD 0.80; 95% CI 0.47, 1.13; p < 0.00001).
Conclusions
Fiber supplementation is effective in improving constipation. Particularly, psyllium, doses above 10 g/d and treatment duration of at least 4 weeks appear optimal, though caution is needed when interpreting the results due to considerable heterogeneity. These findings provide promising evidence on the optimal type and regime of fiber supplementation, which could standardize recommendations to patients.
Systematic review registration: PROSPERO registration number CRD42020191404.
... were excluded with 7 RCTs ultimately eligible. [38][39][40][41][42][43][44] Agreement between investigators for trial eligibility was substantial (kappa statistic=0.80). ...
... The seven RCTs comparing fibre supplementation with placebo/control involved a total of 430 adults with CIC. [38][39][40][41][42][43][44] Six studies were published in English and one in Spanish. 42 Authors of six of the trials were contacted to obtain supplementary information about the methodology used. ...
... Continuous data on stool frequency were reported by six studies including 406 patients. [38][39][40][41][42][43] Overall, fibre supplementation significantly increased stool frequency compared with placebo (SMD=0.39; 95% CI 0.03 to 0.76; P=0.03), indicating a moderate effect size, albeit with statistically significant heterogeneity between studies (I 2 =56%, χ 2 P=0.04) ( Figure S1). ...
Background
Chronic idiopathic constipation is a common symptom-based gastrointestinal disorder responsible for a substantial economic health service burden. Current guidelines recommend the use of fibre as a first-line treatment. AimTo investigate the effect of fibre (including prebiotic) supplementation on global symptom response, stool output, gut microbiota composition and adverse events in adults with chronic idiopathic constipation. Methods
Medline, EmBase, Web of Science, Scopus and the Cochrane central register of controlled trials were searched through to February 2016. Conference proceedings from 2003 to 2015 were hand-searched. There were no language restrictions. Forest plots with 95% CIs were generated using a random-effects model. ResultsThe search strategy generated 1072 citations, of which seven individual randomised controlled trials were eligible. Overall, 113 of 147 (77%) patients assigned to fibre responded to therapy, compared with 61 of 140 (44%) allocated to placebo (RR of success to respond 1.71, 95% CI 1.20-2.42, P = 0.003). Fibre significantly increased stool frequency (SMD, standardised mean difference = 0.39; 95% CI 0.03-0.76; P = 0.03) and softened stool consistency (SMD = 0.35; 95% CI 0.04-0.65; P = 0.02) compared with placebo. Flatulence was significantly higher with fibre compared to placebo (SMD 0.56, 0.12-1.00, P = 0.01). Overall quality of evidence was low. Conclusions
This meta-analysis demonstrates that fibre is moderately effective, but also causes moderate gastrointestinal side effects. However, these findings need to be treated with caution due to a high risk of bias. Accordingly, further large, methodologically rigorous trials are required, before any definitive recommendation regarding its risk-benefit profile can be made. PROSPERO registration number CRD42014007005.
... Overall, adverse event rates were not higher among those taking linaclotide compared with placebo (RR = 1.09, Combined data from the three trials ( 243,245,246 ) suggested that fi ber was benefi cial compared with placebo with the NNT of 2 (95 % CI 1.6 -3) and no statistically signifi cant heterogeneity between studies. Although these trials could be combined for analysis, the defi nitions of improvement were all diff erent, and in one trial ( 245 ) not all patients enrolled in the trial had the outcome that was used to defi ne treatment success present at baseline. ...
... In terms of individual formulations, among the three trials ( 241,243,246 ) that studied psyllium, including the largest identifi ed RCT conducted by Fenn et al. ( 243 ), although outcomes varied between these RCTs, all reported signifi cant benefi ts with psyllium. ...
... In terms of individual formulations, among the three trials ( 241,243,246 ) that studied psyllium, including the largest identifi ed RCT conducted by Fenn et al. ( 243 ), although outcomes varied between these RCTs, all reported signifi cant benefi ts with psyllium. ...
The American Journal of Gastroenterology is published by Nature Publishing Group (NPG) on behalf of the American College of Gastroenterology (ACG). Ranked the #1 clinical journal covering gastroenterology and hepatology*, The American Journal of Gastroenterology (AJG) provides practical and professional support for clinicians dealing with the gastroenterological disorders seen most often in patients. Published with practicing clinicians in mind, the journal aims to be easily accessible, organizing its content by topic, both online and in print. www.amjgastro.com, *2007 Journal Citation Report (Thomson Reuters, 2008)
... [8] The RCT identified by the review found that, compared with placebo, ispaghula husk 3.6 g three times daily significantly increased the frequency of bowel movements at 2 weeks (total number of bowel movements at 2 weeks: 14 with ispaghula v 9 with placebo; P less than 0.001). [23] The RCT also found that, at 2 weeks, compared with placebo, ispaghula husk significantly increased the proportion of people rating their abdominal pain/discomfort as better (assessed using 3-point Likert scale as "better", "the same", or "worse"; rated as better: 44 ...
... The review [8] and RCT [23] identified by the review gave no information on adverse effects. ...
... High 0 0 0 0 4 Ispaghula husk v placebo Frequency of bowel movement 1 (201) [23] Quality point deducted for sparse data Moderate 0 0 0 -1 4 Ispaghula husk v placebo Straining during defecation 1 (196) [23] Quality points deducted for sparse data and incomplete reporting of results (data presented graphically and statistical data not reported) Low 0 0 0 -2 4 Ispaghula husk v lactulose Frequency of bowel movement 1 (124) [25] Quality points deducted for sparse data and incomplete reporting of results (statistical data not reported) Low 0 0 0 -2 4 Ispaghula husk v lactulose Straining during defecation 1 (124) [25] Quality point deducted for sparse data. Directness point deducted for uncertainty of clinical benefit Low 0 -1 0 -1 4 Ispaghula husk v docusate Frequency of bowel movement 1 (170) [27] Quality point deducted for sparse data Moderate 0 0 0 -1 4 Ispaghula husk v docusate Straining during defecation 1 (170) [27] What are the effects of faecal softeners in adults with idiopathic chronic constipation? ...
Although there are defined criteria for the diagnosis of constipation, in practice, diagnostic criteria are less rigid, and depend in part on the perception of normal bowel habit. Constipation is highly prevalent, with approximately 12 million general practitioner prescriptions for laxatives in England in 2001. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-drug interventions, bulk-forming laxatives, faecal softeners, stimulant laxatives, osmotic laxatives, prostaglandin derivatives, and 5-HT4 agonists in adults with idiopathic chronic constipation? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 51systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: arachis oil, biofeedback, bisacodyl, cascara, docusate, exercise, glycerol/glycerine suppositories, high-fibre diet, increasing fluids, ispaghula husk, lactitol, lactulose, lubiprostone, macrogols (polyethylene glycols), magnesium salts, methylcellulose, paraffin, phosphate enemas, seed oils, senna, sodium citrate enemas, prucalopride, and sterculia.
... Placebo-controlled trials of psyllium: Psyllium fibre is partially soluble and is the most studied type of fibre. Three placebo-controlled trials on the efficacy of psyllium have been published232425 . Two found that psyllium was superior to a placebo in increasing the frequency of defecation (P < 0.05) and improving the consistency of the stool (P < 0.05) [23,24] . ...
... Ashraf et al [23] conducted a welldesigned study, but it only lasted 8 wk and only enrolled 22 patients. The third study reported no significant difference between psyllium and a placebo [25] . ...
The second part of the Consensus Statement of the Italian Association of Hospital Gastroenterologists and Italian Society of Colo-Rectal Surgery reports on the treatment of chronic constipation and obstructed defecation. There is no evidence that increasing fluid intake and physical activity can relieve the symptoms of chronic constipation. Patients with normal-transit constipation should increase their fibre intake through their diet or with commercial fibre. Osmotic laxatives may be effective in patients who do not respond to fibre supplements. Stimulant laxatives should be reserved for patients who do not respond to osmotic laxatives. Controlled trials have shown that serotoninergic enterokinetic agents, such as prucalopride, and prosecretory agents, such as lubiprostone, are effective in the treatment of patients with chronic constipation. Surgery is sometimes necessary. Total colectomy with ileorectostomy may be considered in patients with slow-transit constipation and inertia coli who are resistant to medical therapy and who do not have defecatory disorders, generalised motility disorders or psychological disorders. Randomised controlled trials have established the efficacy of rehabilitative treatment in dys-synergic defecation. Many surgical procedures may be used to treat obstructed defecation in patients with acquired anatomical defects, but none is considered to be the gold standard. Surgery should be reserved for selected patients with an impaired quality of life. Obstructed defecation is often associated with pelvic organ prolapse. Surgery with the placement of prostheses is replacing fascial surgery in the treatment of pelvic organ prolapse, but the efficacy and safety of such procedures have not yet been established.
... One study showed no change [131], while the other showed no significant change [132]. In a triple-blind study comparing Psyllium, hibiscus with placebo, the incidence and quality of stools of both the investigator and the patient were statistically significant [133]. In the first study, psyllium was superior to three separate irritant/stimulant laxatives, lactulose and magnesium sulfate, which are suitable for both patients and constipation [134]. ...
Constipation is one of the most common and prevalent chronic gastrointestinal conditions across the globe that is treated or managed through various methods. Laxatives are used for the treatment or management of chronic/acute constipation. But due to the adverse effects associated with these laxatives, herbal foods should be considered as alternative therapies for constipation. In this review, the laxative potential of plant-based medicines used for constipation were discussed. Constipation may be caused by various factors such as lifestyle, particular food habits, pregnancy and even due to some medication. Chronic constipation is responsible for different health issues. Pharmacological and non-pharmacological paradigms are applied for the treatment or management of constipation. In the pharmacological way of treatment, medicinal plants have a key role, because of their fibrous nature. Numerous plants such as Prunus persica (Rosaceae), Cyamopsis tetragonolobus (Leguminosae), Citrus sinensis (Rutaceae), Planta goovata (Plantaginaceae), Rheum emodi (Polygonaceae), Cassia auriculata (Caesalpinacea), Ricinus communis (Euphorbiaceae), Croton tiglium (Euphorbiaceae), Aloe barbadensis (Liliaceae), Mareya micrantha (Euphorbiaceae), Euphorbia thymifolia (Euphorbiaceae), Cascara sagrada (Rhamnaceae), Cassia angustifolia (Fabaceae) have laxative activity. Medicinal plants possess a significant laxative potential and support their folklore therefore, further, well-designed clinical-based studies are required to prove and improve the efficacy of herbal medicine for constipation. The present review showed that herbs laxative effect in various in-vivo/ in-vitro models.
... Constipation occurs three times more frequently among women than among men and is more common among non-white individuals and in low-income families with little formal education (Johanson et al., 1989). Clinical studies have shown the bene its of promoting dietary ibre in the treatment of constipation (Fenn et al., 1986). By raising stool weight and volume, ibre decreases colonic transit time and enhances the rectal re lex. ...
... Constipation occurs three times more frequently among women than among men and is more common among non-white individuals and in low-income families with little formal education (Johanson et al., 1989). Clinical studies have shown the bene its of promoting dietary ibre in the treatment of constipation (Fenn et al., 1986). By raising stool weight and volume, ibre decreases colonic transit time and enhances the rectal re lex. ...
... Constipation occurs three times more frequently among women than among men and is more common among non-white individuals and in low-income families with little formal education (Johanson et al., 1989). Clinical studies have shown the bene its of promoting dietary ibre in the treatment of constipation (Fenn et al., 1986). By raising stool weight and volume, ibre decreases colonic transit time and enhances the rectal re lex. ...
Dietary fibre is the name collectively given to the indigestible carbohydrates present in foods. These carbohydrates consist of cellulose, gum, pectin and mucilage. Enzymes of gastro-intestinal tracts in humans do not digest these fibres. Plants are the only source of dietary fibre. It is found in grains, vegetables and fruits. Dietary fibre helps to keep the digestive system healthy, and it is vital in reducing the risk of diseases such as coronary heart disease, diabetes, diverticulosis, haemorrhoids and intestinal cancer. Undigested fibres enter the large intestine where bacteria ferments them. Carbon dioxide, nitrogen, hydrogen and short-chain fatty acids are the by-products of the fermentation. Soluble fibre and resistant starch also serve as prebiotic and supports the necessary probiotic for digestive health. In grapes, peas, beans and barley, much of the soluble fibre is extracted. When dissolved in the water, a gel-like substance is formed. Soluble fibre helps to support the growth of friendly bacteria needed to maintain a healthy intestinal system. They also help in slowing down the time taken by the food to pass through the stomach into the small intestine, which helps to slow down the absorption of glucose and controls the blood sugar levels and helps in managing diabetes mellitus and keeps you feeling fuller for a longer time. The diets with high fibre intakes are known to have beneficial health effects as they have water holding capacity, helps in adsorption of organic molecules and facilitates its excretion, hypoglycemic effects and hypercholesterolemic effect. The inclusion of fibre rich food in weight-reducing diets is found to helpful since it provides a feeling of fullness without consumption of excess calories. The present review discusses the definition, nutritional properties of dietary fibre and therapeutic functions of dietary fibres in health and diseases.
... None was at low risk of bias. Compared with placebo, psyllium led to significant improvements in global symptoms, abdominal pain and discomfort, and straining in one RCT [16]. In another trial, psyllium led to a significant increase in stool frequency, from 2.9 stools per week at baseline to 3.8 after treatment; there was no improvement with placebo [17]. ...
Background
Chronic constipation is a prevalent disorder that affects quality of life of patients and consumes resources in healthcare systems worldwide. In clinical practice, it is still considered a challenge as clinicians frequently are unsure as to which treatments to use and when. Over a decade ago, a Neurogastroenterology and Motility journal supplement devoted to the investigation and management of constipation was published (Neurogastroenterol Motil 2009;21(Suppl 2):1). In October 2018, the 3rd London Masterclass, entitled “Contemporary management of constipation” was held. The faculty members of this symposium were invited to write two reviews to present a collective synthesis of talks presented and discussions held during this meeting. The first review addresses epidemiology, diagnosis, clinical associations, pathophysiology, and investigation.
Purpose
The present is the second of these reviews, providing contemporary perspectives and clinical challenges regarding behavioral, conservative, medical, and surgical treatments for patients presenting with constipation. It includes a management algorithm to guide clinical practice.
... Soluble and insoluble fiber are also frequently used in patients with IBS, but the status of fiber in general in IBS is far from straightforward.[160][161][162][163][164][165][166] Insoluble fiber may exacerbate symptoms and provide little relief in patients with IBS, but soluble fiber and psyllium, in particular, seem to provide relief in this condition.[167][168][169] These latter effects appear to relate to the relief of constipation, which further supports the use of soluble fiber in patients with constipation, either FC or IBS-C.Future research/unmet needs. ...
Introduction:
Chronic constipation is a common disorder with a reported prevalence ranging from 3% to 27% in the general population. Several management strategies, including diagnostic tests, empiric treatments, and specific treatments, have been developed. Our aim was to develop European guidelines for the clinical management of constipation.
Design:
After a thorough review of the literature by experts in relevant fields, including gastroenterologists, surgeons, general practitioners, radiologists, and experts in gastrointestinal motility testing from various European countries, a Delphi consensus process was used to produce statements and practical algorithms for the management of chronic constipation.
Key results:
Seventy-three final statements were agreed upon after the Delphi process. The level of evidence for most statements was low or very low. A high level of evidence was agreed only for anorectal manometry as a comprehensive evaluation of anorectal function and for treatment with osmotic laxatives, especially polyethylene glycol, the prokinetic drug prucalopride, secretagogues, such as linaclotide and lubiprostone and PAMORAs for the treatment of opioid-induced constipation. However, the level of agreement between the authors was good for most statements (80% or more of the authors). The greatest disagreement was related to the surgical management of constipation.
Conclusions and inferences:
European guidelines on chronic constipation, with recommendations and algorithms, were developed by experts. Despite the high level of agreement between the different experts, the level of scientific evidence for most recommendations was low, highlighting the need for future research to increase the evidence and improve treatment outcomes in these patients.
... Adequate fluid intake is necessary for bulk-forming agents-a lack of water increases bloating and, paradoxically, can increase the incidence of bowel obstruction [14]. Among bulking agents, psyllium relieves constipation, and several randomized clinical trials have demonstrated its benefits in improving bowel function [15][16][17][18]. ...
Psyllium and lactitol have been reported to increase fecal volume, moisture content and bowel movement frequency (BMF). However, the benefits of their combined use on constipation has not been examined. The aim of this study was to evaluate the effects of a 4-week intervention with lactitol and/or psyllium on bowel function in constipated volunteers. Adults (N = 172) who were diagnosed with functional constipation per Rome III criteria were randomized to four treatment groups: 10 g lactitol, 3.5 g psyllium, a combination of 10 g lactitol and 3.5 g psyllium, or placebo. The primary endpoint was change in BMF from Day 0 to 28 as compared to placebo. Secondary endpoints were assessed by inventories, including stool consistency, patient assessment of constipation symptoms and quality of life, relief of constipation, 24-h food recall, physical activity, product satisfaction and adverse events (AE). BMF increased by 3.0 BMs with lactitol, by 2.9 with psyllium, and by 3.1 with the combination, but was not different from placebo (3.7 BMs). Other clinical endpoints were similar between treatments. No serious AEs were reported. In conclusion, this study showed a similar effect on relief of constipation in all treatment groups. The treatments that were administered to the volunteers were well tolerated.
... The effects of psyllium in chronic constipation has been known for decades (15). A number of studies have demonstrated that psyllium has the ability to influence abdominal pain and discomfort as well as the difficulty of defecation (16). ...
Background
It has been proven for many years that probiotics play pivotal role in the treatment of IBS patients. However it is still not very clear which strains are more beneficial than others in the treatment of irritable bowel syndrome (IBS). Our aim in the current clinical observation was to follow up the effect of a novel probiotic product line available on the Bulgarian market - Biopron IB-Symbio (Walmark, Czech Republic) in the treatment of IBS patients.
Methods
This prospective clinical observation included 45 consecutive patients divided into three groups: group 1 – 15 patients with diarrhea predominant post-infectious IBS (IBS-D), group 2 - 15 with constipation-predominant IBS (IBS-C) and group 3 – 15 IBS patients meeting Rome III but not meeting Rome IV criteria. Four week monotherapy with a new probiotic line was commenced in every group. The symptoms were evaluated before and after treatment. Moreover in IBS-D group fecal calprotectin (FCP) was monitored
Results
Significant reduction of FCP mean levels was observed in group 1 – from 152 µg/g at week 0 to 64 µg/g at week 4 (p<0,001). After probiotic treatment diarrhea was present only in 3 (20%) patients, and pain in 5 (33%) of the patients. In group 2 constipation was present after treatment just in 2 (13%) patients and abdominal pain in 4 (27%) of them. In group 3 - at 4 week after treatment discomfort was present in 3 (20%) patients, bloating in 2 (13%) patients and change in frequency of stool in 4 (27%)
Conclusion
The current clinical observation shows that Biopron probiotic product line significantly improves the symptoms in IBS patients. Moreover, it reduces the inflammatory activity in patients with post-infectious IBS. Additional multicenter observations with larger number of patients from different regions are needed to obtain even more accurate data.
... In a randomized, double-blind, parallel study of 170 constipated patients, treatment with psyllium for 2 weeks significantly improved stool weight and freqeuncy (in treatment week 2), compared with docusate. 93 Evidence from nine studies [91][92][93][94][95][96][97][98][99] of psyllium showed that it apparently improved stool frequency, but there were conflicting results regarding stool consistency and transit time. No signficant difference in advese events was observed between the psyllium group and the comparison group. ...
The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This study includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.
... In a randomized, double-blind, parallel study of 170 constipated patients, treatment with psyllium for 2 weeks significantly improved stool weight and freqeuncy (in treatment week 2), compared with docusate. 93 Evidence from nine studies [91][92][93][94][95][96][97][98][99] of psyllium showed that it apparently improved stool frequency, but there were conflicting results regarding stool consistency and transit time. No signficant difference in advese events was observed between the psyllium group and the comparison group. ...
The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This study includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation (AGREE) II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods.
... 13 Two previous studies that compared psyllium with placebo showed that psyllium improved straining and stool consistency but whether this was their predominant symptom was not assessed. 14,15 In this study, we found that excessive straining was the most predominant symptom in both groups of patients, followed by feelings of incomplete evacuation and decreased stool frequency in the mixed fibre group, and incomplete evacuation and hard stools in the psyllium group respectively. Also, in both groups approximately 70% of patients reported improvements in their predominant bowel symptoms. ...
Background
Fibre supplements are useful, but whether a plum-derived mixed fibre that contains both soluble and insoluble fibre improves constipation is unknown. AimTo investigate the efficacy and tolerability of mixed soluble/insoluble fibre vs. psyllium in a randomized double-blind controlled trial. Methods
Constipated patients (Rome III) received mixed fibre or psyllium, 5 g b.d., for 4 weeks. Daily symptoms and stool habit were assessed using stool diary. Subjects with 1 complete spontaneous bowel movement/week above baseline for 2/4 weeks were considered responders. Secondary outcome measures included stool consistency, bowel satisfaction, straining, gas, bloating, taste, dissolvability and quality of life (QoL). ResultsSeventy-two subjects (mixed fibre = 40; psyllium = 32) were enrolled and two from psyllium group withdrew. The mean complete spontaneous bowel movement/week increased with both mixed fibre (P < 0.0001) and psyllium (P = 0.0002) without group difference. There were 30 (75%) responders with mixed fibre and 24 (75%) with psyllium (P = 0.9). Stool consistency increased (P = 0.04), straining (P = 0.006) and bloating scores decreased (P = 0.02) without group differences. Significantly more patients reported improvement in flatulence (53% vs. 25%, P = 0.01) and felt that mixed fibre dissolved better (P = 0.02) compared to psyllium. QoL improved (P = 0.0125) with both treatments without group differences. Conclusions
Mixed fibre and psyllium were equally efficacious in improving constipation and QoL. Mixed fibre was more effective in relieving flatulence, bloating and dissolved better. Mixed fibre is effective and well tolerated.
... 67,68 Our previous 2005 review of fibre supplementation in CC found fair evidence (Level II) with a Grade B recommendation in support of the use of fibre supplementation, particularly for psyllium fibre. [69][70][71] Also, poor evidence (Level III) was found to support a recommendation for or against the use of other fibre agents (Grade C), such as calcium polycarbophil, bran and methylcellulose. It was clear that more well-designed trials with well-defined outcome measures were needed. ...
Dietary fibre supplements have been advocated for the management of chronic constipation (CC) and irritable bowel syndrome (IBS). Recently, a fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) restricted diet has been recommended for IBS.
To systematically examine recent evidence for dietary interventions with fibre in CC and IBS and FODMAP-restricted diet in IBS, and provide recommendations.
We searched PUBMED, MEDLINE, OVID and COCHRANE databases from 2004 to 2014. Published studies in adults with CC and IBS and constipation-predominant IBS (IBS-C) that compared fibre with placebo/alternative and FODMAP-restricted diet with alternative were included.
Of 550 potentially eligible clinical trials on fibre, 11 studies were found and of 23 potentially eligible studies on FODMAPs, six were found. A meta-analysis was not performed due to heterogeneity and methodological quality. Fibre was beneficial in 5/7 studies in CC and 3/3 studies in IBS-C. FODMAP-restricted diet improved overall IBS symptoms in 4/4 and IBS-C symptoms in 1/3 studies and three studies did not meet inclusion criteria. There were significant disparities in subject selection, interventions and outcome assessments in both fibre and FODMAPs studies.
Fibre supplementation is beneficial in mild to moderate CC and IBS-C, although larger, more rigorous and long-term RCTs are needed (Fair evidence-Level II, Grade B). Although the FODMAP-restricted diet may be effective in short-term management of selected patients with IBS (Fair evidence-Level II, Grade C) and IBS-C (Poor evidence-Level III, Grade C), more rigorous trials are needed to establish long-term efficacy and safety, particularly on colonic health and microbiome.
© 2015 John Wiley & Sons Ltd.
... Four of the eligible trials used soluble fi ber (3 with psyllium, 1 with inulin and malto-dextrin) ( 89 -92 ). Th e largest trial was a single-blind RCT with 201 primary care patients who underwent treatment over a 2-week period ( 89 ). Eighty-seven percent of patients allocated to psyllium reported an improvement in symptoms, compared with 47 % of patients receiving placebo ( P < 0.001). ...
Despite years of advising patients to alter their dietary and supplementary fiber intake, the evidence surrounding the use of fiber for functional bowel disease is limited. This paper outlines the organization of fiber types and highlights the importance of assessing the fermentation characteristics of each fiber type when choosing a suitable strategy for patients. Fiber undergoes partial or total fermentation in the distal small bowel and colon leading to the production of short-chain fatty acids and gas, thereby affecting gastrointestinal function and sensation. When fiber is recommended for functional bowel disease, use of a soluble supplement such as ispaghula/psyllium is best supported by the available evidence. Even when used judiciously, fiber can exacerbate abdominal distension, flatulence, constipation, and diarrhea.Am J Gastroenterol advance online publication, 2 April 2013; doi:10.1038/ajg.2013.63.
... There were meta-analyses examining the efficacy of fiber in constipation previously, in which data of fiber and laxative were pooled for analysis [21,22] . Recently, a systematic review of the efficacy of fiber in the management of chronic idiophic constipation was published [23] , six RCTs were included, four RCTs compared the effect of soluble fiber with placebo [24][25][26][27] , and one study [27] used the combined intervention with celandine, aloevera and psyllium. Celandin and aloevera contain several alkaloids with known aperient effect, which may influence the outcome of the patients. ...
To investigate the effect of dietary fiber intake on constipation by a meta-analysis of randomized controlled trials (RCTs).
We searched Ovid MEDLINE (from 1946 to October 2011), Cochrane Library (2011), PubMed for articles on dietary fiber intake and constipation using the terms: constipation, fiber, cellulose, plant extracts, cereals, bran, psyllium, or plantago. References of important articles were searched manually for relevant studies. Articles were eligible for the meta-analysis if they were high-quality RCTs and reported data on stool frequency, stool consistency, treatment success, laxative use and gastrointestinal symptoms. The data were extracted independently by two researchers (Yang J and Wang HP) according to the described selection criteria. Review manager version 5 software was used for analysis and test. Weighted mean difference with 95%CI was used for quantitative data, odds ratio (OR) with 95%CI was used for dichotomous data. Both I(2) statistic with a cut-off of ≥ 50% and the χ(2) test with a P value < 0.10 were used to define a significant degree of heterogeneity.
We searched 1322 potential relevant articles, 19 of which were retrieved for further assessment, 14 studies were excluded for various reasons, five studies were included in the analysis. Dietary fiber showed significant advantage over placebo in stool frequency (OR = 1.19; 95%CI: 0.58-1.80, P < 0.05). There was no significant difference in stool consistency, treatment success, laxative use and painful defecation between the two groups. Stool frequency were reported by five RCTs, all results showed either a trend or a significant difference in favor of the treatment group, number of stools per week increased in treatment group than in placebo group (OR = 1.19; 95%CI: 0.58-1.80, P < 0.05), with no significant heterogeneity among studies (I(2)= 0, P = 0.77). Four studies evaluated stool consistency, one of them presented outcome in terms of percentage of hard stool, which was different from others, so we included the other three studies for analysis. Two studies reported treatment success. There was significant heterogeneity between the studies (P < 0.1, I(2) > 50%). Three studies reported laxative use, quantitative data was shown in one study, and the pooled analysis of the other two studies showed no significant difference between treatment and placebo groups in laxative use (OR = 1.07; 95%CI 0.51-2.25), and no heterogeneity was found (P = 0.84, I(2)= 0). Three studies evaluated painful defecation: one study presented both quantitative and dichotomous data, the other two studies reported quantitative and dichotomous data separately. We used dichotomous data for analysis.
Dietary fiber intake can obviously increase stool frequency in patients with constipation. It does not obviously improve stool consistency, treatment success, laxative use and painful defecation.
... Na behandeling (3 zakjes per dag) was deze in de psylliumgroep en controlegroep respectievelijk 14 en 9 per week (p < 0,001). De volgende eindpunten waren signifi cant verbeterd in de psylliumgroep: consistentie van ontlasting, buikpijn, ongemak en noodzaak tot persen[Fenn 1986]. Bij 22 patiënten met chronische obstipatie (defecatiefrequentie > 3 per week gedurende 6 maanden, bevestigd met dagboek, prikkelbaredarmsyndroom geen specifi ek exclusiecriterium, dieet niet beschreven) werd psyllium vergeleken met placebo gedurende 8 weken. ...
De NHG-Standaarden geven richtlijnen voor het handelen van de huisarts; de rol van de huisarts staat dan ook centraal. Daarbij
geldt echter altijd dat factoren van de kant van de patiënt het beleid mede bepalen. Om praktische redenen komt dit uitgangspunt
niet telkens opnieuw in de richtlijn aan de orde, maar wordt het hier expliciet vermeld. De huisarts stelt waar mogelijk het
beleid vast in samenspraak met de patiënt, met inachtneming van diens specifieke omstandigheden en met erkenning van diens
eigen verantwoordelijkheid, waarbij adequate voorlichting een voorwaarde is.
NHG-Standaard-obstipatie
... Unlike the reports of earlier clinical studies on Isabgol, Senna, or combination of the two, no adverse events were reported in this study. [20,21] All the study patients (i.e., 100%) reported excellent tolerability to the study drug. Also, there were no statistically significant changes in all the safety laboratory parameters at the end of the treatment. ...
Functional constipation is one of the most common gastrointestinal symptoms across the globe. Its high prevalence rate, economic burden, and adverse implications on the quality of life make constipation a major public health issue. Though various treatment options are available for the management of constipation, evidence for their efficacy and safety are limited. An open-label, prospective, interventional, and exploratory clinical trial was carried out to evaluate the efficacy and safety of "TLPL/AY/01/2008" in 34 patients suffering from functional constipation. "TLPL/AY/01/2008" is an Ayurvedic proprietary polyherbal formulation in powder form, containing Isabgol husk, Senna extract, and Triphala extract. Administration of "TLPL/AY/01/2008" for 14 days showed a significant increase in mean weekly bowel movements from 10.19 ± 05.64 to 18.29 ± 05.72 (P<0.05). The mean average time spent on toilet for bowel evacuation reduced significantly from 11.02 ± 05.43 minutes (baseline value) to 08.70 ± 04.72 minutes on day 14 (P<0.05). Mean stool form score assessed on Bristol stool form scale was improved from 02.97 ± 00.48 (baseline value) to 04.61 ± 00.84 (P<0.05) on day 14. A significant improvement (P<0.05) was also noted in straining during defecation, sensation of incomplete evacuation, sensation of anorectal blockage, and other associated symptoms of functional constipation. The significant improvement in most of the above symptoms was endured for a post-treatment observatory period of one week. All the study patients showed an excellent tolerability to the study drug. These findings suggest that "TLPL/AY/01/2008" is an effective, safe, and non-habit-forming herbal laxative formulation for the management of constipation. Comparative clinical studies with larger sample size would be able to confirm the above findings.
... 10,11 En dos de estos tres estudios el psyllium mejoró la frecuencia, la consistencia y la facilidad para defecar. 12,13 En otro estudio cruzado que comparó docusato de sodio contra psyllium, el psyllium aumentó de manera significativa la frecuencia de las evacuaciones comparado con docusato durante la segunda semana, aunque la muestra de pacientes fue pequeña. 14 El psyllium actúa de manera lenta y debe empezarse a dosis bajas, ajustándose al menos una vez por semana. ...
Background:
There are multiple therapeutic options for the management of constipation, from lifestyle modifications to the use of laxatives and in extreme cases surgery.
Objectives and methods:
To establish the clinical guidelines for diagnosis and treatment of chronic constipation in Mexico we conducted a review of the literature regarding medical and surgical treatments for chronic constipation and have made recommendations based on evidence.
Results:
Low water consumption, physical inactivity and low intake of fiber are conditions associated with chronic constipation, but the evidence to prove these associations is scarce. Bolus forming agents are useful in the management of constipation with normal colonic transit and defecation without dissynergia. Evidence supports the use of lactulose (IB) and polyethylene glycol (IA) as the most safe and effective agents in the long term in adults. The use of stimulant laxatives (docusate, picosulfate, senna) is recommended only for short periods. Tegaserod is an agonist of 5-HT4 receptors and there are many clinical trials supporting its effectiveness in the management of functional constipation (IA). However "their cardiovascular safety has been questioned recently. Biofeedback therapy is the gold standard in the management of constipation associated with pelvic floor dyssynergia. Surgical treatment is reserved for extreme cases of colonic inertia.
Conclusions:
The treatment of constipation should be based on the underlying pathophysiological mechanisms and the selection of drugs must be made according to the scientific evidence.
... 8,9 A large study that compared psyllium with placebo showed significant improvement in both stool frequency and stool consistency; and both the investigator and patients noted significant improvement in constipation. 10 However, patients often find fibre supplements inconvenient, particularly during travel, and many dislike liquid preparations. Finally, the taste of fibre supplements, the occurrence of gas or bloating, and rarely choking are often reasons for lack of compliance or discontinuation of therapy. ...
Treatment of chronic constipation remains challenging with 50% of patients dissatisfied with current therapy. There is an unmet need for natural and safe alternatives. Dried plums (prunes) have been used traditionally for constipation but their efficacy is not known. Aim To assess and compare the effects of dried plums and psyllium in patients with chronic constipation.
Subjects were enrolled in an 8-week, single-blind, randomised cross-over study. Subjects received either dried plums (50 g b.d., fibre=6 gm/day) or psyllium (11 g b.d., fibre=6 gm/day) for 3 weeks each, in a crossover trial with a 1-week washout period. Subjects maintained a daily symptom and stool diary. Assessments included number of complete spontaneous bowel movements per week, global relief of constipation, stool consistency, straining, tolerability and taste.
Forty constipated subjects (m/f=3/37, mean age=38 years) participated. The number of complete spontaneous bowel movements per week (primary outcome measure) and stool consistency scores improved significantly (P<0.05) with dried plums when compared to psyllium. Straining and global constipation symptoms did not differ significantly between treatments (P=N.S.). Dried plums and psyllium were rated as equally palatable and both were safe and well tolerated.
Dried plums are safe, palatable and more effective than psyllium for the treatment of mild to moderate constipation, and should be considered as a first line therapy.
... In two out of three placebo-controlled trials it improved stool frequency, consistency and ease of evacuation [Ashraf et al. 1996; Cheskin et al. 1995; Fenn et al. 1986]. In two other studies comparing psyllium with lactulose, the magnitude of effect in terms of fewer hard stools and greater stool frequency was similar with each agent [Dettmar and Sykes, 1998; Rouse et al. 1991]. ...
Constipated patients who are refractory to simple lifestyle interventions will usually resort to laxatives, whether prescribed or over the counter. Clinical trial evidence is scarce for older medications such as laxatives, especially with a condition as chronic and subjective as constipation. Newer polyethylene glycol-based laxatives have been investigated under rigorous clinical trial settings, but comparisons between different laxatives are not available. Newer prokinetic agents, targeting peristalsis, intestinal secretion and the colonic flora, have been developed for laxative refractory constipation. This review focuses on the evidence for each of these agents, and the relative indications for each of them.
Die chronische Obstipation ist eine häufige Erkrankung mit einer Prävalenz von 14 % in der Allgemeinbevölkerung. Unser Ziel war, eine aktuelle Stellungnahme von Schweizer Expert/innen zum klinischen Management der chronischen Obstipation vorzustellen. Nach einer gründlichen Literaturrecherche durch Expert/innen aus den relevanten Bereichen wurden ausgewählte wichtige Empfehlungen der aktuellen ESNM(European Society for Neurogastroenterology and Motility)-Guideline als Grundlage für die Stellungnahme der Schweizer Expert/innen zur Behandlung der Obstipation zusammengestellt und durch einen praxisbezogenen Algorithmus ergänzt. Jeder Empfehlung wurden entsprechende GRADE(Grading of Recommendations, Assessment, Development and Evaluation)-Evidenzniveaus zugewiesen.
Dietary interventions may alleviate symptoms related to functional gastrointestinal disorders, now termed disorders of gut-brain interaction. We reviewed which interventions have high-quality data to support their use in gastroesophageal reflux disease (GERD), functional dyspepsia (FD), irritable bowel syndrome, and chronic idiopathic constipation.
Chronic constipation is a common disorder with a reported prevalence of 14% in the general population. Several management strategies, including diagnostic tests as well as empiric and specific treatments, have been developed. Our aim was to present a current Swiss Expert Opinion State- ment for the clinical management of chronic constipation, focused on functional etiologies. After a thorough review of literature by experts in the relevant fields, important recommendations based on the current ESNM guideline were chosen to compile the Swiss Expert Opinion Statement with a practical algorithm for the treatment of constipation. Respective GRADE evidence levels were as- signed to each recommendation.
This systematic literature review and network meta-analysis (NMA) indirectly compared the Japanese standard dose of linaclotide 500 μg with other oral chronic constipation (CC) treatments. PubMed, Cochrane-CENTRAL, Ichushi-Web, and ClinicalTrials.gov were systematically searched for eligible randomized controlled trials of 43 oral drugs approved globally for CC, including irritable bowel syndrome with constipation (IBS-C) and opioid-induced constipation (OIC). The mean difference (95% credible interval) in change from baseline in weekly number of spontaneous bowel movements (SBM) was compared between linaclotide 500 μg (unapproved in OIC) and other treatments using Bayesian methodology. Fifty-two publications (54 trials) involving 47 treatments (16 drugs, different doses of the same drug treated as different treatments) were included in the NMA. Despite including various drugs/doses, for the mean difference in weekly SBM change, linaclotide 500 μg was statistically significantly more efficacious than other drugs/doses (vs 500 μg linaclotide) including the following: placebo (− 1.907; − 2.568, − 1.237); lubiprostone 16 μg (− 2.090; − 3.226, − 0.968); methylnaltrexone 150 mg (− 1.807; − 3.126, − 0.491), 300 mg (− 1.411; − 2.722, − 0.096), and 450 mg (− 1.405; − 2.708, − 0.097); naloxegol 5 mg (− 2.074; − 4.001, − 0.131) and 12.5 mg (− 1.329; − 2.347, − 0.318); and tegaserod 4 mg (− 1.133; − 2.059, − 0.207) and 12 mg (− 1.024; − 1.822, −0.228), and statistically significantly less effective than linaclotide 600 μg non-approved dose (1.159; 0.123, 2.199) and bisacodyl 10 mg (2.979; 1.723, 4.233). These findings provide relative efficacy data for linaclotide 500 μg vs other constipation drugs/doses regarding improving weekly SBM in CC and IBS-C and may inform clinical decision-making for constipation treatments.
Identified over 80 years ago, pantothenic acid is an essential vitamin, which serves as the metabolic precursor for coenzyme A (CoA). In the form of CoA and as a component of acyl carrier protein, pantothenic acid is a participant in myriad metabolic reactions involving lipids, proteins, and carbohydrates. Though essential, pantothenic acid deficiency in humans is rare due to its ubiquitous distribution in foods of both animal and plant origin. Supplementation with pantothenic acid or its derivatives may have some health benefits, but further investigation into various health claims is necessary before any specific recommendations may be given.
With a worldwide prevalence of 15%, chronic constipation is one of the most frequent gastrointestinal diagnoses made in ambulatory medicine clinics and is a common source cause for referrals to gastroenterologists and colorectal surgeons in the United States. Symptoms vary among patients; straining, incomplete evacuation, and a sense of anorectal blockage are just as important as decreased stool frequency. Chronic constipation is either a primary disorder (such as normal transit, slow transit, or defecatory disorders) or a secondary one (due to medications or in rare cases anatomic alterations). Colonic sensorimotor disturbances and pelvic floor dysfunction (such as defecatory disorders) are the most widely recognized pathogenic mechanisms. Guided by efficacy and cost, management of constipation should begin with dietary fiber supplementation and stimulant and/or osmotic laxatives, as appropriate, followed, if necessary, by intestinal secretagogues and/or prokinetic agents. Peripherally acting μ-opiate antagonists are another option for opioid-induced constipation. Anorectal tests to evaluate for defecatory disorders should be performed in patients who do not respond to over-the-counter agents. Colonic transit, followed if necessary with assessment of colonic motility with manometry and/or a barostat, can identify colonic dysmotility. Defecatory disorders often respond to biofeedback therapy. For specific patients, slow-transit constipation may necessitate a colectomy. No studies have compared inexpensive laxatives with newer drugs with different mechanisms. We review the mechanisms, evaluation, and management of chronic constipation. We discuss the importance of meticulous analyses of patients' histories and physical examination, advantages and disadvantages of diagnostic testing, guidance for individualized treatment, and management of medically refractory patients.
Constipation is a common condition, affecting up to half of all older adults during their lifetime. Untreated constipation has significant impacts, decreasing quality of life and potentially leading to urinary and/or faecal incontinence, faecal impaction and, in severe cases, hospitalisation. The increased constipation prevalence among older populations is multifactorial, with a number of age-related factors contributing to the rise in prevalence with aging. Laxatives are the mainstay of constipation management and are commonly used among older populations for both treatment and prevention of constipation. A range of laxative types including bulk forming agents, softeners and emollients, osmotic agents, stimulants, and the newer prokinetic and secretory agents are available. Despite laxatives being freely available without prescription in many countries and commonly used by older individuals, evidence regarding the effectiveness or safety of most laxatives in older populations is lacking. Additionally, age-related changes increase the risk of adverse effects associated with laxatives, such as electrolyte disturbances, among older persons. Caution must be taken when extrapolating recommendations for general adult populations to older populations. Laxative choice for older individuals should be tailored after careful assessment and consideration of comorbid conditions, concomitant medications and the potential for adverse effects.
The consumption of healthy dietary patterns with adequate dietary fiber (>25 g/day or 14g/1,000 kcals), recommended fluid intake, and regular physical activity, are especially beneficial in preventing and alleviating constipation. Fiber mechanisms associated with improved laxation and alleviated constipation include: increasing stool weight and bulk volume (through fiber and microbiota physical volume and water holding capacity), and gas volume trapped in the stool to increase bowel movement frequency and quality, especially in constipated individuals. Adequate intake of fiber from cereal, fruits, vegetables and common fiber-rich food ingredients including polydextrose, psyllium, chicory inulin and prebiotics or synbiotics have the potential to increase population-wide levels of regularity and provide constipation relief. In general, less fermentable dietary fiber tends to increase fecal weight to a greater amount than more fermentable fibers. Wheat bran is the most widely studied fiber; when baseline transit time was >48 h, each extra g/day of wheat bran significantly increased total stool weight by 3.7 g and reduced transit time by 45 min. Increased fiber intake did not change transit time in individuals with an initial time of <48 h. However, in people with an initial transit time ≥48 h, transit time was reduced by approximately 30 min per gram of cereal, fruit or vegetable fiber, regardless of fermentability. Several RCTs suggest that daily intake of prunes (dried plums) and/or kiwi fruit can help in relieving constipation symptoms similarly to psyllium.
The consumption of adequate dietary fiber (>25 g/day), recommended fluid intake, and regular physical activity are especially beneficial in preventing and alleviating constipation.
Introduction:
Chronic constipation is a frequent syndrome which, not only causes an appreciable deterioration in quality of life, but also entails a high economic cost due, among other things, to its treatment. This is because of the widespread use of laxatives, even by subjects who have not sought medical care, as well as little patient satisfaction with the treatment. Although this generally involves the use of drugs regarded as safe, there is no clear evidence about their short- and long-term effects, something that complicates appropriate prescription and follow-up by health professionals and hinders therapeutic compliance.
Objective:
To review the adverse effects which have been associated with laxatives based on scientific evidence, and ascertain the safety profile of the treatments used for constipation. Expert opinion: While all the drugs currently available for treatment of constipation are generally safe when used at established doses under medical supervision, more rigorous data on their long-term safety are nonetheless required, in view of the fact that constipation is a chronic condition. Their long-term use should be monitored by health professionals to optimize treatment on an individualized basis, with the aim of enhancing efficacy and minimizing adverse effects.
Chronic constipation is a common, persistent condition affecting many patients worldwide, presenting significant economic burden and resulting in substantial healthcare utilization. In addition to infrequent bowel movements, the definition of constipation includes excessive straining, a sense of incomplete evacuation, failed or lengthy attempts to defecate, use of digital manoeuvres for evacuation of stool, abdominal bloating, and hard consistency of stools. After excluding secondary causes of constipation, chronic idiopathic or primary constipation can be classified as functional defecation disorder, slow-transit constipation (STC), and constipation-predominant irritable bowel syndrome (IBS-C). These classifications are not mutually exclusive and significant overlap exists. Initial therapeutic approach to primary constipation, regardless of aetiology, consists of diet and lifestyle changes such as encouraging adequate fluid and fibre intake, regular exercise, and dietary modification. Laxatives are the mainstay of pharmacologic treatment for potential long-term therapy in patients who do not respond to lifestyle or dietary modification. After a failed empiric trial of laxatives, diagnostic testing is necessary to understand underlying anorectal and/or colonic pathophysiology. No single test provides a comprehensive assessment for primary constipation; therefore, multiple tests are used to provide complementary information to one another. Dyssynergic defecation, a functional defecation disorder, is an acquired behavioural disorder of defecation present in two-thirds of adult patients, where an inability to coordinate the abdominal, recto-anal, and pelvic floor muscles during attempted defecation exists. Biofeedback therapy is the mainstay treatment for dyssynergic defecation aimed at improving coordination of abdominal and anorectal muscles. A large percentage of patients with dyssynergic defecation also exhibit rectal hyposensitivity and may benefit from the addition of sensory retraining. Our understanding of the pathophysiology of STC is evolving. The advent of high-resolution colonic manometry allows for the improved identification of colonic motor patterns and may provide further insight into pathophysiological mechanisms. In a minority of cases of STC, identification of colonic neuropathy suggests a medically refractory condition, warranting consideration of colectomy. The pathophysiology of IBS-C is poorly understood with multiple etiological factors implicated. Pharmacological advances in the treatment of primary constipation have added therapeutic options to the armamentarium of this disorder. Drug development in the secretagogue, serotonergic prokinetic, and ileal bile acid transporter inhibition pathways has yielded current and future medical treatment options for primary chronic constipation.
Constipation protocols for different kind of patients and situations.
Chronic constipation is prevalent in the elderly. The most common causes include normal and slow transit constipation as well as dyssynergic defecation. Low fiber and low fluid intake have not been convincingly shown to be secondary causes, and increasing fiber and fluid intake and engaging in exercise have not been shown to effectively treat chronic constipation. Trials of several laxatives in the elderly have been conducted, with psyllium fiber being the most commonly studied bulking agent. Polyethylene glycol (PEG) and lactulose are recommended as first-line laxatives for the elderly. Magnesium salts, stool softeners, stimulants, prokinetics, and chloride channel activator laxatives have not been well studied in older adult populations.
Constipation is a common inpatient condition and a costly consequence of medical illness, treatment, or hospitalization. This article proposes diagnostic criteria for inpatient constipation, reviews existing literature, and recommends protocols for the prevention and treatment of inpatient constipation. More research is needed to develop inpatient-specific data on prevention and treatment strategies, and on how to handle this condition during transitions of care.
Dietary fiber is a collective term for the many carbohydrate polymers that escape hydrolysis by human digestive enzymes, enter the large bowel and contribute to fecal bulk, either directly or after fermentation by gut bacteria. The presence of dietary fiber within the partially digested intraluminal food matrix modifies gastrointestinal function at every stage of the digestive process, but the physiological effects of the different components of the fiber complex vary, depending upon their physical properties and their chemical interactions within the gut lumen. By modifying the rate and site of nutrient absorption, and by increasing fecal mass and delivering fermentation products to the circulation, the various components of the dietary fiber complex can modify human metabolism to a degree which is of major significance for health. Dietary fiber contributes to the maintenance of normal bowel function, and epidemiological evidence suggests that high intakes are associated with reduced incidences of various dyslipidemias, with type 2 diabetes and coronary heart disease, and with several abnormalities of the metabolic syndrome, which predisposes to these major pathologies. In spite of recommendations by public health bodies to consume higher levels of fiber, average intakes remain low in most industrialized countries. There is a continuing need for research to clarify the mechanisms of action of fiber of most relevance to human alimentary and metabolic health, and to facilitate increased levels of fiber intake at all ages, both by public health initiatives and through the development of novel sources and products.
Colonic fermentation produces hydrogen (H2 ), and also produces methane (CH4 ) in subjects with methanogenic flora (M+). Methane production has been associated with chronic constipation (CC) and with changes in gut motility. To determine CH4 production in CC compared to controls, and to assess whether the therapeutic response to Ispaghula husk in CC differs between CH4 -producers and non-producers.
Forty-eight patients with functional constipation or irritable bowel syndrome-constipation and 19 healthy age-and-sex-matched volunteers (HV) filled in a 1-week symptom diary and a dietary questionnaire. They then underwent a lactulose breath test (LBT) to measure H2 and CH4 production (peak and area under the time-concentration curve, AUC-) and a colonic transit time (CTT) assessment. In patients, measurements were repeated after a 4-week treatment with Ispaghula husk.
Prevalence of M+ in patients was 60.5% vs 52.6% in HV (p = 0.37). Patients had significantly longer CTT and greater production of both H2 and CH4 during LBT. There was a significant correlation between CH4 production and CTT (r = 0.51; p = 0.07). Treatment response rate was similar for M+ and M- patients (58.3% vs 52.9%; p = 0.76) as were the increases in bowel movements and Bristol score, changes in abdominal discomfort and bloating. In M+, treatment reduced CTT (-10 ± 35 h; p = 0.029 vs baseline) and CH4 levels: peak CH4 (-13 ± 24 ppm; p = 0.014) and CH4 -AUC (-817 ± 3100 ppm/min; p = 0.04).
Although CH4 production has been associated with CC pathophysiology, we found that CH4 status did not negatively affect the response to Ispaghula husk treatment. The measurement of CH4 levels as a biomarker tool for CC requires further appraisal.
© 2015 John Wiley & Sons Ltd.
Background
Constipation is a very common entity. Despite the high prevalence, treatment of constipation remains problematic.PurposeReview the current literature on new and existing constipation treatment modalities.
Chronic constipation is a common condition in the general population. Although the majority of affected individuals do not seek medical consultation and search for remedies for their condition in the pharmacy or herbal shops, the actual health burden caused by this condition is extremely high. Many laxatives are available, but patients are often dissatisfied with the therapies adopted, whether prescribed by a doctor or self prescribed, and this leads to further social and health burdens. All of the available guidelines promote initiating the therapy of any type of constipation by ensuring an adequate intake of dietary fiber and water. However, high amounts of insoluble vegetable fiber such as those normally contained in fruits and vegetables, can lead to a further worsening of the digestive symptoms typical of chronic constipation, such as bloating and distension and pain. Better results can be obtained with soluble fibers, such as psyllium. Among the various available laxatives, polyethylene glycol (PEG), or macrogol, is the product which has been most studied and has produced the best results with the least number of side effects. This is an inert not absorbable molecule that, diluted in water, forms an isotonic solution that prevents part of the water from being absorbed, thus increasing the volume of the intestinal contents, reducing the consistency and facilitating transport and evacuation. The combination of psyllium and PEG could combine the advantages of fiber and isotonic solutions and represent an important therapeutic option for patients suffering from chronic constipation.
OBJECTIVE:
To evaluate whether laxatives and fiber therapies improve symptoms and bowel movement frequency in adults with chronic constipation.
DATA SOURCES:
English language studies were identified from computerized MEDLINE (1966-1995), Biological Abstracts (1990-1995), and Micromedex searches; bibliographies; textbooks; laxative manufacturers; and experts.
STUDY SELECTION:
Randomized trials of laxative or fiber therapies lasting more than 1 week that evaluated clinical outcomes in adults with chronic constipation
MEASUREMENTS AND MAIN RESULTS:
Two independent reviewers appraised each trial's characteristics including methodologic quality. There were 36 trials involving 1,815 persons from a variety of settings including clinics, hospitals and nursing homes. Twenty-three trials were 1 month or less in duration. Several laxative and fiber preparations were evaluated. Twenty trials had a placebo, usual care, or discontinuation of laxative control group, and 16 directly compared different agents. Laxatives and fiber increased bowel movement frequency by an overall weighted average of 1.4 (95% confidence interval [CI] 1.1-1.8) bowel movements per week. Fiber and bulk laxatives decreased abdominal pain and improved stool consistency compared with placebo. Most nonbulk laxative data concerning abdominal pain and stool consistency were inconclusive, though cisapride, lactulose, and lactitol improved consistency. Data concerning superiority of various treatments were inconclusive. No severe side effects for any of the therapies were reported.
CONCLUSIONS:
Both fiber and laxatives modestly improved bowel movement frequency in adults with chronic constipation. There was inadequate evidence to establish whether fiber was superior to laxatives or one laxative class was superior to another.
: This study aimed to compare the effects of a special bowel recipe with psyllium on symptoms of constipation.
: Women with symptoms of constipation were randomized to 6 weeks of either psyllium or a special bowel recipe. Patients completed a constipation scoring questionnaire and recorded characteristics of each bowel movement.
: A total of 53 participants completed prestudy and poststudy constipation scoring questionnaires. Both groups demonstrated improvement in constipation scores (psyllium: 13.9 ± 4.7 to 9.0 ± 4.6, P < 0.001; recipe: 13.6 ± 4.1 to 8.5 ± 5.0, P < 0.001). Mean differences in pretreatment and posttreatment constipation scores were not statistically different between the 2 groups.Subjects taking the bowel recipe strained only 20% of the time compared with those using psyllium who strained 57% of the time (P = 0.007). Other symptoms improved from baseline, but the majority was not different between treatment groups.
: The bowel recipe demonstrated no significant difference in efficacy to pure fiber.
Multiple studies have addressed the treatment of chronic constipation in adults in general; however, less guidance is available for treating this condition in older patients.
The aim of this paper was to review the effectiveness of laxatives for chronic constipation in the elderly.
Medline, Web of Science, international Pharmaceutical Abstracts, and the Cochrane database of Systematic Reviews were searched for english-language articles evaluating the treatment of chronic constipation in older individuals from the inception of the databases until October 2010. Search terms included constipation, treatment, laxative, elderly, and geriatric. Articles were excluded if the mean age was <65 years.
Thirty-one trials were identified. These studies varied widely in terms of methodology, quality, sample size, efficacy end points, and duration. Mean stool frequency was 9.08 bowel movements per week with psyllium and 8.29 per week with calcium polycarbophil (P = 0.04). docusate sodium daily, docusate sodium q12h, and docusate calcium daily for 3 weeks produced a mean stool frequency of 1.95 bowel movements per week versus 1.50 for placebo (P = NS), 2.29 versus 1.76 (P = NS), and 2.83 versus 1.75 (P<0.02), respectively. Mean stool frequency with lactulose versus placebo was 0.7 and 0.5 bowel movements per day (P<0.02). in patients receiving polyethylene glycol or lactulose, mean stool frequency was 1.3 and 0.9 bowel movements per day (P = 0.005). in a study comparing senna plus a bulking agent with lactulose, mean stool frequency was 4.5 per week for the combination product versus 2.2 per week for lactulose (P<0.001). A study comparing sodium picosulfate with senna reported a mean stool frequency of 0.71 and 0.63 per day (P value not reported). Lubiprostone was associated with 5.69 spontaneous bowel movements per week versus 3.46 per week for placebo (P = 0.001).
Higher-quality trials evaluating the treatment of constipation in older patients are needed to create a basis for more definitive recommendations in this population. The approach to older adults with constipation should be individualized.
While constipation is a common symptom in Korea, there are no existing treatment guidelines. Although constipation may occur as a result of organic cause, there is no obstructive mucosal or structural cause in the vast majority of patients with constipation. The present paper deals with only the management of functional constipation: lifestyle changes; bulking agents and stool softeners; osmotic agents; stimulant laxatives; prokinetics; biofeedback and surgical treatments. Exercise and dietary fiber are helpful in some patients with constipation. Laxatives including bulking agents, stool softeners, osmotic agents, and stimulant laxatives have been found to be more effective than placebo at relieving symptoms of constipation. New enterokinetic agents that affect peristalsis through selective interaction with 5-hydroxytryptamine-4 receptors can be effective in patients with constipation who cannot get adequate relief from current laxatives. Biofeedback can relieve symptoms in selected patients with pelvic floor dyssynergia. Surgical treatments can be helpful in some patients with refractory constipation.
Patients with chronic idiopathic constipation are often told to increase dietary fibre intake. Whether this is of any benefit remains unclear.
To conduct a systematic review of the efficacy of soluble and insoluble fibre supplementation in the management of chronic idiopathic constipation.
MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched to identify randomised controlled trials (RCTs) comparing fibre with placebo or no therapy in adult chronic idiopathic constipation patients. Studies had to report dichotomous data assessing response to therapy, or continuous data examining either effect of therapy on mean number of stools per week, or mean symptom scores. Adverse events data were extracted where reported.
Six RCTs were eligible. Four used soluble fibre and two used insoluble fibre. Formal meta-analysis was not undertaken due to concern about methodological quality of identified studies. Compared with placebo, soluble fibre led to improvements in global symptoms (86.5% vs. 47.4%), straining (55.6% vs. 28.6%), pain on defaecation, and stool consistency, an increase in the mean number of stools per week (3.8 stools per week after therapy compared with 2.9 stools per week at baseline), and a reduction in the number of days between stools. Evidence for any benefit of insoluble fibre was conflicting. Adverse events data were limited, with no RCT reporting total numbers.
Soluble fibre may be of benefit in chronic idiopathic constipation, but data for insoluble fibre are conflicting. More data from high quality RCTs are required before the true efficacy of either fibre type in the treatment of chronic idiopathic constipation is known.
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