The FDA’s database of drug side effects indicates that the benefit can be maintained no matter where Botox is injected.
Botox, a medication derived from a bacterial toxin, is commonly injected to relieve wrinkles, migraines, muscle spasms, excessive sweating, and incontinence. The injection into the forehead of the drug is also currently being tested in clinical trials for its ability to treat depression.
Researchers at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences have mined the US Food and Drug Administration’s (FDA) Adverse Effect Reporting System (FAERS) database to see What almost 40,000 people reported happened to them after Botox treatment for many reasons.
In the study, published on July 30, 2020 in Scientific reportsThe team found that people who received Botox injections, at six different sites, not just the forehead, reported significantly less frequent depression than patients undergoing different treatments for the same conditions.
“For years, doctors have observed that Botox injected for cosmetic reasons appears to alleviate depression in their patients,” said Ruben Abagyan, PhD, professor of pharmacy. “It has been thought that smoothing out severe wrinkles in the forehead region interrupts a feedback loop that reinforces negative emotions. But we have found here that the mechanism can be more complex, because it really doesn’t matter where the Botox is injected.”
Abagyan led the study with Tigran Makunts, PharmD, who was a pharmacy student at the time and is now an investigator at the FDA, and Marc Axel Wollmer, MD, a psychiatrist and researcher in Germany, who has conducted previous clinical studies in which Botox was found to alleviate depression.
The FAERS database contains more than 13 million voluntary reports of adverse effects that people experienced while taking a medication. Abagyan and his team discovered that they can also use the database to see absence of a health complaint when a person takes a medication, compared to a control group. In this case, they looked for the absence of depression.
The team focused on nearly 40,000 FAERS reports of people experiencing adverse events after Botox treatment. The reports cover Botox treatment for eight different reasons and injection sites, including the forehead, neck, limbs, and bladder. The team then applied a mathematical algorithm to find statistically significant differences between Botox users and patients who received different treatments for the same conditions.
Here’s what they found: Botox-treated patients reported 40 to 88 percent less frequency in six of the eight conditions and injection sites.
“This finding is exciting because it supports a new treatment to affect mood and combat depression, one of the common and dangerous mental illnesses, and is based on a wealth of statistical data, rather than limited-scale observations.” Makunts said.
To be clear, the data used in this study was not collected for the purpose of exploring the association between Botox use and depression alone. Furthermore, the FAERS data represent only the subset of Botox users who experienced negative side effects. While the team excluded reports in which a person was also taking antidepressants, the use of other prescription and over-the-counter medications may not have been reported in some cases.
The ongoing clinical trial is directly testing Botox treatment for people with depression, a gold standard approach to gathering information about the relationship between a drug and a health condition. Since that trial only tests Botox injection in the forehead, Abagyan says additional clinical trials may be necessary to determine the best site and dosage to administer the medication specifically for the treatment of depression.
Similarly, more research is needed to determine the mechanism by which Botox acts as an antidepressant, says Abagyan. He and his collaborators hypothesize some possibilities worth investigating: Botox could be transported to the regions of the central nervous system involved in mood and emotions. Or, since Botox is commonly used to treat chronic conditions that may contribute to depression, its success in alleviating the underlying problem may also indirectly alleviate depression.
The World Health Organization estimates that more than 264 million worldwide experience depression. Depression is often treated with psychotherapy, selective serotonin reuptake inhibitors, dopamine-norepinephrine reuptake inhibitors, and / or serotonin-norepinephrine reuptake inhibitors. However, these approaches are ineffective for almost a third of patients. That’s why doctors and researchers are exploring other therapeutic options, including electroconvulsive therapy, transcranial magnetic stimulation, ketamine infusions, and, more recently, Botox injections to the forehead.
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Reference: July 30, 2020, Scientific reports.
DOI: 10.1038 / s41598-020-69773-7
Disclosure: Ruben Abagyan is a co-founder of Molsoft, LLC and has capital. M. Axel Wollmer has consulted for Allergan pharmaceuticals.
