Is Mesotherapy Really Worthwhile?

IS MESOTHERAPY REALLY WORTHWHILE?

FACTS AGAINST MESOTHERAPY

DR SHEHNAZ ARSIWALA

DR VENKATARAM MYSORE

With a large number of physicians incorporating the less evidenced Mesotherapy in practice the editorial board would like to highlight certain mesotherapy facts a physician must know.

Mesotherapy entails by definition, multiple injections of pharmaceutical and homeopathic medications, plant extracts, vitamins, and other ingredients often in combinations into subcutaneous fat.

While initial usage of the term entailed the concept of entire mesoderm as one unit with possible distant effects, it is now often used to mean intradermal therapy locally at the site of injection

Agents used for injections are said to be in minute doses with little volume, few times and in the right place, however there is lack of standardization of actual doses by controlled studies which is an issue of grave concern.

Agents used for mesotherapy are a cocktail of formulations, some of them listed in table 1 and are claimed to work by lipolytic, venostatic,, anaesthetic and anticollagen actions.

TABLE 1: AGENTS USED FOR MESOTHERAPY

The mixture of drugs and other ingredients in mesotherapy formulations include s combinations that is not FDA approved for any purpose. Often these are produced by companies which are little known. The drugs used some times are used for their known physiological role without any proof of pharmacological efficacy.

Current mesotherapy practices are utilized for Fat reduction and cellulite and body contouring, Rejuvenation and glow, hair regrowth but literature evidences are not encouraging.

In an article by Brown the author stresses that to date; the effects of mesotherapy have not been scientifically evaluated. Currently, there is no standardization of dosage and no protocol or treatment algorithm to enable prediction of how much tissue or fat will be "dissolved" with a specific solution in a defined quantity, and injected at a specified subcutaneous tissue depth. Hence this technique is no longer regarded as mesotherapy and is now considered as chemolipolysis. The drug desoxycholic acid has now been standardized under marketed after approval by FDA as Klybella • The American Society of Plastic Surgeons issued a position statement not endorsing mesotherapy- The American Society for Dermatologic Surgery informed its members in February 2005 that "further study is warranted before this technique can be endorsed.“

• A recent publication of guidelines on esthetic practices in Singapore listed mesotherapy as a List B procedure (List B procedure indicates procedures with low or very low evidence or local medical expert consensus that procedure is neither well-established nor acceptable.)

• Guidelines on aesthetic practices for doctors. Academy of Medicine, Singapore, College of Family Physicians, Singapore, and Aesthetic Practice Oversight Committee, Singapore Medical Council

• IADVL position on mesotherapy also said there is not sufficient evidence for its routine usage and suggested that physicians using the drug should exercise caution.

Mesotherapy for hair regrowth

• Total lack of documented data about all aspects of the treatment like mechanism of action,

• Pharmacokinetics and pharmacodynamics, therapeutic regimes, etc., in standard medical journals. NO rationale for cocktail combinations, efficacy and of course safety!

• No peer reviewed clinical trials.

• Two results on medline search are reports of side effects following the use of mesotherapy for hairloss! .One report documented histologically acute noncicatricial alopecia similar to anagen effluvium. Second article reports the development of multiple abscesses

• Data on its safety and efficacy in pattern hair loss have not been adequately and critically evaluated and documented in proper, peer-reviewed clinical trials.

• Data evaluating the rationale and pharmacology of the combination of herbal and allopathic medicines used are not adequate.

• There are no clear-cut guidelines on the dosage and efficacy and safety of the products.

• Further, mesotherapy is not entirely a safe technique as publicized in lay media and can give rise to complications, as stated earlier. In a prospective study, 10 patients underwent four sessions of facial mesotherapy using multivitamins at monthly intervals. This study found that there was no clinically relevant benefit and diverse physiological effects on fibroblasts.

THE MESO BAN!

• It is currently banned in a number of South American countries. Even Brazil, which is less strict than the USA in drug approvals, has banned the drug for these purposes.

• BANNED IN France in 2011!

• In Australia and Singapore under regulatory scanner!! After reports on complication and no efficacy.

LOCAL SYSTEMIC

• Mild pain, skin hyperesthesia, edema, itching and erythema. • Nausea, vomiting,

• Atypical mycobacterial infections (mycobacterium fortuitum) and • HIV, mycobacterium abscessus infection., Ulcers and scarring, • Hepatitis and • Nodularity and irregularity. • Demyelination of nerves • Atrophy, lipodystrophy, subcutaneous oleomas • Ischemic colitis • Lichenoid eruption,

• Post-inflammatory hyperpigmentation

• Koebnerization in psoriasis,

• Localized urticaria pigmentosa, granuloma annulare,

• Non-infectious granulomatous panniculitis

• One case of thyrotoxicosis was reported after using cocktail containing tri iodothyronine

• Rx- dapsone, steroids, colchicine, surgery

Table-2: Side effects of mesotherapy

• CONCLUSION:

• Mesotherapy was discovered by Micheal pistor in 1952, AFTER 64 years and no LITERATURE evidences which are positive, various aesthetic procedures like fillers, botulinum toxin, chemical peels, micro needling etc have large number of literature evidences and randomized controlled studies highlighting their relevance through decades.

• There is paucity of knowledge about the efficacy, mechanism of action and long-term consequences of Mesotherapy with lack of randomized control trials.

• There are far better gold standard, evidence based therapies for all the given indications

• Very low validity and non encouraging scientific evidence

• No randomized control studies

• Banned in most countries

• No approvals by key regulatory authorities and societies

• What is also needed is proper public health education to ensure quality, ethical management and prevention of commercial exploitation of patients.

• DISCLAIMER: THE VIEWS HERE ARE A COMPILATION VALIDATED BY LITERATURE EVIDENCES