Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis-A Randomized Controlled Trial

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.

Keywords: health-related quality of life; integrative medicine; lifestyle-modification; randomized controlled trial; ulcerative colitis.

Figure 1

Flow-chart.

Figure 2

Comprehensive lifestyle-modification program and self-care (control) on health-related quality of life measured with the sum score of the German version of the Inflammatory Bowel Disease Questionnaire. Both groups demonstrated increases in health-related quality of life with no significant difference between the groups within the intention-to-treat analysis (ITT; N = 97; p = 0.251). Within a per-protocol analysis (PP; n = 80), improvement in health-related quality of life was significantly higher in the lifestyle modification group (p = 0.034); Values expressed as mean ± standard deviation. Asterisks indicate significant group differences. The dotted line represents the cut-off of 170 indicating no impairment to quality of life.

Figure 3

Comprehensive lifestyle-modification program and self-care (control) on subscales of health-related quality of life measured with the German version of the inflammatory bowel disease questionnaire. Within the intention-to-treat-analysis (ITT; N = 97), significant group differences in favor of lifestyle-modification were found for the emotional subscale (Emotional (ITT); p = 0.045); within the per-protocol analysis (PP; n = 80), significant group differences in favor of lifestyle-modification were evident for the emotional (Emotional (PP); p = 0.004); and the systemic subscale (Systemic (PP); p = 0.034). No further group differences were found (all p > 0.05). Values expressed as mean ± standard deviation. Asterisks indicate significant group differences.

Figure 4

Comprehensive lifestyle-modification program and self-care (control) on generic quality of life measured with the German version of the 36-item Short Form Health Survey, (A) mental health index score; (B) physical health index score; (C) subscales: PF = physical functioning; PRL = physical role limitations; BP = bodily pain; GHP = general health perceptions; VT = vitality; ERL = emotional role limitations; MH = mental health; SF = social functioning. Values expressed as mean ± standard deviation. Asterisks indicate significant group differences.

Figure 5

Dimension scaling (MDS) plot shows the generalized unifrac distances of the microbial profiles of the intervention and nonintervention groups at Week 12: No significant difference between the intervention and nonintervention groups at week 12 (A) even if controlling for immunosuppressant medications (B).