Patient reported symptoms during an ulcerative colitis flare: A Qualitative Focus Group Study

Waljee, Akbar K.; Joyce, Joel C.; Wren, Patricia A.; Khan, Tahira; Higgins, Peter

doi:10.1097/meg.0b013e328326cacb

Cited by 45 publications

(36 citation statements)

References 22 publications

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“…Ulcerative colitis (UC) affects approximately 220 per 100 000 patients in the United States and is associated with painful and unpredictable symptoms, undesirable psychosocial consequences and disability, particularly during periods of disease flare . Medical treatment is focused on prolonging remission and reducing exposure to environmental triggers of flare .…”

Section: Introductionmentioning

confidence: 99%

Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis

Keefer

Taft

Kiebles

et al. 2013

Aliment Pharmacol Ther

101

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Summary Background Psychotherapy is not routinely recommended for in ulcerative colitis (UC). Gut-directed hypnotherapy (HYP) has been linked to improved function in the gastrointestinal tract and may operate through immune-mediated pathways in chronic diseases. Aims To determine the feasibility and acceptability of hypnotherapy and estimate the impact of hypnotherapy on clinical remission status over a 1 year period in patients with an historical flare rate of 1.3 times per year. Methods 54 patients were randomized at a single site to 7 sessions of gut-directed hypnotherapy (N = 26) or attention control (CON; N = 29) and followed for 1 year. The primary outcome was the proportion of participants in each condition that had remained clinically asymptomatic (clinical remission) through 52 weeks post-treatment. Results One-way ANOVA comparing hypnotherapy and control subjects on number of days to clinical relapse favored the hypnotherapy condition [F = 4.8 (1, 48), p = .03] by 78 days. Chi square analysis comparing the groups on proportion maintaining remission at 1 year was also significant [X2(1) = 3.9, p = .04], with 68% of hypnotherapy and 40% of control patients maintaining remission for 1 year. There were no significant differences between groups over time in quality of life, medication adherence, perceived stress or psychological factors. Conclusions This is the first prospective study that has demonstrated a significant effect of a psychological intervention on prolonging clinical remission in patients with quiescent UC. Clinical Trial # NCT00798642

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Section: Introductionmentioning

confidence: 99%

Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis

Keefer

Taft

Kiebles

et al. 2013

Aliment Pharmacol Ther

101

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“…Sensitivity analyses 5-22: other deterministic sensitivity analyses (medical and surgical options) Table 83 presents the results of the remaining deterministic sensitivity analysis (analyses [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: Assessment Group Model Resultsmentioning

confidence: 99%

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Archer

Tappenden

Ren

et al. 2016

Health Technol Assess

143

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BackgroundUlcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial.ObjectivesTo evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.Data sourcesPeer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.Review methodsA systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.ResultsTen randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.LimitationsThe health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.ConclusionsAdult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…Patients did not have to describe precisely the intensity of their symptoms (e.g., intensity of abdominal pain), or amount (e.g., amount of blood in their stool), but they were only asked if such a symptom is for them present. The included symptoms of ulcerative colitis were based on the Qualitative Focus Group Study by Waljee et al [24], as they identified which symptoms of ulcerative colitis are in fact important for patients, and they compared these symptoms with commonly measured ones to determine whether the patient-reported important symptoms are represented in current disease activity indices for ulcerative colitis. In the referred study, among other symptoms which are reported by patients, as recognized by them, but at the same time, which are not included to used indices of disease activity, there were: presence of mucus in stool, constipations and flatulence [24].…”

Section: Disease Symptomsmentioning

confidence: 99%

Therapeutic Potential of Proanthocyanidins in Ulcerative Colitis in Remission

Głąbska

Guzek

Gałazka

et al. 2020

JCM

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A number of bioactive components of diet are indicated as potential dietary factors for the management of ulcerative colitis, while the recent study conducted in an animal model revealed that proanthocyanidins from grape seeds exert a broadly positive impact. The aim of the study was to verify the influence of dietary proanthocyanidins intake on the symptoms of ulcerative colitis in remission in human subjects. The study was conducted in a group of 55 participants (19 males, 36 females) in remission of ulcerative colitis confirmed based on both the Mayo Scoring system and Rachmilewitz index. Their habitual dietary intake of proanthocyanidins and intake recalculated per 1000 kcal of diet was assessed and it was verified whether they are associated with symptoms of ulcerative colitis. The energy value of diet and intake of other nutrients were analyzed as potential interfering factors. Participants declaring the presence of mucus in their stool compared with other participants were characterized by higher proanthocyanidins intake (142 vs. 75 mg; p = 0.0441) and intake per 1000 kcal (91 vs. 37 mg/1000 kcal; p = 0.0092), while for no other nutrient such association was stated. Participants declaring constipation compared with other participants were characterized by higher proanthocyanidins intake (214 vs. 82 mg; p = 0.0289) and intake per 1000 kcal (118 vs. 41 mg/1000 kcal; p = 0.0194). Similar association for constipation was observed in the case of energy value of diet and protein intake, but only for proanthocyanidins intake, it was confirmed in the logistic regression model (p = 0.0183; OR = 1.01; 95% CI 1.00–1.02). The positive influence of habitual dietary intake of proanthocyanidins was confirmed in the studied group of patients with ulcerative colitis in remission, as this intake may have increased the production of mucus, which is beneficial for intestinal healing, and may have reduced the frequency of bowel movements. However, further experimental human studies are necessary to confirm the potential influence of proanthocyanidins intake in patients with ulcerative colitis in remission.

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Patient reported symptoms during an ulcerative colitis flare: A Qualitative Focus Group Study

Cited by 45 publications

References 22 publications

Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis

Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Therapeutic Potential of Proanthocyanidins in Ulcerative Colitis in Remission

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