We conducted a placebo-controlled, block-randomized double-blind Phase 2 study to examine the effect of 30 mg synthetic genistein daily on serum and tissue biomarkers in patients with localized prostate cancer (CaP). Fifty-four study subjects were recruited and randomized to treatment with genistein (n = 23) or placebo (n = 24) for 3 to 6 wk prior to prostatectomy. Seven study subjects were noncompliant to the study protocol. Adverse events were few and mild. Serum prostate specific antigen (PSA) decreased by 7.8% in the genistein arm and increased by 4.4% in the placebo arm (P = 0.051). The PSA level was reduced in tumor tissue compared to normal tissue in the placebo arm. In the genistein arm, the PSA level in tumor and normal tissue was comparable. Total cholesterol was significantly lower in the genistein arm (P = 0.013). There were no significant effects on thyroid or sex hormones. Plasma concentrations of total genistein were on average 100-fold higher in the genistein arm after treatment (P < 0.001). Genistein at a dose that can be easily obtained from a diet rich in soy reduced the level of serum PSA in patients with localized CaP, without any effects on hormones. It was well tolerated and had a beneficial effect on blood cholesterol.

ObjectiveTo investigate the effect of pharmacist-led medicines management in multimorbid, hospitalised patients on long-term hospital readmissions and survival.DesignParallel-group, randomised controlled trial.SettingRecruitment from an internal medicine hospital ward in Oslo, Norway. Patients were enrolled consecutively from August 2014 to the predetermined target number of 400 patients. The last participant was enrolled March 2016. Follow-up until 31 December 2017, that is, 21–40 months.ParticipantsAcutely admitted multimorbid patients ≥18 years, using minimum four regular drugs from minimum two therapeutic classes. 399 patients were randomly assigned, 1:1, to the intervention or control group. After excluding 11 patients dying in-hospital and 2 erroneously included, the primary analysis comprised 386 patients (193 in each group) with median age 79 years (range 23–96) and number of diseases 7 (range 2–17).InterventionIntervention patients received pharmacist-led medicines management comprising medicines reconciliation at admission, repeated medicines reviews throughout the stay and medicines reconciliation and tailored information at discharge, according to the integrated medicines management model. Control patients received standard care.Primary and secondary outcome measuresThe primary endpoint was difference in time to readmission or death within 12 months. Overall survival was a priori the clinically most important secondary endpoint.ResultsPharmacist-led medicines management had no significant effect on the primary endpoint time to readmission or death within 12 months (median 116 vs 184 days, HR 0.82, 95% CI 0.64 to 1.04, p=0.106). A statistically significantly increased overall survival was observed during 21–40 months follow-up (HR 0.66, 95% CI 0.48 to 0.90, p=0.008).ConclusionsPharmacist-led medicines management had no statistically significant effect on time until readmission or death. A statistically significant increased overall survival was seen. Further studies should be conducted to investigate the effect of such an intervention on a larger scale.Trial registration numberNCT02336113.

Background Knowledge of risk factors for drug-related hospitalizations (DRHs) is limited. Aim To examine the prevalence of DRHs and the relationships between DRHs and various variables in multimorbid patients admitted to an internal medicine ward. Methods Multimorbid patients ≥ 18 years, using minimum of four regular drugs from minimum two therapeutic classes, were included from the Internal Medicine ward, Oslo University Hospital, Norway, from August 2014 to March 2016. Clinical pharmacists prospectively conducted medicines reconciliations and reviews to reveal drug-related problems (DRPs). Blinded for identified DRPs, an interdisciplinary group retrospectively made comprehensive, clinical assessments of each patient case to classify hospitalizations as drug-related (DRH) or non-drug-related (non-DRH). Age, sex distribution, Charlson Comorbidity Index (CCI), renal function, aberrant genotype frequencies, body-mass index, number of drugs, proportion of patients which received assistance for drug administration from the home care service, and/or through multidose-dispensed drugs, and occurrence of specific DRP subgroups, were compared separately between patients with DRHs versus non-DRHs, followed by multiple logistic regression analysis. Results Hospitalizations were classified as drug-related in 155 of the 404 included patients (38%). Factors significantly associated with DRHs were occurrence of adverse effect DRPs (adjusted odds ratio (OR) 3.3, 95% confidence interval (CI) 1.4–8.0), adherence issues (OR 2.9, 1.1–7.2), home care (OR 1.9, 1.1–3.5), drug monitoring DRPs (OR 1.9, 1.2–3.0), and CCI score ≥6 (OR 0.33, 0.14–0.77). Frequencies of aberrant genotypes did not differ between the patient groups, but in 41 patients with DRHs (26.5%), gene-drug interactions influenced the assessments of DRHs. Conclusion DRHs are prevalent in multimorbid patients with adverse effect DRPs and adherence issues as the most important risk factors.

The persons with SCI included in this study used in average the same number of regular drugs compared to persons with other chronic conditions. Regardless of high overall adherence, the participants were more concerned about their medicines compared to other patient groups. Further studies are required for understanding adherence and attitudes toward medicines in this population, especially to help the persons with chronic SCI feel safe about their drug regimen.