Initial management strategies for dyspepsia

Brendan Delaney; Alex C Ford; David Forman; Paul Moayyedi; Michelle Qume

doi:10.1002/14651858.CD001961.pub2

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Analysis 1.1

Comparison 1 Acid suppression ‐ internal comparisons, Outcome 1 PPI vs. Antacid/alginate.

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Analysis 1.5

Comparison 1 Acid suppression ‐ internal comparisons, Outcome 5 PPI vs. H2 Receptor antagonist.

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Analysis 1.7

Comparison 1 Acid suppression ‐ internal comparisons, Outcome 7 H2 receptor antagonist vs. antacid/alginate.

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Analysis 1.9

Comparison 1 Acid suppression ‐ internal comparisons, Outcome 9 Lansoprazole 15mg vs. Omeprazole 10mg.

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Analysis 2.1

Comparison 2 Initial endoscopy vs. empirical management, Outcome 1 Dyspepsia symptom scores.

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Analysis 2.2

Comparison 2 Initial endoscopy vs. empirical management, Outcome 2 Individual symptoms‐ epigastric pain.

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Analysis 2.3

Comparison 2 Initial endoscopy vs. empirical management, Outcome 3 Individual symptoms ‐ heartburn.

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Analysis 2.4

Comparison 2 Initial endoscopy vs. empirical management, Outcome 4 Global assessment of dyspepsia (primary outcome).

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Analysis 2.5

Comparison 2 Initial endoscopy vs. empirical management, Outcome 5 Quality of life scores.

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Analysis 2.6

Comparison 2 Initial endoscopy vs. empirical management, Outcome 6 Patient satisfaction.

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Analysis 2.7

Comparison 2 Initial endoscopy vs. empirical management, Outcome 7 Satisfaction score.

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Analysis 3.1

Comparison 3 H. pylori test and endoscopy vs. empirical therapy, Outcome 1 Dyspepsia symptom scores.

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Analysis 3.2

Comparison 3 H. pylori test and endoscopy vs. empirical therapy, Outcome 2 Quality of life.

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Analysis 3.3

Comparison 3 H. pylori test and endoscopy vs. empirical therapy, Outcome 3 Global assessment of dyspepsia (primary outcome).

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Analysis 4.1

Comparison 4 H. pylori test and treat vs. initial endoscopy, Outcome 1 Dyspepsia symptom scores.

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Analysis 4.2

Comparison 4 H. pylori test and treat vs. initial endoscopy, Outcome 2 Global assessment of dyspepsia (primary outcome).

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Analysis 4.5

Comparison 4 H. pylori test and treat vs. initial endoscopy, Outcome 5 IPD dichotomous symptom scores.

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Analysis 4.6

Comparison 4 H. pylori test and treat vs. initial endoscopy, Outcome 6 Proportion of patients endoscoped.

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Analysis 4.7

Comparison 4 H. pylori test and treat vs. initial endoscopy, Outcome 7 IPD Incremental Net Benefit.

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Analysis 5.1

Comparison 5 H. pylori test and treat vs. acid suppression/placebo, Outcome 1 Global assessment of dyspepsia (primary outcome).

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Analysis 5.2

Comparison 5 H. pylori test and treat vs. acid suppression/placebo, Outcome 2 Endoscopies.

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Table 1. Case mix in primary care dyspepsia trials

Study	Included	Excluded	Likely case mix	Details given
Goves	Heartburn, epigastric pain	Any organic diagnosis	Uninvestigated, Non‐ulcerdyspepsia, ENRD	95% had some reflux symptoms.
Mason	Heartburn, epigastric pain	Any organic diagnosis	Uninvestigated, Non‐ulcerdyspepsia, ENRD	93% had heartburn
Meimiche‐Schmidt 1997	Reflux like, Ulcer like by symptom pattern scoring	Group A ‐ Not investigated or no abnormality on endoscopy. Group B, Proven Peptic ulcer or oesophagitis	Group A Peptic ulcer, oesophagitis, Group B Uninvestigated, Non‐ulcer dyspepsia, ENRD.	Nil
Paton	Reflux like	Ulcer like only, Peptic ulcer or oesophageal stricture/ Barratt's.	ENRD, Oesophagitis	Nil
Jones 1997	Reflux like, Ulcer Like	None	All cases	25% ulcer like alone, 61% reflux like alone, 14% both. 27 cases of duodenal ulcer, 58 of proven oesophagitis.
Jones 1999a	Mild reflux or ulcer like symptoms	Peptic ulcer, Oesophagitis	Non ulcer, ENRD, uninvestigated	Ulcer like alone 15%, Reflux like alone 28%, both 57%.

Table 1. Case mix in primary care dyspepsia trials

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Comparison 1. Acid suppression ‐ internal comparisons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PPI vs. Antacid/alginate Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Global assessment of dyspepsia (primary outcome)	4	2154	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.54, 0.78]
1.2 Heartburn	2	1118	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.45, 0.60]
1.3 Epigastric pain	3	1267	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.63, 1.02]
1.4 Patient satisfaction	1	658	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.25, 0.37]
1.5 Withdrawals due to adverse events	1	828	Risk Ratio (M‐H, Random, 95% CI)	1.47 [0.15, 14.04]
5 PPI vs. H2 Receptor antagonist Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Global assessment of dyspepsia (Primary outcome)	3	1267	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.58, 0.72]
5.2 Epigastric pain	3	1222	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.58, 0.81]
5.3 Heartburn	3	1223	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.37, 0.57]
5.4 Patient satisfaction	1	558	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.21, 0.37]
7 H2 receptor antagonist vs. antacid/alginate Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 Global assessment of dyspepsia (primary outcome)	1	255	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.78, 1.24]
7.3 Heartburn	1	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.35, 2.11]
9 Lansoprazole 15mg vs. Omeprazole 10mg Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 Global assessment	1	562	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.69, 1.00]

Comparison 1. Acid suppression ‐ internal comparisons

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Comparison 2. Initial endoscopy vs. empirical management

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dyspepsia symptom scores Show forest plot	2	694	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.08 [‐0.23, 0.07]

2 Individual symptoms‐ epigastric pain Show forest plot	1	373	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.70, 1.09]

3 Individual symptoms ‐ heartburn Show forest plot	1	373	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.73, 1.19]

4 Global assessment of dyspepsia (primary outcome) Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Proportion of patients 'not improved'	4	1125	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.77, 1.02]
4.2 Proportion of days with symptoms	1	521	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.80, 1.25]
5 Quality of life scores Show forest plot	2	690	Std. Mean Difference (IV, Fixed, 95% CI)	0.09 [‐0.06, 0.24]

6 Patient satisfaction Show forest plot	1	373	Risk Ratio (M‐H, Fixed, 95% CI)	0.13 [0.06, 0.29]

7 Satisfaction score Show forest plot	1		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 Primary care	1	297	Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.23, 0.23]
7.2 Secondary care	1	171	Std. Mean Difference (IV, Fixed, 95% CI)	0.16 [‐0.17, 0.48]
7.3 Endoscopy	1	163	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.39 [‐0.73, ‐0.04]

Comparison 2. Initial endoscopy vs. empirical management

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Comparison 3. H. pylori test and endoscopy vs. empirical therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dyspepsia symptom scores Show forest plot	1	289	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.13 [‐0.37, 0.11]

2 Quality of life Show forest plot	1	288	Std. Mean Difference (IV, Fixed, 95% CI)	0.19 [‐0.05, 0.43]

3 Global assessment of dyspepsia (primary outcome) Show forest plot	3	686	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.84, 1.06]

Comparison 3. H. pylori test and endoscopy vs. empirical therapy

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Comparison 4. H. pylori test and treat vs. initial endoscopy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dyspepsia symptom scores Show forest plot	2	690	Std. Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.58, 0.31]

2 Global assessment of dyspepsia (primary outcome) Show forest plot	5	1682	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.79, 1.15]

5 IPD dichotomous symptom scores Show forest plot	5		Peto Odds Ratio (95% CI)	Subtotals only

5.1 All patients	5	1924	Peto Odds Ratio (95% CI)	0.75 [0.58, 0.96]
5.2 Age under 50	5	1454	Peto Odds Ratio (95% CI)	0.79 [0.58, 1.06]
5.3 Age over 50	4	470	Peto Odds Ratio (95% CI)	0.62 [0.40, 0.97]
5.4 Heartburn predominant	2	366	Peto Odds Ratio (95% CI)	0.80 [0.35, 1.84]
5.5 Epigastric pain predominant	2	563	Peto Odds Ratio (95% CI)	0.80 [0.52, 1.23]
6 Proportion of patients endoscoped Show forest plot	5	1845	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.15, 0.40]

7 IPD Incremental Net Benefit Show forest plot	5		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 Willingness to Pay = $0	5	1771	Mean Difference (IV, Fixed, 95% CI)	401.69 [328.64, 474.73]
7.2 Willingness to pay = $1000	5	1577	Mean Difference (IV, Fixed, 95% CI)	329.53 [236.32, 422.74]

Comparison 4. H. pylori test and treat vs. initial endoscopy

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Comparison 5. H. pylori test and treat vs. acid suppression/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global assessment of dyspepsia (primary outcome) Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 H.pylori positive only	2	563	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.63, 0.91]
1.2 All patients randomised before testing	2	497	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.45, 1.64]
2 Endoscopies Show forest plot	1	294	Odds Ratio (M‐H, Fixed, 95% CI)	0.68 [0.31, 1.53]

Comparison 5. H. pylori test and treat vs. acid suppression/placebo

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