Proton pump inhibitors for functional dyspepsia

Maria Ines Pinto‐Sanchez; Yuhong Yuan; Ahmed Hassan; Premysl Bercik; Paul Moayyedi

doi:10.1002/14651858.CD011194.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Funnel plot of comparison: 3 Proton pump inhibitors versus placebo, outcome: 3.1 Global symptoms (two to eight weeks).

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Analysis 1.1

Comparison 1 Standard‐dose versus low‐dose proton pump inhibitors (PPI), Outcome 1 Global symptoms of dyspepsia.

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Analysis 2.1

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 1 Global symptoms of dyspepsia.

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Analysis 2.2

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 2 Global symptoms of dyspepsia by duration of treatment.

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Analysis 2.3

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 3 Subgrouped by country of origin.

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Analysis 2.4

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 4 Subgrouped byHelicobacter pylori status.

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Analysis 2.5

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 5 Subgroup by PPI subtype.

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Analysis 2.6

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 6 Subgrouped by 24‐hour pH study.

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Analysis 2.7

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 7 Subgrouped by Rome III dyspepsia subtypes.

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Analysis 2.8

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 8 Subgrouped by low vs unclear vs high risk of bias.

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Analysis 2.9

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 9 Subgrouped by publication type.

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Analysis 2.10

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 10 Quality of life.

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Analysis 2.11

Comparison 2 Proton pump inhibitors (PPI) versus placebo, Outcome 11 Adverse events.

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Analysis 3.1

Comparison 3 Proton pump inhibitors (PPI) versus H2 receptor antagonists (H2RA), Outcome 1 Global symptoms of dyspepsia.

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Analysis 3.2

Comparison 3 Proton pump inhibitors (PPI) versus H2 receptor antagonists (H2RA), Outcome 2 Adverse events.

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Analysis 4.1

Comparison 4 Proton pump inhibitors (PPI) versus prokinetics, Outcome 1 Global symptoms of dyspepsia (2‐4 weeks).

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Analysis 4.2

Comparison 4 Proton pump inhibitors (PPI) versus prokinetics, Outcome 2 Quality of life.

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Analysis 4.3

Comparison 4 Proton pump inhibitors (PPI) versus prokinetics, Outcome 3 Adverse events.

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Analysis 5.1

Comparison 5 Proton pump inhibitors (PPI) plus prokinetics versus prokinetics alone, Outcome 1 Global symptoms of dyspepsia (2‐4 weeks).

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Analysis 5.2

Comparison 5 Proton pump inhibitors (PPI) plus prokinetics versus prokinetics alone, Outcome 2 Quality of life.

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Analysis 5.3

Comparison 5 Proton pump inhibitors (PPI) plus prokinetics versus prokinetics alone, Outcome 3 Adverse events.

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Summary of findings for the main comparison. Proton pump inhibitors (PPI) compared to placebo for functional dyspepsia

PPI versus placebo for functional dyspepsia
Patient or population: functional dyspepsia Setting: secondary and tertiary centres Intervention: PPI Comparison: placebo
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with Proton pump inhibitors (PPI)
Global symptoms of dyspepsia (> 2 weeks)	Study population		RR 0.88 (0.82 to 0.94)	6172 (18 RCTs)	⊕⊕⊕⊝ Moderate¹	Measurement of no improvement.
	714 per 1000	629 per 1000 (586 to 671)
Quality of life Psychological General Well‐Being Index (Scale from: 22 to 132) and SF‐36 (Scale from: 0 to 100) combined	The mean post‐treatment PGWB score was 99.84, the mean post‐treatment SF‐36 score was 66.2	SMD 0.01 higher (0.09 lower to 0.11 higher)		1630 (3 RCTs)	⊕⊕⊕⊝ Moderate²	Higher scores means better quality of life.
Adverse events	Study population		RR 0.99 (0.73 to 1.33)	2693 (6 RCTs)	⊕⊕⊕⊝ Moderate¹	Number of adverse events.
	191 per 1000	189 per 1000 (140 to 254)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; PPI: proton pump inhibitor; RCT: randomized controlled trial; RR: risk ratio; SF‐36: 36‐item Short Form.
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.
¹Downgraded one level due to serious inconsistency between studies. ²Downgraded one level due to imprecision.

Summary of findings for the main comparison. Proton pump inhibitors (PPI) compared to placebo for functional dyspepsia

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Summary of findings 2. Proton pump inhibitors (PPI) compared to H2 receptor antagonists (H2RA) for functional dyspepsia

PPI versus H2RA for functional dyspepsia
Patient or population: adults with functional dyspepsia Setting: secondary centres Intervention: PPI Comparison: H2RA
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with H2RA	Risk with PPI
Global symptoms of dyspepsia Follow‐up: range 2‐8 weeks	Study population		RR 0.88 (0.74 to 1.04)	740 (2 RCTs)	⊕⊕⊝⊝ Low¹	Measurement of no improvement.
	739 per 1000	650 per 1000 (547 to 769)
Quality of life Follow‐up: range 2‐8 weeks	‐	‐	Not estimable	(0 studies)	‐	No data available.
Adverse events Follow‐up range 2‐8 weeks	Study population		RR 0.97 (0.64 to 1.46)	589 (1 RCT)	⊕⊕⊕⊝ Moderate²	Number of adverse events.
	144 per 1000	137 per 1000 (89 to 209)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; H2RA: H2 receptor antagonist; PPI: proton pump inhibitor; RCT: randomized controlled trial; RR: risk ratio.
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.
¹Downgraded two levels due to imprecision, substantial heterogeneity (I² = 51%) and high risk of bias in one of the two studies. ²Downgraded one level due to serious imprecision (95% CI included appreciable benefit and harm and low number of events).

Summary of findings 2. Proton pump inhibitors (PPI) compared to H2 receptor antagonists (H2RA) for functional dyspepsia

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Summary of findings 3. Proton pump inhibitors (PPI) compared to prokinetics for functional dyspepsia

PPI versus prokinetics for functional dyspepsia
Patient or population: adults with functional dyspepsia Setting: secondary and tertiary centres Intervention: PPI Comparison: prokinetic
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with prokinetic	Risk with PPI
Global symptoms of dyspepsia Follow‐up: range 2‐4 weeks	Study population		RR 0.89 (0.81 to 0.99)	1033 (5 RCTs)	⊕⊕⊝⊝ Low^1,2	Measurement of no improvement.
	495 per 1000	441 per 1000 (401 to 490)
Quality of life Korean version of the dyspepsia related Nepean Dyspepsia Index (NDI) from: 0 to 99 Follow‐up: range 2‐4 weeks	The mean NDI score change from baseline was 20.4	MD 0.5 lower (4.42 lower to 3.42 higher)		262 (1 RCT)	⊕⊕⊕⊝ Moderate¹	Higher scores denote better outcome.
Adverse events Follow‐up: 4 weeks	Study population		RR 1.09 (0.79 to 1.49)	1033 (5 RCTs)	⊕⊕⊕⊝ Moderate³	Number of adverse events.
	113 per 1000	123 per 1000 (89 to 168)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PPI: proton pump inhibitor; RCT: randomized controlled trial; RR: risk ratio.
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.
¹Downgraded one level due to serious imprecision. ²Downgraded one level due to risk of bias in four of the five studies. ³We did not consider the impact of risk of bias and inconsistency on the results to be serious enough to justify fully downgrading two levels so we have downgraded one level in respect of both considerations.

Summary of findings 3. Proton pump inhibitors (PPI) compared to prokinetics for functional dyspepsia

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Summary of findings 4. Proton pump inhibitors plus prokinetics compared to prokinetics alone for functional dyspepsia

PPI + prokinetics versus prokinetics alone for functional dyspepsia
Patient or population: adults with functional dyspepsia Setting: secondary and tertiary centres Intervention: PPI + prokinetic Comparison: prokinetic alone
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with prokinetic alone	Risk with PPI + prokinetic
Global symptoms of dyspepsia Follow‐up range: 2 to 4 weeks	Study population		RR 0.85 (0.68 to 1.08)	407 (2 RCTs)	⊕⊕⊕⊝ Moderate¹	Measurement of no improvement.
	444 per 1000	377 per 1000 (302 to 479)
Quality of life Korean version of the dyspepsia related Nepean Dyspepsia Index (0 to 99) and Functional Digestive Disorders Quality of Life questionnaire (FDDQL) scale Follow‐up: 4 weeks	NDI		‐	258 (1 RCT)	⊕⊕⊕⊝ Moderate¹	Higher scores denote better outcome.
	The mean NDI score change from baseline was 20.4	MD for NDI score change from baseline 1.10 lower (5.22 lower to 3.02 higher)
	FDDQL		‐	149 (1 RCT)	⊕⊕⊕⊝ Moderate¹	Higher scores denote better outcome.
	The mean post‐treatment FDDQL score was 70.56	MD for FDDQL score 18.96 higher (17.01 lower to 20.91 higher)
Adverse events Follow‐up: 4 weeks	Study population		RR 0.60 (0.39 to 0.93)	407 (2 RCTs)	⊕⊕⊕⊝ Moderate¹	Number of adverse events.
	220 per 1000	132 per 1000 (86 to 204)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; PPI: proton pump inhibitor; RCT: randomized controlled trial; RR: risk ratio.
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.
¹Downgraded one level due to serious imprecision .

Summary of findings 4. Proton pump inhibitors plus prokinetics compared to prokinetics alone for functional dyspepsia

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Table 1. Definitions of functional dyspepsia

Functional dyspepsia	Rome I (1991)	Rome II (1999)	Rome III (2006) Rome IV (2016)	AGA Working Group	Lancet Working Group (1998)
Main criteria	Pain or discomfort centred in the upper abdomen with no evidence of organic disease.	Persistent or recurrent symptoms (pain or discomfort centred in the upper abdomen). AND No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (exclude irritable bowel syndrome and exclude reflux).	≥ 1 symptoms need to be present: Bothersome postprandial fullness; Early satiation; Epigastric pain; Epigastric burning.	Chronic or recurrent pain or discomfort centred in the upper abdomen.	Chronic or recurrent pain or discomfort centred in the upper abdomen or retrosternal pain, discomfort, heartburn, nausea, vomiting or other symptoms of the gastrointestinal tract.
Normal upper endoscopy	Required.	Required.	Required.	Required.	Required.
Symptoms present for the last...	‐	12 weeks, which need not be consecutive.	Criteria fulfilled for the last 3 months.	≥ 3 months.	≥ 4 weeks.
Onset of symptoms	‐	12 months.	6 months.	‐	‐
Subtypes	Ulcer‐like dyspepsia. Dysmotility (stasis)‐like dyspepsia. Reflux‐like dyspepsia.	Ulcer‐like dyspepsia. Dysmotility‐like dyspepsia.	Postprandial distress syndrome. Epigastric pain syndrome.	‐	Reflux‐like dyspepsia.
AGA: American Gastroenterological Association.

Table 1. Definitions of functional dyspepsia

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Table 2. Proton pump inhibitor equivalent doses

Proton pump inhibitor	Daily standard dose
Dex‐lansoprazole	30 mg
Esomeprazole	20 mg to 40 mg
Lansoprazole	30 mg
Omeprazole	20 mg
Pantoprazole	40 mg
Rabeprazole	20 mg

Table 2. Proton pump inhibitor equivalent doses

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Comparison 1. Standard‐dose versus low‐dose proton pump inhibitors (PPI)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global symptoms of dyspepsia Show forest plot	6	2304	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.92, 1.02]

Comparison 1. Standard‐dose versus low‐dose proton pump inhibitors (PPI)

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Comparison 2. Proton pump inhibitors (PPI) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global symptoms of dyspepsia Show forest plot	18	6172	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.82, 0.94]

2 Global symptoms of dyspepsia by duration of treatment Show forest plot	17		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 2 weeks' therapy	4	1169	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.70, 0.87]
2.2 4 weeks' therapy	9	2425	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.76, 1.03]
2.3 8 weeks' therapy	4	2447	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.86, 0.98]
3 Subgrouped by country of origin Show forest plot	18	6172	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.82, 0.94]

3.1 Western countries	14	5213	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.79, 0.92]
3.2 Eastern countries	4	959	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.84, 1.11]
4 Subgrouped byHelicobacter pylori status Show forest plot	6	3023	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.82, 0.96]

4.1 H pylori negative	6	1721	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.83, 1.06]
4.2 H pylori positive	6	1302	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.76, 0.93]
5 Subgroup by PPI subtype Show forest plot	18	6172	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.82, 0.94]

5.1 Omeprazole vs placebo	7	2238	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.79, 0.98]
5.2 Esomeprazole vs placebo	3	1261	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.65, 1.09]
5.3 Lansoprazole vs placebo	5	1801	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.70, 0.97]
5.4 Pantoprazole vs placebo	1	419	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.68, 1.00]
5.5 Rabeprazole vs placebo	2	453	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.84, 1.08]
6 Subgrouped by 24‐hour pH study Show forest plot	2	168	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.73, 1.47]

6.1 Abnormal 24‐hour pH test (> 4% pH < 4)	2	75	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.70, 1.19]
6.2 Normal 24‐hour pH test (< 4% pH < 4)	2	93	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.49, 3.29]
7 Subgrouped by Rome III dyspepsia subtypes Show forest plot	2	326	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.80, 1.03]

7.1 Epigastric pain syndrome	2	77	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.76, 1.28]
7.2 Postprandial distress syndrome	2	249	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.77, 1.03]
8 Subgrouped by low vs unclear vs high risk of bias Show forest plot	18	6172	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.82, 0.94]

8.1 Low risk of bias	4	1691	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.73, 0.98]
8.2 Unclear risk of bias	10	3322	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.79, 0.94]
8.3 High risk of bias	4	1159	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.80, 1.24]
9 Subgrouped by publication type Show forest plot	18	6172	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.82, 0.94]

9.1 Full text	15	5657	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.81, 0.94]
9.2 Abstract	3	515	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.68, 1.15]
10 Quality of life Show forest plot	3	1630	Std. Mean Difference (IV, Random, 95% CI)	0.01 [‐0.09, 0.11]

10.1 Psychological General Well‐Being Index	2	1177	Std. Mean Difference (IV, Random, 95% CI)	0.03 [‐0.09, 0.15]
10.2 36‐item Short Form	1	453	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.25, 0.14]
11 Adverse events Show forest plot	6	2693	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.73, 1.33]

Comparison 2. Proton pump inhibitors (PPI) versus placebo

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Comparison 3. Proton pump inhibitors (PPI) versus H2 receptor antagonists (H2RA)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global symptoms of dyspepsia Show forest plot	2	740	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.74, 1.04]

2 Adverse events Show forest plot	1	589	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.64, 1.46]

Comparison 3. Proton pump inhibitors (PPI) versus H2 receptor antagonists (H2RA)

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Comparison 4. Proton pump inhibitors (PPI) versus prokinetics

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global symptoms of dyspepsia (2‐4 weeks) Show forest plot	5	1033	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.81, 0.99]

2 Quality of life Show forest plot	1	262	Mean Difference (IV, Random, 95% CI)	‐0.5 [‐4.42, 3.42]

3 Adverse events Show forest plot	5	1033	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.79, 1.49]

Comparison 4. Proton pump inhibitors (PPI) versus prokinetics

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Comparison 5. Proton pump inhibitors (PPI) plus prokinetics versus prokinetics alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global symptoms of dyspepsia (2‐4 weeks) Show forest plot	2	407	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.68, 1.08]

2 Quality of life Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 Nepean Dyspepsia Index	1	258	Mean Difference (IV, Random, 95% CI)	‐1.10 [‐5.22, 3.02]
2.2 FDDQL scale	1	149	Mean Difference (IV, Random, 95% CI)	18.96 [17.01, 20.91]
3 Adverse events Show forest plot	2	407	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.39, 0.93]

Comparison 5. Proton pump inhibitors (PPI) plus prokinetics versus prokinetics alone

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