Login Register Cart 0
Generic placeholder image

Current Traditional Medicine

Editor-in-Chief

ISSN (Print): 2215-0838
ISSN (Online): 2215-0846

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Clinical Trial

The Effectiveness of a Poly-herbal Formulation from Traditional Persian Medicine (TPM) in Gastroesophageal Reflux Disease (GERD), a Double- Blinded Randomized Clinical Trial

Author(s): Nazila Ebrahimi, Ebrahim Fallahzadeh Abarghooee, Afsaneh Vazin, Ramin Ansari and Mohammad Mehdi Zarshenas*

Volume 10, Issue 7, 2024

Published on: 07 September, 2023

Article ID: e010823219338 Pages: 8

DOI: 10.2174/2215083810666230801122931

Price: $65

Abstract

Introduction: Gastroesophageal reflux disease (GERD) leads to increased contact of the acidic refluxate with the esophageal mucosa. Nearly 10- 20 % of the world's population is affected by GERD. Due to the complications associated with GERD, as well as complications of long-term treatment with current medications, and global demand toward Complementary and Alternative Medicine (CAM), this study evaluated the efficacy of a poly-herbal formulation known as Mastic pill (Habb-e-Mastaki) from traditional Persian medicine (TPM), previously reformulated and standardized, in a double-blinded randomized clinical trial.

Method: 34 patients in the drug group received 4 capsules of Mastic pill plus Omeprazole capsule 20 mg daily. 34 patients in the placebo group received the same dosing of Omeprazole and placebo. The medication was given to patients for a total duration of 4 weeks. All patients were requested to fill out the modified GERD-HRQL questionnaire at the beginning and every two weeks for a total duration of six weeks.

Result: Reflux, and heartburn severity score as well as disruption of personal life score significantly reduced in both groups, but it was more remarkable in the drug group (P-value = 0.0001). Dysphagia, early satiation, and nausea significantly reduced in the drug group while the placebo group showed no improvement. Our results suggest that constipation, bloating, belching, and odynophagia did not significantly improve in none of the groups.

Conclusion: This study showed that Habb-e-Mastaki is effective against GERD. Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of this formulation and clinical studies involving a larger population will be necessary to explain and confirm the results obtained in the present study.

Graphical Abstract

[1]
Sherman PM, Hassall E, Fagundes-Neto U, et al. A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Arch Pediatr 2010; 17(11): 1586-93.
[http://dx.doi.org/10.1016/j.arcped.2010.08.030] [PMID: 20943357]
[2]
El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: A systematic review. Gut 2014; 63(6): 871-80.
[http://dx.doi.org/10.1136/gutjnl-2012-304269] [PMID: 23853213]
[3]
Richter J, Castell DO. Gastroesophageal reflux. Ann Intern Med 1982; 97(1): 93-103.
[http://dx.doi.org/10.7326/0003-4819-97-1-93] [PMID: 6124198]
[4]
Vakil N. Disease definition, clinical manifestations, epidemiology and natural history of GERD. Best Pract Res Clin Gastroenterol 2010; 24(6): 759-64.
[http://dx.doi.org/10.1016/j.bpg.2010.09.009] [PMID: 21126691]
[5]
Vakil NB, Traxler B, Levine D. Dysphagia in patients with erosive esophagitis: Prevalence, severity, and response to proton pump inhibitor treatment. Clin Gastroenterol Hepatol 2004; 2(8): 665-8.
[http://dx.doi.org/10.1016/S1542-3565(04)00289-7] [PMID: 15290658]
[6]
Bansal A, Kahrilas PJ. Treatment of GERD complications (Barrett’s, peptic stricture) and extra-oesophageal syndromes. Best Pract Res Clin Gastroenterol 2010; 24(6): 961-8.
[http://dx.doi.org/10.1016/j.bpg.2010.09.007] [PMID: 21126707]
[7]
Gyawali CP, Kahrilas PJ, Savarino E, et al. Modern diagnosis of GERD: The lyon consensus. Gut 2018; 67(7): 1351-62.
[http://dx.doi.org/10.1136/gutjnl-2017-314722] [PMID: 29437910]
[8]
Alldredge BK, Corelli RL, Ernst ME, et al. Koda-kimble and Young’s applied therapeutics: the clinical use of drugs. Wolters Kluwer Health Adis. (ESP) 2013.
[9]
Sollano JD. Non-pharmacologic treatment strategies in gastroesophageal reflux disease. J Gastroenterol Hepatol 2004; 19(S3): S44-8.
[http://dx.doi.org/10.1111/j.1440-1746.2004.03593.x] [PMID: 15324381]
[10]
Gasiorowska A, Fass R. The proton pump inhibitor (PPI) test in GERD: Does it still have a role? J Clin Gastroenterol 2008; 42(8): 867-74.
[http://dx.doi.org/10.1097/MCG.0b013e31816c47ed] [PMID: 18645525]
[11]
Komazawa Y, Adachi K, Mihara T, et al. Tolerance to famotidine and ranitidine treatment after 14 days of administration in healthy subjects without Helicobacter pylori infection. J Gastroenterol Hepatol 2003; 18(6): 678-82.
[http://dx.doi.org/10.1046/j.1440-1746.2003.03041.x] [PMID: 12753150]
[12]
Sontag S. The medical management of reflux esophagitis. Role of antacids and acid inhibition. Gastroenterol Clin North Am 1990; 19(3): 683-712.
[http://dx.doi.org/10.1016/S0889-8553(21)00664-6] [PMID: 1977703]
[13]
Craig WR, Hanlon‐Dearman A, Sinclair C, Taback SP, Moffatt M. Metoclopramide, thickened feedings, and positioning for gastro‐oesophageal reflux in children under two years. Cochrane Database Syst Rev 2004; 18(4): CD003502.
[14]
Sheen E, Triadafilopoulos G. Adverse effects of long-term proton pump inhibitor therapy. Dig Dis Sci 2011; 56(4): 931-50.
[http://dx.doi.org/10.1007/s10620-010-1560-3] [PMID: 21365243]
[15]
Ali T, Roberts DN, Tierney WM. Long-term safety concerns with proton pump inhibitors. Am J Med 2009; 122(10): 896-903.
[http://dx.doi.org/10.1016/j.amjmed.2009.04.014] [PMID: 19786155]
[16]
Wolfe MM. Proton pump inhibitors: Overview of use and adverse effects in the treatment of acid related disorders UpToDate. Waltham, MA: UpToDate 2018.
[17]
Ansari R, Dadbakhsh A, Hasani F, Hosseinzadeh F, Abolhassanzadeh Z, Zarshenas M. Traditional aspects to sciatic pain and allied therapies from Persian medical reports. Curr Drug Discov Technol 2020; 18(2): 194-206.
[PMID: 32178615]
[18]
Ekor M. The growing use of herbal medicines: Issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 2014; 4: 177.
[http://dx.doi.org/10.3389/fphar.2013.00177] [PMID: 24454289]
[19]
Karimian A, Sadeghpour H, Khademian S, Zarshenas MM. A gas chromatographic-based method for determination of γ-terpinene in a herbal solid dosage form. Trends Pharmacol Sci 2019; 5(2): 103-10.
[20]
Zohalinezhad ME, Imanieh MH, Samani SM, et al. Effects of Quince syrup on clinical symptoms of children with symptomatic gastroesophageal reflux disease: A double-blind randomized controlled clinical trial. Complement Ther Clin Pract 2015; 21(4): 268-76.
[http://dx.doi.org/10.1016/j.ctcp.2015.09.005] [PMID: 26573454]
[21]
Heravi MJTD. Qarabadin-e-salehi. 1765.
[22]
Chassany O, Holtmann G, Malagelada J, Gebauer U, Doerfler H, Devault K. Systematic review: Health-related quality of life (HRQOL) questionnaires in gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2008; 27(11): 1053-70.
[http://dx.doi.org/10.1111/j.1365-2036.2008.03683.x] [PMID: 18363898]
[23]
Yamagishi H, Koike T. ohara S, Kobayashi S, Arrizumi K, Abe Y. Prevalence of gatroesophageal reflux symptoms in a large un selected general population in Japan. World J Gastroenterol 2008; 14: 1358-64.
[24]
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. CONSORT NPT Group*. CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med 2017; 167(1): 40-7.
[http://dx.doi.org/10.7326/M17-0046] [PMID: 28630973]
[25]
Grzanna R, Lindmark L, Frondoza CG. Ginger--an herbal medicinal product with broad anti-inflammatory actions. J Med Food 2005; 8(2): 125-32.
[http://dx.doi.org/10.1089/jmf.2005.8.125] [PMID: 16117603]
[26]
Charlier C, Michaux C. Dual inhibition of cyclooxygenase-2 (COX-2) and 5-lipoxygenase (5-LOX) as a new strategy to provide safer non-steroidal anti-inflammatory drugs. Eur J Med Chem 2003; 38(7-8): 645-59.
[http://dx.doi.org/10.1016/S0223-5234(03)00115-6] [PMID: 12932896]
[27]
Raji Y, Udoh US, Oluwadara OO, Akinsomisoye OS, Awobajo O, Adeshoga K. Anti-flammatory and analgesic properties of the rhizome extract of Zingiber officinale. Afr J Biomed Res 2010; 5(3)
[http://dx.doi.org/10.4314/ajbr.v5i3.53999]
[28]
Phillips S, Hutchinson S, Ruggier R. Zingiber officinale does not affect gastric emptying rate. Anaesthesia 1993; 48(5): 393-5.
[http://dx.doi.org/10.1111/j.1365-2044.1993.tb07011.x] [PMID: 8317647]
[29]
Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): A review of recent research. Food Chem Toxicol 2008; 46(2): 409-20.
[http://dx.doi.org/10.1016/j.fct.2007.09.085] [PMID: 17950516]
[30]
Afzal M, Al-Hadidi D, Menon M, Pesek J, Dhami MSI. Ginger: An ethnomedical, chemical and pharmacological review. Drug Metabol Drug Interact 2001; 18(3-4): 159-90.
[http://dx.doi.org/10.1515/DMDI.2001.18.3-4.159] [PMID: 11791883]
[31]
Koutsoudaki C, Krsek M, Rodger A. Chemical composition and antibacterial activity of the essential oil and the gum of Pistacia lentiscus Var. chia. J Agric Food Chem 2005; 53(20): 7681-5.
[http://dx.doi.org/10.1021/jf050639s] [PMID: 16190616]
[32]
Kaliora AC, Stathopoulou MG, Triantafillidis JK, Dedoussis GV, Andrikopoulos NK. Chios mastic treatment of patients with active Crohn’s disease. World J Gastroenterol 2007; 13(5): 748-53.
[http://dx.doi.org/10.3748/wjg.v13.i5.748] [PMID: 17278198]
[33]
Rahman H, Kim M, Leung G, Green JA, Katz S. Drug-herb interactions in the elderly patient with IBD: A growing concern. Curr Treat Options Gastroenterol 2017; 15(4): 618-36.
[http://dx.doi.org/10.1007/s11938-017-0154-y] [PMID: 28918484]
[34]
Afrasiabian H, Imanieh MH, Nejati MA, Salehi A. The effect of oral administration of Pistacia atlantica kurdica gum on the eradication of Helicobacter pylori in patients with dyspepsia: A randomized clinical trial. Glob J Health Sci 2016; 9(2): 256.
[http://dx.doi.org/10.5539/gjhs.v9n2p256]
[35]
Sõukand R, Pieroni A, Biró M, et al. An ethnobotanical perspective on traditional fermented plant foods and beverages in Eastern Europe. J Ethnopharmacol 2015; 170: 284-96.
[http://dx.doi.org/10.1016/j.jep.2015.05.018] [PMID: 25985766]
[36]
Jamal A, Siddiqui A. Antiulcerogenic activity of Elettaria cardamomum Maton.and Amomum subulatum Roxb.seeds. IJTK 2005; 4(3): 298-302.
[37]
Gilani AH, Jabeen Q, Khan A, Shah AJ. Gut modulatory, blood pressure lowering, diuretic and sedative activities of cardamom. J Ethnopharmacol 2008; 115(3): 463-72.
[http://dx.doi.org/10.1016/j.jep.2007.10.015] [PMID: 18037596]
[38]
Shahsavari N, Barzegar M, Sahari MA, Naghdibadi H. Antioxidant activity and chemical characterization of essential oil of Bunium persicum. Plant Foods Hum Nutr 2008; 63(4): 183-8.
[http://dx.doi.org/10.1007/s11130-008-0091-y] [PMID: 18810640]
[39]
Majidi Z, Bina F, Kahkeshani N, Rahimi R. Bunium persicum: A review of ethnopharmacology, phytochemistry, and biological activities. Tradit Integr Med 2020; 5(3)
[http://dx.doi.org/10.18502/tim.v5i3.4322]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy