Evaluation of the efficacy of Thymus kotschyanus extract as an additive treatment in patients with ulcerative colitis: a randomized double-blind placebo-controlled trial.


Journal

Inflammopharmacology
ISSN: 1568-5608
Titre abrégé: Inflammopharmacology
Pays: Switzerland
ID NLM: 9112626

Informations de publication

Date de publication:
Dec 2022
Historique:
received: 28 12 2021
accepted: 05 04 2022
pubmed: 21 6 2022
medline: 30 11 2022
entrez: 20 6 2022
Statut: ppublish

Résumé

Ulcerative colitis (UC) is one of the chronic diseases which is increasing in prevalence and patients suffer from illness flare-ups. UC standard regimen treatment has various side effects besides the efficacy, so there is an interest in administering complementary medicine to reduce adverse effects and increase the efficacy, as well. The aim of this study was to evaluate the efficacy and anti-inflammatory effect of Thymus kotschyanus as an additive treatment in a randomized double-blind placebo-controlled trial of UC patients. Thirty UC out-patients with mesalazine regimen treatment that fulfilled the inclusion criteria were participated in a 12 week trial and were randomly chosen for the treatment and control group. Fifteen patients were administered a placebo as a control and 15 patients were received Thymus kotschyanus extract by a dose of 0.5 g in a day in the treatment group. Laboratory tests were performed at baseline and week 12. The primary outcome was a reduction in fecal calprotectin as the main intestine inflammatory marker. Likewise, reduction in SCCAI, SIDBQ, and SEO indices were considered as secondary aims. Fecal calprotectin was decreased by 54.74% in the treatment group, as compared with the placebo group at week 12 (p = 0.02). A significant reduction in SCCAI was also shown between the two study groups (p = 0.01). Thymus kotschyanus extract was safe and no severe side effects were reported. Administration of Thymus kotschyanus revealed improvement in UC symptoms by the intestinal anti-inflammation effect of the plant and could be suggested as a potential additive treatment in UC patients. The study protocol has been registered under the identification code: IRCT20200406046965N2.

Sections du résumé

BACKGROUND BACKGROUND
Ulcerative colitis (UC) is one of the chronic diseases which is increasing in prevalence and patients suffer from illness flare-ups. UC standard regimen treatment has various side effects besides the efficacy, so there is an interest in administering complementary medicine to reduce adverse effects and increase the efficacy, as well. The aim of this study was to evaluate the efficacy and anti-inflammatory effect of Thymus kotschyanus as an additive treatment in a randomized double-blind placebo-controlled trial of UC patients.
METHODS METHODS
Thirty UC out-patients with mesalazine regimen treatment that fulfilled the inclusion criteria were participated in a 12 week trial and were randomly chosen for the treatment and control group. Fifteen patients were administered a placebo as a control and 15 patients were received Thymus kotschyanus extract by a dose of 0.5 g in a day in the treatment group. Laboratory tests were performed at baseline and week 12. The primary outcome was a reduction in fecal calprotectin as the main intestine inflammatory marker. Likewise, reduction in SCCAI, SIDBQ, and SEO indices were considered as secondary aims.
RESULTS RESULTS
Fecal calprotectin was decreased by 54.74% in the treatment group, as compared with the placebo group at week 12 (p = 0.02). A significant reduction in SCCAI was also shown between the two study groups (p = 0.01). Thymus kotschyanus extract was safe and no severe side effects were reported.
CONCLUSION CONCLUSIONS
Administration of Thymus kotschyanus revealed improvement in UC symptoms by the intestinal anti-inflammation effect of the plant and could be suggested as a potential additive treatment in UC patients. The study protocol has been registered under the identification code: IRCT20200406046965N2.

Identifiants

pubmed: 35723850
doi: 10.1007/s10787-022-00991-3
pii: 10.1007/s10787-022-00991-3
doi:

Substances chimiques

Leukocyte L1 Antigen Complex 0
Mesalamine 4Q81I59GXC
Plant Extracts 0

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2145-2152

Subventions

Organisme : Mashhad University of Medical Sciences
ID : 980801

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

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Auteurs

Fatemeh Vazirian (F)

Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

Sara Samadi (S)

Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

Mohammadreza Abbaspour (M)

Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Amirmahdi Taleb (A)

Deputy for The Secretariat of the Council for Basic Medical Sciences, Health and Graduate's Education, Treatment and Medical Sciences, Ministry of Health, Tehran, Iran.

Hadi Bagherhosseini (H)

Department of Gastroenterology and Hepatology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Hooman Mosannen Mozaffari (HM)

Gastroenterology and Hepatology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

Amir Hooshang Mohammadpour (AH)

Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. ah_mp@ymail.com.
Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. ah_mp@ymail.com.

Seyed Ahmad Emami (SA)

Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. EmamiA@mums.ac.ir.

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Classifications MeSH