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Maximise the Shelf-Life of your Botulinum Toxin — Preserved Saline
Dynamic wrinkles (caused by hyper functional muscles) in the perioral, glabellar, and forehead regions can cause a patient’s expressions to be misinterpreted as angry, anxious, fearful, or fatigued. An emerging treatment option to address these issues is the use of a paralysing material such as botulinum toxin to decrease the appearance of the wrinkles, which yields a more aesthetic and youthful facial appearance.
This substance is reconstituted with saline and then injected into the patients affected areas. After injection, the botulinum toxin acts to paralyse or weaken facial mimetic muscles.
What is the difference between Preserved and Un-Preserved Saline?
Studies show botulinum toxin should be used within 4 hours of reconstitution with preservative-free saline (0.9% NaCl). With many physicians needing to keep reconstituted botulinum toxin for more than 4 hours, the use of saline with preservative has become popular. This botulinum toxin solution with preserved saline can be kept for up to one month after reconstituting.
Along with this added benefit of an extended shelf life, its patients reported less pain from injections of botulinum toxin reconstituted with preserved saline than from injections reconstituted with preservative-free saline. Many studies have been done on this theory and one in particular has been included below.
STUDY: Archives of Dermatology
Vol. 138 No. 4, April 2002
Pain Associated With Injection of Botulinum A Exotoxin Reconstituted Using Isotonic Sodium Chloride With and Without Preservative
A Double-blind, Randomized Controlled Trial
Murad Alam, MD; Jeffrey S. Dover, MD, FRCPC; Kenneth A. Arndt, MD
Arch Dermatol. 2002;138:510-514.
In the RA arm of the study, 20 patients (18 women, 2 men) with a mean age of 49 years (range, 30-61 years) were enrolled. Of these, 18 (90%) noted that the botulinum toxin injections that they had just received (reconstituted with preserved saline) had been less painful than their most recent previous treatments (reconstituted with preservative-free saline). Except for 1 patient treated for axillary hyperhidrosis, all of the patients’ current and prior treatments were for dynamic creases of the upper face. The patients who noticed decreased pain with the current treatments estimated, on average, that these treatments were 55% (range, 20%-80%) less painful than those in the past. The 2 remaining patients, to the best of their recollections, recalled no significant difference in pain between the successive treatments.
In the RCT arm of the study, 15 women with mean age of 48 years (range, 33-64 years) were enrolled. Of these, 15 (100%) reported that they experienced less pain in the side of the face treated with preservative-containing botulinum toxin injections than in the side treated with preservative-free toxin. Statistical analysis was performed by application of the binomial probability distribution. The results were determined to be highly statistically significant (P<.001) despite the small sample size.
The average pain level on the preservative-containing side was 54% less severe than on the preservative-free side (range, 33%-80%). Subjective pain assessments of the preservative-free solution communicated a greater degree of “piercing,” “stinging,” “sharpness,” and “pinching,” whereas the preservative-containing side “barely hurt” or “didn’t hurt at all.”
In summary, this study indicates that reconstitution of botulinum toxin with preservative-containing saline can markedly decrease patient discomfort at the time of injection. The difference is statistically and clinically significant.
Enhanced Results
Preservative-containing and preservative-free botulinum toxin preparations are equally safe and effective. Along with the obvious increase in shelf life, the increase in patient satisfaction associated with the preserved saline is the main benefit. Minimising the pain and suffering of your patient is an important responsibility. |
