PMID- 37674104
OWN - NLM
STAT- MEDLINE
DCOM- 20230908
LR  - 20231121
IS  - 1471-230X (Electronic)
IS  - 1471-230X (Linking)
VI  - 23
IP  - 1
DP  - 2023 Sep 6
TI  - Multicentre prospective study to evaluate effectiveness and safety of gel-forming 
      and hyaluronic-acid containing chewable tablets as add-on treatment in patients 
      with gastroesophageal reflux disease (GERD) symptoms and unsatisfying proton pump 
      inhibitor therapy.
PG  - 304
LID - 10.1186/s12876-023-02946-6 [doi]
LID - 304
AB  - BACKGROUND: Gastroesophageal reflux disease (GERD) is a common disease which in 
      the majority of patients is treated with proton pump inhibitors (PPI). However, 
      up to 45% of the patients remain symptomatic on a standard dose of PPI. This 
      study investigated the effectiveness and safety of an add-on therapy with the 
      gel-forming chewable tablet Sobrade(R) in patients unsatisfied with PPI treatment. 
      The bioadhesive gel covers the oesophagus and thereby protects the mucosa from 
      reflux events. METHODS: 47 patients with symptomatic GERD despite PPI treatment 
      participated in this study. The gel-forming tablets were taken up to four times 
      daily after meals and prior to bedtime. Severity and frequency of GERD symptoms 
      were evaluated during two onsite visits prior and following 14 days of treatment 
      and used to calculate the GERD score of the Reflux Disease Questionnaire. 
      Furthermore, patients recorded symptoms as well as onset and duration of symptoms 
      relief daily in their electronic dairies. Effectiveness of treatment was analysed 
      using non-parametric paired Wilcoxon test. In addition, anchor-based minimal 
      important differences (MID) were assessed. RESULTS: Treatment resulted in 
      significant reduction of GERD symptoms. Severity and frequency of 8 of the 9 
      assessed symptoms improved significantly during the treatment phase whereby most 
      pronounced improvement was observed for heartburn. In agreement, all three 
      subscales of the GERD score improved significantly. MID results suggest that 
      patients considered a mean improvement of symptoms > 30% of initial severity as 
      beneficial. Self-assessments by patients revealed first significant improvements 
      of symptoms like heartburn and regurgitation from day 5 of treatment onwards. 49% 
      of patients reported relief of symptoms within 15 min which lasted on average for 
      3.5 h. During the study no treatment emergent adverse events were reported and in 
      98% of all cases tolerability of the product was rated as very good or good. 
      CONCLUSIONS: This study revealed a pronounced improvement of the symptoms after 
      add-on treatment with the gel-forming medical device. The very good safety and 
      tolerability profile indicate an advantageous risk-benefit ratio. TRIAL 
      REGISTRATION: This non-interventional study was prospectively positively 
      evaluated by the responsible ethic-committees.
CI  - (c) 2023. BioMed Central Ltd., part of Springer Nature.
FAU - Gross, Manfred
AU  - Gross M
AD  - Department of Internal Medicine, Internistisches Klinikum Munchen Sud, 81379, 
      Gastroenterology, Munchen, Germany.
FAU - Neuschwander, Dennis
AU  - Neuschwander D
AD  - GCP-Service International Ltd. & Co. KG, 28359, Bremen, Germany.
FAU - Steffens, Lisa
AU  - Steffens L
AD  - G. Pohl-Boskamp GmbH & Co. KG, 25551, Hohenlockstedt, Germany.
FAU - Thomsen, Jorn
AU  - Thomsen J
AD  - G. Pohl-Boskamp GmbH & Co. KG, 25551, Hohenlockstedt, Germany. 
      j.thomsen@pohl-boskamp.de.
FAU - Roschmann-Doose, Kristina
AU  - Roschmann-Doose K
AD  - G. Pohl-Boskamp GmbH & Co. KG, 25551, Hohenlockstedt, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230906
PL  - England
TA  - BMC Gastroenterol
JT  - BMC gastroenterology
JID - 100968547
RN  - 0 (Proton Pump Inhibitors)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - 0 (Tablets)
SB  - IM
MH  - Humans
MH  - Prospective Studies
MH  - *Proton Pump Inhibitors/adverse effects
MH  - Hyaluronic Acid/adverse effects
MH  - Heartburn/drug therapy/etiology
MH  - *Gastroesophageal Reflux/drug therapy
MH  - Tablets
PMC - PMC10483795
OTO - NOTNLM
OT  - Bioadhesive gel-forming tablet
OT  - Gastroesophageal reflux disease (GERD)
OT  - Hyaluronic acid
OT  - Proton pump inhibitor (PPI)
COIS- M.G. received personal fees from G. Pohl-Boskamp GmbH & Co KG D.N. declares that 
      he has no competing interestsLS, JT, KRD are employees of the sponsor of this 
      study
EDAT- 2023/09/07 00:41
MHDA- 2023/09/08 06:42
PMCR- 2023/09/06
CRDT- 2023/09/06 23:33
PHST- 2022/11/07 00:00 [received]
PHST- 2023/09/04 00:00 [accepted]
PHST- 2023/09/08 06:42 [medline]
PHST- 2023/09/07 00:41 [pubmed]
PHST- 2023/09/06 23:33 [entrez]
PHST- 2023/09/06 00:00 [pmc-release]
AID - 10.1186/s12876-023-02946-6 [pii]
AID - 2946 [pii]
AID - 10.1186/s12876-023-02946-6 [doi]
PST - epublish
SO  - BMC Gastroenterol. 2023 Sep 6;23(1):304. doi: 10.1186/s12876-023-02946-6.