Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial
Background. The Trachyspermum ammi L. (TA), Anethum graveolens L. (AG), and Zataria multiflora Boiss (ZM) herbal oils are among the most used herbal products in traditional medicine as the antiseptic, anesthetic, carminative, and antispasmodic. However, there are no clinical studies to evaluate the...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2020-01-01
|
| Series: | Gastroenterology Research and Practice |
| Online Access: | http://dx.doi.org/10.1155/2020/5152736 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850157239286890496 |
|---|---|
| author | Ghasem Bordbar Mohammad Bagher Miri Mahmoud Omidi Saeed Shoja Malihe Akhavan |
| author_facet | Ghasem Bordbar Mohammad Bagher Miri Mahmoud Omidi Saeed Shoja Malihe Akhavan |
| author_sort | Ghasem Bordbar |
| collection | DOAJ |
| description | Background. The Trachyspermum ammi L. (TA), Anethum graveolens L. (AG), and Zataria multiflora Boiss (ZM) herbal oils are among the most used herbal products in traditional medicine as the antiseptic, anesthetic, carminative, and antispasmodic. However, there are no clinical studies to evaluate the efficacy of the herbs mentioned in the treatment of functional dyspepsia (FD). This study was designed to appraise the efficacy and safety of a novel herbal medicine consisting of ZM, AG, and TA essential oils compared to omeprazole in FD treatment. Methods. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in control and intervention arms received omeprazole 20 mg once a day and 250 mg soft-gel capsules containing 180 mg of essential oils of ZM, AG, and TA twice a day for two weeks, respectively. The primary outcome was the sufficient response rate in the postprandial distress syndrome (PDS) and/or epigastric pain syndrome (EPS) at the end of the intervention. Secondary outcomes were the improvement rate in the PDS, EPS, Gastrointestinal Symptom Rating Scale (GSRS), and quality of life scores. Also, safety and tolerability were assessed. Results. The within-group comparison of EPS, PDS, total GSRS, GSRS Pain, and GSRS Dyspepsia scores with that at the end of the treatment indicated a significant reduction in both control and intervention groups (p<0.001). However, after two weeks of treatment, the herbal medication and omeprazole arms were significantly different in the sufficient response rate based on PDS (p<0.01) and EPS (p<0.05) scores (78.3% (18/23) and 73.7% (14/19) in the intervention group vs. 36.4% (8/22) and 40.9% (9/22) in the control group). Also, the mean reduction in EPS (p<0.05), PDS (p<0.01), and GSRS (p<0.001) scores after treatment was significantly higher in the intervention group than control group. Conclusion. Based on the study findings, this herbal medicine can be considered as an appropriate treatment of FD. However, a larger multicenter trial is needed to confirm the results of the trial. |
| format | Article |
| id | doaj-art-2c67a9cc44bd44278f2c679d6147a063 |
| institution | OA Journals |
| issn | 1687-6121 1687-630X |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Gastroenterology Research and Practice |
| spelling | doaj-art-2c67a9cc44bd44278f2c679d6147a0632025-08-20T02:24:14ZengWileyGastroenterology Research and Practice1687-61211687-630X2020-01-01202010.1155/2020/51527365152736Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical TrialGhasem Bordbar0Mohammad Bagher Miri1Mahmoud Omidi2Saeed Shoja3Malihe Akhavan4Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, IranDepartment of Gastroenterology, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, IranDepartment of Pharmacology and Toxicology, Faculty of Pharmacy and Pharmaceutical Sciences, Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, IranInfectious and Tropical Diseases Research Center, Research Institute for Health, Hormozgan University of Medical Sciences, Bandar Abbas, IranPharmaceutical Sciences Research Center, Department of Medicinal Chemistry, Mazandaran University of Medical Sciences, Sari, IranBackground. The Trachyspermum ammi L. (TA), Anethum graveolens L. (AG), and Zataria multiflora Boiss (ZM) herbal oils are among the most used herbal products in traditional medicine as the antiseptic, anesthetic, carminative, and antispasmodic. However, there are no clinical studies to evaluate the efficacy of the herbs mentioned in the treatment of functional dyspepsia (FD). This study was designed to appraise the efficacy and safety of a novel herbal medicine consisting of ZM, AG, and TA essential oils compared to omeprazole in FD treatment. Methods. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in control and intervention arms received omeprazole 20 mg once a day and 250 mg soft-gel capsules containing 180 mg of essential oils of ZM, AG, and TA twice a day for two weeks, respectively. The primary outcome was the sufficient response rate in the postprandial distress syndrome (PDS) and/or epigastric pain syndrome (EPS) at the end of the intervention. Secondary outcomes were the improvement rate in the PDS, EPS, Gastrointestinal Symptom Rating Scale (GSRS), and quality of life scores. Also, safety and tolerability were assessed. Results. The within-group comparison of EPS, PDS, total GSRS, GSRS Pain, and GSRS Dyspepsia scores with that at the end of the treatment indicated a significant reduction in both control and intervention groups (p<0.001). However, after two weeks of treatment, the herbal medication and omeprazole arms were significantly different in the sufficient response rate based on PDS (p<0.01) and EPS (p<0.05) scores (78.3% (18/23) and 73.7% (14/19) in the intervention group vs. 36.4% (8/22) and 40.9% (9/22) in the control group). Also, the mean reduction in EPS (p<0.05), PDS (p<0.01), and GSRS (p<0.001) scores after treatment was significantly higher in the intervention group than control group. Conclusion. Based on the study findings, this herbal medicine can be considered as an appropriate treatment of FD. However, a larger multicenter trial is needed to confirm the results of the trial.http://dx.doi.org/10.1155/2020/5152736 |
| spellingShingle | Ghasem Bordbar Mohammad Bagher Miri Mahmoud Omidi Saeed Shoja Malihe Akhavan Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial Gastroenterology Research and Practice |
| title | Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial |
| title_full | Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial |
| title_fullStr | Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial |
| title_full_unstemmed | Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial |
| title_short | Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial |
| title_sort | comparison of a novel herbal medicine and omeprazole in the treatment of functional dyspepsia a randomized double blinded clinical trial |
| url | http://dx.doi.org/10.1155/2020/5152736 |
| work_keys_str_mv | AT ghasembordbar comparisonofanovelherbalmedicineandomeprazoleinthetreatmentoffunctionaldyspepsiaarandomizeddoubleblindedclinicaltrial AT mohammadbaghermiri comparisonofanovelherbalmedicineandomeprazoleinthetreatmentoffunctionaldyspepsiaarandomizeddoubleblindedclinicaltrial AT mahmoudomidi comparisonofanovelherbalmedicineandomeprazoleinthetreatmentoffunctionaldyspepsiaarandomizeddoubleblindedclinicaltrial AT saeedshoja comparisonofanovelherbalmedicineandomeprazoleinthetreatmentoffunctionaldyspepsiaarandomizeddoubleblindedclinicaltrial AT maliheakhavan comparisonofanovelherbalmedicineandomeprazoleinthetreatmentoffunctionaldyspepsiaarandomizeddoubleblindedclinicaltrial |