Cocoa flavanols and multivitamins are two of the most promising and exciting nutritional interventions available, and this new randomized trial
is the natural next step in advancing our understanding of their potential benefits," says JoAnn Manson, MD, chief of the division of Preventive Medicine at BWH.
In five randomized trials
of participants with heavy short-term physical stress, vitamin C halved the incidence of the common cold.
The Phase III randomized trial
in acute myeloid leukemia ("AML") is in response to the FDA's complete response letter to Vion's New Drug Application for Onrigin(TM) requiring that a randomized trial
be conducted to support the approval of Onrigin(TM) for the treatment of AML.
While sorting out these controversies is beyond the scope of this article, the following review will present a list of probable, common problems that are useful to consider when evaluating a randomized trial
and its results (Table 1).
The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial
But this form of constipation is a long-term problem--and although uncontrolled studies have suggested good long-term maintenance of efficacy with biofeedback, it was important to establish in a more rigorous randomized trial
setting whether this nonpharmacologic therapy maintains its effectiveness over time.
The randomized trial
compared four doses of tiagabine--4, 6, 8, and 10 mg at bedtime--and a placebo in a two-night polysomnographic study.
A causal relationship between gatifloxacin and these ADEs is supported by animal data (8), manufacturer safety cohort studies (5), in vitro assays (9), a large randomized trial
(10), and >20 published case reports.
A small (40-patient) randomized trial
in patients on HAART with peripheral neuropathy showed a statistically significant increase in CD4 (T-cell) counts over 12 weeks.
What to do: Earlier research had suggested that vitamin E or a multi might boost immunity in older people (see cover story, March 2002), but this randomized trial
trumps that evidence.
As far as can be determined from appendices in the report, only one of these studi es, involving a test of a specialized instructional strategy in the context of the Paideia program, depended on a randomized trial
Study 806 represents the largest randomized trial
of HIV-infected persons in the last decade and the first large-scale trial to study an immune-based therapy.