PMID- 27622897
OWN - NLM
STAT- MEDLINE
DCOM- 20170426
LR  - 20221207
IS  - 1751-2980 (Electronic)
IS  - 1751-2972 (Linking)
VI  - 17
IP  - 11
DP  - 2016 Nov
TI  - Alginate antacid (Gaviscon DA) chewable tablets reduce esophageal acid exposure 
      in Chinese patients with gastroesophageal reflux disease and heartburn symptoms.
PG  - 725-734
LID - 10.1111/1751-2980.12406 [doi]
AB  - OBJECTIVE: To assess the efficacy of Gaviscon Double Action (DA) alginate antacid 
      chewable tablets for reducing esophageal acid exposure in Chinese patients with 
      gastroesophageal reflux disease (GERD). METHODS: Altogether 44 patients reporting 
      moderate to severe heartburn symptoms underwent two pH monitoring visits. The 
      treatment sequence was randomized to patients received DA alginate antacid or 
      placebo at one visit and the alternate treatment 7 days later. After a 
      standardized reflux-provoking meal, patients took four tablets of DA alginate 
      antacid or placebo. Esophageal pH was measured for 4 h post-dosing using an 
      electrode positioned 5 cm above the lower esophageal sphincter. The primary 
      end-point was the percentage of 4-h post-dosing period with pH <4. Secondary 
      end-points were number of acid reflux episodes (pH <4), longest reflux time and 
      DeMeester scores. RESULTS: All 44 patients completed the study and provided data 
      for analysis. With DA alginate antacid, the mean percentage time with pH <4 was 
      5.1%, significantly less (P = 0.0003) than with placebo (14.8%). DA alginate 
      antacid was statistically significantly superior (P = 0.0290) to placebo (from at 
      least twofold to threefold better) for all other end-points. Two patients 
      reported two mild adverse events (AEs) that resolved within a month of completing 
      the study. No patients had serious and/or severe AEs and none withdrew due to 
      AEs. CONCLUSIONS: DA alginate antacid was statistically significantly superior to 
      placebo in reducing post-prandial acid exposure without serious clinically 
      relevant health risks. These findings suggest DA alginate antacid tablets are 
      appropriate for treating acid reflux in Chinese GERD patients with heartburn 
      symptoms.
CI  - (c) 2016 Chinese Medical Association Shanghai Branch, Chinese Society of 
      Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University 
      School of Medicine and John Wiley & Sons Australia, Ltd.
FAU - Yuan, Yao Zong
AU  - Yuan YZ
AD  - Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University 
      School of Medicine, Shanghai, China.
FAU - Fang, Jing Yuan
AU  - Fang JY
AD  - Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology 
      and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and 
      Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 
      Shanghai Institute of Digestive Disease, Shanghai, China.
FAU - Zou, Duo Wu
AU  - Zou DW
AD  - Department of Gastroenterology, Changhai Hospital, Second Military Medical 
      University, Shanghai, China.
FAU - Levinson, Nigel
AU  - Levinson N
AD  - Reckitt Benckiser, Hull, United Kingdom.
FAU - Jenner, Bartosz
AU  - Jenner B
AD  - Reckitt Benckiser, Hull, United Kingdom.
FAU - Wilkinson, Joanne
AU  - Wilkinson J
AD  - Reckitt Benckiser, Hull, United Kingdom.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Australia
TA  - J Dig Dis
JT  - Journal of digestive diseases
JID - 101302699
RN  - 0 (Alginates)
RN  - 0 (Antacids)
RN  - 0 (Drug Combinations)
RN  - 0 (Tablets)
RN  - 1343-98-2 (Silicic Acid)
RN  - 5QB0T2IUN0 (Aluminum Hydroxide)
RN  - 66220-44-8 (alginate, aluminium hydroxide, magnesium trisilicate, sodium 
      bicarbonate drug combination)
RN  - 8MDF5V39QO (Sodium Bicarbonate)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Alginates/*administration & dosage
MH  - Aluminum Hydroxide/*administration & dosage
MH  - Antacids/*administration & dosage
MH  - Asian People
MH  - Cross-Over Studies
MH  - Drug Combinations
MH  - Esophageal pH Monitoring
MH  - Female
MH  - Gastroesophageal Reflux/diagnosis/*drug therapy
MH  - Heartburn/diagnosis/*drug therapy
MH  - Humans
MH  - Male
MH  - Manometry
MH  - Middle Aged
MH  - Silicic Acid/*administration & dosage
MH  - Sodium Bicarbonate/*administration & dosage
MH  - Tablets
OTO - NOTNLM
OT  - esophageal pH monitoring
OT  - esophagitis
OT  - gastroesophageal reflux disease
OT  - heartburn
OT  - sodium alginate
EDAT- 2016/09/14 06:00
MHDA- 2017/04/27 06:00
CRDT- 2016/09/14 06:00
PHST- 2016/05/26 00:00 [received]
PHST- 2016/09/07 00:00 [revised]
PHST- 2016/09/12 00:00 [accepted]
PHST- 2016/09/14 06:00 [pubmed]
PHST- 2017/04/27 06:00 [medline]
PHST- 2016/09/14 06:00 [entrez]
AID - 10.1111/1751-2980.12406 [doi]
PST - ppublish
SO  - J Dig Dis. 2016 Nov;17(11):725-734. doi: 10.1111/1751-2980.12406.