Table 2.
Mean change from baseline | Tr. effect | (95 % Confidence interval) | p value | |||
---|---|---|---|---|---|---|
Variable | Control | Treatment | Low | High | ||
Treatment effects on physical and psychological outcomes after 4 weeks* | ||||||
Primary outcomes | ||||||
Patient assessment of constipation | ||||||
Physical discomfort | −0.23 | −0.84 | −0.61 | −0.88 | −0.34 | < 0.001 |
Psychosocial discomfort | −0.15 | −0.63 | −0.48 | −0.74 | −0.22 | 0.001 |
Worries and concerns | −0.14 | −0.82 | −0.68 | −0.95 | −0.40 | < 0.001 |
Satisfaction | 0.21 | 0.77 | 0.56 | 0.22 | 0.89 | 0.001 |
All | −0.17 | −0.76 | −0.59 | −0.81 | −0.37 | < 0.001 |
Secondary outcomes | ||||||
SF-12v2 | ||||||
Physical component score | −0.36 | 2.69 | 3.05 | 0.85 | 5.25 | 0.008 |
Mental component score | 0.30 | 3.12 | 2.82 | −0.10 | 5.74 | 0.061 |
Modified bowel function index | −4.2 | −18.1 | −13.8 | −22.5 | −5.1 | 0.002 |
Hemorrhoid symptom score | −0.03 | −0.43 | −0.40 | −0.63 | −0.17 | 0.001 |
* Values are the mean change from the baseline for the treatment and control groups using a Last Observation Carried Forward (LOCF) method for dealing with the nine missing values. All data included. ITT analysis. p values based on heteroskedastic robust standard errors