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Abstract Background In recent years , red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; however, the large majority of commercially available products have not been studied according to current research standards. Methods In a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. As a primary outcome measure, we compared the before-after difference in lipid levels between both groups. As secondary outcome measures we looked at side-effects, CK elevation and a change in cardiovascular risk. Results LDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group. This result was statistically significant as compared to the control group, in which no reduction in total cholesterol and LDL was observed (p < 0.001). There was no marked difference in CK (creatine kinase)-elevation or reported side-effects between study groups. In 5/31 participants in the intervention group, the lipid lowering effect resulted in lower cardiovascular risk as measured with SCORE (Systematic COronary Risk Evaluation). Conclusions The RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population. RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering. However, consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations, which raises effectiveness and safety issues. Trial registration Clinicaltrials.gov, nr: NCT01558050

BACKGROUND: During the cluster randomised TRIAGE-trial, a nurse advised 13% of low-risk patients presenting at an emergency department in Belgium to visit the adjacent general practitioner cooperative. Patients had the right to refuse this advice. This exploratory study examines the characteristics of refusers by uncovering the determinants of non-compliance and its impact on costs, as charged on the patient's invoice. METHODS: Bivariate analyses with logistic regressions and T-tests were used to test the differences in patient characteristics, patient status, timing characteristics, and costs between refusers and non-refusers. A chi-square automatic interaction detection analysis was used to find the predictors of non-compliance. RESULTS: 23.50% of the patients refused the advice to visit the general practitioner cooperative. This proportion was mainly influenced by the nurse on duty (non-compliance rates per nurse ranging from 2.9% to 52.8%) and the patients' socio-economic status (receiving increased reimbursement versus not OR 1.37, 95%CI: 0.96 to 1.95). Additionally, non-compliance was associated (at the 0.10 significance level) with being male, not living nearby and certain reasons for encounter. Fewer patients refused when the nurse perceived crowding level as quiet relative to normal, and more patients refused during the evening. The mean cost was significantly higher for patients who refused, which was a result of more extensive examination and higher out-of-pocket expenses at the ED. CONCLUSIONS: The nurse providing the advice to visit the general practitioner cooperative has a central role in the likelihood of patients' refusal. Interventions to reduce non-compliance should aim at improving nurse-patient communication. Special attention may be required when managing patients with a lower socio-economic status. The overall mean cost was higher for refusers, illustrating the importance of compliance. TRIAL REGISTRATION: The trial was registered on registration number NCT03793972 on 04/01/2019.