Clinical Briefs
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is a consultant for GlaxoSmithKline and is on the speaker’s bureau of GlaxoSmithKline, 3M, Wyeth-Ayerst, Pfizer, Novartis, Bristol-Myers Squibb, AstraZeneca, Jones Pharma, and Boehringer Ingelheim.
Modafinil for Excessive Sleepiness Associated with Shift-Work Sleep Disorder
Although persons who work rotating shifts not uncommonly experience transient sleep disturbances, in some individuals who maintain a night-shift jobs, sleep disturbances are persistent and may be accompanied by sleepiness at work. Shift-work sleep disorder (SWSD) is defined as excessive sleepiness during night work, coupled with daytime insomnia. Estimates suggest that as many as 5-10% of night-shift workers experience SWSD. SWSD may be associated with diverse consequences, including depression, motor-vehicle accidents, and missed social activities.
Modafinil (MOD), which is classified as a 'wakefulness-promoting agent’, is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and SWSD.
Czeisler, et al performed a randomized placebo-controlled trial in SWSD patients (n = 209) of MOD 200 mg daily, administered prior to each work shift for 3 months.
MOD treatment improved sleep latency time, overall clinical symptoms, psychomotor vigilance and motor vehicle accident or near-accidents experiences to a statistically significant degree. Although these are encouraging results, a meaningful degree of excessive sleepiness and impaired performance at night remained in treated individuals, suggesting that there is need for further evolution in management of SWSD.
Czeisler CA, et al. N Eng J Med. 2005;353:476-486; Erratum in: N Engl J Med. 2005;353:1078.
Acupuncture in Patients with OAK
Currently available validated treatment options for osteoarthritis of the knee (OAK) include acetaminophen, NSAIDs (systemic and topical), glucosamine, chondroitin, opioid analgesics, exercise, physical therapy, and with advanced disease, surgery. Increasingly, the cardiovascular and GI risks of NSAIDs are causing clinicians to reconsider the risk-benefit ratio of various therapies, and seek alternative interventions.
Previous data about the role of acupuncture (ACU) in OAK has suggested that ACU is superior to placebo for pain reduction in OAK, but the data is comprised primarily of small trials with brief follow-up (eg, 3 months). To provide more definitive insight, a large, long-term trial began enrollment in March, 2002.
A total of 294 middle-aged OAK patients were enrolled and randomly assigned to ACU, sham ACU (needles placed at distant, non-acupuncture sites) or placebo. Subjects received 12 sessions of treatment over 8 week’s time, and were followed for 52 weeks.
At 8 weeks, there was a statistically significant difference in pain and function favoring ACU. At 26 and 52 weeks, between-group differences were no longer statistically significant. Acupuncture is effective in reducing pain and increasing functionality in sufferers of OAK.
Witt C, et al. Lancet. 2005;366:136-143.
Risk of Prostate Cancer-Specific Mortality Following Biochemical Recurrence after Radical Prostatectomy
Although radical prostatectomy (RPT) is often curative for prostate cancer (PCA), more than one third of men will experience a recurrence of PSA elevation, indicating likely eventual clinical disease recurrence. The interval after which clinical disease recurs, once a recurrence of PSA elevation is noted, is highly variable: a previous report of 131 men found the median time metastasis was 8 years, and from metastasis to death, 5 years.
In order to better predict PCA-related mortality, men who had undergone RPT for PCA (n = 379) and sustained a PSA recurrence were retrospectively studied in reference to their PSA doubling time and its relationship to outcomes. Gleason scores and time from RPT to PSA recurrence were also studied, and entered into multifactorial analysis.
Each of the 3 factors was found associated with risk of PCA mortality. Of the three factors, having a PSA doubling time of less than 3 months was associated with the most steep decline in survival. A risk prediction table, using the combined impact of all three factors, was developed as a result of the study. The combination of PSA doubling time, Gleason score, and time to PSA recurrence provides an opportunity for refined risk stratification, allowing patients who might benefit from more aggressive treatment to select it.
Freedland SJ, et al. JAMA. 2005;294: 433-439.
Modafinil for Excessive Sleepiness Associated with Shift-Work Sleep Disorder; Acupuncture in Patients with OAK; Risk of Prostate Cancer-Specific Mortality Following Biochemical Recurrence after Radical ProstatectomyYou have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content