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Surgery and Cosmetics

Lisa M. Donofrio, MD

Mesotherapy and Nonsurgical Fat Melting

lisa donofrio

Tuesday, November 08, 2005


Mesotherapy Defined

The term "mesotherapy" applies not so much to a procedure with a particular outcome, but to an injection technique. Similar to descriptive terminology like "intramuscular injection," "subcutaneous tumescent infiltration," and "oral administration," the term "mesotherapy" does not address the drugs or products that are being administered or the reason for administration but merely the way it is injected.

Developed in France in the 1940s, mesotherapy was the term used for the injection of drugs into the "mesoderm" in targeted areas to address conditions such as tinnitus and pain. Other published medical indications over the decades have included musculoskeletal disorders and vascular diseases.1-4

Mesotherapy has recently gained widespread media popularity with promises of weight loss, nonsurgical fat reduction, treatment of male-pattern alopecia, and wrinkle reduction. It should be noted that, at this time, mesotherapy has not been subjected to critical evidence based medical protocols. Moreover, there have, as yet, not been full comparisons of benefits with detrimental effects, such as infection. Ultimately, all of these issues must be addressed before the various forms of mesotherapy may be promoted with any confidence that they are safe and effective.

Mesotherapy Applied

The drug "cocktails" administered via mesotherapy are tailored to the condition being treated. They have included a variety of prescription medications (both those intended for parenteral use and those only found in oral formulations), herbs, vitamins, hormones, beta agonists, cyclic amp inhibitors, or emulsifying agents.

There are 4 distinct administration techniques:

  1. Duperficial injection (as one would administer Zyderm I®)
  2. Intradermal injection (as one would administer Zyderm II®)
  3. Deep dermal (as one would administer Restylane®)
  4. Subcutaneous (as one would perform fat injection)

The choice of level of injection is tailored to the condition being treated. These injections are administered either with a syringe or mechanical delivery gun attached to a small gauge needle with a serial puncture technique.

The important point to understand is that there are no standardized formulations or injection techniques, so data collection on both the efficacy and safety of mesotherapy with various cocktails is lacking. There is a dearth of any published papers on mesotherapy for cosmetic indications in the English-speaking medical literature.

One of the only papers published came out of the bariatric literature in the 1980s. In this study, isoproterenol was injected into the thighs of obese women. The injected thigh showed decrease girth as compared to the thigh that received a placebo injection. The caveat, though, was that the most statistically significant reduction was seen in the subjects who had also lost weight.5 It seems that beta-adrenergic agents like isoproterenol may stimulate "spot reduction" in situations of caloric deprivation. Of course, beta-adrenergic agents can affect a variety of tissues and indeed isoproterenol can be found in the American Heart Association's algorithm for bradycardia.

Other concerns with the efficacy and safety of various mesotherapy cocktails are as follows:

  • Many drugs in the mesotherapy cocktails are oral or topical medications/vitamins/herbs "sterilized" for use parenterally. Do these drugs change after heat sterilization to an inactive or potentially toxic compound? Are oral drugs even active in their current forms, or do they need to be ingested and undergo conjugation by the liver? Do drugs originally intended for topical use need epidermal enzymes for activation? Are these drugs truly sterile and what quality control ensures this?
  • What is the correct therapeutic dose when drugs are administered via mesotherapy? When one considers the multiple studies done to find the safe mg/kg dose of lidocaine used in tumescent anesthesia, one can appreciate the amount of data required to assess safety. Some drugs in the mesotherapy cocktails are lipid soluble, others are not. Which law of pharmacokinetics applies to which drug? Is safety determined in total dose, or is it dependent on weight or on total body fat?
  • Do these drugs (intended for solo use) interact with each other and negate or potentiate each other's benefits? Do they combine to form a unique compound? Is this "new" compound toxic? Do any of the drugs in the cocktail interact with medications the patient may be taking on a regular basis?


Mesotherapy Complications

Complications from mesotherapy that have been described in the literature include atypical mycobacterial infections, Koebnerization, irregular contours, urticarial and lichenoid reactions, and skin atrophy and necrosis.6-10 Physicians who employ mesotherapy should be cognisant of these and all other potential complications.

Mesotherapy for Body Contouring

Mesotherapy using a mixture of deoxycholate and phosphatidylcholine is often termed "lipotherapy". Phosphatidylcholine induces lipolysis and can lower blood triglyceride levels when ingested orally. Recent data suggests that its lipolytic effects when administered via mesotherapy, however, are from the detergent properties of deoxycholate.11 Because of solubility problems with phosphatidylcholine in a mesotherapy solution, deoxycholate is always necessary, so the effects of phosphatidylcholine alone cannot be evaluated.

One small clinical trial has been done to evaluate the efficacy and safety of phosphatidylcholine in the treatment of localized fat in the suborbital area over a 9-month period. The study was open label, and frequently multiple injection sessions were needed. Edema and erythema lasting up to 3 days was observed in 70% and 90% of the patients respectively. Although the majority of patients expressed satisfaction with the results, 50% showed recurrence of the suborbital fat at 9 months.12

Injectable phosphatidylcholine is not approved by the Food and Drug Administration (FDA) in the United States for any use, and there are no FDA-approved injectable agents for body contouring through mesotherapy.

Other Technologies

Recently, an adaptated Neodimium YAG Laser (NdYAG) operating at a wavelength of 1064 has shown promise as a lipolytic device. It utilizes a 1mm cannula with a fiberoptic delivery system. Clinical trials are currently underway in the United States. Previous reports have shown promise not only in its ability to lyse adipocytes and thus improve body contours, but also in its apparent capability to induce tissue contraction in areas of skin flaccidity. It is not a replacement for conventional tumescent liposuction, but rather a complement to it.

The shortcomings of this technology are the cost of equipment, the minimal amount of fat removal per session, and the increased learning curve.13,14

Conclusion

Mesotherapy is a name given to a method of delivery of various single drugs and drug cocktails into skin. Information on its safety and efficacy is at present anecdotal.

Lipotherapy using a mixture of deoxycholate and phosphatidylcholine shows promise as a nonspecific lipolytic agent, but it is currently not approved by the FDA. Other technologies, like lipolytic lasers are on the horizon but in their infancy.

The lack of reliable data where nonsurgical fat removal is concerned gives rise to ethical issues when performing these "experimental" procedures. Until proven otherwise, dermatologist-performed tumescent liposuction is still the safest fat-removal technique currently available.

It should be noted once again that mesotherapy has not been proven effective through critical evidence-based medical protocols. Moreover, there have, as yet, not been full comparisons of benefits with detrimental effects, such as infection. Ultimately, all of these issues must be addressed before the various forms of mesotherapy may be promoted with confidence.

References

  1. Menkes CJ, Laoussadi S, Kac-Ohana N, et al. Controlled trial of injectable diclofenac in mesotherapy for the treatment of tendinitis. Rev Rhum Mal Osteoartic. 1990 Jul-Sep;57(7-8):589-91.
  2. Guazzetti R, Iotti E, Marinoni E. Mesotherapy with naproxen sodium in musculoskeletal diseases. Riv Eur Sci Med Farmacol. 1988 Dec;10(6):539-42.
  3. Gallo R. Mesotherapy in phlebology. Phlebologie. 1980 Jan-Mar;33(1):153-6.
  4. Donini I, De Anna D, Carella G, et al. Mesotherapy in the treatment of lymphedema: histologic and ultrastructural observations. Chir Patol Sper. 1982 Feb;30(1):25-34.
  5. Greenway FL, Bray GA. Regional fat loss from the thigh in obese women after adrenergic modulation. Clin Ther. 1987;9(6):663-9.
  6. Lee DP, Chang SE. Subcutaneous nodules showing fat necrosis owing to mesotherapy. Dermatol Surg. 2005 Feb;31(2):250-1.
  7. Grojean MF, Vaillant L. Lichenoid eruption caused by mesotherapy. Ann Med Interne. 1995;146(5):365-6.
  8. Urbani CE. Urticarial reaction to ethylenediamine in aminophylline following mesotherapy. Contact Dermatitis. 1994 Sep;31(3):198-9.
  9. Friedel J, Piemont Y, Truchetet F, et al. Mesotherapy and cutaneous mycobacteriosis caused by Mycobacterium fortuitum: alternative medicine at risk. Ann Dermatol Venereol. 1987;114(6-7):845-9.
  10. Rosina P, Chieregato C, Miccolis D, et al. Psoriasis and side-effects of mesotherapy. Int J Dermatol. 2001 Sep;40(9):581-3.
  11. Rotunda AM, Suzuki H, Moy RL, et al. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol Surg. 2004 Jul;30(7):1001-8.
  12. Ablon G, Rotunda AM. Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review. Dermatol Surg. 2004 Mar;30(3):422-7.
  13. Ichikawa K, Miyasaka M, Tanaka R, et al. Histologic evaluation of the pulsed Nd:YAG laser for laser lipolysis. Lasers Surg Med. 2005 Jan;36(1):43-6.
  14. Badin AZ, Moraes LM, Gondek L, et al. Laser lipolysis: flaccidity under control. Aesthetic Plast Surg. 2002 Sep-Oct;26(5):335-9.
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