Kadir, Noor Purdah Abdul
(2017)
A randomized trial comparing empirical and guide therapy for unexplained non-cardiac chest pain.
Masters thesis, Universiti Sains Malaysia.
Abstract
Background Non-cardiac chest pain (NCCP) is prevalent in Malaysia with almost two-thirds
a result of gastroesophageal reflux disease. Treatment approach to NCCP is currently unclear.
We aimed to determine if therapy guided by results of 24-hour pH-impedance test would be
better than empirical trial of PPI.
Methods Consecutive participants with chest pain and normal angiogram or negative stress
test were consented. Participants were randomized into guided group or empirical group. In
guided group, all underwent 24-hour pH-impedance test (Sandhills, US) and if GERD then
eight weeks of Dexlansoprazole 30mg OD but if functional chest pain or reflux
hypersensitivity then four weeks of Theophylline SR 250mg OD were prescribed. In
empirical group, two weeks of Dexlansoprazole 60mg OD were prescribed. Visual analog
scale assessment (VAS) of chest pain, Gastroesophageal Reflux Disease Questionnaire
(GERD Q), and Quality Of Life in Reflux And Dyspepsia (QOLRAD) questionnaire were
evaluated during each visits at weeks 0, 2 and 8. Differences between visits were analyzed
with Repeated Measures ANOVA.
Results Of 200 screened patients, 145 did not meet inclusion criteria, and 55 randomized (26
empirical and 29 guided). A further 9 withdrew (5 empirical and 4 guided). No participants
experienced serious adverse events. With RM-ANOVA, the results demonstrated that guided
therapy did better than empirical therapy in mean VAS at week 2 vs. 0 and at week 8 vs. 0.
The mean values of guided group were outside the confidence intervals of empirical group.Therefore, the mean VAS were significantly different. The results also demonstrated
significant improvement of mean QOLRAD at week 8 vs. 0 in the guided therapy with
p value=0.007, MD (95%CI) -3.2(-5.7,-0.8).However, no significant improvement in GERD
Q were observed.In within-group analysis, mean QOLRAD was significantly better at week 8
vs. 0 (P=0.007) for guided group and for empirical group, mean QOLRAD was better at
week 2 vs. 0 (P=0.004) and week 8 vs. 0 (P=0.01). On the other hand, mean GERDQ was
better at week 8 vs. 0 (P=0.02) for empirical group only. We also observed that duration of
treatment was the factor associated in the improvement of VAS in guided group. A duration
of one week treatment would result in reduction of VAS scores by 0.7 points (95% CI -1.2, -
0.2; p=0.007).
Conclusion In this analysis, guided therapy seems better than PPI trial in relieving chest pain
symptom of NCCP patients. Both therapies improved QOL but those with GERD symptoms
are better with PPI trial.
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