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Saturday, November 19, 2005Researchers at the University of California, San Francisco, recently published what they call the first rigorous randomized placebo-controlled, double-blinded trial conducted entirely via the Internet (Jacobs et al. Medicine (Baltimore). 2005;84:197-207). The study found that herbal extracts of kava and valerian, dietary supplements used in the self-management of anxiety and insomnia, respectively, did no better than placebo. "The main issue is access," Jacobs said. "How many people eligible for clinical trials can’t get to the cities where they’re being conducted? The Internet allows anyone, anywhere to participate." Jacobs has an equity stake in an information technology company whose products were used in this trial. Jacobs’ study used e-mail recruitment letters to subscribers of Alternative Medicine magazine and banner advertisements on two Web sites specializing in women’s health to recruit 1551 participants from 45 states over an 8-week period. After determining whether the potential participants fulfilled the inclusion criteria for anxiety and insomnia, 391 individuals were randomized to receive kava with valerian placebo, valerian with kava placebo, or double placebo. Data were collected online at baseline and at 2 and 4 weeks through e-mail prompts. Anxiety was assessed using an online version of the STAI-State subtest, a 20-item measure of symptoms. Insomnia was assessed using the Insomnia Severity Index. Beyond access, Jacobs said, the study highlighted that using the Internet can help reduce the bottleneck effect that typically occurs when enrolling participants in traditional clinical studies. "To recruit 390 people into a clinical trial normally takes from 9 to 18 months—the Internet reduced that to 8 weeks," he said. An Internet-assisted trial can also reduce expenditures, added Jacobs, who estimated a 50% cost reduction for his herbal extract trial. Like most things on the internet - cheaper and faster. It does, however, present some selection bias. Internet users are skewed towards the young and affluent, but the old way is skewed toward the urban poor. As time goes on, and more people use the internet, it just might become the superior method for gathering research subjects. It also opens up the possibility for doctors in private practice, outside academic centers, to do their own research, if they are so inclined. It could be the harbringer of the liberation of academic medicine. posted by Sydney on 11/19/2005 01:58:00 PM 0 comments 0 Comments: |
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