Non Cardiac Chest Pain Clinical Trial
Official title:
The Evaluation of Effectiveness Between Empirical and Guided Therapy for Unexplained Non-Cardiac Chest Pain
This is a prospective randomised clinical trial performed in a single center at Hospital Universiti Sains Malaysia (USM), Kelantan, Malaysia. Participants will be randomly allocated into either the empirical group or guided group for 8 weeks.The effectiveness in relieving chest pain (frequency and severity) will assessed after 2 weeks and 8 weeks of therapy with Gastroesophageal Reflux Disease Questionnaire (GERDQ) and Quality of Life Reflux and Dyspepsia (QOLRAD) questionnaire, and visual analogue scale (VAS) (score 1-10).
Non-cardiac chest pain (NCCP) is very common in the general population but symptom alone or
patient's characteristics do not adequately differentiate cardiac and esophageal cause.
Cardiologists are usually consulted first to exclude life-threatening acute coronary
syndrome. Tests that are performed to exclude ischemic heart disease include exercise stress
test and the more invasive coronary angiography. A negative stress test or angiogram or the
presence of mild blockage of a single vessel disease will usually be adequate to exclude
significant ischemia as a cause for chest pain.
The next most important cause of unexplained chest pain would be gastro-esophageal reflux
disease (GERD). GERD and its complications of Barrett's oesophagus and oesophageal
adenocarcinoma have increased markedly in recent decades, not just in the developed countries
but also in Asia. Although relatively less common among populations in Malaysia, there are
data to suggest an increasing prevalence of reflux disease largely a result of obesity and
increased intra-abdominal pressure.
Dexlansoprazole (Takeda Pharmaceuticals, Japan) is a novel dual delayed release system
recently approved by the FDA for treatment of heartburn associated with non-erosive and
erosive reflux disease. It is unknown if dexlansoprazole is effective as an empirical therapy
for NCCP.
Another approach would be therapy guided by investigations including high resolution (HR)
esophageal impedance manometry and 24-hour pH-impedance studies. Study of esophageal function
has greatly evolved with the recent availability of high resolution multi-channel solid state
manometer and impedance. Water swallows are commonly used in esophageal manometric studies to
evaluate for peristaltic abnormalities. Esophageal pH monitoring does not detect all
gastroesophageal reflux (GER) events but with the combination of impedance, this technique
allows detection of GER of gas and acid or non-acid liquids. These tests would enable
diagnosis of GERD and functional chest pain and thereby allow targeted therapy.
For treatment of GERD, dexlansoprazole is effective and for functional chest pain,
nonspecific adenosine antagonist, theophylline is proven to improve symptoms in patient with
hypersensitive esophagus. A selective serotonin reuptake inhibitor (SSRI) is also effective
for functional chest pain , however it is not known if theophylline is more effective than
any other SSRIs.It is unknown about the response rates based on the guided therapy approach
compared to the empirical PPI therapy.
Therefore, the aim of the intervention is to evaluate the effectiveness of empirical therapy
vs. guided therapy on symptoms unexplained non-cardiac chest pain.
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