While the exciting and disruptive new product or treatment often catches our eye, sometimes this focus on the new and novel distracts us from more closely examining the known, or even mundane, for gems with much potential to impact our world. The concepts and concerns investigated in three recently-published peer-reviewed clinical trials prove learning and discovery are never finished, but rather only limited by our desire to expand our understanding and awareness.
PAIN CONTROL WITH MINDFULNESS MEDITATION
As the concept of wellness and its value in personal healthcare becomes more firmly entrenched, wellness-based holistic medicine continues to gain traction. The added impetus of the opioid epidemic fuels the search for optimized pain management with minimized drug intervention. Facial plastic and reconstructive surgeon Natalie Krane, MD (Portland, Ore.), is lead author on a study of mindfulness meditation as a pain management option, specifically after septorhinoplasty, which was published in Facial Plastic Surgery & Aesthetic Medicine.1 “What brought the study about was the opioid epidemic,” she said. “It isn’t going away, in fact it has gotten worse during the COVID-19 pandemic. Many studies examine the various pharmacologic options for pain control, including opioids, but not much at all – at least in facial plastic surgery literature – explore nonpharmacologic alternatives. I teach mindfulness meditation, and when I found that it has been shown to improve pain scores associated with other types of surgery, I thought it was ripe for exploration in plastic surgery.”
In the prospective randomized, controlled pilot study, patients undergoing some form of primary septorhinoplasty received a standardized post-operative pain management protocol. Routine acetaminophen usage was encouraged with ibuprofen added in combination on day three, supplemented with tramadol tablets (15 were supplied) as needed for uncontrolled severe pain. “We chose this particular surgery because it is associated with more challenging control of discomfort.” Prior rhinoplasty, history of chronic pain, narcotic use, or regular use of mindfulness meditation served as exclusion criteria; prior endonasal septoplasty and/or inferior turbinate reduction did not disqualify patients.
The subject pool was randomized into two groups: those who received guided mindfulness meditation (n=21) and those who did not (n=24) serving as a control. The meditation protocol was a web-based guided mindfulness meditation tool developed by the lead author.
Primary outcome measures included pain scores, opioid use and mindfulness scores. Pain was assessed pre-operatively as well as on days zero through five post-operatively; opioid use was recorded; mindfulness scores, when applicable, using a validated grading scale, were obtained pre-operatively and one week post-operatively for the study group.
Opioid use or pain scores between the two groups did not vary significantly. There was a significant difference in opioid consumption in those with intranasal splints when compared to those without; however, this difference did not apply to those who practiced mindfulness. Significant improvement was noted in pre- to post-operative mindfulness scores using the validated scale.
“Secondarily, we wanted to evaluate patient experience and opinion about the web-based tool,” Dr. Krane added, “so we gave study group patients a nine-question multiple choice survey addressing accessibility and usability of the website, perceived benefit and improvement in pain (as well as sleep), and if they would recommend it to others undergoing a similar procedure.” Of the 20 patients who filled out the survey all respondents said they would recommend it, while the majority in the study group said the guided meditation was beneficial (90%), eased pain/discomfort (85%), and helped them sleep (80%). “These results indicate that the web-based meditation tool does what it is supposed to, that patients can easily understand it, and that they will use it. Also, the almost universal perceived benefits, including less discomfort and improved sleep, matter a great deal because pain, like quality of life, is largely subjective anyway.”
According to Dr. Krane, the overall results suggest that mindfulness meditation as a post- operative recovery tool may be beneficial but needs more study. “We were limited by a small sample size from a single study center with a potentially homogenous patient population, so the study is underpowered,” she said. “Also, we may find a more well-rounded evaluation of the pain experience and pain acceptance to be revealing. There are benefits associated with mindfulness meditation, pain is subjective and opioid dependence is a problem. Mindfulness meditation doesn’t hurt and patients seem to think it helps, so we need to be mindful of that.”
1. Krane NA, Simmons JK, Sykes KJ, Kriet JD, Humphrey CD. Guided mindfulness meditation for pain control after septorhinoplasty: a randomized-controlled pilot study. Facial Plast Surg Aesthet Med. 2021 Dec; epub ahead of print.
The original article Guided Mindfulness Meditation for Pain Control after Septorhinoplasty: A Randomized-Controlled Pilot Study, is open access and available online at: https://www. liebertpub.com/doi/abs/10.1089/fpsam.2021.0184?journalCode =fpsam
BREAST IMPLANT ILLNESS
Breast augmentation has become ubiquitous in the sphere of public awareness. News media has often focused on the side effects and potential problems of existing or emerging technologies and treatments, but sometimes the personal and painful realities for individuals get lost in the hype. The poorly understood issue of Breast Implant Illness (BII), which affects a subset of those who have undergone this common cosmetic procedure, is the subject of one recent investigation published in the Aesthetic Surgery Journal.1
“In decades of breast implant use, the phenomenon of BII is relatively new. The term itself is more a social media creation than a scientific one and does not yet meet the criteria of a medically-recognized disease. In fact, currently there are no well-defined criteria or set of symptoms for the condition, which the patients themselves attribute to their implants. Nor is there much, if any, real science on BII,” explained plastic surgeon and co-author William Adams Jr., MD, who is the current president of The Aesthetic Society and practices in Dallas, Texas.
“There is a proliferation of ideas from various groups based on anecdotal experiences rather than evidence,” Dr. Adams continued. “Advocacy groups suggest the possibility of implant toxicity despite existing FDA data that does not support that. Researchers may find a psychological origin facilitated by social media, resulting in physical symptoms. Regardless, the distress associated with this broad range of physical and psychological symptoms is very real to sufferers, and deserves our scientific scrutiny, especially given the prevalence of this procedure.”
To this end the study enrolled volunteer subjects (recruited online via social media support groups) self-reporting BII with implants still in place (n=51); women self-reporting BII but had implants explanted (n=60); and a final group (n=58) with implants in place without BII. An online survey was created and administered with significant effort to comprehensively examine experiences of women with implants, including mental and physical health. This survey utilized validated scales to assess basic physical health, smoking and alcohol use history, generalized side effects, ten common symptoms from the general population and 15 symptoms commonly associated with BII (with intensity rating), and anxiety and depression. Basic self-reported medical history information was also gathered.
While there is just too much information to thoroughly summarize in detail, there are key trends of note, according to Dr. Adams. “About two-thirds of the time BII is reported within the first two years after surgery. Approximately 80% said their symptoms changed over time. Women with BII reported more severe physical symptoms and clinically significant higher rates of anxiety and depression than their non- BII counterparts; that is a finding that suggests practices may consider proactively screening for depression and anxiety, especially because well under half of BII sufferers report having undergone psychological or psychiatric care.”
More than 85% of women with BII made lifestyle changes in an attempt to manage symptoms, approximately 75% of whom changed their diet and about 25% of whom abstained from, or reduced, alcohol consumption, as the two most common. “About 75% of subjects had specific ideas about the origin of their symptoms, the culprit mostly being an immune response or toxicity issue. The remaining 25% simply believed their symptoms were caused by the implants. These ideas help direct patient efforts to seek avenues of care.”
Evaluation also meant looking at the potential effect of explantation on BII. There is some evidence suggesting that explantation is effective for reducing reported symptoms, but this investigation’s data was less promising. “Among explant patients, we saw a reduction of their symptoms, but the reduction never dropped to the baseline rates seen in the non-BII group with implants; and the anxiety and depression scores of the explanted BII group still remained in the clinically significant level. If there was a toxin causing issues we would expect a greater resolution of these signs and symptoms. This doesn’t support a toxin related cause.”
According to Dr. Adams, the study is the first of its kind and serves as a launching pad for additional and more extensive investigation shedding light on the causes, effects, risk factors and potential therapies for BII.
“Overall, breast augmentation surgery is a well-understood procedure despite the controversy over the years,” Dr. Adams reported. “We have to rely on good science to lead us down the pathway of truth. The Aesthetic Society and the Aesthetic Surgery Education and Research Foundation (ASERF) are carrying out multiple high-level studies on this topic. We intend to use all of our best resources and science to provide our patients with real answers to these questions.
“To be clear, no one is being dismissive here, and in fact we have pro-actively commissioned several key studies that are already published and others that will be done in the next year,” he continued. “We are finding critical data that has already changed the way we approach and treat patients seeking care. After all, 99.1% of study subjects said they sought professional healthcare intervention from the primary care physician, a plastic surgeon, and then others. Most went that more traditional, recommended route before self-diagnosis. The vast majority (98.2%) sought support online eventually. We must grow our understanding, inform our perspectives, and drive future investigation.”
1. Newby JM, Tang S, Faase K, Sharrock MJ, Adams WP. Understanding breast implant illness. Aesthet Surg J 2021;41(12:1367–1379.
The original article Understanding Breast Implant Illness, is open access and available online at: http://sadil.ws/bitstream/ handle/123456789/1511/Understanding%20breast%20implant. pdf?sequence=1&isAllowed=y
ANDROGENETIC ALOPECIA TREATMENT
A recent article published in the Journal of Cosmetic Dermatology by Nestor and colleagues reviewed the spectrum of treatment options for androgenic alopecia (AGA).1 “AGA is still a common concern and not particularly well managed, despite being well understood,” said lead author Mark S. Nestor, MD, PhD, director of the Center for Cosmetic Enhancement as well as the Center for Clinical and Cosmetic Research (Aventura, Fla.) “This is proven by the overwhelming response to our article from physicians in various disciplines, individuals and advocacy groups, everyone, which dramatically exceeds what I normally expect. We tried to be incredibly thorough and balanced, looking at all sides and providing solid information. It obviously hits home. AGA is, after all, a lifelong condition.”
“Normally, articles are about efficacy and side effects,” Dr. Nestor continued. “How does this work, what is the safety profile, how does it compare with alternatives? This is because what physicians do best is present options with reasonable efficacy and minimal side effects. We went for an all-aspects approach, factoring in compliance rates, cost of therapy, what the ethics involved might be, and what the short- and long-term outlook is for patients.”
In the minds of most people, perhaps, AGA treatment options include hair transplantation, minoxidil and snake oil. “That is what people tend to believe but it couldn’t be farther from the truth because the spectrum of options is much broader,” said Dr. Nestor. “Right now, the only FDA-approved therapies for AGA are oral finasteride, low-level light therapy and minoxidil. But, there are a great deal more alternatives and lack of regulatory approval doesn’t suggest inferior efficacy. Oral and topical formulations, exosome and platelet-rich plasma (PRP) treatments, hormone therapies and hair transplantation, among others, are growing in popularity and undergoing more study. Each has pros and cons.”
As with any review article, the information is the fruit of an extensive literature search. “Our review quickly highlighted the lack of clear standards for efficacy. How does it look and feel? What are the hair counts or measures of thickness? Comparing efficacy between modalities is virtually impossible, which is why there is a dearth of comparison studies on the treatment of AGA.”
Treatment options were categorized, then broken down by efficacy, side effects, ease of use and cost. “Remember that AGA is a lifelong condition, so cost over time is a key consideration here,” Dr. Nestor began. Topical minoxidil and finasteride were examined first. “We follow that up with an extensive breakdown of oral finasteride, not mincing words about side effects and cost over time, but not forgetting how ease of use factors in because nothing is easier than taking a pill once a day.”
Well-rounded examination of the pros and cons of hormone therapies were next, followed by light therapies. “Light therapies are interesting because not only do they rank among the FDA-approved modalities, efficacy, as per clinical studies, is surprisingly high and side effects are almost nonexistent. They are also ideal for adjunctive use,” Dr. Nestor pointed out. Study of injectables centers largely around PRP, with exosomes emerging. “Efficacy has been there in many studies but ease of use and cost are downsides.”
“Nutraceuticals are a popular option,” he continued, “because they tend to be safe, cost-effective, easy to use, and the body of research about them is growing. There is a wide variety available.” More esoteric options are also highlighted.
“We finish with two things,” he said. “Combination therapy and hair transplantation. Most people take a multivector approach to treatment. Hair transplantation is a very expensive option but over time, the cost may be worth it given the efficacy and persistence of results.”
“When you consider variation between individuals and their differing needs, it is to our advantage to have a broad and well-understood armamentarium,” Dr. Nestor concluded. “Our goal should be to offer the best individualized care profiles based on patient need and the available evidence independent of our financial benefit. We hope this study moves us forward in that endeavor.”
1. Nestor MS, Ablon G, Gade A, Han H, Fischer DL. Treatment options for androgenetic alopecia: efficacy, side effects, compliance, financial considerations, and ethics. J Cosmet Dermatol 2021;20:3759–3781.
The original article Treatment Options for Androgenetic Alopecia: Efficacy, Side Effects, Compliance, Financial Considerations, and Ethics, is open access and available online at: https://www. researchgate.net/publication/355973883_Treatment_options_ for_androgenetic_alopecia_Efficacy_side_effects_compliance_financial_considerations_and_ethics