OBJECTIVE: To determine whether varenicline is effective for the balance in Parkinson disease (PD). METHODS: This was an investigator-initiated, double-blind, placebo-controlled study. Participants with a clinical diagnosis of PD were randomized to receive varenicline or placebo for 8 weeks. After dose escalation, participants took 1 mg of drug twice daily until the end of the study. Patients with severe tremor were excluded. Primary outcome was a change on the Berg Balance Scale (BBS) from baseline to 8 weeks. The BBS is a 14-item measure consisting of basic balance tasks. The study had a secondary, exploratory outcome of a change in cognition, measured with the Frontal Assessment Battery (FAB) and the Mini-Mental State Exam (MMSE) from baseline to 8 weeks. The FAB is a 6-item measure of executive functioning. RESULTS: Thirty-six participants were randomized (82% men, 100% White). Average age was 71.0 years (± 8.1). Average baseline motor Movement Disorder Society Unified Parkinson's Disease Rating Scale was 34.7 (± 11.6). There were no differences between treatment groups on the BBS (F[1,28] = 2.85, p = 0.10) or FAB (d = 0.16, 95% confidence interval [CI] = [-1.39 to 1.53]) or MMSE (d = 0.81, 95% CI = [-0.40 to 1.40]). CONCLUSION: The results did not suggest that varenicline had an effect on balance in patients with PD. Furthermore, varenicline did not seem to affect cognition. Perhaps, if an objective measure of balance had been used in place of the BBS, the analysis would show a difference between the groups. However, the authors do not recommend further study. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in patients with PD with Hoehn and Yahr stages 2, 3, or 4, varenicline does not improve balance as assessed by the BBS.
OBJECTIVE: To determine whether varenicline is effective for the balance in Parkinson disease (PD). METHODS: This was an investigator-initiated, double-blind, placebo-controlled study. Participants with a clinical diagnosis of PD were randomized to receive varenicline or placebo for 8 weeks. After dose escalation, participants took 1 mg of drug twice daily until the end of the study. Patients with severe tremor were excluded. Primary outcome was a change on the Berg Balance Scale (BBS) from baseline to 8 weeks. The BBS is a 14-item measure consisting of basic balance tasks. The study had a secondary, exploratory outcome of a change in cognition, measured with the Frontal Assessment Battery (FAB) and the Mini-Mental State Exam (MMSE) from baseline to 8 weeks. The FAB is a 6-item measure of executive functioning. RESULTS: Thirty-six participants were randomized (82% men, 100% White). Average age was 71.0 years (± 8.1). Average baseline motor Movement Disorder Society Unified Parkinson's Disease Rating Scale was 34.7 (± 11.6). There were no differences between treatment groups on the BBS (F[1,28] = 2.85, p = 0.10) or FAB (d = 0.16, 95% confidence interval [CI] = [-1.39 to 1.53]) or MMSE (d = 0.81, 95% CI = [-0.40 to 1.40]). CONCLUSION: The results did not suggest that varenicline had an effect on balance in patients with PD. Furthermore, varenicline did not seem to affect cognition. Perhaps, if an objective measure of balance had been used in place of the BBS, the analysis would show a difference between the groups. However, the authors do not recommend further study. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in patients with PD with Hoehn and Yahr stages 2, 3, or 4, varenicline does not improve balance as assessed by the BBS.
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