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

Abstract

Background: Ulcerative colitis (UC) is one of the chronic diseases which is increasing in prevalence and patients suffer from illness are-ups. UC standard regimen treatment has various side effects besides the e cacy, so there is an interest in administering complementary medicine to reduce adverse effects and increase the e cacy, as well. The aim of this study was to evaluate the e cacy and anti-in ammatory effect of Thymus kotschyanus as an additive treatment in a randomized double-blind placebo-controlled trial of UC patients.Methods: Thirty UC out-patients with mesalazine regimen treatment that ful lled 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 administered received Thymus kotschyanus extract by a dose of 0.5 grams in a day in the treatment group. Laboratory tests were performed at baseline and week 12. The primary outcome was reduction in fecal calprotectin as the main intestine in ammatory marker. Likewise, reduction in SCCAI, SIDBQ, and SEO indices were considered as the secondary aims. The primary outcome was a reduction in SCCAI as the main intestine in ammatory marker. Likewise, reduction in fecal calprotectin, SIDBQ, and SEO indices were the secondary aims.Results: Fecal calprotectin Comparing the treatment and placebo groups at week 12 indicated a was decreased in fecal calprotectin by 54.74% in the treatment group, as compared with placebo group at week 12 (p=0.02). and alsoA signi cant difference reduction was shown in SCCAI was also shown between two study groups (p=0.01). Thymus kotschyanus extract was safe and no severe side effects were reported.Conclusion: Administration of Thymus kotschyanus revealed improvement in UC symptoms by the intestinal anti-in ammation effect of the plant and could be suggested as a potential additive treatment in UC patients. The study protocol has been registered under the identi cation code: IRCT20200406046965N2.

Herbal Medicines for the Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

“…Only mild adverse events, including mouth ulcers and bloating, were reported, with no significant difference between groups in the study by Vazirian et al [47]. No serious adverse events were reported.…”

“…There was a significant baseline difference in mean SIBDQ score between groups at the outset of the study by Vazirian et al [47], which may have influenced outcomes. Other limitations of this study include a small sample size, attrition rate, and lack of clarity if a per protocol or intention to treat approach was used to analyze outcomes.…”

“…Thymus kotschyanus is an aromatic perennial herb native to the Mediterranean, of which the aerial parts have been used in TPM for a variety of ailments due to its antispasmodic, antibacterial, and antioxidant effects [47,100]. The oil components, including thymol, carvacol, and geraniol, among others, contain flavonoids, polyphenols, anthocyanins, and other bioactive polyphenols [47].…”

“…Thymus kotschyanus is an aromatic perennial herb native to the Mediterranean, of which the aerial parts have been used in TPM for a variety of ailments due to its antispasmodic, antibacterial, and antioxidant effects [47,100]. The oil components, including thymol, carvacol, and geraniol, among others, contain flavonoids, polyphenols, anthocyanins, and other bioactive polyphenols [47]. The monoterpene thymol has exhibited anti-inflammatory, antioxidant, and antitumor potential through free radical scavenging [101], cyto/genotoxic effects on colorectal cancer cells [102], NFκB and MAPK inhibition, and downregulation of COX-2 expression, inflammatory cytokine production, and NO production in murine colitis models and in vitro studies [47,103].…”

“…Vazirian et al [47] investigated the use of Thymus kotschyanus capsules in patients with mild to moderate UC on stable doses of mesalamine [47]. At 12 weeks, the treatment group had a significantly lower mean fecal calprotectin level and median SCCAI score when compared to placebo, while there was no difference in median SIBDQ score, Seo index, ESR (p = 0.572), or CRP (p = 0.160) [47].…”