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"Moving forward Dr Ravindran and Professor Smith are working to change BoNT Toxin regulations in the UK using their survey findings to guide the development of a proposed framework."
Dr. Roshan Ravindran from KLNIK in Wimslow, UK and Professor Lee Smith from Anglia Ruskin University UK have joined forces to elevate research in the field of Aesthetic Medicine and address some of the most pressing issues in this area. Dr Ravindran is an experienced GP, cardiologist and aesthetics practitioner, he has spent almost 20 years working in medicine and is recognised as a world leader in the medical field of aesthetics. Professor Lee Smith is a University of Cambridge graduate and holds a PhD in the field of Medical Sciences, Epidemiology. He currently holds the position of Professor of Public Health and has previously been listed among the world’s most influential scientists.
After Dr. Ravindran and Professor Smith met and through lengthy discussion in relation to the science produced in aesthetic medicine and the real-world need to both elevate and progress this field of research, they decided to join forces to implement robust, high quality science to ultimately advance the field per se and specifically address industry concerns relating to patient safety. Since the commencement of their collaboration, just two years ago, they have published three peer reviewed academic journal articles, launched a nationwide survey, and have multiple additional papers in press, under review and in preparation. Their first study was a systematic review and meta-analysis focusing on “Cryolipolysis and associated health outcomes, adverse events, and satisfaction” this meta-analysis is now published in Obesity Reviews.
This work included 30 studies with 3158 participants. The result of meta-analyses showed reduced body mass index, waist-to hip ratio, mean abdominal circumference, and mean suprailiac fat thickness, 12 weeks after cryolipolysis as compared with baseline values.
The satisfaction rate was 80.4% and the adverse event rates of cryolipolysis was 49.5% for numbness, 44.5% for erythema, 30.5% for edema, 28.8% for pain, 25.4% for sensitivity, 15.2% for tingling, and 2% for hyperpigmentation. They subsequently concluded that cryolipolysis was associated with a reduction in the number of adiposity parameters at 3 months follow-up. A relatively high level of minor adverse events was reported; however, patient satisfaction was high suggesting that the treatment is well tolerated.
Their second study was titled “Biostimulants in Aesthetic Medicine: A Systematic Review and Meta analysis of Efficacy, Safety, and Patient Satisfaction” this meta-analysis is now published in Aesthetic Surgery Journal. The work included 25 studies. The results of meta-analyses indicated that the pooled satisfaction rate of biostimulants was estimated to be 91%, with the following adverse event rates: bruising, 27%; ecchymosis, 22%; edema, 5%; erythema, 16%; nodule development, 5%; and pain, 92%. Among studies not included in the meta-analysis, all parameters studied showed significant improvements in terms of dermal, volume, anatomic, and satisfaction outcomes. They subsequently concluded that biostimulants demonstrate clinical promise and a favorable tolerability profile in aesthetic medicine despite the common occurrence of minor adverse events, most notably pain.
After the completion of these two needed and informative systematic reviews and meta-analyses they decided to tackle the field of Botulinum Toxins (BoNT) by launching the Great British and Northern Ireland BoNT survey. The aim of the survey was to capture real-world experiences of cosmetic BoNT in the UK focusing on patient safety, ethical standards, and practitioner accountability. A total of 919 participants completed the survey from across the UK. The first peer-reviewed journal article from this survey has now been published in Aesthetic Surgery Journal Open Forum. This published article shows that 91% of the participants were female, the majority (54%) had received more than five BoNT treatments, and their treatment was most commonly delivered in beauty clinics (46%). Regarding people’s motivation for treatment, 81% said anti-ageing reasons, while only 11% cited medical conditions.
Despite existing requirements for BoNT to be dispensed by a qualified prescriber, worryingly only 42% said that a prescriber was present during their consultation, while 9% said they were not provided with a written consent form prior to their procedure and 18% reported not being informed of possible complications. Only 26% of participants said they received any form of post treatment support, while just 28% recalled receiving advice on how to manage potential side effects.
Although most people reported a high level of satisfaction, with 90% expressing positive views about their treatment, short-term complications included bruising or swelling in 26% of cases, headaches (25%) and injection site pain (10%). Long-term complications were relatively rare, with botulinum toxin resistance (3%) the most common.
Formal complaints following treatment were filed by only 5% of individuals, but at the same time only 35% admitted they were familiar with current regulations and 74% said they were unaware of the national Yellow Card reporting system. Through Yellow Card, the Medicine and Healthcare products Regulatory Agency (MHRA) collects information reported by the public about suspected safety concerns.
In addition to the article summarised here this survey has produced other data that is now being prepared for publication covering topics such as the risk of adverse events among those with chronic conditions undergoing BoNT treatment, risk of adverse events in relation to administer professional role, detailed analyses in relation to redress and so on. Moreover, the survey has been repeated in Ecuador, and the data is now being prepared for analyses.
Moving forward Dr Ravindran and Professor Smith are working to change BoNT Toxin regulations in the UK using their survey findings to guide the development of a proposed framework. They will continue to address key areas in the field through meta-analyses, epidemiological surveys and randomised-controlled trials.
