It is an “emotional experience” as described by a conscious medical expert from Southern California about a response from a well-known number of his patients who received botulinum toxin treatment during coronavirus disease 2019 (COVID-19). Despite the fact that several needles were not available, these patients were particularly pleased to cook themselves (albeit briefly) in their sanctum sanctorum of autoimmunity, effectively captured from the inhibition of certain stresses that are now understood to be associated with COVID-19.1,2
This isolated news could be a simple serendipity or an example of a potential intervention. A recently published article may provoke a debate about the potential for widespread effective regulation of neurotoxin injection.
Makunts and colleagues3 they used the FDA’s Adverse Event Reporting System (FAERS) to analyze more than 40,000 botulinum toxin treatment reports across a number of medical and cosmic symptoms including hyperhidrosis, facial rhytides, migraine prophylaxis, spasticity, and spasms. They reported a significantly lower number of reports of depression across all symptoms and injection sites compared to patients receiving other treatments for the same conditions.
They also found a significantly lower incidence of depression-related adverse events (AE) with neurotoxin treatment compared to the control groups. For example, reporting of odds ratios (RORs) of botulinum toxin depression frequency was significantly lower compared to controls, ranging from 0.12 (95% CI: 0.04, 0.33) to 0.60 (95 % CI: 0.48, 0.74), regardless of signal. The ROR analysis calls for a basic pharmacodynamic hypothesis of depression risk associated with neurotoxin use. Therefore, these conclusions should be considered carefully, as they may not reflect the actual number of cases or frequency in the general population because the FAERS system is voluntary and open to the public.
Although botulinum toxin is not licensed for the treatment of depression in the United States, this information should provide food for thought to suggest the potential for neurotoxin treatment to show promise in relieving severe symptoms. -mind. Indeed, several reports confirm the efficacy of botulinum toxin in reducing symptoms associated with major depressive disorder,4-6 including several placebo-controlled randomized trials and observational studies.7-13 Some believe that the muscles involved in facial sensation, such as the frown-lifting corrugator muscles, play an important role in altering the emotional circulation of the brain and neural activity.14-17 Air Put simply, it has been posted that emotional behavior can alter emotional states, likely through a change in relative consciousness.15
Botulinum toxin injection has a good safety profile. Brin and colleagues18 did not report any significant difference in the frequency of AEs, including true AEs, in nearly 2000 patients treated with botulinum toxin compared with patients treated by injection placebo based on the collected results of 9 trials. Notably, in trials of severe depression, corrugator injection and prootus neurotoxin have detected that emergency treatment AEs were localized to the treatment site and were temporary (headache and injection site humiliation).9.12 That said, it will still be critical to evaluate the relative effectiveness of neurotoxin treatment against established psychopharmacological options and psychotherapy strategies and to determine whether and where it might fit the conventional treatment pattern.
One of the hurdles is training mental health professionals on how to perform free-hand injections, especially those that require dose accuracy at multiple injection sites as with neurotoxin injections. Even with extensive experience, it is difficult to achieve injection dose accuracy. Kwolek and Bloc19 recently estimated that the average accuracy error associated with a free-injection of 40 doses of 0.025 mL continuous from a 1.0 cc syringe was approximately 10% for 2 very familiar injections. Recognizing the speed with which dose accuracy is achieved, several neurotoxin-dedicated devices have been developed and are undergoing clinical and regulatory evaluation.20
Finally, preliminary evidence indicates that botulinum toxins may have a positive effect on depressive symptoms. Further research is needed to better determine the safety and effectiveness of this treatment. If the data indicates that this may be a valuable treatment option, administrative barriers also need to be addressed
Dr. Blockis an independent clinical tester and medical device consultant in San Francisco, CA. Website: www.drjonblock.com. The author reports that there is no conflict of interest on the subject of this article.
References
1. Salari N, Hosseinian-Far A, Jalali R, et al. Frequency of stress, anxiety, depression among the general population during COVID-19 pandemic: a systematic review and meta-analysis. Global Health. 2020; 16 (1): 57.
2. Ettman CK, Abdalla SM, Cohen GH, et al. Depression symptoms in US adults Before and during Pandemic COVID-19. JAMA Netw Open. 2020; 3 (9): e2019686.
3. Makunts T, Wollmer MA, Abagyan R. Post-sales safety monitoring data reveal antidepressant effects of botulinum toxins across several indications and injection sites. Sci Producer. 2020; 10 (1): 12851.
4. Alam M, Barrett KC, Hodapp RM, Arndt KA. Botulinum Toxin and the Reversal: can you look better so you feel happier? J Am Dermatol Acad. 2008; 58 (6): 1061-1072.
5. Finzi E Update: Botulinum Toxin for Depression: More on deep skin. Surg Dermatol. 2018; 44 (10): 1363-1365.
6. Parsaik AK, Mascarenhas SS, Hashmi A, et al. Role of Botulinum toxins in depression. J Psychological user. 2016; 22 (2): 99-110.
7. Brin MF, Durgam S, Lum A, et al. OnabotulinumtoxinA for the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled phase 2 trial in adult women. Int Clin Psychopharmacol. 2020; 35 (1): 19-28.
8. Chugh S, Chhabria A, Jung S, et al. Botulinum toxin as a treatment for depression in a real world setting. J Psychological user. 2018; 24 (1): 15-20.
9. Finzi E, Rosenthal NE. Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo-controlled trial. J Psychiatr Res. 2014; 52: 1-6.
10. Magid M, Finzi E, Kruger TH, et al. Treating depression with botulinum toxin: an aggregated study of randomized controlled trials. Pharmacopsychiatry. 2015; 48 (6): 205-210.
11. Magid M, Reichenberg JS, Poth PE, et al. Treatment of major depressive disorder using botulinum toxin A: a 24-week, double-blind, placebo-controlled randomized trial. J Clin Psychiatry. 2014; 75 (8): 837-844.
12. Wollmer MA, de Boer C, Kalak N, et al. Combating depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res. 2012; 46 (5): 574-581.
13. Zamanian A, Ghanbari Jolfaei A, Mehran G, Azizian Z. Efficacy of Botox versus Placebo for the treatment of patients with depression. Iran J Public Health. 2017; 46 (7): 982-984.
14. Franca K, Lotti T. Botulinum toxin for the treatment of depression. Dermatol Ther. 2017; 30 (2).
15. Hennenlotter A, Dresser C, Castrop F, et al. The link between facial feedback and cloud activity within the central circulatory circuits of emotions – new perspectives from botulinum toxin depletion. Cortex Cereb. 2009; 19 (3): 537-542.
16. Kim MJ, Neta M, Davis FC, et al. Botulinum toxin-induced facial muscle paralysis affects amygdala responses to the expression of emotional expressions: initial conclusions from ABA design. Biol Mood Anxiety Disorder. 2014; 4:11.
17. Lewis MB. The interaction between botulinum-toxin-based face treatments and innate emotions. Sci Producer. 2018; 8 (1): 14720.
18. Brin MF, Boodhoo TI, Pogoda JM, et al. Safety and tolerability of onabotulinumtoxinA in frontline treatment: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Dermatol Acad. 2009; 61 (6): 961-970 e961-911.
19. Kwolek MS, Bloc JE. Increasing botulinum toxin injection for cosmeceutical and therapeutic applications with a single dose, adjuvant injection dispenser. Clin Cosmet Investig Dermatol. 2019; 12: 35-46.
20. Yoelin SG, Kwolek MS, Bloc JE. Description of Botulinum Toxin injection: a call for better accuracy. J Clin Aesthet Dermatol. 2020; 13 (8).