Table 5.
Median changes in the IBDQ bowel function component and IBDQ rectal bleeding scores from baseline to 12 months in patients assessed within 10–14 months
|
Median score at baseline (IQR) |
Median score at 12 months (IQR) |
Median change from baseline to 12 months (IQR) |
Mann-Whitney testUscore | p value | ||||
|---|---|---|---|---|---|---|---|---|
| Sham | Hyperbaric oxygen | Sham | Hyperbaric oxygen | Sham | Hyperbaric oxygen | |||
| Bowel function* | 51 (44 to 59) | 48 (42 to 52) | 53 (40 to 59) | 51 (36 to 62) | 4 (−6 to 9) | 3·5 (−3 to 11) | 0·67 | 0·50 |
| Rectal bleeding† | 3 (2 to 4) | 3 (2 to 4) | 4 (2 to 6) | 6 (3 to 7) | 1 (1 to 2) | 3 (1 to 3) | 1·69 | 0·092 |
Positive changes indicate higher median Inflammatory Bowel Disease Questionnaire (IBDQ) scores, which signify improvement in symptoms.
Analysis included 23 patients in the sham control group and 46 patients in the hyperbaric oxygen treatment group.
Analysis included 11 patients in the sham control group and 29 patients in the hyperbaric oxygen treatment group. 40 (47%) of 84 patients scored grade 1–5 (clinically significant) rectal bleeding on the IBDQ bowel function component, compared with 57 (68%) patients reporting any rectal bleeding in their medical history (panel). 46 (55%) patients had grade 1–3 rectal bleeding at baseline according to Common Terminology Criteria for Adverse Events scoring system, and 47 (59%) patients had grade 1–3 rectal bleeding in response to EORTC QLQ-CR38 Question 59.