TABLE 1.
a PPI treatment of ECP related to GERD | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Referenc e |
Method s Score |
Interventio n |
Study Design |
Study Size (n) |
Mean Age Years |
F/M | Duratio n |
Outcome Measures |
Patient characteristics |
Results | Safety Analysis |
14 Fass et al. |
5 | Omeprazole 40 mg a.m. and 20 mg p.m. or Placebo |
Double-blind, placebo controlled crossover |
39 | 60 | 1/38 | 7 days then crossov er for 7 days |
CPF and CPS on a VAS Composite chest pain score severity x frequency/wk |
+ve and −ve EGD and/ or positive pH metry, no manometry, −ve cardiac angiogram or – ve cardiac stress tests |
|
1 diarrhea and 1 abdominal pain |
19 Achem et al. |
5 | Omeprazole 20 mg BID or Placebo |
Double-blind, placebo controlled |
36 | 49 | 23/1 1 |
8 weeks | CPF and CPS (0– 10); global chest pain rating (better, same and worse) |
−ve EGD (90%), +ve pH metry (100%), +ve/−ve manometry, −ve coronary angiography, or −ve stress thallium test |
|
Mild symptoms of headaches, abdominal pain, diarrhea, nausea and rash |
20 Pandak et al. |
5 | Omeprazole 40 mg BID or Placebo |
Double-blind, placebo controlled crossover |
42 | 48 | 24/1 8 |
14 days then crossov er for 14 days |
CPF and CPS improvement in 2 points from baseline VAS(0–10) and > 50% response |
+ve and −ve EGD and/ or +ve pH metry, −ve stress test |
|
Not performed |
21Xia et al | 2 | Lansoprazole 30 mg/day or placebo |
Single blind, placebo controlled |
68 | 58 | 26/42 | 4 weeks | CPF and CPS= severity x frequency/wk |
−ve EGD, +ve and −ve pH metry, no manometry, −ve coronary angiography |
|
Not reported |
22Bautista et al. |
4 | Lansoprazole 60 mg am and 30 mg pm or placebo |
Double blind, placebo-controlled crossover |
40 | 54 | 9/31 | 7 days then crossover for 7days |
CPF and CPS VAS Composite chest pain score severity x frequency/wk |
+ve EGD and / or pH metry −ve coronary angiogram or – ve cardiac stress test |
|
Not reported |
23Dickman et al. |
4 | Rabeprazole 20 mg/day or placebo |
Double blind, placebo controlled, crossover |
35 | 56 | 12/23 | 7 days | CPF and CPS improvement > 50% |
+ve and −ve EGD, and/ or pH metry, no manometry, −ve coronary angiogram or – ve stress test |
|
Not reported |
24Kim et al. |
0 | Rabeprazole 20 mg BID |
Open label trial, First week vs second week |
42 | 54 | 17/25 | 2 weeks | CPF and CPS = >50% improvement Composite score= severity x frequency/wk |
+ve and −ve EGD and/ or +ve pH metry, no manometry, −ve stress test |
|
Not performed |
b Quality assessment of PPIs | ||||
---|---|---|---|---|
Reference | Randomization | Blinding | Statement on Withdrawals | Total Score |
Fass et al. (14) | 2 | 2 | 1 | 5 |
Achem et al. (19) | 2 | 2 | 1 | 5 |
Pandak et.al. (20) | 2 | 2 | 1 | 5 |
Xia et al. (21) | 1 | 0 | 1 | 2 |
Bautista et al. (22) | 2 | 2 | 0 | 4 |
Dickman et al. (23) | 2 | 2 | 0 | 4 |
Kim et al. (24) | 0 | 0 | 0 | 0 |
CPF: Chest Pain Frequency CPS: Chest Pain Score (severity) VAS: Visual Analog Scale GERD: Gastroesophageal Reflux Disease
NS: Not Significant