
Efficacy of Rose Oil Soft Capsules on Clinical Outcomes in Ulcerative Colitis: A Pilot Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Background: Ulcerative colitis is the most common form of inflammatory bowel disease worldwide, which presents with superficial ulcers in the rectum and colon. The aim of this study was to assess the effectiveness of rose oil soft capsules over placebo on the clinical outcomes in moderate to severe ulcerative colitis. Materials and Methods: This study was a pilot randomized, double-blind clinical trial, and the 40 patients were assigned into rose oil and placebo groups (n=20 per group). All patients were instructed to use their prescribed two soft capsules three times daily for two months. The clinical symptoms, quality of life the patients, and calprotectin level were evaluated via partial Mayo clinic score, irritable bowel disease questionnaire (IBDQ-9), and calprotectin kit as primary outcome measures. Results: The mean age of the participants was 41±10 years. Most of them (53.6%) were male, and the remaining (46.4%) were female. The demographic and baseline data showed no differences between the two groups. Partial Mayo clinic scores decreased in both groups after the treatment, but the difference between the rose oil and placebo groups was not statistically significant (P=0.99). IBDQ-9 score also increased in both interventions before and after the treatment (P=0.012), though the differences between these two groups were not statistically significant (P=0.61). There were no significant differences between the two study groups either in terms of calprotectin level (P=0.219). Conclusion: This study showed that rose oil might improve ulcerative colitis clinical outcomes, but for a better evaluation, it is imperative to conduct experiments with a large sample size and longer follow-up observation. [GMJ.2019;8:e1307]
Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet 2017; 389(10080): 1756-70.
https://doi.org/10.1016/S0140-6736(16)32126-2
Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol 2015; 110(9): 1324-38.
https://doi.org/10.1038/ajg.2015.233
PMid:26303131
Gibson PR, Vaizey C, Black CM, Nicholls R, Weston AR, Bampton P et al. Relationship between disease severity and quality of life and assessment of health care utilization and cost for ulcerative colitis in Australia: A cross-sectional, observational study. J Crohns Colitis 2014; 8(7): 598-606.
https://doi.org/10.1016/j.crohns.2013.11.017
PMid:24345767
Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet 2007; 369(9573): 1641-57.
https://doi.org/10.1016/S0140-6736(07)60751-X
Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010; 105(3): 501-23; quiz 24.
https://doi.org/10.1038/ajg.2009.727
PMid:20068560
Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011; 106(4): 644-59, quiz 60.
https://doi.org/10.1038/ajg.2011.73
PMid:21407183
Jagtap AG, Shirke SS, Phadke AS. Effect of polyherbal formulation on experimental models of inflammatory bowel diseases. J Ethnopharmacol 2004; 90(2-3): 195-204.
https://doi.org/10.1016/j.jep.2003.09.042
PMid:15013181
Razi MZ. Al-Havi Fi Al-Tibb (Arabic). Beirut: Dar Al Kotob Al-islmiyah; 2000.
Aghili Shirazi MH. Qarabadin-e Kabir (Great Pharmacopoeia). Tehran: Institute of Meical History, Islamic Medicine and Complementary Medicine; Iran Medical University; 1970.
Mahboubi M. Rosa damascena as holy ancient herb with novel applications. J Tradit Complement Med 2016; 6(1): 10-6.
https://doi.org/10.1016/j.jtcme.2015.09.005
PMid:26870673 PMCid:PMC4737971
Avicenna. Al-Qanun fi al-Tibb (The Canon of Medicine). Tehran: Soroush Press; 2005.
Loghmani H, Sabzi O, Safari J. Essential oil composition of Rosa damascena Mill cultivated in central Iran. Scientia Iranica 2007; 14: 316-9.
Soubh AA, Abdallah DM, El-Abhar HS. Geraniol ameliorates TNBS-induced colitis: Involvement of Wnt/beta-catenin, p38MAPK, NFkappaB, and PPARgamma signaling pathways. Life Sci 2015; 136: 142-50.
https://doi.org/10.1016/j.lfs.2015.07.004
PMid:26165751
Medicherla K, Sahu BD, Kuncha M, Kumar JM, Sudhakar G, Sistla R. Oral administration of geraniol ameliorates acute experimental murine colitis by inhibiting pro-inflammatory cytokines and NF-kappaB signaling. Food Funct 2015; 6(9): 2984-95.
https://doi.org/10.1039/C5FO00405E
PMid:26190278
Cohen BL, Zoega H, Shah SA, Leleiko N, Lidofsky S, Bright R et al. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity. Aliment Pharmacol Ther 2014; 39(8): 811-22.
https://doi.org/10.1111/apt.12659
PMid:24612278 PMCid:PMC4670472
Habtemariam S, Belai A. Natural Therapies of the Inflammatory Bowel Disease: The Case of Rutin and its Aglycone, Quercetin. Mini Rev Med Chem 2018; 18(3): 234-43.
https://doi.org/10.2174/1389557517666170120152417
PMid:28117024
Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008; 14(12): 1660-6.
https://doi.org/10.1002/ibd.20520
PMid:18623174 PMCid:PMC2597552
Bijari B, Soltani B. Validation of the Persian Version of Inflammatory Bowel Disease Questionnaire in Patients Who Referred to Clinics and Hospitals of Birjand University of Medical Sciences, Iran. Ann Colorectal Res 2017; 5(1): e46367.
https://doi.org/10.5812/acr.46367
Hosseini SV, Jafari P, Taghavi SA, Safarpour AR, Rezaianzadeh A, Moini M et al. Fecal Calprotectin is an Accurate Tool and Correlated to Seo Index in Prediction of Relapse in Iranian Patients With Ulcerative Colitis. Iran Red Crescent Med J 2015; 17(2): e22796.
https://doi.org/10.5812/ircmj.22796
Gonzalez R, Ballester I, Lopez-Posadas R, Suarez MD, Zarzuelo A, Martinez-Augustin O et al. Effects of flavonoids and other polyphenols on inflammation. Crit Rev Food Sci Nutr 2011; 51(4): 331-62.
https://doi.org/10.1080/10408390903584094
PMid:21432698
Garcia-Lafuente A, Guillamon E, Villares A, Rostagno MA, Martinez JA. Flavonoids as anti-inflammatory agents: implications in cancer and cardiovascular disease. Inflamm Res 2009; 58(9): 537-52.
https://doi.org/10.1007/s00011-009-0037-3
PMid:19381780
Yassa N, Masoomi F, Rohani Rankouhi S, Hadjiakhoondi A. Chemical Composition and Antioxidant Activity of the Extract and Essential oil of Rosa damascena from Iran, Population of Guilan. Daru 2009; 17(3): 175-80.
Periasamy S, Hsu DZ, Chandrasekaran VR, Liu MY. Sesame oil accelerates healing of 2,4,6-trinitrobenzenesulfonic acid-induced acute colitis by attenuating inflammation and fibrosis. JPEN J Parenter Enteral Nutr 2013; 37(5): 674-82.
https://doi.org/10.1177/0148607112468768
PMid:23243149
Kondamudi PK, Kovelamudi H, Mathew G, Nayak PG, Rao MC, Shenoy RR. Investigation of sesamol on myeloperoxidase and colon morphology in acetic acid-induced inflammatory bowel disorder in albino rats. Scientific World J 2014; 2014: 802701.
https://doi.org/10.1155/2014/802701
PMid:24616646 PMCid:PMC3926374
Sebepos-Rogers GM, Rampton DS. Herbs and Inflammatory Bowel Disease. Gastroenterol Clin North Am 2017; 46(4): 809-24.
https://doi.org/10.1016/j.gtc.2017.08.009
PMid:29173523
Langmead L, Rampton DS. Review article: complementary and alternative therapies for inflammatory bowel disease. Aliment Pharmacol Ther 2006; 23(3): 341-9.
https://doi.org/10.1111/j.1365-2036.2006.02761.x
PMid:16422993
Sandborn WJ, Targan SR, Byers VS, Rutty DA, Mu H, Zhang X et al. Andrographis paniculata extract (HMPL-004) for active ulcerative colitis. Am J Gastroenterol 2013; 108(1): 90-8.
https://doi.org/10.1038/ajg.2012.340
PMid:23044768 PMCid:PMC3538174
Valdiani A, Kadir MA, Tan SG, Talei D, Abdullah MP, Nikzad S. Nain-e Havandi Andrographis paniculata present yesterday, absent today: a plenary review on underutilized herb of Iran's pharmaceutical plants. Mol Biol Rep 2012; 39(5): 5409-24.
https://doi.org/10.1007/s11033-011-1341-x
PMid:22198549
Langmead L, Feakins RM, Goldthorpe S, Holt H, Tsironi E, De Silva A et al. Randomized, double-blind, placebo-controlled trial of oral aloe vera gel for active ulcerative colitis. Aliment Pharmacol Ther 2004; 19(7): 739-47.
https://doi.org/10.1111/j.1365-2036.2004.01902.x
PMid:15043514
Gong Y, Zha Q, Li L, Liu Y, Yang B, Liu L et al. Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine: a double-blinded and randomized study. J Ethnopharmacol 2012; 141(2): 592-8.
https://doi.org/10.1016/j.jep.2011.08.057
PMid:21911045
Gordon M, MacDonald JK, Parker CE, Akobeng AK, Thomas AG. Osmotic and stimulant laxatives for the management of childhood constipation. Cochrane Database Syst Rev 2016; (8): Cd009118.
https://doi.org/10.1002/14651858.CD009118.pub3
PMCid:PMC6513425
Zezos P, Nguyen GC. Use of Complementary and Alternative Medicine in Inflammatory Bowel Disease Around the World. Gastroenterol Clin North Am 2017; 46(4): 679-88.
https://doi.org/10.1016/j.gtc.2017.08.001
PMid:29173516
Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR et al. Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial. Explore (NY) 2015; 11(3): 199-207.
https://doi.org/10.1016/j.explore.2015.02.007
PMid:25777290
Sedigh-Rahimabadi M, Fani M, Rostami-Chijan M, Zarshenas MM, Shams M. A Traditional Mouthwash (Punica granatum var pleniflora) for Controlling Gingivitis of Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial. J Evid Based Complementary Altern Med 2017; 22(1): 59-67.
https://doi.org/10.1177/2156587216633370
PMid:26922436 PMCid:PMC5871205
Mosaffa-Jahromi M, Pasalar M, Afsharypuor S, Choopani R, Mosaddegh M, Kamalinejad M et al. Preventive care for gastrointestinal disorders; role of herbal medicines in traditional persian medicine. Jundishapur J Nat Pharm Prod 2015; 10(4).
https://doi.org/10.17795/jjnpp-21029
Hajhashemi V, Ghannadi A, Hajiloo M. Analgesic and Anti-inflammatory Effects of Rosa damascena Hydroalcoholic Extract and its Essential Oil in Animal Models. Iran J Pharm Res 2010; 9(2): 163-8.
Refbacks
- There are currently no refbacks.