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. 2021 Apr 30;27(2):165–175. doi: 10.5056/jnm20161

Table 2.

Grading of Recommendations, Assessment, Development, and Evaluation Assessment for Proton Pump Inhibitor Plus Prokinetic Versus Proton Pump Inhibitor Monotherapy Studies

PPI plus prokinetic compare to PPI for GERD
Patient: GERD
Setting: out patients
Intervention: PPI plus prokinetic
Comparison: PPI monotherapy

Outcome Anticipated absolute effects (95% CI) Relative effect (95% CI) No of participants (studies) Certainty of the evidence (GRADE) Comments

Risk with PPI Risk with PPI plus prokinetic

Symptom improvement 51 per 100 (46 to 56) 64 per 100 (59 to 69) RR 1.22 (1.11-1.35) 1032 (9 RCTs) Moderatea Higher scores mean better quality of life
Change of QoL scores - - - 300 (2 RCTs) Very lowa,b,c
Adverse events 11 per 100 (6 to 16) 10 per 100 (5 to 15) RR 0.91 (0.57-1.45) 725 (8 RCTs) Lowa,b

aDowngraded one level due to study limitations: most information were obtained from studies with unclear risk of bias.

bDowngraded one levels due to imprecision (small number of included trials).

cDowngraded one level due to serious inconsistency: significant heterogeneity.

Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)––working group grades of evidence:

  • High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
  • Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
  • Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

PPI, proton pump inhibitor; GERD, gastroesophageal reflux disease; RR, risk ratio; RCTs, randomized controlled trials; QoL, quality of life.