Effects of a Traditional Rose-Based Polyherbal Formula on Clinical Symptoms of Patients with Functional Dyspepsia: A Double-Blind Randomized Controlled Trial
Functional dyspepsia (FD) is a common gastroduodenal disorder that can be long-lasting. In the present study, we aimed to investigate the effect of herbal medicine, Ghors-e-Vard (Vard), on clinical symptoms in FD patients. Seventy adult FD patients according to the Rome IV criteria and without Helicobacter pylori infection were included. Participants were randomly allocated to either Vard or placebo group for 4 weeks of intervention. Treatments were given orally in a double-blind fashion (500 mg, three times a day, and half an hour after each meal). Patients were evaluated prior to and following 2, 4, and 8 weeks after the intervention, in terms of changes in the total score of gastrointestinal symptoms rating scale (GSRS), Depression Anxiety Stress Scales (DASS-21), scores of various components of the 36-item short-form health survey (SF-36), and any reported side effects. The differences of GSRS and DASS-21 total scores from baseline to the end of intervention were significantly larger in Vard group (P<0.001). Except for reflux, the other subtypes of FD symptoms were decreased with a significantly greater effect in Vard group (P < 0.05). Also, changes in the total score of SF-36 at 4 and 8 weeks after the intervention were significantly greater in Vard group (P<0.001). Except for the reflux, improvement of gastrointestinal symptoms, along with depression, stress, and anxiety, as well as the quality of life in Vard group, was significantly superior to the placebo group. These findings suggest that the Vard, as a complementary therapy, may have a promising effect on resolving the FD symptoms.
Vandenberghe A, Schol J, Van den Houte K, Masuy I, Carbone F, et al. Current and emerging therapeutic options for the management of functional dyspepsia. Expert Opin Pharmacother 2020;21:365-576.
Lacy B, Weiser K, Kennedy A, Crowell M, Talley N. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther 2013;38:170-177.
Mirzapour M, Mojahedi M, Shokri J, Khafri S, Memariani Z. Treatment of patients with refractory functional dyspepsia using nardostachys jatamansi (D. Don) DC. hydroalcoholic extract: a case series. Trad Integr Med 2019;4:191-199.
Carbone F, Vanuytsel T, Tack J. Analysis of postprandial symptom patterns in subgroups of patients with rome III or rome IV functional dyspepsia. Clin Gastroenterol Hepatol 2020;18:838-846.
Madisch A, Andresen V, Enck P, Labenz J, Frieling T, et al. The diagnosis and treatment of functional dyspepsia. Dtsch Ärztebl Int 2018;115:222.
Ford AC, Marwaha A, Sood R, Moayyedi P. Global prevalence of, and risk factors for, uninvestigated dyspepsia: a meta-analysis. Gut 2015;64:1049-1057.
El‐Serag H, Talley N. The prevalence and clinical course of functional dyspepsia. Aliment Pharmacol Ther 2004;19:643-654.
Toghiani A, Maleki I, Afshar H, Kazemian A. Translation and validation of the farsi version of rome III diagnostic questionnaire for the adult functional gastrointestinal disorders. J Res Med Sci 2016; 21:104.
Amini E, Keshteli AH, Jazi MSH, Jahangiri P, Adibi P. Dyspepsia in Iran: SEPAHAN systematic review No. 3. Int J Prev Med 2012;3:S18-S25.
Ford AC, Mahadeva S, Carbone MF, Lacy BE, Talley NJ. Functional dyspepsia. The Lancet 2020; 396:1689-1702
Yarandi SS, Christie J. Functional dyspepsia in review: pathophysiology and challenges in the diagnosis and management due to coexisting gastroesophageal reflux disease and irritable bowel syndrome. Gastroenterol Res Pract 2013;2013:351086.
Feinle-Bisset C, Azpiroz F. Dietary and lifestyle factors in functional dyspepsia. Nat Rev Gastroenterol Hepatol 2013;10:150-157.
Bordbar G, Miri MB, Omidi M, Shoja S, Akhavan M. Comparison of a novel herbal medicine and omeprazole in the treatment of Functional dyspepsia: a randomized double-blinded clinical trial. Gastroenterol Res Pract 2020;2020:5152736.
Diaconu S, Predescu A, Moldoveanu A, Pop C, Fierbințeanu-Braticevici C. Helicobacter pylori infection: old and new. J Med life 2017;10:112-117.
Ford AC, Moayyedi P, Black CJ, Yuan Y, Veettil SK, et al. Systematic review and network meta-analysis: efficacy of drugs for functional dyspepsia. Aliment Pharmacol Ther 2021;53:8-21.
Makunts T, Cohen IV, Awdishu L, Abagyan R. Analysis of postmarketing safety data for proton-pump inhibitors reveals increased propensity for renal injury, electrolyte abnormalities, and nephrolithiasis. Sci Rep 2019;9:1-10.
Pittayanon R, Yuan Y, Bollegala NP, Khanna R, Leontiadis GI, et al. Prokinetics for functional dyspepsia. Cochrane Database Syst Rev 2018;10:CD009431.
Drossman DA, Tack J, Ford AC, Szigethy E, Törnblom H, et al. Neuromodulators for functional gastrointestinal disorders (disorders of gut− brain interaction): a rome foundation working team report. Gastroenterology 2018;154:1140-1171.
Chey WD, Lacy BE, Cash BD, Epstein M, Corsino PE, et al. A novel, duodenal-release formulation of a combination of caraway oil and L-menthol for the treatment of functional dyspepsia: a randomized controlled trial. Clin Transl Gastroenterol 2019;10(4):e00021.
Suzuki H, Matsuzaki J, Fukushima Y, Suzaki F, Kasugai K, et al. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia -a multicenter, double‐blind, randomized, placebo‐controlled study. Neurogastroenterol Motil 2014;26:950-961.
Aghili M. Summary of wisdom. Esmailian Publication. Quom 2006; pp 35-42.
Jorjani S. Zakhireye Kharazmshahi. Academy of Medical Sciences of IR. Tehran 2003; pp 36-90.
Chashti M. Exir-e-Azam. Research Institute for Islamic and Complementary Medicine. Tehran University of Medical Sciences, Tehran 2004; p 4.
Ibn Sina A. al-Qanun fi al-Tibb. Alamy Le-Al-Matbooat Institute. Lebanon 2005; pp 125-127.
Matini J. Hidayat al-Mutaallimin fi al-Tibb by Abubakr Rabi ibn Ahmad al-Akhawayni al-Bukhari. Mashhad University Press. Mashhad 1965.
Memariani Z, Hajimahmoodi M, Minaee B, Khodagholi F, Yans A, et al. Protective effect of a polyherbal traditional formula consisting of Rosa damascena Mill., Glycyrrhiza glabra L. and Nardostachys jatamansi DC., against ethanol-induced gastric ulcer. Iran J Pharm Res 2017;16:694-707.
Arezoomandan R, Kazerani HR, Behnam-Rasooli M. The laxative and prokinetic effects of Rosa damascena Mill in rats. Iranian J Basic Medical Sci 2011;14:9-16.
Tirupathi H, Golla P. To evaluate and compare antidepressant activity of Rosa damascena in mice by using forced swimming test. Int J Basic Clin Pharmacol 2016;5:1949-1952.
Talebi M, Zarshenas M, Yazdani E, Moein M. Preparation and evaluation of possible antioxidant activities of Rose traditional tablet “[Qurs-e-Vard]” a selected Traditional Persian Medicine [TPM] formulation via various procedures. Curr Drug Discov Technol 2021;18:e28092020186381.
Sadra A, Kweon H-S, Huh S-O, Cho J. Gastroprotective and gastric motility benefits of AD-lico/Healthy Gut™ Glycyrrhiza inflata extract. Anim Cells Syst 2017;21:255-262.
Razack S, Kandikattu HK, Venuprasad M, Amruta N, Khanum F, et al. Anxiolytic actions of Nardostachys jatamansi via GABA benzodiazepine channel complex mechanism and its biodistribution studies. Metab Brain Dis 2018;33:1533-1549.
Wang Z, Li L, Yan J, Yao Y. Approaching high-accuracy side effect prediction of traditional chinese medicine compound prescription using network embedding and deep learning. IEEE Access 2020;8:82493-82499.
Yao Y, Wang Z, Li L, Lu K, Liu R, et al. An ontology-based artificial intelligence model for medicine side-effect prediction: taking traditional Chinese medicine as an example. Comput Math Methods Med 2019;2019.
Kolangi F, Memariani Z, Bozorgi M, Mozaffarpur SA, Mirzapour M. Herbs with potential nephrotoxic effects according to the traditional Persian medicine: review and assessment of scientific evidence. Curr Drug Metab 2018;19:628-637.
Isbrucker R, Burdock G. Risk and safety assessment on the consumption of Licorice root (Glycyrrhiza sp.), its extract and powder as a food ingredient, with emphasis on the pharmacology and toxicology of glycyrrhizin. Regul Toxicol Pharmacol 2006;46:167-192.
Kwon YJ, Son DH, Chung TH, Lee YJ. A review of the pharmacological efficacy and safety of licorice root from corroborative clinical trial findings. J Med Food 2020;23:12-20.
Gardner Z, McGuffin M. American Herbal Products Association’s Botanical Safety Handbook. 2nd ed. CRC Press Taylor & Francis Group, Boca Raton 2013; pp 417-420.
Assessment report on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos [Internet]. EMA/HMPC/137298/ Committee on Herbal Medicinal Products (HMPC). 2013. Available from: https://www.ema.europa.eu/en/medicines/herbal/rosae-flos.
Brendler T, Gruenwald J, Jaenicke C. PDR for herbal medicines: 4th ed. NJ: Thomson. Montvale 2007; p 433.
Heravi M. Qarabadin-e-salehi. Dar-ol-khalafeh. Tehran 1765; p 116.
Dababneh BF. An innovative microwave process for microbial decontamination of spices and herbs. African J Microbiol Res 2013;7:636-645.
Mazaheri M, SadatKhoshouei M. Comparison between psychometric characteristics of persian version of the gastrointestinal symptoms rating scale in functional gastrointestinal disorders and normal groups. Govaresh 2012;17:18-24.
Sahebi A, Asghari MJ, Salari RS. Validation of depression anxiety and stress scale (DASS-21) for an Iranian population. J Dev Psycol 2005;1:36-54.
Mohtashami R, Huseini HF, Heydari M, Amini M, Sadeqhi Z, et al. Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial. J Ethnopharmacol 2015;175:147-152.
Choi Y, Kim N, Noh GT, Lee JY, Lee DH. The efficacy and safety of GCWB104 ( flos lonicera extract) in functional dyspepsia: a single-center, randomized, double-blind, placebo-controlled study. Gut Liver 2020;14:67-78.
Hasler WL. Functional dyspepsia: a review of the symptoms, evaluation, and treatment options. Gastroenterol Hepatol 2020;16:67-74.
Choi Y, Kim N, Noh GT, Lee JY, Lee DH. The efficacy and safety of GCWB104 (flos lonicera extract) in functional dyspepsia: a single-center, randomized, double-blind, placebo-controlled study. Gut Liver 2020;14:67-78.
Masuy I, Van Oudenhove L, Tack J. Treatment options for functional dyspepsia. Aliment Pharmacol Ther 2019;49:1134-1172.
Wang YP, Herndon CC, Lu CL. Non-pharmacological approach in the management of functional dyspepsia. J Neurogastroenterol Motil 2020;26:6-15.
Sharangi AB, Das S. Healing indigestion: a phytotherapeutic review. Adv Tradit Med 2020:1-17.
Gwee KA, Holtmann G, Tack J, Suzuki H, Liu J, et al. Herbal medicines in functional dyspepsia Untapped opportunities not without risks. Neurogastroenterol Motil 2021;33:e14044.
Ko SJ, Park J, Kim Mj, Kim J, Park JW. Effects of the herbal medicine Rikkunshito, for functional dyspepsia: A systematic review and meta‐analysis. J Gastroenterol Hepatol 2021;36:64-74.
Allescher HD, Abdel-Aziz H. Mechanism of action of STW 5 in functional dyspepsia and IBS: the origin of multi-target. Dig Dis 2017;35:18-24.
Sadraei H, Asghari G, Emami S. Effect of Rosa damascena Mill. flower extract on rat ileum. Res Pharm Sci 2013;8:277-284.
Kumar N, Bhandari P, Singh B, Bari SS. Antioxidant activity and ultra-performance LC-electrospray ionization-quadrupole time-of-flight mass spectrometry for phenolics-based fingerprinting of Rose species: Rosa damascena, Rosa bourboniana and Rosa brunonii. Food Chem Toxicol 2009;47:361-367.
Dolati K, Rakhshandeh H, Shafei MN. Effect of aqueous fraction of Rosa damascena on ileum contractile response of guinea pigs. Avicenna J Phytomed 2013;3:248-253.
Heshmati Moghaddam M, Dolati K, Rakhshandeh H. Cholinergic and histaminergic effects of the aqueous fraction of Rosa damascena extract in guinea pig ileum and rabbit jejunum. Asian J Biol Sci 2013;6:67-75.
Rodríguez Varón A, Zuleta J. From the physiology of gastric emptying to the understanding of gastroparesis. Rev Colomb Gastroenterol 2010;25:219-225.
Chen G, Zhu L, Liu Y, Zhou Q, Chen H, et al. Isoliquiritigenin, a flavonoid from licorice, plays a dual role in regulating gastrointestinal motility in vitro and in vivo. Phytother Res 2009;23:498-506.
Yang R, Yuan B-C, Ma Y-S, Zhou S, Liu Y. The anti-inflammatory activity of licorice, a widely used Chinese herb. Pharm Biol 2017;55:5-18.
Latifi G, Ghannadi A, Minaiyan M. Anti-inflammatory effect of volatile oil and hydroalcoholic extract of Rosa damascena Mill. on acetic acid-induced colitis in rats. Res Pharma Sci 2015;10:514-522.
Nakagawa K, Hara K, Fikree A, Siddiqi S, Woodland P, et al. Patients with dyspepsia have impaired mucosal integrity both in the duodenum and jejunum: in vivo assessment of small bowel mucosal integrity using baseline impedance. J Gastroenterol 2020;55:273-280.
Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, et al. Efficacy and safety of Jollab to treat functional dyspepsia: a randomized placebo–controlled clinical trial. Explore 2015;11:199-207.
Raveendra KR, Jayachandra, Srinivasa V, Sushma KR, Allan JJ, et al. An extract of Glycyrrhiza glabra (GutGard) alleviates symptoms of functional dyspepsia: a randomized, double-blind, placebo-controlled study. Evid Based Complement Alternat Med 2012;2012:216970.
Puasripun S, Thinrungroj N, Pinyopornpanish K, Kijdamrongthum P, Leerapun A, et al. Efficacy and safety of clidinium/chlordiazepoxide as an add-on therapy in functional dyspepsia: a randomized, controlled, trial. J Neurogastroenterol Motil 2020;26:259-266.
Lapina TL, Trukhmanov AS. Herbal preparation STW 5 for functional gastrointestinal disorders: clinical experience in everyday practice. Dig Dis 2017;35:30-35.
Biswas M, Singh KNM, Shetty YC, Koli PG, Ingawale S, et al. Prescription pattern & adverse drug reactions of prokinetics. Indian J Med Res 2019;149:748-754.
Esfandiary E, Abdolali Z, Omranifard V, Ghanadian M, Bagherian-Sararoud R, et al. Novel effects of Rosa damascena extract on patients with neurocognitive disorder and depression: a clinical trial study. Int J Prev Med 2018;9:57-61.
Li R, Wang ZM, Wang Y, Dong X, Zhang LH, et al. Antidepressant activities and regulative effects on serotonin transporter of Nardostachys jatamansi DC. J Ethnopharmacol 2021;268:113601.
Wang B, Lian YJ, Dong X, Peng W, Liu LL, et al. Glycyrrhizic acid ameliorates the kynurenine pathway in association with its antidepressant effect. Behav Brain Res 2018;353:250-257.
Xiao D, Liu L, Li Y, Ruan J, Wang H. Licorisoflavan a exerts antidepressant-like effect in mice: involvement of BDNF-TrkB pathway and AMPA receptors. Neurochem Res 2019;44:2044-2056.
Trauner G, Khom S, Baburin I, Benedek B, Hering S, et al. Modulation of GABAA receptors by valerian extracts is related to the content of valerenic acid. Planta Med 2008;74:19-24.
Pesce M, Cargiolli M, Cassarano S, Polese B, De Conno B, et al. Diet and functional dyspepsia: Clinical correlates and therapeutic perspectives. World J Gastroenterol 2020;26:456-465.
|Issue||Vol 7, No 1, 2022|
|Functional dyspepsia Gastroenterology Glycyrrhiza glabra Nardostachys jatamansi Rosa damascena Traditional persian medicine|
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