Monday, March 31, 2008

Evidence for Safety & Efficacy of Mesotherapy

Mesotherapy is performed by thousands of doctors worldwide for fat destruction. The safety & efficacy of this procedure is often questioned by medical professionals not familiar with it.

These are just a few papers published in reputable medical journals that look at what happens to the fat after treatment, whether it works and whether it is safe. There is none so blind as those who won't see. Mesotherapy may be slow, but there is good evidence that it is effective and safe.

[1]
Dermatol Surg. 2008 Jan;34(1):60-6; discussion 66.

Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study.

Salti G, Ghersetich I, Tantussi F, Bovani B, Lotti T.
Centro Chirurgico Florence, Florence, Italy. giosal@fol.it

Each patient received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, each single patient being herself the control. Four treatments were carried out every 8 weeks in a double-blind, randomized fashion.

Both treatments have shown moderate and equivalent efficacy in treating localized fat, with sodium deoxycholate having a slower postoperative resolution, suggesting that sodium deoxycholate could be sufficient by itself to determine fat cell destruction and that phosphatidylcholine could be useful for obtaining a later emulsification of the fat.

[2] Dermatol Surg. 2004 Jul;30(7):1001-8.

Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution.

Rotunda AM, Suzuki H, Moy RL, Kolodney MS.
Division of Dermatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, USA.

Cell viability and cell membrane lysis assays were performed on cell cultures and porcine skin after treatment with the phosphatidylcholine formula, isolated sodium deoxycholate, or common laboratory detergents Triton-X 100 and Empigen BB.

A significant and comparable loss of cell viability, cell membrane lysis, and disruption of fat and muscle architecture was seen in cell cultures and tissue specimens treated with the phosphatidylcholine formula and isolated sodium deoxycholate.

[3] Dermatol Surg. 2007 Feb;33(2):178-88; discussion 188-9.

Action of sodium deoxycholate on subcutaneous human tissue: local and systemic effects.

Yagima Odo ME, Cucé LC, Odo LM, Natrielli A.
Department of Dermatology, School of Medicine, University of Santo Amaro, São Paulo, Brazil. marina.odo@uol.com.br

Sodium deoxycholate (SD) induces an inflammatory reaction in subcutaneous human fat and dose-dependent adipocyte lysis with acute pain and fibrosis. No systemic effects were detected.

[4] Dermatol Surg. 2006 Apr;32(4):465-80

Mesotherapy and phosphatidylcholine injections: historical clarification and review.

Rotunda AM, Kolodney MS.

Department of Dermatology, University of Southern California School of Medicine, Los Angeles, California, USA. arotunda@hotmail.com

All the published studies evaluating the clinical efficacy of traditional mesotherapy currently originate from Europe. These reports focus primarily on musculoskeletal pain and vascular disease, rather than cosmetic applications. Although experimental data suggest that a number of traditional mesotherapy ingredients may theoretically reduce fat, these effects have not been supported in peer-reviewed studies. An increasing number of reports demonstrate that subcutaneous injections of a formula containing phosphatidylcholine combined with its emulsifier, deoxycholate, are effective in removing small collections of adipose tissue. Cell lysis, resulting from the detergent action of deoxycholate, may account for this clinical effect.

Mesotherapy is distinct from a method of treating adipose tissue with subcutaneous injections of deoxycholate alone or in combination with phosphatidylcholine.

[5] J Cosmet Dermatol. 2007 Dec;6(4):250-7.

Submental fat reduction by mesotherapy using phosphatidylcholine alone vs. phosphatidylcholine and organic silicium: a pilot study.

Co AC, Abad-Casintahan MF, Espinoza-Thaebtharm A.
Jose R. Reyes Memorial Medical Center, Rizal Avenue, Sta. Cruz, Manila, Philippines. genjoabby@hotmail.com

Mesotherapy using phosphatidylcholine vs. phosphatidylcholine plus organic silicium was similarly effective in reducing submental fat. There was no significant difference between them in terms of rate and degree of reduction. Optimal reduction of submental fat was achieved after three treatment sessions. Adverse reactions were few, mild, and transitory. Therefore, both regimens are safe, efficacious, cost-effective, and can be used as alternatives to invasive surgical procedures.

[6] J Drugs Dermatol. 2003 Oct;2(5):511-8

Phosphatidylcholine in the treatment of localized fat.

Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D.
Doris Hexsel Dermatologic Clinic, Porto Alegre, Brazil. dohexsel@zaz.com.br

Clinical results reflect that phosphatidylcholine was efficacious in reducing the fatty pads in the treated areas, with few side effects. From the authors' point of view, the off-label use of phosphatidylcholine in the treatment of fatty pads and small areas of localized fat is safe, low cost, and effective.

[7] J Cosmet Laser Ther. 2005 Mar;7(1):17-9.

Histological changes associated with mesotherapy for fat dissolution.

Rose PT, Morgan M.

Punch biopsies were taken at one and two weeks after mesotherapy with PC and DC. Each of the biopsies taken at one and two weeks after treatment with PC and DC showed a normal epithelium and dermis, with a mixed septal and lobular panniculitis. The fat lobules were infiltrated by increased numbers of lymphocytes and, in particular, macrophages. The macrophages consisted of conventional forms, foam cells, and multinucleated fat-containing giant cells. The inflammation was associated with serous atrophy and microcyst formation.

[8] Aesthetic Plast Surg. 2006 Jul-Aug;30(4):474-8.

Injection of phosphatidylcholine in fat tissue: experimental study of local action in rabbits.

Rittes PG, Rittes JC, Carriel Amary MF.
Santa Casa School of Medicine, Rua Afonso Braz, 864, cj. 72, Vila Nova Conceição, São Paulo, SP, Brazil. prittes@terra.com.br

Using a randomized, blind approach, 10 rabbits were injected with an experimental assay of phosphatidylcholine (the biologic model), and another 10 rabbits were injected with physiologic saline. A histologic study was conducted, and the Mann-Whitney test was applied.

A marked difference was observed between the two groups with respect to necrosis, inflammatory exudation, and fibrosis.

[9] Aesthetic Plast Surg. 2003 Jul-Aug;27(4):315-8.

The use of phosphatidylcholine for correction of localized fat deposits.

Rittes PG.

Subjects with localized fat deposits commonly receive suction lipectomy as a cosmetic procedure. A new office procedure for correction of those superficial fat deposits was applied in 50 patients by injection of phosphatidylcholine. The method itself consists of using a 3OG1/2 insulin needle to inject about 5 ml (250 mg/5 ml) of phosphatidylcholine into the fat, distributing it evenly in an 80 cm2 area. Pre- and posttreatment photographs were taken for technical planning and analysis of the results over the long term.

A clear improvement occurred in all, with a marked reduction of the fat deposits without recurrence over a 2-year follow-up period and no weight gain. The injection of phosphatidylcholine into the fat deposits is a simple office procedure that can sometimes postpone or even replace surgery and liposuction.

[10] Dermatol Surg. 2001 Apr;27(4):391-2.

The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads.

Rittes PG.
Clínica Patrícia Rittes, Sao Paulo, Brazil. prittes@ruralsp.com.br

Thirty patients were treated for prominent lower eyelid fat pads with phosphatidylcholine injection. Pre- and posttreatment photographs were taken for long-term analysis. A marked reduction of the lower eyelid fat pads was noted over the 2-year follow-up period. There were no recurrences.

The injection of phosphatidylcholine (250 mg/5 ml) into the fat pads is a simple office procedure that may postpone or even substitute for lower eyelid blepharoplasty.

[11] J Cosmet Dermatol. 2006 Sep;5(3):218-26.

Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study.

Palmer M, Curran J, Bowler P.
British Association of Cosmetic Doctors, 30b Wimpole St, London, UK. mark.palmer@mail.com

Thirty-nine UK doctors specifically trained and experienced in this treatment completed questionnaires, focusing on outcome and adverse effects experienced by patients. Ten thousand five hundred and eighty-one treatments had been administered over a mean duration of 13.1 months. Localized adverse effects (swelling, erythema, burning/stinging, pain, tenderness and bruising) were described by most patients as "very mild' (18.4%) or "mild" (39.2%). The total incidence of systemic side-effects was 3%: diarrhoea, nausea, dizziness/light-headedness and intermenstrual bleeding were described by most patients as "very mild" (36%) or "mild" (55%). Only 15 (0.14%) "unexpected, unusually severe or prolonged" adverse reactions (commonly pain and/or swelling) were reported. These were all self-limiting and none were judged as serious. 73.8% of patients were either "very satisfied" or "satisfied" with treatment.

This treatment appears to be associated with minimal risks when used by specifically trained and experienced doctors. The possible risks associated with this treatment should be balanced against the risks of other treatment options.

[12] J Am Acad Dermatol. 2005 Dec;53(6):973-8.

Lipomas treated with subcutaneous deoxycholate injections.

Rotunda AM, Ablon G, Kolodney MS.
Division of Dermatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, USA. arotunda@hotmail.com

All lipomas decreased in size (mean area reduction, 75%; range, 37%-100%) as determined by clinical measurement (with ultrasound confirmation in one lipoma) after an average of 2.2 treatments. Several lipomas fragmented or became softer in addition to decreasing in volume. Adverse effects, including transient burning, erythema, and local swelling, were associated with higher deoxycholate concentrations but resolved without intervention. There was no clear association between deoxycholate concentration and efficacy. Low concentration deoxycholate may be a relatively safe and effective treatment for small collections of fat.


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