ABSTRACT
BACKGROUND: Excessive daytime somnolence (EDS) commonly complicates Parkinson's disease (PD). The aetiology of EDS is probably multifactorial but is probably exacerbated by dopaminergic medications. Modafinil is a wake-promoting agent approved for use in narcolepsy, but it is often used to treat a variety of somnolent conditions. METHOD: A double blind, placebo controlled parallel design trial was conducted to assess the efficacy of modafinil (200-400 mg/day) for the treatment of EDS in PD. The primary efficacy measure was the Epworth Sleepiness (ES) scale score. Secondary efficacy points included the Unified Parkinson's Disease Rating Scale (UPDRS), the Fatigue Severity Scale, the Hamilton Depression Scale, and the multiple sleep latency test (MSLT). RESULTS: Of a total of 40 subjects (29 men, mean (SD) age 64.8 (11.3) years), randomised to modafinil or placebo, 37 completed the study. Modafinil failed to significantly improve ES scores compared with placebo (2.7 v 1.5 points improvement, respectively, p = 0.28). MSLT failed to improve with modafinil relative to placebo (-0.16 v -0.70, respectively, p = 0.14). UPDRS, global impressions, Fatigue Severity Scale, and Hamilton Depression Scale scores were unchanged. Adverse events were minimal. CONCLUSION: Modafinil failed to significantly improve EDS in PD compared with placebo. The drug did not alter motor symptoms in PD and was well tolerated.
Subject(s)
Benzhydryl Compounds/therapeutic use , Central Nervous System Stimulants/therapeutic use , Disorders of Excessive Somnolence/drug therapy , Disorders of Excessive Somnolence/etiology , Parkinson Disease/complications , Parkinson Disease/drug therapy , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Modafinil , Placebos , Severity of Illness Index , Treatment OutcomeABSTRACT
This study showed the efficacy of large loop excision of the transformation zone (LLETZ) in the management of cervical intraepithelial neoplasia (CIN). Eighty-three women with abnormal cervical cytology were recruited. Colposcopic examination and directed punch biopsy were performed and the women had LLETZ therapy as an outpatient procedure. There were 2 cases of microinvasive cervical carcinoma that were missed by directed punch biopsy, the diagnosis being made after the patients underwent LLETZ treatment. There was a large disparity in the histological analysis between directed punch biopsy and LLETZ specimen. This disparity would not have been detected if the women were treated by ablative methods. In women with cervical dysplasia, LLETZ procedure is preferred as the whole excised lesion can be examined histologically and diagnostic error is reduced.
