The effect of a therapeutic trial of high-dose rabeprazole on symptom response of patients with non-cardiac chest pain: a randomized, double-blind, placebo-controlled, crossover trial.
BACKGROUND
Therapeutic trials with high-dose lansoprazole and omeprazole have been shown to be sensitive clinical tools for diagnosing patients with gastro-oesophageal reflux disease-related non-cardiac chest pain.


OBJECTIVE
To determine the clinical value of a therapeutic trial of high-dose rabeprazole over 7 days in detecting patients with gastro-oesophageal reflux disease-related non-cardiac chest pain.


METHODS
Double-blind, randomized, placebo-controlled, crossover study. Patients referred by a cardiologist after a comprehensive cardiac work-up were enrolled into the study. Oesophageal mucosal disease was determined by upper endoscopy and 24-h oesophageal pH monitoring assessed acid exposure. Patients were then randomized to either placebo or rabeprazole 20 mg am and 20 mg pm for 7 days. After a washout period of 1 week, patients crossed over to the other arm of the study for an additional 7 days. Patients completed a daily diary assessing severity and frequency of chest pain throughout the baseline, treatment and wash-out periods. The rabeprazole therapeutic trial was considered as a diagnostic tool, if chest pain scores improved > or =50% from baseline.


RESULTS
Of the 35 patients enrolled, 16 (46%) were diagnosed as gastro-oesophageal reflux disease-positive and 19 (54%) as gastro-oesophageal reflux disease-negative. Of the gastro-oesophageal reflux disease-positive patients, 12 of 16 (75%) had a significant symptom improvement on rabeprazole when compared with 3 of 16 (19%) on placebo (P = 0.029). Of the gastro-oesophageal reflux disease-negative group, only two of 19 (11%) improved significantly on the medication and four of 19 (21%) on placebo (P = 0.6599). The calculated sensitivity and specificity of the rabeprazole therapeutic trial was 75% and 90%, respectively.


CONCLUSIONS
A rabeprazole therapeutic trial is highly sensitive and specific for diagnosing gastro-oesophageal reflux disease-related non-cardiac chest pain patients.
Dickman
R
R
The Neuro-Enteric Clinical Research Group, Section of Gastroenterology, Department of Medicine, Southern Arizona VA Health Care System, Tucson, AZ 85723, USA.
Emmons
S
S
Cui
H
H
Sewell
J
J
Hernández
D
D
Esquivel
R F
RF
Fass
R
R
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D001562:Benzimidazoles / Q000008:administration & dosage; D002637:Chest Pain / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives*; D064750:Rabeprazole; D012680:Sensitivity and Specificity
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D064750:Rabeprazole; D009853:Omeprazole