Even though the difference between the two group is statistically significant, is it clinically significant to use Botox therapy to get 2 more headache free days compared to placebo? To answer this question, we need to look at the cost of therapy, and safety. Botox therapy generally is considered safe. However, its side effect profile has neck pain, headaches and worsening of migraines. Also, the therapy is not convenient considering IM injections in 31 different sites of neck and head regions every 12 weeks. Last but not the least, the cost of therapy estimated is very high. One vial of 200 Unit vial costs around $1260. In addition to that, the physician will charge a dispensing fee, visit fee and injection fee. If the patient has good insurance, it might cover up to $5.48 per unit after prior-authorization. However, after all the reimbursement from the insurance, the patient's out of pocket cost might end up being about $1,000-$2,000 per treatment (every 12 weeks). This could be $8,000 per year.
Considering the cost, the inconvenience of Botox therapy and the difference of 2 headache free days between the placebo and Botox therapy, it is not clinically significant to use Botox for prophylaxis of migraines. However, the effect of placebo on headache free days should be explored as it almost as effective as botulinum toxin (Botox).