학술논문

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.
Document Type
Academic Journal
Author
Abdul Kadir NP; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Ma ZF; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Abdul Hafidz MI; Gastroenterology Unit, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Malaysia.; Annamalai C; Gastroenterology Unit, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Malaysia.; Jayaraman T; Gastroenterology Unit, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Malaysia.; Hamid N; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Norhasliza S; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Abd Aziz A; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Yusof Z; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Lee H; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Lee YY; School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.; Gut Research Group, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Source
Publisher: Frontiers Media S.A Country of Publication: Switzerland NLM ID: 101648047 Publication Model: eCollection Cited Medium: Print ISSN: 2296-858X (Print) Linking ISSN: 2296858X NLM ISO Abbreviation: Front Med (Lausanne) Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
2296-858X
Abstract
Background: Non-cardiac chest pain is common with two-thirds due to gastroesophageal reflux disease (GERD). Objective: To evaluate the effectiveness and safety of guided vs. empirical therapy in non-cardiac chest pain. Methods: Adults with normal angiogram or stress test were randomized into either a guided or empirical group. In the guided group, after the ambulatory pH-impedance test, if GERD then dexlansoprazole 30 mg/day for 8 weeks, but if functional or hypersensitive chest pain, then theophylline SR 250 mg/day for 4 weeks. In the empirical group, dexlansoprazole 60 mg/day was given for 2 weeks. The primary outcome was global chest pain visual analog score (VAS) and secondary outcomes were Quality of Life in Reflux and Dyspepsia (QOLRAD), GERD questionnaire (GERDQ), and pH parameters, all determined at baseline, 2nd and 8th weeks. Results: Of 200 screened patients, 132 were excluded, and of 68 randomized per-protocol, 33 were in the guided group and 35 in the empirical group. For between-group analysis, mean global pain scores were better with guided vs. empirical group at 8th week ( P = 0.005) but not GERDQ or QOLRAD or any of pH measures (all P > 0.05). For within-group analysis, mean QOLRAD improved earliest at 8th week vs. baseline ( P = 0.006) in the guided group and 2nd week vs. baseline ( P = 0.011) in the empirical group but no differences were seen in other secondary outcomes ( P > 0.05). No serious adverse events were reported. Conclusions: Guided approach may be preferred over short-term empirical therapy in symptom response, however QOLRAD, acid-related symptoms, or pH measures are not significantly different (trial registration ID no. NCT03319121).
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2021 Abdul Kadir, Ma, Abdul Hafidz, Annamalai, Jayaraman, Hamid, Norhasliza, Abd Aziz, Yusof, Lee and Lee.)