The Raynaud's Treatment Study (RTS)
Objectives:
To evaluate and compare the effectiveness of
sustained-release nifedipine, and the effectiveness of temperature biofeedback,
for the treatment of patients with Primary Raynaud's Phenomenon.
Background:
Primary Raynaud's Phenomenon is a peripheral vascular
disease of multiple etiologies. Patients with PRP experience episodes, or
attacks of severe vasoconstriction. The extremities turn white or blue, often
accompanied by numbness and pain which at times can be incapacitating. These
attacks are often brought on by cold temperatures or stress. Treatment for PRP
include management techniques for avoiding exposures to cold temperatures. In
severe cases treatment may include use of vasodilators. Immediate release
nifedipine has been shown to reduce the frequency and severity of attacks;
however, side-effects also can be severe, inducing the patient to discontinue
treatment. Sustained release nifedipine may be a more desirable alternative
although the efficacy and adverse effects in patients with PRP has not been
shown. Another alternative is non-pharmacological treatment involving
temperature biofeedback. Temperature biofeedback uses voluntary control of
blood flow and skin temperature, achieved by training, to reduce the frequency
and severity of attacks. Temperature biofeedback may be a desirable alternative
to vasodilators for patients with a preference for a non-drug treatment or have
adverse reactions to vasodilators. Beginning in 1993, 313 patients were
enrolled in the NHLBI sponsored, multicenter, Raynaud's Treatment Study and
randomly assigned to 1 of 4 treatment groups: sustained-release nifedipine,
matching pill placebo control, temperature biofeedback, or biofeedback control
(frontalis muscle surface electromyographic biofeedback). Endpoints (verified
attacks, all attacks) were collected during a 4 week period directly after a 2
month assessment and a 1 year assessment.
Subjects:
Subjects were eligible if they were 18-75 years of age
and reported at least 2 attacks on an average day during the previous cold
season. Efforts were made to exclude subjects with secondary Raynaud's
Phenomenon during the medical evaluation. A total of 313 subjects were enrolled
from 5 clinical centers (113 November 1993 - February 1994 and 200 November
1994 - February 1995).
Conclusions:
Nifedipine treated patients had a 66% reduction in
verified attacks compared to placebo patients. There was no significant
difference in temperature biofeedback compared to biofeedback control.
Nifedipine patients tended to have fewer attacks than temperature biofeedback
patients; however, this difference was not statistically significant. Sustained
release nifedipine is a safe and effective treatment for PRP and may be
superior to temperature biofeedback in reducing the frequency of attacks from
PRP. (Arch Intern Med, 2000; 160:1101-1108)
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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