A survey of patient informational preferences when choosing between medical and surgical therapy for ulcerative colitis: a sub-study from the DISCUSS project.

AIM: People living with ulcerative colitis (UC) have two broad treatment avenues, namely medical or surgical therapy. The choice between these can depend on patient preference as well as the receipt of relevant information. The aim of this study was to define the informational needs of patients with UC. METHOD: A postal survey was designed to capture respondent demographics, treatment experienced within the previous 12 months and informational preferences by rating a long list of items. It was delivered through two hospitals that provide tertiary inflammatory bowel disease services. Descriptive analyses were performed to describe demographics and experiences. Principal component analysis was carried out using a varimax rotation to investigate informational needs. RESULTS: A total of 101 responses were returned (20.1% response rate). The median age of respondents was 45 years and the median time since diagnosis was 10 years. Control preferences skewed towards shared (42.6%) or patient-led but clinician-informed (35.6%). Decision regret was low for the population (median 12.5/100, range 0-100). Key informational needs related to medical therapy were benefits and risks of long-term therapy, burden of hospital attendance, reproductive health, need for steroid treatment and impact on personal life. For surgery, these were stoma information, effect on daily life, effect on sexual and reproductive health, risks and benefits and disruption of life due to surgery. CONCLUSION: This study has identified key areas for discussion when counselling patients about treatment decisions around medical therapy and surgery for UC.

A systematic review and meta-analysis of outcomes after elective surgery for ulcerative colitis.

AIM: Approximately 20%-30% of patients with ulcerative colitis (UC) will undergo surgery during their disease course, the vast majority being elective due to chronic refractory disease. The risks of elective surgery are reported variably. The aim of this systematic review and meta-analysis is to summarize the outcomes after elective surgery for UC. METHODS: A systematic review was conducted that analysed studies reporting outcomes for elective surgery in the modern era (>2002). It was prospectively registered on the PROSPERO database (ref: CRD42018115513). Searches were performed of Embase and MEDLINE on 15 January 2019. Outcomes were split by operation performed. Primary outcome was quality of life; secondary outcomes were early, late and functional outcomes after surgery. Outcomes reported in five or more studies underwent a meta-analysis of incidence using random effects. Heterogeneity is reported with I2 , and publication bias was assessed using Doi plots and the Luis Furuya-Kanamori index. RESULTS: A total of 34 studies were included (11 774 patients). Quality of life was reported in 12 studies, with variable and contrasting results. Thirteen outcomes (eight early surgical complications, five functional outcomes) were included in the formal meta-analysis, all of which were outcomes for ileal pouch-anal anastomosis (IPAA). A further 71 outcomes were reported (50 IPAA, 21 end ileostomy). Only 14 of 84 outcomes received formal definitions, with high inter-study variation of definitions. CONCLUSION: Outcomes after elective surgery for UC are variably defined. This systematic review and meta-analysis highlights the range of reported incidences and provides practical information that facilitates shared decision making in clinical practice.

The informational and decisional preferences of patients undergoing surgery for Crohn's anal fistula: a qualitative study.

AIM: One in three patients with Crohn's disease will develop a perianal fistula, but only a few achieve long-term healing. Treatment is both medical and surgical. Since there is no 'best' surgical procedure, patient preference is important in selecting the appropriate treatment for this condition. The aim of this study was to investigate the informational and decisional preferences of patients when surgical treatment is being considered. METHOD: Patients who had undergone surgery for Crohn's anal fistula underwent face-to-face semi-structured interviews. These explored the experience of treatments for fistula, of receiving information and of participation in decision-making. Transcripts were analysed by two investigators through inductive thematic analysis. Saturation was assessed for at 12 interviews and then after each subsequent interview. RESULTS: Seventeen patients completed interviews, and saturation was achieved. Five themes were identified, of which two (desired information and decision-making) were relevant to this study. Other themes included experience of Crohn's disease, experience of receiving information and procedure-specific comments. Participants wanted to have information on any risks, high-level outcomes (e.g. success), impact on day-to-day life and aftercare. Participants felt they did not always receive the information they needed to select the best treatment option. Participants felt uninvolved in treatment decisions and would have liked to trade off operations to reach their treatment goal. CONCLUSION: Information provided to patients about surgical treatment of Crohn's perianal fistula does not meet their needs. Clinicians should address aftercare, impact on quality of life and the risks and benefits of the any proposed procedure.

The assessment of online health videos for surgery in Crohn's disease.

AIM: YouTube™ is an open-access, nonpeer-reviewed video-hosting site and is used as a source of publicly available healthcare information. This study aimed to assess the thematic content of the most viewed videos relating to surgery and Crohn's disease and to explore the viewer interactions with these videos. METHOD: A search of YouTube™ was carried out using one search string. The 50 most viewed videos were identified and categorized by source and content themes and assessed for viewer interactions. Video comments were used to describe the usefulness of the video content to viewers. RESULTS: The majority of videos were uploaded by patients (n = 21).The remainder were uploaded by individual healthcare professionals (n = 9), hospital/speciality associations (n = 18) and industry (n = 2). The median number of likes for patient videos was significantly higher than for hospital/speciality association videos (P < 0.001). Patient videos received more comments praising the video content (n = 27) and more comments asking for further information (n = 14). The median number of likes for 'experience of surgery' (P < 0.001) and 'experience of disease' (P = 0.0015) themed videos were significantly higher than for 'disease management' themed videos. CONCLUSION: Crohn's disease patients use YouTube™ as a surgical information source. The content of patient-sourced videos focused on surgical and disease experience, suggesting that these themes are important to patients. Current patient developed videos provide limited information, as reflected by viewers requesting further information. Storytelling patient-centred videos combined with clinical evidence may be a good model for future videos.

Patients with perianal Crohn's fistulas experience delays in accessing anti-TNF therapy due to slow recognition, diagnosis and integration of specialist services: lessons learned from three referral centres.

AIM: Crohn's anal fistula should be managed by a multidisciplinary team. There is no clearly defined 'patient pathway' from presentation to treatment. The aim of this study was to describe the patient route from presentation with symptomatic Crohn's anal fistula to starting anti-tumour necrosis factor (anti-TNF) therapy. METHOD: Case note review was undertaken at three hospitals with established inflammatory bowel disease services. Patients with Crohn's anal fistula presenting between 2010 and 2015 were identified through clinical coding and local databases. Baseline demographics were captured. Patient records were interrogated to identify route of access, and clinical contacts during the patient pathway. RESULTS: Seventy-nine patients were included in the study, of whom 54 (68%) had an established diagnosis of Crohn's disease (CD). Median time from presentation to anti-TNF therapy was 204 days (174 vs 365 days for existing and new diagnosis of CD, respectively; P = 0.019). The mean number of surgical outpatient attendances, operations and MRI scans per patient was 1.03, 1.71 and 1.03, respectively. Patients attended a mean of 1.49 medical clinics. Seton insertion was the most common procedure, accounting for 48.6% of all operations. Where care episodes ('clinical events per 30 days') were infrequent this correlated with prolongation of the pathway (r = -0.87; P < 0.01). CONCLUSION: This study highlights two key challenges in the treatment pathway: (i) delays in diagnosis of underlying CD in patients with anal fistula and (ii) the pathway to anti-TNF therapy is long, suggesting issues with service design and delivery. These should be addressed to improve patient experience and outcome.

Assessing internet-based information used to aid patient decision-making about surgery for perianal Crohn's fistula.

BACKGROUND: Decision-making in perianal Crohn's fistula (pCD) is preference sensitive. Patients use the internet to access healthcare information. The aim of this study was to assess the online information and patient decision aids relating to surgery for pCD. METHODS: A search of Google™ and the Decision Aids Library Inventory (DALI) was performed using a predefined search strategy. Patient-focussed sources providing information about pCD surgery were included in the analysis. Written health information was assessed using the International Patient Decision Aids Standards (IPDAS) and DISCERN criteria. The readability of the source content was assessed using the Flesch-Kincaid score. RESULTS: Of the 201 sources found, 187 were excluded, leaving 14 sources for analysis. Three sources were dedicated to pCD, and six sources mentioned pCD-specific outcomes. The most common surgical intervention reported was seton insertion (n = 13). The least common surgical intervention reported was proctectomy (n = 1). The mean IPDAS and DISCERN scores were 4.43 ± 1.65 out of 12 (range = 2-8) and 2.93 ± 0.73 out of 5 (range = 1-5), respectively. The mean reading ease was US college standard. CONCLUSIONS: We found no patient decision aids relating to surgery for pCD. The online sources relating to surgery for pCD are few, and their quality is poor, as seen in the low IPDAS and DISCERN scores. Less than half of the sources mentioned pCD-specific outcomes, and three sources were solely dedicated to providing information on pCD. Healthcare professionals should look to create a patient tool to assist decision-making in pCD.

Combined modality treatment for complex fistulating perianal Crohn's disease.

AIM: Perianal disease affects 33% (range 8-90%) of patients with Crohn's disease. Fistulae are often complex and their management is often difficult and unsatisfactory. This study was a retrospective assessment of a combination of surgical treatment with a standardized protocol of infliximab (IFX) therapy. METHOD: A consecutive series of patients with complex perianal Crohn's disease, presenting between January 2003 and June 2008, were included. Acute sepsis was initially treated with antibiotics and/or surgical drainage (MRI guided when appropriate) and loose seton insertion. IFX was given at 5 mg/kg, at 0, 2 and 6 weeks. End-points were complete, partial or no response. Setons were empirically removed after the second cycle of IFX. RESULTS: Forty-eight patients, average age 46 (range 24-82)years, with perianal Crohn's disease were identified. Three patients stopped IFX after the second infusion, either because of allergy (two patients) or for failure to respond (one patient). Fourteen patients were given maintenance IFX at 8-weekly intervals. Results were recorded for 48 patients, of whom 14 (29%) had a complete response, 20 (42%) had a partial response and 14 (29%) had no response to treatment. Outpatient follow-up was for a median of 20 months. CONCLUSION: Combining surgical procedures with IFX resulted in complete and partial remission in 29% and 42% of patients, respectively. No serious side effects occurred. Using a combined, intensive medico-surgical approach, good initial control of perianal disease was achieved safely.

Prodromal irritable bowel syndrome may be responsible for delays in diagnosis in patients presenting with unrecognized Crohn's disease and celiac disease, but not ulcerative colitis.

INTRODUCTION: We aimed to determine the prevalence and duration of prodromal periods in patients with celiac disease and inflammatory bowel disease (Crohn's disease and ulcerative colitis). Furthermore, we explored to what extent vague abdominal symptoms consistent with both disorders were attributed to irritable bowel syndrome (IBS) and if the presence of prodromal IBS (P-IBS) had an impact on prodrome duration. METHODS: In the study, 683 biopsy-proven patients (celiac n = 225, ulcerative colitis n = 228, Crohn's disease n = 230) completed a postal survey including an assessment of prodromal periods and IBS symptoms during both the prodrome and at present (achieved by completion of the ROME II criteria). Results were compared to age/sex-matched controls (n = 348). RESULTS: Crohn's disease patients had the highest prevalence of prodromes (94%) in comparison to ulcerative colitis (48%) and celiac disease (44%). However, Crohn's disease patients have the lowest prevalence of P-IBS (29%) in comparison to ulcerative colitis (38%) and celiac disease (67%). Prodrome duration in patients with P-IBS Crohn's disease was 4 years in comparison to 2 years without (p = 0.018). Prodrome duration in P-IBS celiac disease was 10 years in comparison to 7 years without (p = 0.046). Prodrome duration in patients with ulcerative colitis was not affected by P-IBS (p ≥ 0.05). Age and sex were not confounding factors. CONCLUSIONS: This is the first study to make direct comparisons of prodrome periods between celiac disease and IBD. Prodrome duration in celiac disease is significantly longer and more often characterized by P-IBS than IBD. In celiac disease and CD, P-IBS increases prodrome duration. This may represent a failure to understand the overlap between IBS and celiac disease/IBD.

Review article: pathogenesis of Crohn's perianal fistula-understanding factors impacting on success and failure of treatment strategies.

BACKGROUND: Evidence from groups who have studied fistula aetiology and extrapolation from interventional studies supports a multifactorial hypothesis of Crohn's perianal fistula, with several pathophysiological elements that may contribute to fistula formation, persistence and resistance to treatment. AIM: An evidence synthesis of current understanding of pathophysiological factors underlying Crohn's perianal fistula is presented, exploring the fundamental reasons why some treatments succeed and others fail, as a means of focussing clinical knowledge on improving treatment of Crohn's perianal fistula. METHODS: Evidence to support this review was gathered via the Pubmed database. Studies discussing pathophysiological factors underpinning perianal fistula, particularly in Crohn's disease, were reviewed and cross-referenced for additional reports. RESULTS: Pathophysiological factors that impact on success or failure of interventions for Crohn's perianal fistulae include the high-pressure zone, obliterating the dead space, disconnecting the track from the anus, removing epithelialisation, eradicating sepsis and by-products of bacterial colonisation, correcting abnormalities in wound repair and removing the pro-inflammatory environment which allows fistula persistence. Most current interventions for Crohn's perianal fistulae tend to focus on a single, or at best two, aspects of the pathophysiology of Crohn's anal fistulae; as a result, failure to heal fully is common. CONCLUSIONS: For an intervention or combination of interventions to succeed, multiple factors must be addressed. We hypothesise that correct, timely and complete attention to all of these factors in a multimodal approach represents a new direction that may enable the creation of an effective treatment algorithm for Crohn's anal fistula.

Is exocrine pancreatic insufficiency in adult coeliac disease a cause of persisting symptoms?

BACKGROUND: Patients with coeliac disease may have diarrhoea despite being on a gluten-free diet. AIM: To assess whether exocrine pancreatic insufficiency causes persisting symptoms compared with controls, we determined whether pancreatic enzyme supplementation provided symptomatic benefit in coeliac patients with chronic diarrhoea. METHODS: Patients (n = 259) were subdivided into four groups: (a) new coeliac disease (n = 57), (b) coeliac disease patients on a gluten-free diet without gastrointestinal symptoms (n = 86), (c) coeliac disease patients on a gluten-free diet with chronic diarrhoea (n = 66) and (d) patients with chronic diarrhoea without coeliac disease (n = 50). Stool frequency and weight, before and after treatment with pancreatic enzyme supplementation were recorded. RESULTS: The prevalence of a low faecal elastase-1 within the groups was: group (A) six of 57 (11%), group (B) five of 86 (6%), group (C) 20 of 66 (30%) and group (D) two of 50 (4%). Low faecal elastase-1 was more frequent in coeliac disease patients with chronic diarrhoea vs. other subgroups of coeliac disease (P < or = 0.0001) and controls (P < or = 0.0003). In 18 of 20 stool frequency reduced following pancreatic enzyme supplementation from four per day to one (P < or = 0.001). No weight increase (P = 0.3) was observed. CONCLUSIONS: Low faecal elastase is common in patients with coeliac disease and chronic diarrhoea, suggesting exocrine pancreatic insufficiency. In this group of patients, pancreatic enzyme supplementation may provide symptomatic benefit.

Variations in the reporting of endoscopies by different endoscopists.

All gastroscopies and colonoscopies performed in two U.K. teaching hospitals over a period of one year were audited to investigate whether endoscopic reporting of gastroscopies and colonoscopies by different endoscopists is consistent. Endoscopic diagnoses were retrieved from the hospitals' endoscopy databases. The results of 1814 colonoscopies and 2127 gastroscopies were analysed using chi2 (Chi squared). The frequency of reporting common diagnoses was variable and the differences between specialist endoscopists were highly significant, including for important conditions such as peptic ulceration (range 2-10%, p = 0.001) and colonic polyps (16-45%, p < 0.001). There is a large variation in the frequency of the diagnoses reported by different endoscopists. This is unlikely to be explained by casemix or chance. This may have major implications for the health of patients. More emphasis must be placed during training on the correct interpretation of endoscopies.

Outcome of elective withdrawal of anti-tumour necrosis factor-α therapy in patients with Crohn's disease in established remission.

BACKGROUND AND AIMS: Outcomes of cessation of anti-TNF therapy for Crohn's disease (CD) in clinical and/or endoscopic remission in routine clinical practice is uncertain. This study aimed to evaluate clinical outcomes and factors associated with relapse in CD patients following formal disease assessment and elective anti-TNF withdrawal. METHODS: Prospective observational study of CD patients in whom anti-TNF therapy was stopped electively after ≥12months and follow-up of ≥6months. Investigations at assessment prior to cessation included ≥1 of clinical assessment, endoscopic and/or imaging. Relapse was defined as recurrent symptoms of CD requiring medical or surgical therapy. RESULTS: Eighty-six patients received anti-TNF for a median duration of 23 (12-80) months for severe active luminal (70%), fistulating perianal (25.5%) and other fistulating disease (4.5%). Relapse rates at 90,180 and 365days were 4.7%, 18.6% and 36%, respectively. If anti-TNF dose escalation occurred 6months prior to withdrawal, 88% (7/8) relapsed. Based on multivariate analysis, risk factors for relapse include ileocolonic disease at diagnosis and previous anti-TNF therapy. An elevated faecal calprotectin (FC) is likely to predict relapse (p=0.02), with a PPV of 66.7% at >50µg/g. Of 36 patients who relapsed, 31 were retreated with anti-TNF, with an overall recapture rate of 93%. CONCLUSION: Relapse rates at 1year following elective withdrawal of anti-TNF are 36%, with high retreatment response rate. Predictors of relapse include ileocolonic involvement, previous anti-TNF therapy and raised FC. Endoscopic/radiologic assessment prior to cessation of therapy does not appear to predict those at lower risk of relapse.

Systematic review: psychological morbidity in young people with inflammatory bowel disease - risk factors and impacts.

BACKGROUND: Psychological morbidity in young people aged 10-24 years, with inflammatory bowel disease (IBD) is increased, but risk factors for and impacts of this are unclear. AIM: To undertake a systematic literature review of the risk factors for and impact of psychological morbidity in young people with IBD. METHODS: Electronic searches for English-language articles were performed with keywords relating to psychological morbidity according to DSM-IV and subsequent criteria; young people; and IBD in the MEDLINE, PsychInfo, Web of Science and CINAHL databases for studies published from 1994 to September 2014. RESULTS: One thousand four hundred and forty-four studies were identified, of which 30 met the inclusion criteria. The majority measured depression and anxiety symptoms, with a small proportion examining externalising behaviours. Identifiable risk factors for psychological morbidity included: increased disease severity (r(2) = 0.152, P < 0.001), lower socioeconomic status (r(2) = 0.046, P < 0.001), corticosteroids (P ≤ 0.001), parental stress (r = 0.35, P < 0.001) and older age at diagnosis (r = 0.28, P = 0.0006). Impacts of psychological morbidity in young people with IBD were wide-ranging and included abdominal pain (r = 0.33; P < 0.001), sleep dysfunction (P < 0.05), psychotropic drug use (HR 4.16, 95% CI 2.76-6.27), non-adherence to medication (12.6% reduction) and negative illness perceptions (r = -0.43). CONCLUSIONS: Psychological morbidity affects young people with IBD in a range of ways, highlighting the need for psychological interventions to improve outcomes. Identified risk factors provide an opportunity to develop targeted therapies for a vulnerable group. Further research is required to examine groups under-represented in this review, such as those with severe IBD and those from ethnic minorities.

Changing trends in the UK management of upper GI bleeding: is there evidence of reduced UK training experience?

OBJECTIVE: The aim of this study was to evaluate UK trainee experience in endoscopy for acute upper gastrointestinal bleeding (AUGIB). METHODS: Data was prospectively collected from all patients presenting to South Yorkshire Hospitals with AUGIB from September 2011 to December 2011 and compared with data from 1996. Concurrently, all gastroenterology trainees registered with the British Society of Gastroenterology were invited to respond to a web-based questionnaire regarding their experience in AUGIB management. RESULTS: 77% (589/766) of the patient cohort underwent endoscopy for AUGIB; 15% (90/589) were performed by trainees. 7.2% (9/125) of the out of hours endoscopy case load was performed by trainees; all were low-risk or medium-risk cases (pre-endoscopy Rockall score ≤4). During the study period, dual therapy was delivered by a trainee on only four occasions. Comparison with the 1996 cohort demonstrated a marked reduction in the number of trainee performed endoscopies (76% vs 15%; p<0.001). Questionnaires were returned by 51% (245/478) of British Society of Gastroenterology trainees. 81% (198/245) thought that <10% of the gastroscopies they had performed involved therapeutic intervention. 23% (57/245) felt they would not be competent in AUGIB endoscopy by completion of specialty training. CONCLUSIONS: This study demonstrates the decline over time in trainee experience in AUGIB endoscopy. It also highlights a lack of trainee exposure to more challenging cases, out of hours endoscopy and therapeutic procedures. Furthermore, trainees are concerned that a level of competency may not be attained during specialty training. We advocate reviewing UK endoscopic training provision for AUGIB to ensure that experienced endoscopists are produced to meet future service needs.

Oral tobramycin in ulcerative colitis: effect on maintenance of remission.

Oral tobramycin for 7 days has been shown to be of benefit as an adjunct to conventional medication in acute ulcerative colitis. Eighty-one patients (40 who had received tobramycin; 41 placebo) who had been enrolled in a double-blind placebo-controlled trial of this drug in acute disease were subsequently followed to determine whether this short-term benefit persisted. Relapse was defined as a liquid stool frequency of three times daily with rectal bleeding. Results were analysed by the log-rank test on Kaplan-Meier survival curves. Treatment failure was defined as a lack of response by the end of the acute trial period, or subsequent relapse. In a second analysis, only those entering remission at the end of the acute trial were considered, and followed to relapse. Although at the start of the follow-up period significantly fewer patients in the tobramycin group had failed (failed: tobramycin 9, placebo 24; not failed tobramycin 31; placebo 17; P = 0.001), the failure-free survival curves subsequently converged and did not differ significantly. After 1 and 2 years, the failure-free survival rates were 40% (S.E. = 7.8%) and 20% (S.E. = 6.3%) for the tobramycin group and 24% (S.E. = 6.7%) and 12% (S.E. = 5.1%) for the placebo group. When only those entering remission were considered, there was no significant difference in the relapse rates in the two groups. Benefit from tobramycin is therefore short-lived and may reflect short-term changes in the faecal flora.

Maintenance of Crohn's disease over 12 months: fixed versus flexible dosing regimen using budesonide controlled ileal release capsules.

BACKGROUND: It may be possible to achieve more effective management of Crohn's Disease by introducing a flexible dosage regimen sensitive to patients' needs. AIM: Comparison of the efficacy and tolerability of a fixed vs. flexible budesonide controlled ileal release treatment regimen for the prevention and management of relapse in Crohn's disease patients. Budesonide controlled ileal release is an oral formulation which delivers drug directly to disease sites in the ileum and ascending colon, by preventing more proximal release and absorption. METHODS: A randomized, double-blind comparison of a fixed dose of budesonide controlled ileal release (6 mg o.m.) and a flexible dose of budesonide controlled ileal release (3, 6 or 9 mg o.m.) for 12 months, in 143 patients in remission from ileal or ileo-caecal Crohn's Disease. RESULTS: Very low rates of clinical relapse in Crohn's disease were achieved with budesonide controlled ileal release 6 mg o.m. There was no significant difference between the treatment groups with respect to the survival estimate of percentage of treatment failures (flexible group 15%, fixed group 19%; P=0.61). The average consumed dose of budesonide was comparable in both groups (5.8 mg flexible, 6.0 mg fixed). Similar proportions of patients reported adverse events (flexible 100%, fixed 97%). There were 33 serious adverse events (flexible 19, fixed 14) and 13 withdrawals due to significant adverse events (flexible 9, fixed 4). CONCLUSION: Maintenance treatment with budesonide controlled ileal release 6 mg o.m. is well-tolerated and is associated with low rates of clinical relapse in stable Crohn's disease over 12 months. Flexible dosing remains an option for individual patients, but this study has shown no advantage over a standard fixed dosing regimen.

Helicobacter pylori antimicrobial resistance in the United Kingdom: the effect of age, sex and socio-economic status.

BACKGROUND: Helicobacter pylori antimicrobial resistance is the most common reason for eradication failure. Small studies have shown metronidazole resistance to be more prevalent in certain population groups. AIM: To determine the resistance rates in a large cohort of patients from a single centre in the UK, and to evaluate resistance patterns over time, according to age, sex and socio-economic status. METHODS: Consecutive patients with H. pylori-positive antral gastric biopsy samples were studied from 1994 to 1999. Susceptibility testing was performed to metronidazole, tetracycline, macrolide and amoxicillin by the modified disk diffusion METHOD: The Jarman under-privileged area score was used as a measure of socio-economic status. RESULTS: A total of 1064 patients were studied. Overall metronidazole resistance was 40.3%, decreasing with age (P < 0.0001, odds ratio for patients over 60 years 0.63, 95% CI: 0.48-0.80). Women were more likely to have metronidazole resistant strains (P=0.003, odds ratio 1.5, 95% CI: 1.15-1.91), but there was no association with Jarman score. Macrolide resistance was associated with metronidazole resistance (P=0.03, odds ratio 2.14, 95% CI: 1.07-4.28). CONCLUSIONS: Metronidazole resistance in H. pylori is highly prevalent and more common in women and the young, but does not appear to be related to socio-economic status.

Preservation of gastric antral mucus is associated with failure of eradication of Helicobacter pylori by bismuth, metronidazole and tetracycline.

METHODS: Forty-three patients positive for Helicobacter pylori by histology and culture of antral biopsies (n = 40) or histology alone (n = 3) were investigated. They received either regimen 1--tripotassium dicitrato bismuthate 120 mg q.d.s. and tetracycline 250 mg q.d.s. for 4 weeks, with metronidazole 200 mg q.d.s. for the first 2 weeks, or regimen 2--omeprazole 20 mg b.d., amoxycillin 500 mg t.d.s., tetracycline 500 mg q.d.s. each for 3 weeks. Gastric antral biopsies were scored (0-3) histologically for mucus depletion, polymorphonuclear and mononuclear cell infiltrate. H. pylori eradication was assessed by biopsy and culture 1 month after the cessation of treatment. RESULTS: With regimen 1, pre-treatment mucus depletion was significantly higher where eradication was successful (median score 2) compared to where it was not (median score 1, P < 0.01); there were no differences in the scores for polymorphonuclear or mononuclear cell infiltrates. In patients receiving regimen 2, there were no differences in either mucus depletion or polymorphonuclear or mononuclear cell infiltrate, between those where eradication was successful and those where it was not. Metronidazole minimum inhibitory concentrations rose when eradication with regimen 1 was unsuccessful (median before 0.19 mg/L, median after treatment 16 mg/L; P = 0.04). CONCLUSION: Pre-treatment mucus depletion is identified as a factor affecting H. pylori eradication. Preservation of mucus may facilitate acquisition of metronidazole resistance.

Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months. ABACUS Investigator group.

BACKGROUND: Despite widespread use of aminosalicylates as maintenance treatment for ulcerative colitis (UC), patients still report troublesome symptoms, often nocturnally. AIM: To compare the efficacy and safety of balsalazide (Colazide) with mesalazine (Asacol) in maintaining UC remission. METHODS: A randomized, double-blind comparison of balsalazide 3 g daily (1.04 g 5-ASA) and mesalazine 1.2 g daily for 12 months, in 99 (95 evaluable) patients in UC remission. RESULTS: Balsalazide patients experienced more asymptomatic nights (90% vs. 77%, P=0.0011) and days (58% vs. 50%, N.S.) during the first 3 months. Balsalazide patients experienced more symptom-free nights per week (6.4+/-1.7 vs. 4.7+/-2.8; P=0.0006) and fewer nights per week with blood on their stools or on the toilet paper, mucus with their stools or with sleep disturbance resulting from symptoms or lavatory visits (each P < 0.05). Fewer balsalazide patients relapsed within 3 months (10% vs. 28%; P=0.0354). Remission at 12 months was 58%, in both groups. Similar proportions of patients reported adverse events (61% balsalazide vs. 65% mesalazine). There were five serious adverse events (two balsalazide, three mesalazine) and four withdrawals due to unacceptable adverse events (three balsalazide, one mesalazine), of which one in each group was also a serious adverse event. CONCLUSIONS: Balsalazide 3 g/day and mesalazine 1.2 g/ day effectively maintain UC remission and are equally well tolerated over 12 months. At this dose balsalazide prevents more relapses during the first 3 months of treatment and controls nocturnal symptoms more effectively.