Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.
Atypical odontalgia is surprisingly common, of uncertain origin, and potentially treatable.
The purpose of this study was to evaluate the effect of changing mandibular position on body posture and reciprocally, body posture on mandibular position. Forty-five (45) asymptomatic subjects (24 males and 21 females, ages 21-53 years, mean age 30.7 years) were included in this study and randomly assigned to one of two groups, based on the table of random numbers. The only difference between group I and group II was the sequence of the testing. The MatScan (Tekscan, Inc., South Boston, MA) system was used to measure the result of changes in body posture (center of foot pressure: COP) while subjects maintained the following 5 mandibular positions: (1) rest position, (2) centric occlusion, (3) clinically midlined jaw position with the labial frena aligned, (4) a placebo wax appliance, worn around the labial surfaces of the teeth and (5) right eccentric mandibular position. The T-Scan II (Tekscan, Inc., South Boston, MA) system was used to analyze occlusal force distribution in two postural positions, with and without a heel lift under the right foot. Total trajectory length of COP in centric occlusion was shorter than in the rest position (p < 0.05). COP area in right eccentric mandibular position was larger than in centric occlusion (p < 0.05). When subjects used a heel lift under the right foot, occlusal forces shifted to the right side compared to no heel lift (p < 0.01). Based on these findings, it was concluded that changing mandibular position affected body posture. Conversely, changing body posture affected mandibular position.
This randomized double-blind study evaluated the effectiveness of pulsed radio frequency energy therapy (PRFE) in patients with temporomandibular joint arthralgia. Forty subjects (age range 22 to 55 yrs.) were assigned randomly into two equal groups: (1) Experimental group received PRFE using the Energex unit (Energex, Inc. Emerson, New Jersey) and (2) Control group received PRFE placebo treatment using a sham device. Both groups received six applications to the TMJ area over two weeks. Data were analyzed for the following times: baseline, first and second follow-up visits. Numerical Rating Scale scores for TMJ pain showed a significant reduction over time for the experimental group (mean = 6.13 to 3.05, p < 0.001). There was also a significant effect for the controls (mean = 5.35 to 4.20, p = 0.01). The effect for experimental subjects was a mean reduction of 3.07 versus 1.15 for controls. The significant reduction in controls was attributed to the placebo effect. The experimental group showed a significant increase in mouth opening (mean = 34.95 to 41.70 mm, p = 0.002), right lateral movement (mean = 7.85 to 10.80 mm, p = 0.001) and left lateral movement (mean = 7.65 to 10.85 mm, p < 0.0001). No significant (p > 0.1) change in the control group occurred for mouth opening (mean = 38.50 to 39.65 mm), right lateral movement (mean = 8.60 to 8.75 mm) and left lateral movement (mean = 8.50 to 8.80 mm). No side effects were reported during the treatment and the two week follow-up. These results suggest strongly that PRFE is a safe and effective treatment for TMJ arthralgia as well as for increasing mandibular range of motion.
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