Minor digestive symptoms and their impact in the general population: a cluster analysis approach.

BACKGROUND: The classification and treatment of patients who do not meet the criteria for a functional gastrointestinal (GI) disorder has not been well established. This study aimed to record the prevalence of minor digestive symptoms (MDSs) in the general population attempting to divide them into symptom clusters as well as trying to assess their impact and the way sufferers cope with them. METHODS: Following face-to-face interviews, a web-based, self-administered questionnaire was designed to capture a range of GI sensations using 34 questions and 12 images depicting abdominal symptoms. A randomly selected sample of 1515 women and 409 men representing the general population in France was studied. Cluster analysis was used to identify groups of respondents with naturally co-occurring symptoms. Data were also collected on other factors such as exacerbating and relieving strategies. RESULTS: MDSs were reported at least every 2 months in 66.5% of women and 47.7% of men. A total of 11 symptom clusters were identified: constipation-like, flatulence, abdominal pressure, abdominal swelling, acid reflux, diarrhoea-like, intestinal heaviness, intestinal pain, gurgling, burning and gastric pain. Despite being minor, these problems had a major impact on vitality and self-image as well as emotional, social and physical well-being. Respondents considered lifestyle, food and disordered function as the main factors responsible for MDSs. Physical measures and dietary modification were the most frequent strategies adopted to obtain relief. CONCLUSIONS: MDSs are common and improved methods of recognition are needed so that better management strategies can be developed for individuals with these symptoms. The definition of symptom clusters may offer one way of achieving this goal.

Systematic review: probiotics in the management of lower gastrointestinal symptoms - an updated evidence-based international consensus.

BACKGROUND: In 2013, a systematic review and Delphi consensus reported that specific probiotics can benefit adult patients with irritable bowel syndrome (IBS) and other gastrointestinal (GI) problems. AIM: To update the consensus with new evidence. METHODS: A systematic review identified randomised, placebo-controlled trials published between January 2012 and June 2017. Evidence was graded, previously developed statements were reassessed by an 8-expert panel, and agreement was reached via Delphi consensus. RESULTS: A total of 70 studies were included (IBS, 34; diarrhoea associated with antibiotics, 13; diarrhoea associated with Helicobacter pylori eradication therapy, 7; other conditions, 16). Of 15 studies that examined global IBS symptoms as a primary endpoint, 8 reported significant benefits of probiotics vs placebo. Consensus statements with 100% agreement and "high" evidence level indicated that specific probiotics help reduce overall symptom burden and abdominal pain in some patients with IBS and duration/intensity of diarrhoea in patients prescribed antibiotics or H. pylori eradication therapy, and have favourable safety. Statements with 70%-100% agreement and "moderate" evidence indicated that, in some patients with IBS, specific probiotics help reduce bloating/distension and improve bowel movement frequency/consistency. CONCLUSIONS: This updated review indicates that specific probiotics are beneficial in certain lower GI problems, although many of the new publications did not report benefits of probiotics, possibly due to inclusion of new, less efficacious preparations. Specific probiotics can relieve lower GI symptoms in IBS, prevent diarrhoea associated with antibiotics and H. pylori eradication therapy, and show favourable safety. This study will help clinicians recommend/prescribe probiotics for specific symptoms.

Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness.

OBJECTIVE: (Primary) To establish the effect of antenatal group self-hypnosis for nulliparous women on intra-partum epidural use. DESIGN: Multi-method randomised control trial (RCT). SETTING: Three NHS Trusts. POPULATION: Nulliparous women not planning elective caesarean, without medication for hypertension and without psychological illness. METHODS: Randomisation at 28-32 weeks' gestation to usual care, or to usual care plus brief self-hypnosis training (two × 90-minute groups at around 32 and 35 weeks' gestation; daily audio self-hypnosis CD). Follow up at 2 and 6 weeks postnatal. MAIN OUTCOME MEASURES: Primary: epidural analgesia. Secondary: associated clinical and psychological outcomes; cost analysis. RESULTS: Six hundred and eighty women were randomised. There was no statistically significant difference in epidural use: 27.9% (intervention), 30.3% (control), odds ratio (OR) 0.89 [95% confidence interval (CI): 0.64-1.24], or in 27 of 29 pre-specified secondary clinical and psychological outcomes. Women in the intervention group had lower actual than anticipated levels of fear and anxiety between baseline and 2 weeks post natal (anxiety: mean difference -0.72, 95% CI -1.16 to -0.28, P = 0.001); fear (mean difference -0.62, 95% CI -1.08 to -0.16, P = 0.009) [Correction added on 7 July 2015, after first online publication: 'Mean difference' replaced 'Odds ratio (OR)' in the preceding sentence.]. Postnatal response rates were 67% overall at 2 weeks. The additional cost in the intervention arm per woman was £4.83 (CI -£257.93 to £267.59). CONCLUSIONS: Allocation to two-third-trimester group self-hypnosis training sessions did not significantly reduce intra-partum epidural analgesia use or a range of other clinical and psychological variables. The impact of women's anxiety and fear about childbirth needs further investigation.

The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life.

BACKGROUND: Although gas-related symptoms (GRS) are common and intrusive, there are no questionnaires to quantitate this problem. This study aimed to develop an instrument to rectify this gap in our knowledge. METHODS: Concepts were initially identified from the literature and interviews with gastroenterologists. Exploratory one-to-one interviews and focus groups with irritable bowel syndrome (IBS) patients (n = 28) and non-IBS subjects (n = 27) with GRS were conducted in UK, France, and Spain leading to a conceptual framework for the questionnaire. Last, iterative rounds of cognitive debriefing were performed with IBS (n = 16) and non-IBS subjects (n = 14). KEY RESULTS: From the first three steps, nine GRS (bloating, distension, flatulence, odorous flatulence, difficult gas evacuation, stomach rumbling, belching, bad breath, and abdominal movement) were identified although abdominal movement was subsequently excluded. Twelve quality of life domains affected by these symptoms were identified as: Clothing, emotional, physical appearance, diet, daily living, work, social life, physical activity, relationships, sex life, sleep, and cognitive function. A 24-h recall for symptoms and a 7-day recall for impact assessment were supported by the qualitative findings. Cognitive debriefing confirmed the understanding of the instrument. Across the three languages, the instrument was conceptually and linguistically consistent. CONCLUSIONS & INFERENCES: The International Gas Questionnaire is a 2-part instrument, developed rigorously and simultaneously in three languages assessing seven symptoms (17 items) and their impact on 12 domains (26 items) in IBS and general population. It is now undergoing psychometric validation and should provide a unique tool for epidemiological surveys and clinical trials for developing new treatments for these symptoms.

Hypnotherapy for irritable bowel syndrome: an audit of one thousand adult patients.

BACKGROUND: Gut-focused hypnotherapy improves the symptoms of irritable bowel syndrome (IBS) with benefits being sustained for many years. Despite this, the technique has not been widely adopted by healthcare systems, possibly due to relatively small numbers in published studies and uncertainty about how it should be provided. AIM: To review the effect of hypnotherapy in a large cohort of refractory IBS patients. METHODS: One thousand IBS patients fulfilling Rome II criteria, mean age 51.6 years (range 17-91 years), 80% female, receiving 12 sessions of hypnotherapy over 3 months, were studied. The primary outcome was a 50 point reduction in the IBS Symptom Severity Score. The fall in scores for Noncolonic Symptoms, Quality of Life and Anxiety or Depression, were secondary outcomes. The Federal Drug Administration's recommended outcome of a 30% or more reduction in abdominal pain was also recorded. RESULTS: Overall, 76% met the primary outcome which was higher in females (females: 80%, males: 62%, P < 0.001) and those with anxiety (anxious: 79%, non-anxious: 71%, P = 0.010). The mean reduction in other scores was: IBS Symptom Severity Score, 129 points (P < 0.001), Noncolonic Symptom Score, 65 (P < 0.001) and Quality of Life Score, 66 (P < 0.001). Sixty-seven per cent reported a 30% or more reduction in abdominal pain scores. Pain days fell from 18 to 9 per month. Patients with anxiety and depression fell from 63% to 34% and 25% to 12% respectively (P < 0.001). Outcome was unaffected by bowel habit subtype. CONCLUSION: These results provide further evidence that gut-focused hypnotherapy is an effective intervention for refractory IBS.

Conducting multinational, cross-cultural research in the functional gastrointestinal disorders: issues and recommendations. A Rome Foundation working team report.

BACKGROUND: Cross-cultural, multinational research can advance the field of functional gastrointestinal disorders (FGIDs). Cross-cultural comparative research can make a significant contribution in areas such as epidemiology, genetics, psychosocial modulators, symptom reporting and interpretation, extra-intestinal co-morbidity, diagnosis and treatment, determinants of disease severity, health care utilisation, and health-related quality of life, all issues that can be affected by geographical region, culture, ethnicity and race. AIMS: To identify methodological challenges for cross-cultural, multinational research, and suggest possible solutions. METHODS: This report, which summarises the full report of a working team established by the Rome Foundation that is available on the Internet, reflects an effort by an international committee of FGID clinicians and researchers. It is based on comprehensive literature reviews and expert opinion. RESULTS: Cross-cultural, multinational research is important and feasible, but has barriers to successful implementation. This report contains recommendations for future research relating to study design, subject recruitment, availability of appropriate study instruments, translation and validation of study instruments, documenting confounders, statistical analyses and reporting of results. CONCLUSIONS: Advances in study design and methodology, as well as cross-cultural research competence, have not matched technological advancements. The development of multinational research networks and cross-cultural research collaboration is still in its early stages. This report is intended to be aspirational rather than prescriptive, so we present recommendations, not guidelines. We aim to raise awareness of these issues and to pose higher standards, but not to discourage investigators from doing what is feasible in any particular setting.

Irritable bowel syndrome: the problem and the problem of treating it - is there a role for probiotics?

The aim of this review is to highlight the impact of irritable bowel syndrome (IBS) in those patients who consult the medical profession and examine the therapeutic potential of probiotics in this condition, where there is a strong need for new treatment options. Traditionally, IBS is frequently regarded as a trivial condition which is certainly not life threatening and mainly psychological in origin. However, these preconceptions are misplaced, as in some patients the condition can be devastating with the pain being as severe as that of childbirth coupled with incapacitating bowel dysfunction. In addition, patients suffer from a variety of non-colonic symptoms such as low backache, constant lethargy, nausea and genito-urinary problems, all of which lead to these patients having extremely poor quality of life. Unfortunately, the treatment of IBS is very unsatisfactory with only one new medication being developed for this condition in the last 25 years. It is now recognised that IBS is a multifactorial condition with symptoms being triggered by a variety of factors, some of which appear to be influenced by probiotics, resulting in speculation that they may have therapeutic potential in this condition. There have been over thirty controlled clinical trials of probiotics in IBS with approximately two-thirds of these studies showing evidence of an improvement in symptoms. However, not all probiotics appear to be effective with different symptoms being improved by different strains and some improving symptoms more than others. Consequently, the ideal probiotic for the treatment of IBS has yet to be defined, but the evidence is good enough to encourage further research with the aim of identifying an optimal strain or strains.

Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice -- an evidence-based international guide.

BACKGROUND: Evidence suggests that the gut microbiota play an important role in gastrointestinal problems. AIM: To give clinicians a practical reference guide on the role of specified probiotics in managing particular lower gastrointestinal symptoms/problems by means of a systematic review-based consensus. METHODS: Systematic literature searching identified randomised, placebo-controlled trials in adults; evidence for each symptom/problem was graded and statements developed (consensus process; 10-member panel). As results cannot be generalised between different probiotics, individual probiotics were identified for each statement. RESULTS: Thirty seven studies were included; mostly on irritable bowel syndrome [IBS; 19 studies; treatment responder rates: 18-80% (specific probiotics), 5-50% (placebo)] or antibiotic-associated diarrhoea (AAD; 10 studies). Statements with 100% agreement and 'high' evidence levels indicated that: (i) specific probiotics help reduce overall symptom burden and abdominal pain in some IBS patients; (ii) in patients receiving antibiotics/Helicobacter pylori eradication therapy, specified probiotics are helpful as adjuvants to prevent/reduce the duration/intensity of AAD; (iii) probiotics have favourable safety in patients in primary care. Items with 70-100% agreement and 'moderate' evidence were: (i) specific probiotics help relieve overall symptom burden in some patients with diarrhoea-predominant IBS, and reduce bloating/distension and improve bowel movement frequency/consistency in some IBS patients and (ii) with some probiotics, improved symptoms have led to improvement in quality of life. CONCLUSIONS: Specified probiotics can provide benefit in IBS and antibiotic-associated diarrhoea; relatively few studies in other indications suggested benefits warranting further research. This study provides practical guidance on which probiotic to select for a specific problem.

Unraveling functional abdominal bloating and distension: the role of thoraco-abdominal accommodation and a physical sign to aid its detection.

Bloating and distension are common complaints in patients with irritable bowel syndrome of which the cause has remained elusive, although it has been shown that the obvious explanation of excessive gas is unlikely. The recent application of technologies such as the gas challenge technique, abdominal inductance plethysmography, CT scanning, as well as electromyography of the diaphragm and anterior abdominal wall, have allowed the situation to be slowly unraveled. It is now seems probable that the pathophysiology of bloating and distension are subtly different with the former having a sensory component whereas mechanical factors, such as disordered abdominal accommodation, contribute more to the latter.

Abdominal bloating and distension: what is the role of the microbiota.

Most patients with irritable bowel syndrome complain of a sensation of an increase in pressure within their abdomen during the course of the day which is called bloating and, in approximately half of these individuals, this symptom is accompanied by an actual increase in abdominal girth, which is referred to as distension. The pathophysiology of these two phenomena is somewhat different and it is now recognised that a whole variety of overlapping mechanisms are involved. Some of these are potentially amenable to treatment by modification of the bacterial flora of the gut and this article reviews the evidence for this.

Visceral hypersensitivity in endometriosis: a new target for treatment?

OBJECTIVE: In women presenting to gynaecological clinics with lower abdominal pain, the cause is frequently attributed to endometriosis irrespective of whether it is found to be minimal or extensive at laparoscopy. Irritable bowel syndrome (IBS) is also common in this setting, and it was speculated that the visceral hypersensitivity associated with this condition might be amplifying the symptoms of endometriosis. METHODS: Visceral sensitivity to balloon distension, symptoms and psychological status were assessed following laparoscopy in 20 women with minimal to mild endometriosis, 20 with moderate to severe endometriosis, 20 with laparoscopy negative abdominal pain and 20 asymptomatic women undergoing laparoscopic sterilisation who acted as controls, and compared with 20 women with IBS. RESULTS: Compared with controls, patients with minimal to mild and moderate to severe endometriosis had a higher prevalence of symptoms consistent with IBS (0% vs 65% and 50%, respectively, p<0.001) with significantly lower mean pain thresholds (39.5 mm Hg (95% CI 36.0 to 43.0) vs 28.1 mm Hg (95% CI 24.5 to 31.6), p=0.001 and 28.8 mm Hg (95% CI 24.9 to 32.6), p=0.002) not explained by differences in rectal compliance. Patients with laparoscopy negative pain had symptoms and visceral sensitivity similar to patients with IBS. Controls undergoing laparoscopy had normal sensitivity, indicating that the laparoscopic procedure was not inducing hypersensitivity. CONCLUSION: Visceral hypersensitivity is extremely common in endometriosis and could be intensifying the pain. This finding might explain why mildly affected individuals often complain of severe symptoms out of proportion to the extent of their disease. This study has introduced a completely new concept into the understanding of pain in endometriosis and could open up new opportunities for treatment.

Severity in irritable bowel syndrome: a Rome Foundation Working Team report.

OBJECTIVES: The concept of severity in irritable bowel syndrome (IBS) is clinically recognized and operative in diagnostic decision making and treatment planning. Yet, there is no consensus on its definition, and there are limited data on the prevalence of severity subgroups, its medical and psychosocial determinants, and its association with other health status measures. The aims of the Rome Foundation Working Team Committee were to summarize current research, to develop a consensus of understanding on this concept, and to make recommendations for its use in research and clinical care. METHODS: In 2006, a multinational committee of clinical investigators with expertise in IBS and/or psychometric research methods undertook a systematic review of the literature relating to severity in IBS. Owing to limited data, the Foundation commissioned three clinical studies to better characterize the concept of severity in IBS, and summary information and recommendations for future research and clinical care were developed. RESULTS: The main findings were: (i) severity in IBS is defined as a biopsychosocial composite of patient-reported gastrointestinal and extraintestinal symptoms, degree of disability, and illness-related perceptions and behaviors; (ii) both visceral and central nervous system physiological factors affect severity; as severity increases, the central nervous system provides a greater contribution; (iii) severity is related to and influences health-related quality of life and health behaviors and also guides diagnostic and therapeutic clinical decision making; (iv) severity can be subcategorized into clinically meaningful subgroups as mild (∼40%), moderate (∼35%), and severe (∼25%), and this provides a working model for use in future research and clinical care. CONCLUSIONS: Future work is required to understand more precisely the factors contributing to severity and to develop a valid patient-reported instrument to measure severity in IBS.

The Patient Health Questionnaire 12 Somatic Symptom scale as a predictor of symptom severity and consulting behaviour in patients with irritable bowel syndrome and symptomatic diverticular disease.

BACKGROUND: Anxiety, depression and nongastrointestinal symptoms are often prominent in irritable bowel syndrome (IBS), but their relative value in patient management has not been quantitatively assessed. We modified the Patient Health Questionnaire 15 (PHQ-15) by excluding three gastrointestinal items to create the PHQ-12 Somatic Symptom (PHQ-12 SS) scale. AIMS: To compare the value of the PHQ-12 SS scale with the Hospital Anxiety and Depression (HAD) scale in predicting symptoms and patient behaviour in IBS and diverticular disease. METHODS: We compared 151 healthy volunteers (HV), 319 IBS patients and 296 patients with diverticular disease (DD), 113 asymptomatic [ASYMPDD] and 173 symptomatic DD (SYMPDD). RESULTS: Patient Health Questionnaire 12 SS scores for IBS and SYMPDD were significantly higher than HV. Receiver-operator curves showed a PHQ-12 SS >6, gave a sensitivity for IBS of 66.4% with a specificity of 94.7% and a positive likelihood ratio (PLR) = 13.2, significantly better than that associated with an HAD anxiety score >7, PLR = 3.0 and depression score >7 PLR = 6.5. PHQ-12 SS correlated strongly with IBS severity scale and GP visits in both IBS and DD. CONCLUSION: The PHQ-12 SS scale is a useful clinical tool which correlates with patient behaviour in both IBS and symptomatic DD.