Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial

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.

Efficacy of herbal treatments for functional dyspepsia: A systematic review and meta‐analysis of randomized clinical trials

“…Of these, 359 articles remained for the full-text review, in which 171 studies met inclusion criteria. Finally, 49 RCTs (Azimi et al, 2017;Bordbar, Miri, Omidi, Shoja, & Akhavan, 2020;Bortolotti, Coccia, Grossi, & Miglioli, 2002;Braden, Caspary, Börner, Vinson, & Schneider, 2009;Chen et al, 2020;Chitapanarux, Lertprasertsuke, & Toworakul, 2020;M.-G. Choi et al, 2015;Y. Choi, Kim, Noh, Lee, & Lee, 2020;Dabos et al, 2010;Du, Ming, Chen, & Li, 2014;Eftekharafzali, Zahedi, Mehrabani, Ahmadi, & Tajadini, 2018;Fani et al, 2010;Ghoshegir et al, 2015;Giacosa et al, 2015;Holtmann et al, 2003;Jung et al, 2016;Khonche, Huseini, Mohtashami, Nabati, & Kianbakht, 2017;J.…”

“…It has been reported previously that herbal remedies can be antiinflammatory, favorably modify gut microbiota, balance to (Bordbar et al, 2020;Jung et al, 2016;Lin et al, 1998;Madisch et al, 1999;Rösch et al, 2002;Wang et al, 2017;Zhao & Gan, 2005) Qualitative efficacy 35.25, <.0001, 74% 1.09 [1.02-1.17] 2.41, .02 (M.-G. Choi et al, 2015;Jung et al, 2016;Li et al, 2013;Lin et al, 1998;Liu et al, 2013;Madisch et al, 1999;Rösch et al, 2002;Wang et al, 2017;Zhao & Gan, 2005) Adverse events 14.66, .07, 45% 0.97 [0.75-1.26] 0.23, .82 (Azimi et al, 2017;Bordbar et al, 2020;M.-G. Choi et al, 2015;Jung et al, 2016;Li et al, 2013;Lin et al, 1998;Madisch et al, 1999;Rösch et al, 2002 Choi et al, 2015;Fani et al, 2010;Jung et al, 2016;Li et al, 2013;Liu et al, 2013;Zhao & Gan, 2005) T A B L E 4 Meta-analysis results of sensitive analysis for different outcomes in comparing herbal remedies with placebo or active control Choi et al, 2015;Li et al, 2013;Zhao & Gan, 2005) improve immune function and tolerance, affect central processing of afferent stimuli, and regulate intestinal motility, visceral hypersensitivity, gastric emptying, and lower esophageal sphincter pressure in FD (Y. S. Kim, Kim, Ha, Kim, & Ryu, 2020). By and large, the mechanism of action of most herbal remedies in FD is yet to be known…”

Food, Dietary Patterns, or Is Eating Behavior to Blame? Analyzing the Nutritional Aspects of Functional Dyspepsia

“…Several herbal remedies have been proven effective and safe in FD with comparable outcomes with conventional treatments, and can serve as complementary and alternative medicine, especially when first line therapeutic approaches fail or are inaccessible to patients [ 9 ]. Some herbal oils improve PDS and EPS, and improve gastrointestinal symptom rating scale (GSRS) numbers and quality of life scores [ 15 ]. Herbal treatments show anti-inflammatory effects and contribute to an improvement in the function of gut microbiota, immune system, central stimuli, and intestinal motility in FD [ 16 ].…”

“…Chinese herbal medicines have been considered an effective alternative to prokinetics, according to a meta-analysis of 28 RCTs showing that Chinese herbal remedies were more effective than prokinetics at reducing the overall symptoms [ 18 ]. A combination of three herbs ( Trachyspermum ammi L., Anethum graveolens L., and Zataria multiflora Boiss) may be important in the treatment of FD, as the essential oils were proven more effective than omeprazole [ 15 ]. Similarly, the Japanese Yukgunja-tang, also known as Rikkunshito, is a mixture of eight herbs that is frequently prescribed in FD [ 19 ], and it was proven more effective in the total clinical efficacy rate in a meta-analysis of 10 studies with 1246 patients, when combined with Western medicine over the use of Western medicine alone [ 20 ].…”

Efficacy and Safety of a Persian Medicine Formula on Functional Dyspepsia Symptoms: A Randomized Double-Blind Active-Control Clinical Trial

“…Celery and ajwain seeds (fruit) have been traditionally used for different gastrointestinal ailments such as abdominal pain/cramp, bloating, indigestion, nausea, vomiting, inappetence, constipation, and reflux [21][22][23][24]. Based on PM textbooks, the powdered mixture of celery and ajwain seeds is a unique treatment for indigestion [20,22,23] and this is while only few recent trials support this recommendation [25,26]. Although there is no exact equivalent of FD in PM [27], the study of the symptoms of PDS showed that the mixture of Apium graveolens L. and Trachyspermum copticum (L.) Link can be traditionally used for the treatment of similar symptoms in PM [20,25,28].…”