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Efficacy and Safety of a Standardized Extract From Achillea Wilhelmsii C. Koch in Patients With Ulcerative Colitis: A Randomized Double Blind Placebo-Controlled Clinical Trial Publisher Pubmed



Amiri M1 ; Navabi J2 ; Shokoohinia Y1 ; Heydarpour F3 ; Bahrami G1 ; Behbood L1 ; Derakhshandeh P4 ; Momtaz S5, 6 ; Farzaei MH1
Authors
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Authors Affiliations
  1. 1. Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran
  2. 2. Department of Internal Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
  3. 3. Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
  4. 4. Shahrekord University of Medical Sciences, Shahrekord, Iran
  5. 5. Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran
  6. 6. Toxicology and Diseases Group, the Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran

Source: Complementary Therapies in Medicine Published:2019


Abstract

Background: Using Achillea wilhelmsii as a dietary supplement for gastrointestinal disorders is common in Persian traditional medicine. Its anti-inflammatory, anti-spasmodic and antibacterial properties have been proven by different in vitro and in vivo studies, yet it has not been evaluated in a controlled clinical trial. Aim: This study intended to evaluate the efficacy and safety of A. wilhelmsii in patients with mild to moderate active ulcerative colitis in a randomized, double-blinded, placebo-controlled clinical trial. The hydroalcoholic extract of A. wilhelmsii was standardized based on caffeic acid. Methods: Forty-nine patients were randomly received A. wilhelmsii capsules or placebo, twice daily for 4 weeks in a 1:1 ratio. The disease activity index (DAI) (Partial Mayo Score), haemoglobin, platelet count, erythrocyte sedimentation rate (ESR) and serum level of C-reactive protein (CRP) were measured at the entry and the end of the treatment. To standardize the extract, caffeic acid was detected and measured in the plant extract using high performance liquid chromatography (HPLC). Results: Of 49 patients who entered the trial, 40 patients completed the study. In both treatment and placebo groups, significant reductions were observed in stool frequency, rectal bleeding, physician global assessment and partial mayo score. There was no significant difference in stool frequency (P = 0.176), rectal bleeding (P = 0.523), physician global assessment (P = 0.341) and partial mayo score (P = 1) in the treatment versus the placebo groups. Laboratory variables including hemoglobin, platelet count, ESR and CRP showed no significant difference between the treatment and the placebo group. Of all participants, only one patient in the treatment group complained about skin rash (grade 1 based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). Conclusion: Oral administration of A. wilhelmsii powder for 4 weeks did not create a clinical response more than placebo. It seemed to be safe in UC patients. Further studies are obligatory to evaluate the therapeutic potential of A. wilhelmsii in the form of extract in UC patients. © 2019 Elsevier Ltd