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. Author manuscript; available in PMC: 2015 Aug 1.
Published in final edited form as: Clin Gastroenterol Hepatol. 2013 Aug 28;12(8):1224–1245. doi: 10.1016/j.cgh.2013.08.036

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
  • Response to Omeprazole in GERD+ ve vs GERD −ve

    • Resolution: 52% vs 4%.

    • > 50% improvement:26% vs 18%

    • <50% improvement: 18% vs 27%

    • No change:4% vs 51%

  • Response to Placebo in GERD+ vs GERD-=23% vs 7%

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
  • CPF: decreased 39% (omeprazole) and 10% (placebo), p<0.006

  • CPS: decreased 41% (omeprazole) and 15% (placebo), p<0.032

  • global severity: Omeprazole better 81%, same 6%, worse 13% vs placebo 6%, 72%, and 22% respectively (p<0.001)

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
  • Overall Response: 71% (Omeprazole) and 18% (placebo)

  • Responders:

    • GERD +ve: 95% omeprazole v 10% placebo

    • GERD − ve:39% omeprazole

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
  • Overall improvement 53% (Lansoprazole) vs 34% (placebo), p<0.127

  • Responders:

    • GERD +ve: 92% (Lansoprazole) vs 33% (placebo), p<0.001

    • GERD −ve: 33% (Lansoprazole) vs 35% (Placebo), p=NS

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
  • Lanzoprazole Response

  • GERD+ ve vs GERD −ve

    • Resolution: 39% vs 0%.

    • > 50% improvement:39% vs 9%

    • <50% improvement: 5% vs 50%

    • No change: 17% vs 41%

  • Lansoprazole vs placebo

    • GERD + ve 78% vs 22%, p=0.01

    • Gerd −ve: 9% vs 36%, p=0.7

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
  • Rabeprazole vs Placebo: > 50% improvement

  • GERD+ve: 75% vs 11%

  • GERD−ve: 19% vs 21%

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
  • Overall response, week 2: 81% (Rabeprazole) and 27% (placebo)

  • GERD+ ve vs GERD −ve

    • Resolution: 45% vs 12%.

    • > 50% improvement:38% vs 14%

    • <50% improvement: 6% vs 28%

    • No change:11% vs 46%

  • Week 1: GERD +ve vs GERD −ve = 8.5% vs 6.2%, p=NS

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