Focus of the Report: Use of botulinum toxin (BTX) for treatment of gastroparesis.

Technology Description: BTX, a neurotoxin produced by the bacterium Clostridium botulinum, inhibits the release of the neurotransmitter acetylcholine at the neuromuscular junction and causes muscle paralysis. 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. Presently, only 2 serotypes, botulinum toxin type A (BTX-A) and botulinum toxin type B (BTX-B), have formulations approved by the Food and Drug Administration (FDA). The mechanisms of action for BTX-A and BTX-B are similar. BTX-A cleaves the protein SNAP-25 while BTX-B cleaves vesicle-associated membrane protein; both of which inhibit the release of acetylcholine.

Controversy: Medical management of gastroparesis typically includes prokinetic and antiemetic agents; however, side effects and lack of effectiveness limits long-term use. Pyloric BTX injection remains controversial in whether it results in symptomatic improvement in patients with refractory gastroparesis; questions remain regarding proven clinical effectiveness. Furthermore, BTX has not been cleared for treatment for gastroparesis by the FDA and is considered off-label use.

Key Questions:

  • Is pyloric injection of BTX effective in treating gastroparesis?

  • How does pyloric injection of BTX compare with clinical alternatives for gastroparesis?

  • Is pyloric injection of BTX safe for treating gastroparesis?

  • Have definitive patient selection criteria been identified for pyloric injection of BTX?

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