PMID- 30970442
OWN - NLM
STAT- MEDLINE
DCOM- 20200423
LR  - 20200423
IS  - 2005-1212 (Electronic)
IS  - 1976-2283 (Print)
IS  - 1976-2283 (Linking)
VI  - 13
IP  - 6
DP  - 2019 Nov 15
TI  - The Clinical Efficacy of a Pure Alginate Formulation (Lamina G) for Controlling 
      Symptoms in Individuals with Reflux Symptoms: A Randomized Clinical Study.
PG  - 642-648
LID - 10.5009/gnl18378 [doi]
AB  - BACKGROUND/AIMS: Bicarbonate-containing alginate formulations are reported to be 
      effective for controlling reflux symptoms. However, the efficacy of Lamina G 
      alginate without gas production has not been reported. The aim is to evaluate the 
      efficacy of a non-bicarbonate alginate in individuals with reflux symptoms 
      without reflux esophagitis. METHODS: Participants who had experienced heartburn 
      or regurgitation for 7 consecutive days were randomized to one of the following 
      treatment groups: proton pump inhibitors (PPI) plus alginate (combination) or PPI 
      plus placebo (PPI only). In addition, as a reference group, patients received 
      placebo plus alginate (alginate only). The primary endpoint compared the 
      percentage of patients with complete resolution of symptoms for the final 7 days 
      of the treatment. Secondary endpoints compared changes in symptom score, 
      symptom-free days during the treatment period, the Reflux Disease Questionnaire, 
      Patient Assessment of Upper Gastrointestinal Disorders (PAGI)-Quality of Life and 
      PAGI-Symptoms Severity Index scores, the investigator's assessment of symptoms, 
      and incidence of adverse events. RESULTS: Complete resolution of heartburn or 
      regurgitation was not significantly different between the combination and PPI 
      only groups (58.7% vs 57.5%, p=0.903). The secondary endpoints were not 
      significantly different between the two groups. Complete resolution of heartburn 
      or regurgitation, did not differ between the alginate only reference group and 
      the PPI only group (75.0% vs 57.5%, p=0.146). CONCLUSIONS: The addition of 
      non-bicarbonate alginate to PPI was no more effective than PPI alone in 
      controlling reflux symptoms.
FAU - Kim, Jie-Hyun
AU  - Kim JH
AUID- ORCID: 0000-0002-9198-3326
AD  - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Lee, Yong Chan
AU  - Lee YC
AUID- ORCID: 0000-0001-8800-6906
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Department of Internal Medicine, Severance Hospital, Seoul, Korea.
FAU - Kim, Eun Hye
AU  - Kim EH
AUID- ORCID: 0000-0001-6691-6837
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Department of Internal Medicine, Severance Hospital, Seoul, Korea.
FAU - Park, Jun Chul
AU  - Park JC
AUID- ORCID: 0000-0001-8018-0010
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Department of Internal Medicine, Severance Hospital, Seoul, Korea.
FAU - Shin, Sung Kwan
AU  - Shin SK
AUID- ORCID: 0000-0001-5466-1400
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Department of Internal Medicine, Severance Hospital, Seoul, Korea.
FAU - Lee, Sang Kil
AU  - Lee SK
AUID- ORCID: 0000-0002-0721-0364
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
AD  - Department of Internal Medicine, Severance Hospital, Seoul, Korea.
FAU - Jung, Da Hyun
AU  - Jung DH
AUID- ORCID: 0000-0001-6668-3113
AD  - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Park, Jae Jun
AU  - Park JJ
AUID- ORCID: 0000-0001-9974-1658
AD  - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Youn, Young Hoon
AU  - Youn YH
AUID- ORCID: 0000-0002-0071-229X
AD  - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Park, Hyojin
AU  - Park H
AUID- ORCID: 0000-0003-4814-8330
AD  - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
AD  - Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, 
      Korea.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Korea (South)
TA  - Gut Liver
JT  - Gut and liver
JID - 101316452
RN  - 0 (Alginates)
RN  - 0 (Proton Pump Inhibitors)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Alginates/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Gastroesophageal Reflux/complications/*drug therapy
MH  - Heartburn/*drug therapy/etiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Omeprazole/*therapeutic use
MH  - Proton Pump Inhibitors/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6860038
OTO - NOTNLM
OT  - Alginates
OT  - Bicarbonates (CRIS KCT0002297)
OT  - Gastroesophageal reflux
OT  - Proton pump inhibitors
COIS- CONFLICTS OF INTEREST No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2019/04/12 06:00
MHDA- 2020/04/24 06:00
PMCR- 2019/11/01
CRDT- 2019/04/12 06:00
PHST- 2018/08/25 00:00 [received]
PHST- 2018/11/24 00:00 [revised]
PHST- 2018/12/08 00:00 [accepted]
PHST- 2019/04/12 06:00 [pubmed]
PHST- 2020/04/24 06:00 [medline]
PHST- 2019/04/12 06:00 [entrez]
PHST- 2019/11/01 00:00 [pmc-release]
AID - gnl18378 [pii]
AID - gnl-13-642 [pii]
AID - 10.5009/gnl18378 [doi]
PST - ppublish
SO  - Gut Liver. 2019 Nov 15;13(6):642-648. doi: 10.5009/gnl18378.