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. Author manuscript; available in PMC: 2019 Jul 1.
Published in final edited form as: Gastroenterology. 2018 Apr 25;155(1):47–57. doi: 10.1053/j.gastro.2018.03.063

Table 2.

Percent of Responders on CGI as Reported by Patients and Physicians

Per Protocol Intent-To-Treat
Condition Immediate 3 Month 6 Month Immediate 3 Month 6 Month
Patient-Report CGI
 MC-CBT 68.1% ± 8.1 64.0% ± 8.8 63.9% ± 8.8 61.0% ± 8.0 57.0% ± 8.4 56.6% ± 8.4
 S-CBT 64.6% ± 8.9 64.6% ± 9.3 58.1% ± 9.4 54.5% ± 8.4 53.3% ± 8.6 48.1% ± 8.6
 EDU 46.7% ± 8.8 49.5% ± 9.3 51.0% ± 9.6 43.5% ± 8.4 45.8% ± 9.0 47.0% ± 9.2
 MC-CBT – S-CBT 3.5% ± 12.0 <1% ± 12.7 5.9% ± 12.9 6.5% ± 11.6 3.7% ± 12.0 8.5% ± 12.0
 MC-CBT – EDU 21.5% ± 12.0** 14.5% ± 12.8* 12.9% ± 13.0a,b 17.6% ± 11.6** 11.2% ± 12.3a,b 9.6% ± 12.5
 S-CBT – EDU 18.1% ± 12.5** 15.0% ± 13.1* 7.1% ± 13.4 11.1% ± 11.9a,b 7.5% ± 12.2 1.1% ± 12.6
 MC-CBT – S-CBT CI −8.5% to 15.5% −13.2% to 12.5% −7.0% to 18.7% −5.1% to 18.0% −8.3% to 15.8% −3.6% to 20.5%
Physician-Rated CGI
 MC-CBT 63.0% ± 9.0 - 66.4% ± 9.1 55.7% ± 8.6 - 58.4% ± 8.9
 S-CBT 61.0% ± 9.4 - 64.0% ± 9.9 50.6% ± 8.7 - 51.6% ± 9.2
 EDU 43.6% ± 9.2 - 49.6% ± 10.5 40.4% ± 8.8 - 44.8% ± 10.0
 MC-CBT – S-CBT 2.0% ± 13.0 - 2.4% ± 13.5 5.1% ± 12.2 - 6.8% ± 12.8
 MC-CBT – EDU 19.4% ± 12.9** - 16.8% ± 13.9* 15.2% ± 12.3** - 13.7% ± 13.4*
 S-CBT – EDU 17.4% ± 13.1* - 14.4% ± 14.5a,b 10.1% ± 12.4 - 6.8% ± 13.6
 MC-CBT – S-CBT CI −10.0% to 15.0% - −11.1% to 15.9% −7.1% to 17.3% - −5.9% to 19.6 %

notes:

*

p < 0.05,

**

p < 0.01,

a

p < 0.08;

b

trend p value using listwise deletion is p < 0.05 for chained equation missing data algorithm; MC-CBT - S-CBT CI = 95% CI for difference; numbers after ± are margins of error (half widths of 95% CIs); IBSOS was not designed to collect blind ratings at 3 month follow up