Pleiotropic Effects of Comarum palustre L. in Patients with Osteoarthritis and Diabetes Mellitus with High Comorbidity Burden: An Exploratory Study.

Background Patients with osteoarthritis (OA) and diabetes mellitus (DM) are at increased risk of polypharmacy. A potential approach to this group of patients could be the use of herbal treatments influencing multiple biological pathways and aiming simultaneously at both OA and related comorbid conditions. Comarum palustre L. is widely used in traditional medicine but there is a lack of studies evaluating its pleiotropic effects in OA and DM. Primary study objective To investigate pleiotropic effects of Comarum palustre L. in patients with OA and diabetes mellitus (DM). Methods This was open-label, single-arm exploratory study on patients with knee OA and DM. Setting Single-center study. Participants Fifteen adult patients (mean age 68.6 years, fourteen women, one man) with knee OA and DM. Intervention The patients received Comarum palustre L.tablets 500 mg twice daily for 28 days. Primary outcome measure Changes from baseline in Visual Analogue Scale (VAS) for Pain. Results At the end of treatment there were significant reductions in VAS pain (effect size (ES) 1.45, 95% confidence interval (CI) 0.61 to 2.3), OA symptoms (ES 1.1 95% CI (-1.9 to -0.29), and disability (ES -0.88 95% CI -1.66 to -0.09). Treatment with Comarum palustre L. resulted in decrease in total cholesterol (TC), cholesterol ratio, and an increase in HDL-C. There was decrease of circulating TNF-α concentrations, and increase in circulating IL-10 and adiponectin levels. Conclusion Treatment with Comarum palustre L.is associated with pleiotropic effects in patients with OA and comorbid DM. These results provide a rationale for larger randomized controlled studies.