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.
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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