Helicobacter pylori and functional dyspepsia: An unsolved issue?

Table 1 Double-blind, placebo-controlled trials on Helicobacter pylori eradication in functional dyspepsia patients

Patients (follow-up)	Low-dose aspirin	Gastric erosions	Symptoms evaluated	Score used (period)	Primary end-point	Comment	Ref.
Therapy = 160 Placebo = 158 (12 mo)	No	NA	Pain or discomfort; heartburn; nausea; postprandial fullness	GDSS: 0-20 (the last 6 mo)	Therapy better than placebo	Evaluation according to the final H. pylori status was lacking	[11]
Therapy = 170 Placebo = 167 (12 mo)	Yes	< 5	Ulcer-like; motility-like; reflux-like	GSRS: 0-6 (the last 7 d)	No difference	Rate of family history of ulcers (34% vs 23%) and caffeine use (82% vs 73%) were significantly higher in therapy group than placebo. Distribution of low-dose aspirin use was lacking. The rate of “indeterminate” UBT result was unexpectedly high (16%)	[16]
Therapy = 129 Placebo = 124 (12 mo)	No	No	Epigastric pain; nausea; abdominal distension; eructation; vomiting; early satiety; regurgitation; retrosternal burning	Likert score: 0-5 (the last 7 d)	Therapy better than placebo	Difference remained significant when symptoms resolution was assessed according to final H. pylori status	[23]
Therapy = 81 Placebo = 80 (12 mo)	No	NA	Epigastric pain; burning; postprandial fullness; nausea; vomiting	Score: 0-3 (the last 1 d)	No difference	No difference was observed when symptoms resolution was assessed according to final H. pylori status	[24]
Therapy = 135 Placebo = 143 (12 mo)	NA	< 5	Ulcer-like; motility-like; reflux-like	GSRS: 1-7 (the last 7 d)	No difference	No difference according to final H. pylori status. A significant difference was observed between patients with persistent gastritis and those with gastritis healing	[25]
Therapy = 135 Placebo = 143 (6 mo)	No	< 10	Epigastric pain or burning; epigastric fullness; heartburn, regurgitation; nausea vomiting, abdominal pain; flatulence; diarrhoea; constipation	Likert score: 0-3 (the last 7 d)	No difference	No difference was observed when symptoms resolution was assessed according to final H. pylori status	[26]
Therapy = 71 Placebo = 65 (12 mo)	Yes	No	Epigastric pain; nausea; bloating; heartburn early satiety; vomiting; regurgitation; hunger pain	Score: 0-16 (the last 1 d)	No difference	No difference was observed according to final H. pylori status. Both patient groups received omeprazole therapy during the first 3 mo	[27]
Therapy = 201 Placebo = 203 (12 mo)	Yes	Yes	Rome III criteria	PADYQ: 0-44 (the last 30 d)	Therapy better than placebo	Therapy success occurred for “postprandial distress syndrome” but not for “epigastric pain syndrome”	[28]
Therapy = 75 Placebo =82 (12 mo)	Yes	< 5	Epigastric pain; belching; heartburn, bloating; flatulence; sour taste; nausea; halitosis	DSS likert score: 1-5	No difference	No difference was observed when symptoms resolution was assessed according to final H. pylori status	[29]
Therapy = 50 Placebo = 50 (12 mo)	No	No	Ulcer-like; motility-like; reflux-like; unspecified	Score for severity: 0-2 Score for frequency: 0-3	Therapy better than placebo	Difference was based on the reduction on mean score. Difference remained significant according to final H. pylori status. The rate of asymptomatic patients was lacking	[30]
Therapy = 50 Placebo = 50 (12 mo)	NA	NA	Abdominal fullness; early satiety; bloating; nausea (Rome II criteria)	Likert score: 0-6	No difference	No difference was observed when symptoms resolution was assessed according to final H. pylori status	[31]
Therapy = 164 Placebo = 164 (12 mo)	NA	< 5	Indigestion; diarrhoea constipation; reflux; abdominal pain	GSRS: 1-7 (the last 7 d)	No difference	No difference was observed when symptoms resolution was assessed according to final H. pylori status	[32]

GSRS: Gastrointestinal symptoms rating score; GDSS: Glasgow dyspepsia severity score; PADYQ: Porto Alegre dyspeptic symptoms questionnaire; DSS: Dyspepsia summary score; NA: Not available.