Raynaud's and Viagra - successful therapy scientists report

Researchers and pharmaceutical companies are taking a closer look at new treatments that may improve patients’ blood flow and reduce Raynaud’s episodes. At the recent annual meeting of the American Association for Hand Surgery, Dr. Michael Neumeister - professor and chair of the division of plastic surgery at Southern Illinois University – reported promising results with Botox.

He reported that Botox (botulinum toxin type A) sharply reduced pain, improved blood flow, and fostered healing of ischemic fingertip ulcerations in every patient he has treated—16 to date. Ranging in age from 23 to 64 years, all patients treated by Dr. Neumeister had failed medical therapy; three had undergone prior sympathectomies. According to Dr. Neumeister, sympathectomy produces benefit in approximately half of people who undergo the complex procedure, and many Raynaud's symptoms recur, requiring reoperation.

Botox injections, however, brought almost instant pain relief, he noted, and the pain has not recurred in more than three years. Allergan Inc., the company that makes Botox, is funding Dr. Neumeister's research on the agent's mechanisms of action in Raynaud's disease and phenomenon.

Are we on the cusp of an effective treatment?
     Not so fast, warns Dr. Fredrick M. Wigley, Professor of Medicine and Associate Director of the Division of Rheumatology at Johns Hopkins School of Medicine. Dr. Wigley, one of the leading Raynaud’s researchers worldwide – and a member of the Raynaud’s Association’s Medical Advisory Board – is cautious about the implications of the Botox study. “It makes sense that it might help, but when we tried it in complex patients we were not impressed with any significant benefit,” he said. Dr. Wigley also pointed out that Botox is costly and is not covered by insurance.

“In other drugs that we have used there is as high as a 40% placebo response in Raynaud’s patients,” he added. A broader, controlled study needs to be done to determine if Botox works or not, Dr. Wigley concluded.

Another treatment under study is the impotence drug Viagra (sildenafil). In a German study published in the November 8, 2005 issue of Circulation, sildenafil improved both microcirculation and symptoms in patients with secondary Raynaud's phenomenon resistant to vasodilatory therapy. The authors, led by Dr. Roland Fries, reported that capillary blood flow was severely impaired and sometimes hardly detectable in patients with Raynaud's phenomenon. “Sildenafil led to a more than 400% increase of flow velocity,” he wrote. Again, not so fast. In an accompanying editorial, Drs. Felix Mahler and Iris Baumgartner (University of Bern, Switzerland) cautioned that the amount of sildenafil taken in this study was much greater than that usually used in impotence. If applied to larger numbers of patients, they noted, adverse cardiovascular events due to pressure drops (especially together with nitroglycerin preparations), visual disturbances, or other symptoms may occur.


Variations on medications now commonly used for Raynaud’s are also in the pipeline. Pharmacist Dr. Sam Alawieh is currently working in association with the Fiechtner Research group and the University of Michigan to perform clinical trials on a topical cream that may hold promise for Raynaud's patients.

The cream uses the common Raynaud’s nifedipine, but reportedly in a more stable formulation. All of the ingredients have been approved by the FDA for off-label use, Dr. Alawieh says. The Raynaud’s Association’s Medical Advisory Board – Drs. Wigley, Hal Mitnick, Thomas Lehman and Daniel Furst – welcome reports of clinical trials before commenting on the efficacy of the new drug.

Another new topical drug under study is Vascana, which contains nitroglycerin. Mediquest Technologies, the manufacturer of the drug, claims Vascana is more rapidly absorbed into the skin than topical treatments currently being used for Raynaud’s. Vascana is in clinical trials and has the potential to become the first FDA-approved treatment for Raynaud’s. The aims of Raynaud’s treatment are to reduce the number and severity of attacks and to prevent tissue damage and loss in the fingers and toes.

Many doctors recommend non-drug treatments and self-help measures as a first line of defense for patients whose Raynaud’s episodes are mild and infrequent. Raynaud’s patients are told to avoid the cold as much as possible - advice that’s easier said than done. (When first diagnosed, this writer was told by a smug doctor to “move to Florida.”) To date, medications such as calcium channel blockers (including nifedipine), angiotensin II receptor antagonists (such as losartan), vasodilators (such as nitroglycerin and hydralazine), which are used to treat high blood pressure, and selective serotonin reuptake inhibitors (such as fluoxetine) are prescribed to help increase blood flow to hands and feet and relieve symptoms.

Some limited studies have shown that alternative treatments such as Ginkgo biloba may show promise in treating Raynaud's phenomenon. Certain behavioral therapies such as biofeedback have also shown positive results for some patients. The Raynaud’s Association website offers scores of anecdotal reports about treatments that patients have found helpful. Although a universally effective and safe treatment to avoid and treat Raynaud’s has yet to be found, there is a growing consensus that Raynaud’s is a serious concern that warrants greater study. And that’s a research milestone in itself.