Provigil for Fatigue
Some of the new studies with ginseng, donepezil, and Provigil for the treatment of fatigue in cancer patients presented here at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) show a glimmer of promise, but so far there is not enough evidence to support any pharmacological treatment, and the only consistent evidence of benefit is from exercise programs. This was the conclusion of Ian Tannock, MD, PhD, from Princess Margaret Hospital, University of Toronto, Ontario, who was discussing the new studies.
Dr. Tannock praised the research efforts in this area but said that more work was urgently needed. Fatigue is the number-one symptom that cancer patients complain about, and yet doctors frequently do not even ask about it, he said. A survey of more than 1000 cancer patients reported in the Annals of Oncology found that 58% complained of fatigue, more than double the patients who complained about pain (22%) or about nausea and vomiting (18%)
Insomnia and Provigil
For excessive daytime somnolence, the researchers cited 2 class I studies that found that Provigil improved subjective symptoms using the Epworth Sleepiness Score, whereas a third found some subjective improvement. However, some studies found no objective improvement.
“Suppose you feel like you’re more awake and you operate heavy machinery or get into a car,” said Dr. Zesiewicz. “There’s no objective improvement with Provigil so that could be concerning — it’s a false sense of alertness.”
The reviewers found evidence that the stimulant methylphenidate may be useful in treating fatigue, another common concern of patients with PD. A 6-week, class II, randomized, double-blind, placebo-controlled trial in 36 patients found a reduction in the mean Fatigue Severity Scale score and the Multidimensional Fatigue Inventory score in the treatment arm (P < .04). However, this agent has the potential for abuse, including addiction.
Provigil for Shift Work Sleep Disorder
Health Canada approved a new indication for Provigil (Alertec tablets, made by Shire BioChem, Inc), allowing its use for the symptomatic treatment of excessive sleepiness in shift work sleep disorder.
The approval was based on data from a double-blind, 12-week study in 209 patients showing that nightly treatment with 200 mg of Provigil increased sleep latency from baseline (1.7 ± 0.4 vs 0.3 ± 0.3 minutes; P = .002) and improved clinical symptoms in a greater proportion of patients (74% vs 36%; P < .001) compared with placebo.
Provigil-treated patients also experienced a decrease from baseline in the frequency and duration of attention lapses during nighttime testing, contrasting with the increase observed among those receiving placebo (Psychomotor Vigilance Test score, –2.6 vs 3.8; P < .001).
In addition, patients receiving Provigil therapy reported fewer accidents or near misses while driving home from work compared with those receiving placebo (29% vs 54%; P < .001).