Abstract
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.
Highlights
Functional gastrointestinal disorders (FGIDs) include a series of digestive symptoms caused by a disturbance in the interactions of the gastrointestinal (GI) system and the brain that is arisen from a dysfunction in the sensory-motor and immune systems in the GI tract to the altered central nervous system processing [1]
Four patients were excluded from the study, because no efficacy assessment was performed after the initiation of treatment; one from the control group and three of the intervention group due to lack of cooperation
The statistical analysis of efficacy based on the ITT principle was performed with 60 patients (29 in the intervention group and 31 in the control group)
Summary
Functional gastrointestinal disorders (FGIDs) include a series of digestive symptoms caused by a disturbance in the interactions of the gastrointestinal (GI) system and the brain that is arisen from a dysfunction in the sensory-motor and immune systems in the GI tract to the altered central nervous system processing [1]. The most common medications used to treat FD include proton pump inhibitors, H2 antagonists, and prokinetic medications They may cause various adverse effects such as the increased risk of intestinal infections, small intestinal bacterial overgrowth, and malabsorption of substances, e.g., iron and vitamin B12, atrophic gastritis [3,4,5]. 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). 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). A larger multicenter trial is needed to confirm the results of the trial
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