Mesotherapy for Fat Reduction
Indeed, mesotherapy has some attractive features, according to Adam M. Rotunda, M.D., clinical instructor of dermatology at the David Geffen School of Medicine, University of California, Los Angeles. It is quick and easy to perform using familiar injection techniques, and it can be used to treat collections of fat that may be too small for liposuction treatment, said Dr. Rotunda, who spoke about mesotherapy at the American Society for Dermatologic Surgery annual meeting. Mesotherapy has potential as a complementary treatment to liposuction - it is far from a replacement, he said.
Mesotherapy, however, has not been rigorously studied to be safe and effective in clinical trials that meet the FDA regulatory standards, and the substances and mixtures used in this treatment are not approved by the FDA for fat reduction, Dr. Rotunda pointed out. In addition, standardized dosing and injection techniques are lacking, he said.
ADVISORIES ISSUED
Medical societies have cautioned people to avoid injection fat-loss treatments until additional research is conducted on their safety and efficacy. In a press release issued by the American Society for Aesthetic Plastic Surgery last year, society president Foad Nahai, M.D., stated: “Safety needs to come first. We do not have definitive information on injection fat loss treatments. All we have is a few small studies and anecdotal evidence. Until we know more, we cannot recommend these procedures to patients.”
Introduced by a French physician in 1952, mesotherapy typically consists of numerous epidermal, dermal, or subcutaneous injections of nonstandardized ingredients, including pharmaceuticals and homeopathic agents, vitamins, and natural extracts. Some clinicians refer to this as ‘traditional mesotherapy’ to differentiate it from ‘injection lipolysis’ or ‘Lipodissolve’, which involves subcutaneous injections of pharmacologically active detergents such as bile salts to chemically ablate or destroy adipose tissue. Nevertheless, many clinicians still classify all of these techniques as ‘mesotherapy,’ which has generally been met with skepticism from the medical community.
WHAT THE LITERATURE SAYS
Traditional mesotherapy as a tool for fat loss is based on the theory of pharmacologically induced localized lipolysis, which involves the preservation of fat cells and their active release of breakdown products of fat metabolism, namely glycerol and free fatty acids. Recent data suggest that commonly used compounds in traditional mesotherapy have lipolytic activity. Researchers incubated human adipocytes with some of these substances. Spectrophotometric analysis of the solutions after incubation showed that isoproterenol, aminophylline, yohimbine, and melilotus each induce lipolysis, and the effect is enhanced by using these compounds in combination, according to a report in the Journal of Plastic Reconstructive & Aesthetic Surgery (2008;61:1321-1324).
Dr. Rotunda notes that although these data are promising, they have not been demonstrated in robust clinical studies in humans. Furthermore, it may be that localized fat loss using these traditional mesotherapy ingredients are due to their necrotic effects rather than inducing localized lipolysis. Many of these agents may have deleterious systemic effects on the cardiovascular system or endocrine systems, for example, with the use of B-adrenergic agents or hormones, respectively. Some observers have contended that if fat is not being aspirated or ablated, the effect of treatment will not be permanent.
Evidence of clinical efficacy of mesotherapy is mixed. Abigail C. Co, M.D., and her colleagues at Jose R. Reyes Memorial Center in Manila, Philippines, compared phosphatidylcholine alone or in combination with organic silicum as mesotherapy for submental fat. The pilot study involved 12 patients, of whom 11 finished the treatment course. Both regimens achieved significant and similar reductions in the thickness of submental fat after three treatment sessions, according to a report in the Journal of Cosmetic Dermatology (2007;6:250-257). Adverse reactions in both groups were mild and transitory. The researchers noted that the mechanism of action of both treatments are not known. They concluded that “both regimens are safe, efficacious, cost-effective, and can be used as alternatives to invasive surgical procedures.”
Investigators at the Korea University Medical Center in Seoul, however, reported no success using mesotherapy for body contouring in a 12-week study involving 20 women. The researchers injected a solution containing aminophylline, buflomedil, and lidocaine into the superficial dermis of the medial aspect of one thigh weekly using a mechanical delivery gun. The other thigh was not treated. They evaluated the change in fat level by measuring thigh girth and by computed tomography (CT) scans.
At the conclusion of the course of treatment, the girth of the treated thigh did not differ significantly from that of the other thigh. The CT scans showed no significant difference in cross-sectional area or thickness of the fat layer between the treated and untreated thighs, the researchers reported in Plastic and Reconstructive Surgery (2008;121:179e-185e).
In Dr. Rotunda’s view, the most promising ‘mesotherapy’ method of localized fat loss involves subcutaneous injections of detergents such as deoxycholate, but, as yet, this is not approved by the FDA. This agent appears to have a well defined mechanism of action (cell lysis) and is physiologic - our body produces endogenous bile salts. Other agents are commonly used, but less well defined in their mechanism, and are also not FDA approved, like phosphatidylcholine (which is combined with deoxycholate), beta adrenergic compounds (such as isoproterenol), carnitine, and caffeine derivatives. “Nevertheless, physicians may obtain any of these agents from compounding pharmacies,” he observed. “Compounding practices are ultimately determined by state medical and pharmacy authorities.”
He noted that a privately held pharmaceutical company, Kythera Biopharmaceuticals, of Calabasas, Calif., is seeking regulatory approval of a novel compound similar to deoxycholate to reduce lipomas and localized at for aesthetic contouring.
Mesotherapy’s place as a legitimate therapy, one that is standard of practice in the community, will be decided after clinicians have access to FDA-approved medication, he said. “Until that time, if indeed it ever comes, mesotherapy will be unregulated. The dose, technique, medication, and [medication] source will be subject to such wide variations that complications and perhaps even unscrupulous practices will be common. This is not unlike what we see currently.”
Intrigued clinicians interested in incorporating mesotherapy into their practice should read the literature, receive hands on training with experts, attend courses, check with their malpractice carrier and use a reputable compounding pharmacy, he said. Conservative practitioners should wait for regulatory approval.