Efficacy and safety of alpha-pinene capsule in the management of functional dyspepsia and eradication of helicobacter pylori: a randomized clinical trial.
Alphapinen
Clinical trial
Functional dyspepsia
Helicobacter pylori
Journal
Gastroenterology and hepatology from bed to bench
ISSN: 2008-2258
Titre abrégé: Gastroenterol Hepatol Bed Bench
Pays: Iran
ID NLM: 101525875
Informations de publication
Date de publication:
2024
2024
Historique:
received:
03
10
2023
accepted:
25
12
2023
medline:
12
7
2024
pubmed:
12
7
2024
entrez:
12
7
2024
Statut:
ppublish
Résumé
Our objective was to assess the efficacy and safety of adding alpha-pinene (a herbal terpenoid) to quadruple therapy compared to a placebo in improving symptoms and Helicobacter pylori (H. pylori) eradication rates in Functional dyspepsia (FD) patients. FD is a prevalent upper gastrointestinal condition, and no definitive pharmacological treatment is available for its management. We conducted a randomized, double-blinded, placebo-controlled trial on FD patients diagnosed with H. pylori infection. We collected baseline demographic data and assessed FD symptoms in the participants. Patients were randomly allocated to receive either standard quadruple therapy with α-pinene capsules (0.25 mg/day) or quadruple therapy with a placebo for two weeks. We employed a validated questionnaire, the Short Form Leeds Dyspepsia Questionnaire (SF-LDQ), to evaluate FD symptoms. The eradication rate of H. pylori was compared between the two groups one month after completing the treatment regimens. Any reported adverse drug reactions (ADRs) were documented throughout the trial. Over four months, a total of 66 patients completed the trial. Notably, there were no significant differences in baseline SF-LDQ scores between the two groups (p=0.83); however, a significant divergence emerged at the trial's conclusion (p=0.03). The H. pylori eradication rates did not show notable differences between the two treatment arms (p=0.43). Importantly, there were no dropouts from the trial due to ADRs. Among reported ADRs, participants experienced abdominal pain, headache, diarrhea, and a metallic taste, with no significant variance in incidence rates observed between the two groups (p=0.62). These findings suggest that α-pinene could be an effective and safe agent for reducing FD symptoms.
Sections du résumé
Aim
UNASSIGNED
Our objective was to assess the efficacy and safety of adding alpha-pinene (a herbal terpenoid) to quadruple therapy compared to a placebo in improving symptoms and Helicobacter pylori (H. pylori) eradication rates in Functional dyspepsia (FD) patients.
Background
UNASSIGNED
FD is a prevalent upper gastrointestinal condition, and no definitive pharmacological treatment is available for its management.
Methods
UNASSIGNED
We conducted a randomized, double-blinded, placebo-controlled trial on FD patients diagnosed with H. pylori infection. We collected baseline demographic data and assessed FD symptoms in the participants. Patients were randomly allocated to receive either standard quadruple therapy with α-pinene capsules (0.25 mg/day) or quadruple therapy with a placebo for two weeks. We employed a validated questionnaire, the Short Form Leeds Dyspepsia Questionnaire (SF-LDQ), to evaluate FD symptoms. The eradication rate of H. pylori was compared between the two groups one month after completing the treatment regimens. Any reported adverse drug reactions (ADRs) were documented throughout the trial.
Results
UNASSIGNED
Over four months, a total of 66 patients completed the trial. Notably, there were no significant differences in baseline SF-LDQ scores between the two groups (p=0.83); however, a significant divergence emerged at the trial's conclusion (p=0.03). The H. pylori eradication rates did not show notable differences between the two treatment arms (p=0.43). Importantly, there were no dropouts from the trial due to ADRs. Among reported ADRs, participants experienced abdominal pain, headache, diarrhea, and a metallic taste, with no significant variance in incidence rates observed between the two groups (p=0.62).
Conclusion
UNASSIGNED
These findings suggest that α-pinene could be an effective and safe agent for reducing FD symptoms.
Identifiants
pubmed: 38994508
doi: 10.22037/ghfbb.v17i2.2903
pmc: PMC11234487
doi:
Types de publication
Journal Article
Langues
eng
Pagination
140-145Informations de copyright
© 2024, Gastroenterology and Hepatology From Bed to Bench (GHFBB).
Déclaration de conflit d'intérêts
The authors declare that there is no conflict of interests regarding the publication of this paper.