PMID- 26909885
OWN - NLM
STAT- MEDLINE
DCOM- 20170815
LR  - 20181202
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 43
IP  - 8
DP  - 2016 Apr
TI  - Randomised clinical trial: alginate (Gaviscon Advance) vs. placebo as add-on 
      therapy in reflux patients with inadequate response to a once daily proton pump 
      inhibitor.
PG  - 899-909
LID - 10.1111/apt.13567 [doi]
AB  - BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton 
      pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a 
      raft on top of the stomach content and thus offer a supplemental mechanism of 
      action to acid suppression. AIM: To assess the efficacy of an alginate (Gaviscon 
      Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with 
      persistent symptoms despite once daily PPI. METHODS: This was a multicentre, 
      randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day 
      run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia 
      Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients 
      were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition 
      to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment 
      compared to baseline. RESULTS: One hundred and thirty-six patients were 
      randomised. Change in HRDQ reflux score was significantly greater for Gaviscon 
      Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an 
      LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean 
      (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in 
      the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. 
      This reduction was significantly greater in the Gaviscon Advance group than in 
      the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01]. 
      CONCLUSION: In patients with residual reflux symptoms despite PPI treatment, 
      adding an alginate offers additional decrease in the burden of reflux symptoms 
      (EudraCT/IND Number: 2011-005486-21).
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Reimer, C
AU  - Reimer C
AD  - Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.
FAU - Lodrup, A B
AU  - Lodrup AB
AD  - Department of Gastroenterology, Koge Hospital, Koge, Denmark.
AD  - Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark.
FAU - Smith, G
AU  - Smith G
AD  - Reckitt Benckiser Brands, Slough, UK.
FAU - Wilkinson, J
AU  - Wilkinson J
AD  - Reckitt Benckiser Brands, Slough, UK.
FAU - Bytzer, P
AU  - Bytzer P
AD  - Department of Gastroenterology, Koge Hospital, Koge, Denmark.
AD  - Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark.
LA  - eng
SI  - EudraCT/2011-005486-21
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160222
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Alginates)
RN  - 0 (Drug Combinations)
RN  - 0 (Proton Pump Inhibitors)
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
CIN - Aliment Pharmacol Ther. 2016 Jul;44(2):207. PMID: 27296687
CIN - Aliment Pharmacol Ther. 2016 Jul;44(2):208. PMID: 27296689
MH  - Adult
MH  - Aged
MH  - Alginates/*therapeutic use
MH  - Aluminum Hydroxide/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Heartburn/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Silicic Acid/*therapeutic use
MH  - Sodium Bicarbonate/*therapeutic use
MH  - Treatment Outcome
EDAT- 2016/02/26 06:00
MHDA- 2017/08/16 06:00
CRDT- 2016/02/25 06:00
PHST- 2015/11/22 00:00 [received]
PHST- 2015/12/29 00:00 [revised]
PHST- 2016/01/31 00:00 [revised]
PHST- 2016/02/01 00:00 [accepted]
PHST- 2016/02/26 06:00 [pubmed]
PHST- 2017/08/16 06:00 [medline]
PHST- 2016/02/25 06:00 [entrez]
AID - 10.1111/apt.13567 [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2016 Apr;43(8):899-909. doi: 10.1111/apt.13567. Epub 2016 
      Feb 22.