The efficacy and safety of adjunct bromocriptine therapy for levodopa-induced motor complications: A systematic review

OBJECTIVES: To assess the efficacy and safety of adjunct bromocriptine (BR) compared with placebo in the treatment of patients with Parkinson's disease (PD) who have motor complications. DESIGN: A systematic review of the literature from 1966-1999 on randomized, controlled trials. Outcome measures were occurrence and severity of motor complications, scores on impairment and disability, and the occurrence of side effects. RESULTS: We included eight trials of which the methodologic quality of seven showed important shortcomings. All studies failed to adequately describe randomization procedures and seven studies failed to report sample size calculations. Only one trial was analyzed according to the intention-to-treat principle. It frequently remained unclear if patients with PD actually had motor complications. Differences between studies concerning the baseline characteristics, the BR titration phase, and the applied outcomes were found. The various methods used to evaluate the occurrence and/or severity of motor complications lacked a sound clinimetric basis. A great diversity of impairment and disability scales were applied. For those studies that reported the incidence of side effects, no clear pattern of BR-related side effects emerged. A trend was found for orthostatic hypotension, which more frequently resulted in withdrawal of patients in the BR group. CONCLUSIONS: Major methodologic problems and sources of heterogeneity not only hamper the comparability of trials, but also preclude a conclusion on the efficacy and safety of BR in the adjunct treatment of patients with PD who have motor complications

LOFIT (Lifestyle front Office For Integrating lifestyle medicine in the Treatment of patients): a novel care model towards community-based options for lifestyle change-study protocol

BACKGROUND: A healthy lifestyle is indispensable for the prevention of noncommunicable diseases. However, lifestyle medicine is hampered by time constraints and competing priorities of treating physicians. A dedicated lifestyle front office (LFO) in secondary/tertiary care may provide an important contribution to optimize patient-centred lifestyle care and connect to lifestyle initiatives from the community. The LOFIT study aims to gain insight into the (cost-)effectiveness of the LFO. METHODS: Two parallel pragmatic randomized controlled trials will be conducted for (cardio)vascular disorders (i.e. (at risk of) (cardio)vascular disease, diabetes) and musculoskeletal disorders (i.e. osteoarthritis, hip or knee prosthesis). Patients from three outpatient clinics in the Netherlands will be invited to participate in the study. Inclusion criteria are body mass index (BMI) ≥25 (kg/m 2) and/or smoking. Participants will be randomly allocated to either the intervention group or a usual care control group. In total, we aim to include 552 patients, 276 in each trial divided over both treatment arms. Patients allocated to the intervention group will participate in a face-to-face motivational interviewing (MI) coaching session with a so-called lifestyle broker. The patient will be supported and guided towards suitable community-based lifestyle initiatives. A network communication platform will be used to communicate between the lifestyle broker, patient, referred community-based lifestyle initiative and/or other relevant stakeholders (e.g. general practitioner). The primary outcome measure is the adapted Fuster-BEWAT, a composite health risk and lifestyle score consisting of resting systolic and diastolic blood pressure, objectively measured physical activity and sitting time, BMI, fruit and vegetable consumption and smoking behaviour. Secondary outcomes include cardiometabolic markers, anthropometrics, health behaviours, psychological factors, patient-reported outcome measures (PROMs), cost-effectiveness measures and a mixed-method process evaluation. Data collection will be conducted at baseline, 3, 6, 9 and 12 months follow-up. DISCUSSION: This study will gain insight into the (cost-)effectiveness of a novel care model in which patients under treatment in secondary or tertiary care are referred to community-based lifestyle initiatives to change their lifestyle. TRIAL REGISTRATION: ISRCTN ISRCTN13046877 . Registered 21 April 2022