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The Lancet. Gastroenterology &... Feb 2020Although novel therapies for irritable bowel syndrome (IBS) continue to be developed, many doctors rely on more established, traditional therapies as first-line or...
BACKGROUND
Although novel therapies for irritable bowel syndrome (IBS) continue to be developed, many doctors rely on more established, traditional therapies as first-line or second-line treatment options. These therapies include soluble fibre (eg, ispaghula husk), antispasmodic drugs, peppermint oil, and gut-brain neuromodulators (including tricyclic antidepressants, selective serotonin reuptake inhibitors, or α-2-δ calcium channel subunit ligands). However, the relative efficacy of traditional treatments in patients with IBS is unclear because there have been few head-to-head randomised controlled trials (RCTs). We aimed to compare and rank the efficacy of traditional therapies in patients with IBS to help inform clinical decisions.
METHODS
For this systematic review and network meta-analysis, we searched MEDLINE, Embase, Embase Classic, and the Cochrane Central Register of Controlled Trials from inception to week 2 of August 2019; ClinicalTrials.gov for unpublished trials or supplementary data published up to Aug 18, 2019; and gastroenterology conference proceedings for study abstracts published between 2001 and Aug 18, 2019. We included RCTs that compared any of these treatments with each other (head-to-head trials) or with placebo, in which the efficacy of soluble fibre, antispasmodic drugs, peppermint oil, or gut-brain neuromodulators was assessed in adults (aged at least 18 years) with IBS of any subtype after 4-12 weeks of treatment. Only RCTs reporting a dichotomous assessment of overall response to therapy, in terms of either improvement in global IBS symptoms or improvement in abdominal pain, were included. The efficacy and safety of all treatments were reported as a pooled relative risk (RR) with 95% CIs to summarise the effect of each comparison tested, and treatments were ranked according to their P-score.
FINDINGS
Our search identified 5863 references, of which 81 were screened for eligibility. 51 RCTs with data from 4644 patients were eligible for inclusion in our analysis, but only 13 of these trials were at low risk of bias. Based on an endpoint of failure to achieve improvement in global IBS symptoms at 4-12 weeks, peppermint oil capsules were ranked first for efficacy (RR 0·63, 95% CI 0·48-0·83, P-score 0·84) and tricyclic antidepressants were ranked second (0·66, 0·53-0·83, P-score 0·77). For failure to achieve an improvement in global IBS symptoms at 4-12 weeks, there were no significant differences between active treatments after direct or indirect comparisons. For failure to achieve improvement in abdominal pain at 4-12 weeks, tricyclic antidepressants were ranked first for efficacy (0·53, 0·34-0·83, P-score 0·87); however, this result was based on data from only four RCTs involving 92 patients. For failure to achieve an improvement in abdominal pain, none of the active treatments showed superior efficacy upon indirect comparison. Tricyclic antidepressants were more likely than placebo to lead to adverse events (1·59, 1·26-2·06, P-score 0·16).
INTERPRETATION
In this network meta-analysis of RCTs of soluble fibre, antispasmodic drugs, peppermint oil, and gut-brain neuromodulators for IBS, few of which were judged as being at a low risk of bias, peppermint oil was ranked first for efficacy when global symptoms were used as the outcome measure, and tricyclic antidepressants were ranked first for efficacy when abdominal pain was used as the outcome measure. However, because of the lack of methodological rigour of some RCTs analysed in our study, there is likely to be considerable uncertainty around these findings. In addition, because treatment duration in most included trials was 4-12 weeks, the long-term relative efficacy of these treatments is unknown.
FUNDING
None.
Topics: Brain; Dietary Fiber; Humans; Intestinal Mucosa; Irritable Bowel Syndrome; Network Meta-Analysis; Neurotransmitter Agents; Parasympatholytics; Treatment Outcome
PubMed: 31859183
DOI: 10.1016/S2468-1253(19)30324-3 -
Alimentary Pharmacology & Therapeutics Aug 2018Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available;...
BACKGROUND
Fibrotic stricture is a common complication of Crohn's disease (CD) affecting approximately half of all patients. No specific anti-fibrotic therapies are available; however, several therapies are currently under evaluation. Drug development for the indication of stricturing CD is hampered by a lack of standardised definitions, diagnostic modalities, clinical trial eligibility criteria, endpoints and treatment targets in stricturing CD.
AIM
To standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Chron's disease.
METHODS
An interdisciplinary expert panel consisting of 15 gastroenterologists and radiologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 109 candidate items derived from systematic review and expert opinion focusing on small intestinal strictures were anonymously rated as inappropriate, uncertain or appropriate. Survey results were discussed as a group before a second and third round of voting.
RESULTS
Fibrotic strictures are defined by the combination of luminal narrowing, wall thickening and pre-stenotic dilation. Definitions of anastomotic (at site of prior intestinal resection with anastomosis) and naïve small bowel strictures were similar; however, there was uncertainty regarding wall thickness in anastomotic strictures. Magnetic resonance imaging is considered the optimal technique to define fibrotic strictures and assess response to therapy. Symptomatic strictures are defined by abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain and post-prandial abdominal pain. Need for intervention (endoscopic balloon dilation or surgery) within 24-48 weeks is considered the appropriate endpoint in pharmacological trials.
CONCLUSIONS
Consensus criteria for diagnosis and response to therapy in stricturing Crohn's disease should inform both clinical practice and trial design.
Topics: Catheterization; Clinical Trials as Topic; Colon; Consensus; Constriction, Pathologic; Crohn Disease; Dilatation; Endoscopy; Expert Testimony; Fibrosis; Humans; Intestinal Obstruction; Intestine, Small; Practice Guidelines as Topic; Reference Standards
PubMed: 29920726
DOI: 10.1111/apt.14853 -
BMC Complementary and Alternative... Jan 2019Peppermint oil (PO) has intrinsic properties that may benefit patients with irritable bowel syndrome (IBS) symptoms. The study objective was to determine the effect of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Peppermint oil (PO) has intrinsic properties that may benefit patients with irritable bowel syndrome (IBS) symptoms. The study objective was to determine the effect of peppermint oil in the treatment of the IBS.
METHODS
We systematically searched MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (Cochrane CENTRAL), ClinicalTrials.gov, EMBASE (Ovid), and Web of Science for randomized controlled trials (RCTs) of PO for IBS. We appraised the eligible studies by the Cochrane risk of bias tool. We performed random-effects meta-analysis on primary outcomes including global improvement in IBS symptoms and abdominal pain. A PRISMA-compliant study protocol is registered in PROSPERO Register [2016, CRD42016050917].
RESULTS
Twelve randomized trials with 835 patients were included. For global symptom improvement, the risk ratio (RR) from seven RCTs for the effect of PO (n = 253) versus placebo (n = 254) on global symptoms was 2.39 [95% confidence interval (CI): 1.93, 2.97], I = 0%, z = 7.93 (p < 0.00001). Regarding abdominal pain, the RR from six RCTs for the effect of PO (n = 278) versus placebo (n = 278) was 1.78 [95% CI: 1.43, 2.20], I = 0%, z = 5.23 (p < 0.00001). Overall, there were no differences in the reported adverse effects: PO (32 events, 344 total, 9.3%) versus placebo (20 events, 327 total, 6.1%) for eight RCTs; RR 1.40 [95% CI: 0.87, 2.26] I = 0%, z = 1.39 (p = 0.16). The number needed to treat with PO to prevent one patient from having persistent symptoms was three for global symptoms and four for abdominal pain.
CONCLUSIONS
In the most comprehensive meta-analysis to date, PO was shown to be a safe and effective therapy for pain and global symptoms in adults with IBS.
Topics: Humans; Irritable Bowel Syndrome; Mentha piperita; Plant Oils; Treatment Outcome
PubMed: 30654773
DOI: 10.1186/s12906-018-2409-0 -
BMC Pregnancy and Childbirth Nov 2018Pregnancy is a period of transition with important physical and emotional changes. Even in uncomplicated pregnancies, these changes can affect the quality of life (QOL)...
BACKGROUND
Pregnancy is a period of transition with important physical and emotional changes. Even in uncomplicated pregnancies, these changes can affect the quality of life (QOL) of pregnant women, affecting both maternal and infant health. The objectives of this study were to describe the quality of life during uncomplicated pregnancy and to assess its associated socio-demographic, physical and psychological factors in developed countries.
METHODS
A systematic review was performed according to the PRISMA guidelines. Searches were made in PubMed, EMBASE and BDSP (Public Health Database). Two independent reviewers extracted the data. Countries with a human development index over 0.7 were selected. The quality of the articles was evaluated on the basis of the STROBE criteria.
RESULTS
In total, thirty-seven articles were included. While the physical component of QOL decreased throughout pregnancy, the mental component was stable and even showed an improvement during pregnancy. Main factors associated with better QOL were mean maternal age, primiparity, early gestational age, the absence of social and economic problems, having family and friends, doing physical exercise, feeling happiness at being pregnant and being optimistic. Main factors associated with poorer QOL were medically assisted reproduction, complications before or during pregnancy, obesity, nausea and vomiting, epigastralgia, back pain, smoking during the months prior to conception, a history of alcohol dependence, sleep difficulties, stress, anxiety, depression during pregnancy and sexual or domestic violence.
CONCLUSIONS
Health-related quality of life refers to the subjective assessment of patients regarding the physical, mental and social dimensions of well-being. Improving the quality of life of pregnant women requires better identification of their difficulties and guidance which offers assistance whenever possible.
Topics: Abdominal Pain; Alcoholism; Anxiety; Back Pain; Depression; Exercise; Female; Gestational Age; Happiness; Humans; Maternal Age; Nausea; Obesity; Optimism; Parity; Pregnancy; Pregnancy Complications; Pregnant Women; Quality of Life; Reproductive Techniques, Assisted; Sleep Wake Disorders; Smoking; Social Support; Stress, Psychological; Vomiting
PubMed: 30470200
DOI: 10.1186/s12884-018-2087-4 -
The Cochrane Database of Systematic... Feb 2021Functional Abdominal Pain Disorders (FAPDs) present a considerable burden to paediatric patients, impacting quality of life, school attendance and causing higher rates... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Functional Abdominal Pain Disorders (FAPDs) present a considerable burden to paediatric patients, impacting quality of life, school attendance and causing higher rates of anxiety and depression disorders. There are no international guidelines for the management of this condition. A previous Cochrane Review in 2011 found no evidence to support the use of antidepressants in this context.
OBJECTIVES
To evaluate the current evidence for the efficacy and safety of antidepressants for FAPDs in children and adolescents.
SEARCH METHODS
In this updated review, we searched the Cochrane Library, PubMed, MEDLINE, Embase, PsycINFO and two clinical trial registers from inception until 03 February 2020. We also updated our search of databases of ongoing research, reference lists and 'grey literature' from inception to 03 February 2020.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing antidepressants to placebo, to no treatment or to any other intervention, in children aged 4 to 18 years with a FAPD diagnosis as per the Rome or any other defined criteria (as defined by the authors). The primary outcomes of interest included treatment success (as defined by the authors), pain severity, pain frequency and withdrawal due to adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors checked all citations independently, resolving disagreement with a third-party arbiter. We reviewed all potential studies in full text, and once again made independent decisions, with disagreements resolved by consensus. We conducted data extraction and 'Risk of bias' assessments independently, following Cochrane methods. Where homogeneous data were available, we performed meta-analysis using a random-effects model. We conducted GRADE analysis.
MAIN RESULTS
We found one new study in this updated search, making a total of three trials (223 participants) eligible for inclusion: two using amitriptyline (AMI) and one using citalopram. For the primary outcome of treatment success, two studies used reports of success on a symptom-based Likert scale, with either a two-point reduction or the two lowest levels defined as success. The third study defined success as a 15% improvement in quality of life (QOL) ratings scales. Therefore, meta-analysis did not include this final study due to the heterogeneity of the outcome measure. There is low-certainty evidence that there may be no difference when antidepressants are compared with placebo (risk ratio (RR) 1.17, 95% confidence interval (CI) 0.87 to 1.56; 2 studies, 205 participants; I = 0%). We downgraded the evidence for significant imprecision due to extremely sparse data (see Summary of findings table 1). The third study reported that participants receiving antidepressants were significantly more likely than those receiving placebo to experience at least a 15% improvement in overall QOL score at 10 and 13 weeks (P = 0.007 and P = 0.002, respectively (absolute figures were not given)). The analysis found no difference in withdrawals due to adverse events between antidepressants and placebo: RR 3.17 (95% CI 0.65 to 15.33), with very low certainty due to high risk of bias in studies and imprecision due to low event and participant numbers. Sensitivity analysis using a fixed-effect model and analysing just for AMI found no change in this result. Due to heterogeneous and limited reporting, no further meta-analysis was possible.
AUTHORS' CONCLUSIONS
There may be no difference between antidepressants and placebo for treatment success of FAPDs in childhood. There may be no difference in withdrawals due to adverse events, but this is also of low certainty. There is currently no evidence to support clinical decision making regarding the use of these medications. Further studies must consider sample size, homogenous and relevant outcome measures and longer follow up.
Topics: Abdominal Pain; Adolescent; Amitriptyline; Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Child; Citalopram; Gastrointestinal Diseases; Humans; Irritable Bowel Syndrome; Placebos; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 33560523
DOI: 10.1002/14651858.CD008013.pub3 -
The American Surgeon May 2023In the United States, the third leading cause of a large bowel obstruction (LBO) is colonic volvulus with torsion occurring most commonly in the sigmoid and the cecum.... (Review)
Review
BACKGROUND
In the United States, the third leading cause of a large bowel obstruction (LBO) is colonic volvulus with torsion occurring most commonly in the sigmoid and the cecum. Transverse colonic volvulus (TCV) is exceedingly rare and specific involvement of the splenic flexure (SFV) is even less common. The present analysis was undertaken to interrogate current trends in presentation, management, and outcomes of TCV.
METHODS
In the present report, the world literature was reviewed for the past 90 years (1932 to 2021). We conducted a systematic review to identify all cases of TCV following the PRISMA guidelines.
RESULTS
We identified 317 cases of TCV. This included SFV (n = 75), TCV in pediatric patients (n = 63), TCV in pregnant patients (n = 8), and TCV associated with other pathology such as Chilaiditi's syndrome (n = 11). Compared to sigmoid and cecal volvulus, TCV was rare (.94%). It affected slightly more women (54%) than men, commonly in their third decade of life (37.7 ± 23.8). The clinical presentation and diagnostic imaging were consistent with LBO. Compared to sigmoid volvulus, there was a limited role for conservative management and colonoscopic decompression was less effective. The most common operation was segmental resection (25%). Mortality was (20%) commonly because of cardiopulmonary complications and affected more women (63%). The average age of this cohort was 55.7±24.6 years old.
DISCUSSION
Our review showed that TCV is an uncommon surgical entity. The diagnosis is likely to be made at laparotomy. Prompt recognition is paramount in preventing ischemia necrosis and perforation. Compared to sigmoid and cecal volvulus, the mortality for TCV remains high.
Topics: Male; Humans; Female; Child; Adult; Middle Aged; Aged; Aged, 80 and over; Intestinal Volvulus; Colon, Transverse; Colonic Diseases; Intestinal Obstruction; Colonoscopy
PubMed: 34461758
DOI: 10.1177/00031348211041564 -
Pancreatology : Official Journal of the... Oct 2021Pain is the most common symptom in chronic pancreatitis (CP) with a major impact on quality of life. Few validated questionnaires to assess pain in CP exist, and the...
Pain is the most common symptom in chronic pancreatitis (CP) with a major impact on quality of life. Few validated questionnaires to assess pain in CP exist, and the lack of consensus negatively impacts clinical management, research and meta-analysis. This guideline aims to review generic pain questionnaires for their usability in CP, to outline how pain assessment can be modified by confounding factors and pain types, to assess the value of additional measures such as quality of life, mental health and quantitative sensory testing, and finally to review pain assessment questionnaires used specifically in CP. A systematic review was done to answer 27 questions that followed the PICO (Population; Intervention; Comparator; Outcome) template. Quality of evidence of the statements was judged by Grades of Recommendation, Assessment, Development and Evaluation (GRADE) criteria. The manuscript was sent for review to 36 experts from various disciplines and continents in a multi-stage Delphi process, and finally reviewed by patient representatives. Main findings were that generic pain instruments are valid in most settings, but aspects of pain are specific for CP (including in children), and instruments have to account for the wide phenotypic variability and development of sensitization of the central nervous system. Side effects to treatment and placebo effects shall also be considered. Some multidimensional questionnaires are validated for CP and are recommended together with assessment of quality of life and psychiatric co-morbidities. This guideline will result in more homogeneous and comprehensive pain assessment to potentially improve management of painful CP.
Topics: Abdominal Pain; Chronic Pain; Consensus; Humans; Pain Measurement; Pancreatitis, Chronic; Quality of Life; Surveys and Questionnaires
PubMed: 34391675
DOI: 10.1016/j.pan.2021.07.004 -
Family Practice Oct 2014Diagnostic reasoning in primary care patients with abdominal pain is a complex challenge for GPs. To ensure evidence-based decision making for this symptom, GPs need... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Diagnostic reasoning in primary care patients with abdominal pain is a complex challenge for GPs. To ensure evidence-based decision making for this symptom, GPs need setting-specific knowledge about the prevalence, potential risks for diseases and chance of recovery or risk of undesirable courses of disease.
AIM
We conducted a systematic review of symptom-evaluating studies on prevalence, aetiology or prognosis of abdominal pain.
METHODS
We included all studies evaluating the symptom 'abdominal pain' as a reason for consultation in primary care. We included all types of study designs except for qualitative studies. Studies focussed solely on children or settings other than primary care were also excluded.
RESULTS
We identified 14 studies. Mean consultation prevalence is 2.8% for abdominal pain. In about one-third of patients the underlying cause of abdominal pain cannot be specified. The most common aetiologies are gastroenteritis (7.2-18.7%), irritable bowel disease (2.6-13.2%), urological cause (5.3%) and gastritis (5.2%). About 1 in 10 abdominal pain patients suffers from an acute disease like appendicitis (1.9%), diverticulitis (3.0%), biliary/pancreatic (4.0%) or neoplastic (1.0%) diseases needing immediate therapy.
CONCLUSION
There is a high prevalence of patients consulting GPs for abdominal pain. The review identified a comparably high rate of acute underlying diseases in need of further investigation or therapy. At the same time, the underlying cause of the complaints often remains unexplained. Further symptom-evaluating studies are necessary, ideally using standardized methodology in order to gain sufficient evidence for developing much-needed guidelines and decision support tools.
Topics: Abdominal Pain; Biliary Tract Diseases; Gastroenteritis; General Practice; Humans; Irritable Bowel Syndrome; Neoplasms; Pancreatic Diseases; Prevalence; Prognosis; Referral and Consultation; Urologic Diseases
PubMed: 24987023
DOI: 10.1093/fampra/cmu036 -
Pain Management Sep 2018Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids. (Review)
Review
BACKGROUND
Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids.
OBJECTIVES
To evaluate all single-drug mortality due to tapentadol and assess serious adverse events caused by tapentadol.
METHODS
The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) reporting guidelines, an evidence-based minimum set of items for reporting in systematic reviews, were followed in this systematic review.
RESULTS
24 peer-reviewed papers were identified. They indicate that tapentadol toxicity can cause mortality and serious adverse effects.
CONCLUSION(S)
At least four confirmed fatalities, and serious adverse effects have been documented for individuals abusing or using tapentadol as prescribed. Serious adverse effects of tapentadol use may include respiratory depression, confusion, coma, hallucination/delusion, seizures, tachycardia, hypertension, agitation, tremor, miosis, hypotension, dyspnea, electrolyte abnormality, atrial fibrillation or severe upper abdominal pain. Tapentadol is unlikely to cause serotonin syndrome. The toxicity of tapentadol is significantly less than pure mu opioids, such as oxycodone.
Topics: Analgesics, Opioid; Drug-Related Side Effects and Adverse Reactions; Humans; Phenols; Tapentadol
PubMed: 30079795
DOI: 10.2217/pmt-2018-0027 -
Integrative Medicine Research Dec 2023Current endometriosis treatments do not always provide symptom relief, with many using complementary approaches. This study examined the effectiveness of acupuncture on... (Review)
Review
BACKGROUND
Current endometriosis treatments do not always provide symptom relief, with many using complementary approaches. This study examined the effectiveness of acupuncture on pain and quality of life in people with endometriosis.
METHODS
Searches were conducted on Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Allied and Complementary Medicine Database (AMED) and Embase (Ovid), Epistemonikos, and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOhost) on 20 March 2023. Trials were included if they used penetrating acupuncture. Risk of bias was assessed with Cochrane RoB2 and GRADE for overall evidence certainty. Random-effects meta-analyses were undertaken, using Hedges' g or mean difference (MD) both with 95 % confidence intervals (CI).
RESULTS
Six studies involving a total of 331 participants were included. Evidence for benefit was found for acupuncture compared to non-specific acupuncture on overall pelvic pain ( = 1.54, 95 % CI 0.92 to 2.16, 3 RCTs, = 231, low certainty evidence, <0.001), menstrual pain ( = 1.67, 95 % CI 1.23 to 2.12, 1 RCT, = 106, moderate certainty evidence, <0.001), and non-specified pelvic pain (MD -2.77, 95 % CI 2.15 to 3.38, 2 RCTs, = 125, low certainty evidence, <0.001), and compared to usual care on menstrual pain ( = 0.9, 95 % CI 0.15 to 1.64, 1 RCT, = 19, very low certainty evidence, = 0.02). Most studies reported low rates of adverse events.
CONCLUSION
Acupuncture treatment for endometriosis demonstrated clinically relevant improvements in pelvic pain and should be considered as a potential treatment intervention.
STUDY REGISTRATION
PROSPERO ID: CRD42023408700.
PubMed: 38033648
DOI: 10.1016/j.imr.2023.101003