Efficacy and safety of Achillea wilhelmsii C. Koch capsules on symptom severity and quality of life in patients with irritable bowel syndrome: a randomized, placebo-controlled clinical trial.

Background Irritable bowel syndrome (IBS) is one of the most common digestive diseases. The aim of this clinical trial was to determine the effectiveness of Achillea wilhelmsii C. Koch on the symptom severity and quality of life (QOL) in patients with IBS. Methods The patients were randomized into two groups of 45 each. The QOL and symptom severity of the patients were evaluated at baseline and at completion of the treatments by means of IBS-QOL and IBS severity index. Results The mean severity of clinical symptoms in the Achillea wilhelmsii C. Koch receiving groups before and after the treatment was 282.56 ± 103.57 and 178.06 ± 88.40, and in the placebo group was 265.93 ± 93.56 and 197.74 ± 106.26, respectively. The mean QOL in the Achillea wilhelmsii C. Koch receiving group before and after treatment was 51.49 ± 11.98 and 50.44 ± 13.39 and in the placebo group was 60.71 ± 11.97 and 58.39 ± 11.67, respectively. In both groups, there was a significant difference in the recovery rate in each group (p<0.05). However, the mean difference between the two groups before and after intervention was not significantly different (p>0.05). Also, no patient reported any adverse events during the trial. Although the symptom severity and QOL in both groups were improved compared to those before intervention, there was no significant difference between the two groups. Conclusion It is recommended to conduct future studies with larger sample size and longer treatment periods, and also investigate the efficacy on the IBS subtypes, separately.

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.

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.