Allergan announcement on botox for depression obscures negative results

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

No mention is made of the cost of botox. GoodRx lists one 100-unit vial of botox selling for around $615 on average in the United States.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

We really don’t have a good idea from the release of the degree of benefit. Some numbers provided trend towards statistical significance, but there is a big difference between statistical significance and clinical significance. How much of a change in these rating scales makes a difference to the way a patient is really feeling such that it makes a difference in their lives? Also the fact that one dose of the drug seemed to provide effects and the other higher dose didn’t calls into question the whole idea of why botox may work for depression. The theory is that by paralyzing certain muscles in the face, botox affects emotions often reflected in those muscles. So shouldn’t some benefit be present or comparable at the higher doses?

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No mention is made of possible negative side effects. According to MayoClinic.com, possible side effects include “pain, swelling or bruising at the injection site, headache or flu-like symptoms, droopy eyelid or cockeyed eyebrows, crooked smile or drooling, eye dryness or excessive tearing.” In rare cases, the effect of botulinum toxin can spread to other parts of the body and cause botulism-like signs and symptoms.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Information is provided about the study design (a randomized, double-blind, placebo-controlled, single treatment study), the number of study volunteers (258 adult women), the proportion of people in each arm of the study, and the length of the trial.

But the release seems to go to pretty significant lengths to conceal the fact that the primary outcome was negative. It introduces the results with the sentence: “The BOTOX^® 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo.” However, the release itself indicates that is not true. At the predetermined endpoint of six weeks, there was no statistically significant difference between either dose of botox and the placebo groups.

We also have concerns about the headline which announces that the results support advancement of botox for treatment of major depressive disorder. That’s a stretch. Other outside experts have called these results mixed at best, unimpressive at worst.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The article makes no comparison between botox and current treatments for depression so we’re left wondering: what does botox bring to the table? How does its benefits compare with medication? Does botox have fewer side effects? Does it cost less than other therapies? Readers are given no context within which to interpret the news.

Does the news release establish the true novelty of the approach?

Not Satisfactory

Allergan is not the first to test the effectiveness of single doses of botox to treat depression. Other researchers have conducted small, placebo-controlled studies with encouraging results, and a mention of the previous research should have been included in the release.