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An Evidence-Based Approach on the efficacy of Botox in treating glabellar frown lines
In the present days, the cosmetic surgery has become increasingly popular in the domain of the natural personal care industry. Cosmeceuticals are advanced cosmetic pharmaceutical hybrids with additional ingredients those can enhance beauty as well as other health related benefits. Cosmetic products, contain several ingredients those can influence the skin biological functions (1). The impacts of these products may be severe or mild depend upon the functional type of ingredients they contain. Botox, hyluranic acids are some of the best examples of this category. Such ingredients have the capability to cure crow’s feet wrinkles, eyebrow elevation, gingival or gummy smile, glabeller rhytides, and mental crease and so on. In this assignment, Evidence-Based Approach on the efficacy of Botox in treating glabellar frown lines has been discussed.
1.1 Botox- Treatment for Glabellar frown lines
According to the Food, Drug and Cosmetic Act, cosmetics are nothing but the articles intended to be poured, rubbed, and sprinkled into the human body for cleansing, beautifying or altering the appearance.(2) The cosmetic use of BT type A has been traced back in late 1980s, as Carruthers and Carruthers have noted a progress in galbeller lines in patients with BT injection while providing the treatment for blepharospasm. (3)
Table 1: Characteristics of botulinum Toxin (3)
|Composition||Clostridium botulinum toxin type A hemagglutinin complex (0.5 mg) human serum albumin|
|Molecular weight (Neurotoxin)||150kDa|
|Bulk Active Substance(total protein content)||Approx 5 ng|
|Vial Size||100 units|
|Recommended Storage(post reconstitution)||-5*C (2*-8* C/use within 4 hours)|
|Mechanism of Action||Through chemical denervation inhibits the release of Ach from the presynaptic neuron of the neuromuscular junction of striated muscles|
Understanding the importance of Botox in treating Glabellar frown lines, this study has discussed an Evidence-Based Approach using the following steps:
To continue evidence based medicine, one must follow two important factors such as:
- 1. Discard the irrelevant information
- 2. Spend more time to seek high quality information according to the concept of hierarchy of evidence.
Suzanne Fletcher and Dave Sackett described “level of evidence” as the evaluation of the validity of evidence regarding the value of preventive maneuvers. Finally they renamed the level of evidence as “grades of recommendations”. (5) Basically, all EBM (Evidence-Based Medicine) have utilized both levels of evidence and grades of recommendation. However, these modifications have been put forwarded over the last few years. But in general, Levels of evidence are based on the design and the methodological quality of individual studies whereas the grades of recommendation are based on the strength of supporting evidence. (6, 7). In order to pursue evidence-based practice, the clinician must be familiar with the following Harbour and Miller's Grading Recommendations (8) :
- 1++: High-quality meta-analyses, systematic reviews of RCTs, or RCTs whose risk of bias is low.
- 1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs whose risk of bias is low.
- 1−: Meta-analyses, systematic reviews or RCTs, or RCTs whose risk of bias is high
- 2++: High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies whose risk of bias is very low or relationship is casual
- 2+: Well conducted case-control or cohort studies whose risk of bias is very low or relationship is casual at a moderate probability
- 2−: Case-control or cohort studies whose risk of bias is high or chance and relationship is not casual at a significant probability
- 3: Non-analytic studies including case reports and case series
- 4: opinion of the experts (9)
Table 2: Grades of recommendations (8)
|A||A minimum of one meta-analysis, systematic review, or RCT rated as 1++ and directly applicable to the target population, or a systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results|
|B||A body of evidence including studies rated as 2++ directly applicable to the target population and demonstrating overall consistency of results, or extrapolated evidence from studies rated as 1++ or 1+|
|C||A body of evidence including studies rated as 2+ directly applicable to the target population and demonstrating overall consistency of results, or extrapolated evidence from studies rated as 2++|
|D||Evidence level 3 or 4 or extrapolated evidence from studies rated as 2+.|
This study discusses an Evidence-Based Approach on the efficacy of Botox in treating glabellar frown lines based on the following studies:
1.2 Meta-analysis of onabotulinumtoxinA
Recently, six randomized, doubled blind, placebo-controlled trials and three open label studies have been exposed to meta-analysis. The results including 1678 subjects confirmed that onabotulinumtoxinA are safety and efficacy in the treatment of glabeller and crow’s feet areas. (10) SAEs were generally mild to moderate in severity and in line with the expected AEs for this product. Here, neither SAEs nor any new treatment related to AEs have been emerged. Altogether indicated that the two formulation of botulinum toxin type A such as onabotulinumtoxinA and abotulinumtoxin A have found to be safe and secure in the treatment of glabellar lines.
1.2.1 Efficacy of onabotulinumtoxinA
In the pool of 537 subjects with onabotulinumtoxinA treatement, the primary outcome measures have been identified as: the investigator’s rating of glabellar line severity and the subject’s global assessment of improvement at 30 days of post treatment. In accordance to investigator’s rating, 80% of patients have been classified as peak responders at 30 days of post treatment whereas 25% of patients were remained classified as responders at 120 days of post treatment. (11) Similarly, subject rating also followed the same pattern as investor rating with 89% of patients as peak responders at day 30 and 39% were rated as responders at day 120. (11) After completing the blinded study period (120 days), the subjects have been qualified to get a second, open-label treatment. In addition, the injection option was also opted for patients. Out of 537, two hundred and fifty eight subjects were found to receive all three types of treatment. The final outcome indicated that the ratio of patients at maximum frown has been considerably large after receiving second and third treatment than first. (12)
1.2.2 Efficacy of abobotulinumtoxinA
The efficacy of abobotulinumtoxinA has been evaluated at day 30 of post treatment. (13) The success rate of abobotulinumtoxinA were ranged from 55% to 60% (n= 376) in comparison to 0% with placebo (n=224) across all the three studies. Further, the investigator ratings as well as subject rating regarding the post-treatment follow-up have been presented for each of the three studies. (14) Here it is important to note that it is not possible to compare the results of onabotulinumtoxinA with abobotulinumtoxinA, but the results of this study has indicated the same pattern of onabotulinumtoxinA.
The purpose of this study is to evaluate the efficacy and safety of BTX-A treatment of glabellar lines in 234 patients. Based on the severity, the patients have been treated with intramuscular injections of 20 U BTX-A or placebo into 5 glabellar sites (BTX-A: 203, placebo: 61). Subsequently, patients have been monitored for next 120 days so as to identify the efficacy of BTX-A treatment. The following are the important factors to be measured for 120 days are: patient assessment of improvement, glabeller severity at maximum frown and rest, vital signs and symptoms etc. The results indicated that there’s a significant reduction in gallbladder lines in patients treated with BTX-A than placebo (P<0.22). The effect has been monitored for all 120 days and only mild occurrence (5.4%) of blepharoptosis was observed in patients with BTX-A injection. Thus, it was concluded that BTX-A injections are safe and efficient in reducing the severity of glabeller lines. (15)
The value of cosmeceuticals has become increasingly popular in the invasive procedures. Of this, Botullinum toxin injection has played a major role in the revolution of facial treatments. As performing BT injection, physicians must be aware of several implications include the characteristics of available products such as quantity of does, reconstitution, appropriate storage, dilution, etc. These can be achieved only by appropriate usage of technique, and the knowledge of the possible complications and their prevention and treatment. Apart from this, proper patient’s selection with pre and post treatment procedure could minimize the risk of side effects as well. These are the important factors that help to achieve good results on the subject of cosmetic surgery.
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1. Grace R. Cosmeceuticals: Functional food for the skin. Natural Foods Merchandiser. 2002; XXIII: 92-9.
2. FDA / CFSAN. Is it a Cosmetic, a Drug or Both (or is it Soap?). U.S. Food and Drug Administration. Centre for food safety & applied nutrition. Office of cosmetics and colors fact sheet. 2002.
3. Grimes, P. E. Aesthetics and Cosmetic Surgery for Darker Skin Types. India: lippincott williams & wilkins. 2008.
4. Benedetto AV.The cosmetic uses of Botulinum toxin type A. Int Jrnl Dermatology. 1999; 38(9): 641-655.
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9. Goh CL. (2009) The Need for Evidence-Based Aesthetic Dermatology Practice. J Cutan Aesthet Surg. 2009; 2(2): 65-71.
10. Brin MF, Boodhoo TI, Pogoda JM, et al. Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: A meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Acad Dermatol. 2009;61(6):961–970.
11. Botox Cosmetic [package insert] Irvine. CA: Allergan, Inc.; 2009.
12. Carruthers A, Carruthers J, Lowe NJ, et al. for the BOTOX® Glabellar Lines I and II Study Groups One-year, randomised, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res. 2004;7:1–20.
13. Dysport [package insert] Brisbane. CA: Medicis Aesthetics Inc.; 2009.
14. Brandt F, Swanson N, Baumann L, Huber B. Randomized, placebo-controlled study of a new botulinum toxin type A for treatment of glabellar lines: efficacy and safety. Dermatol Surg.2009;35:1893–1901.
15. Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J et al. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002; 46(6): 840-9.
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