Abstract

Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM; n = 47; 50.28 ± 11.90 years) or control (n = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference (p = 0.251). If patients attended more than 50% of the training sessions, a significant group effect (p = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary (p = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.

Highlights

  • Ulcerative colitis represents a chronic inflammatory bowel disease with a high burden of disease for the patients

  • Patients diagnosed with ulcerative colitis who had been in clinical remission for no longer than 12 months at the longest (Clinical Activity Index according to Rachmilewitz (CAI) ≤4 [16]), were aged between 18 and 75 years and had impaired quality of life (Inflammatory Bowel Disease Questionnaire (IBDQ) total score

  • The results imply that a comprehensive lifestyle-modification program is safe and feasible in patients with ulcerative colitis

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Summary

Introduction

Ulcerative colitis represents a chronic inflammatory bowel disease with a high burden of disease for the patients. In IBD, the reporting of irritable bowel syndrome (IBS)-type symptoms by patients with quiescent disease is common and is associated with psychological disorders, impaired quality of life, and increased health-care use [10]. Our limited understanding of the role of psychosocial and lifestyle factors have hindered the development of effective comprehensive therapeutic approaches This has further led to patients seeking complementary treatment options outside conventional medication based medicine; often without informing their attending physician [4]. Within the present study we focused on patients with impaired quality of life and assessed the efficacy of a comprehensive lifestyle modification program on health-related quality of life and disease activity in patients with ulcerative colitis in clinical remission

Study Design
Study Procedure
Eligibility Criteria
Randomization
Comprehensive Lifestyle-Modification Program
Control
Measures
Health-Related Quality of Life
Generic Quality of Life
Clinical Disease Activity
2.10. Fecal Biomarkers
2.11. Endoscopy and Histology
2.13. Microbiome
2.15. Sample Size Calculation
2.16. Statistical Analyses
Primary Outcome
Disease Activity
Microbiome Diversity
Safety
Findings
Discussion
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