Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36, Italian version 1.6) questionnaire
Baseline and 6 months
Mean change of each domain score between baseline and 6 months in the mesalazine and rifaximin group. Difference of the mean scores of each domain at baseline and 6 months between the two groups.
Physical health:
In the mesalazine group there was a significant improvement of physical functioning (p=0.05), role limitation-physical (p=0.034), general health (p=0.01), and social functioning (p<0.01) at 6 months. In the rifaximin group there was a significant improvement of role limitation-physical (p=0.04) and social functioning (p=0.03) at 6 months. There was no statistically significant difference of SF-36 mean scores between the two groups at baseline. There was a higher improvement of physical functioning (p<0.05) and general health (p=0.01) in the mesalazine than rifaximin group at 6 months.
Difference of the mean quality-of-life sub-scores at baseline and 24 months between mesalazine and placebo group.
Sleeping problem Physical status interfering with sexual activity Problem in out-door activities Problem in social activities Problem in in-house activities different from house works Problem in daily work activities Problem in free-time activities
There was no statistically significant difference of the total quality-of-life sub-score between the mesalazine and placebo group at baseline and 24 months.
(1) EuroQol five dimensions questionnaire (EQ-5D) (2) Health Utilities Index Version Mark 2 (HUI2) questionnaire
Baseline and 16, 52, 78, 104 weeks
Difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms (mesalazine 1200mg, mesalazine 2400mg, mesalazine 4800mg, placebo).
EQ-5D questionnaire:
There was no statistically significant difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms.
(1) EuroQol five dimensions questionnaire (EQ-5D) (2) Health Utilities Index Version Mark 2 (HUI2) questionnaire
Baseline and 16, 52, 78, 104 weeks
Difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms (mesalazine 1200mg, mesalazine 2400mg, mesalazine 4800mg, placebo).
EQ-5D questionnaire:
There was no statistically significant difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms.
Mobility
Self-care
Usual activities
Pain/discomfort
Anxiety/depression
HUI2 questionnaire:
Sensation
Cognition
Mobility
Self-care
Emotion
Pain
Fertility
EQ-5D, EuroQol five dimensions; HUI2, Health Utilities Index Version Mark 2. validated to measure generic health outcomes in all therapeutic areas. -item questionnaire: the sum of items 1-4 defines the physical condition subscore, while the sum of items 5-11 defines the quality-of-life subscore.
