. Author manuscript; available in PMC: 2022 Jun 1.

Published in final edited form as: Gastroenterology. 2021 Jun;160(7):2512–2556.e9. doi: 10.1053/j.gastro.2021.04.023

Table 16.

GRADE Evidence Profile evaluating thiopurines or antibiotics versus placebo for achieving fistula remission in patients with moderate to severe fistulizing Crohn’s disease.

Outcomes	Study event rates (95% CI)		Relative effect (95% CI)	Absolute effect*	No of participants (studies)	Quality of the evidence (GRADE)
THIOPURINES COMPARED TO PLACEBO FOR MODERATE TO SEVERE FISTULIZING CROHN’S DISEASE
Outcomes	Risk with placebo	Risk with thiopurines	Relative effect (95% CI)	Absolute effect*	No of participants (studies)	Quality of the evidence (GRADE)
Achieving fistula remission (CRITICAL)	1/5 (20%)	1/5 (20%)	RR 1.00 (0.08 to 11.93)	0 fewer per 1,000 (from 184 fewer to 1,000 more)	10 (1 RCT)	⨁◯◯◯^1,2 VERY LOW
¹ Rated down for risk of bias (subgroup analysis where randomization was not stratified by presence or absence of fistula)
² Rated down for very serious imprecision (very wide 95% CI where significant benefit or harm with thiopurines could not be excluded)
ANTIBIOTICS COMPARED TO PLACEBO FOR MODERATE TO SEVERE FISTULIZING CROHN’S DISEASE
Outcomes	Study event rates (95% CI)		Relative effect (95% CI)	Absolute effect*	No of participants (studies)	Quality of the evidence (GRADE)
Outcomes	Risk with placebo	Risk with antibiotics	Relative effect (95% CI)	Absolute effect*	No of participants (studies)	Quality of the evidence (GRADE)
Induction of clinical remission (CRITICAL)	7/8 (87.5%)	14/17 (82.4%)	RR 0.94 (0.67 to 1.33)	18 fewer per 1,000 (from 210 fewer to 315 more)	35 (1 RCT)	⨁⨁◯◯² LOW
¹ Rated down for very serious imprecision (very wide 95% CI where significant benefit or harm with thiopurines could not be excluded)
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect