Focus of the Report: For use of botulinum toxin (BTX) for Raynaud phenomenon (RP).

Technology Description: BTX has been investigated as a treatment for various chronic painful conditions because of its potential to reduce muscle tension and modulate pain receptor activity in the central nervous system. For the treatment of RP, there is currently no standard protocol for BTX dilution, doses, and timing of follow-up or retreatment due to its off-label use status. The BTX dilution is injected into the fingers and/or the palmar arch of the symptomatic hand at specific injection sites in the interstitial space around the digital neurovascular bundles. By injecting BTX adjacent to the digital arteries, a chemical sympathectomy is produced, reversing vasoconstriction and resulting in symptomatic relief.

Controversy: The pathophysiology of the vasoconstriction in RP is not well understood. Conservative measures to treat RP are often used and considered safe; however, there is inconsistency in the amount of benefit experienced. Pharmacologic interventions typically result in modest effects and may result in systemic side effects. BTX has demonstrated the ability to reduce vasoconstriction; however, BTX has not been cleared for treatment for RP by the FDA and its use for RP is off label. For those who experience severe symptoms, surgery may be an option, albeit an invasive and expensive alternative associated with its own risks.

Key Questions:

  • Is BTX effective in treating primary or secondary RP?

  • How does BTX compare with clinical alternatives for treating primary or secondary RP?

  • Is BTX safe?

  • Have definitive patient selection criteria been identified for BTX as a treatment for primary or secondary RP?

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