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Estudio Omeoformula 1 en reducción de adiposidad localizada

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Page 1: Estudio Omeoformula 1 en reducción de adiposidad localizada

PHYSIOLOGICAL REGULATING MEDICINE 1/2008

37

BACKGROUND/OBJECTIVES

Mesotherapy has gain popularity as a method for body con-touring and treatment of localized fat deposits.The study aimed to determine the safety and efficacy of pop-ular mesotherapy cocktails in the treatment of localized fatdeposits in Filipino adult females.

METHODS

Sixty healthy female subjects, aged 25-45 years, complainingof localized excess fat deposits on their upper arms wererecruited to join the study. The subjects were randomized intothree treatment groups with 20 participants each. Group Areceived phosphatidylcholine and organic silicium (PC - OS);Group B received phaphatidylcholine, tiratricol and L-carni-tine (PC+L), and Group C received the homeopathic formulaOmeoformula 1 (Guna S.p.a., Italy). The cocktails were pre-pared beforehand in identical 10 mL syringes. The methodconsisted of using a tuberculin syringe with a 30G½” needleto inject the cocktail into the subcutaneous fat of the postero-medial aspects of bilateral upper arms of the subjects, evenlydistributing it over a 10x4 cm area; each injection distanced2 cm apart using 0,2 mL per injection. The study was 8 weeksin length, and injection of the cocktails was done at weeks 1,2, 3 and 4. the subject’s mid-upper arm circumferences weremeasured at weeks 1, 2, 3, 4 and 8. The study participantsunderwent blood extraction at weeks 1 (baseline), 3 and 8 fordetermination of renal function (BUN, creatinine), liver func-tion (AST, ALT, ALP), lipid profile (total cholesterol, triglyc-erides, HDO, LDL, VLDL), as well as a complete blood countwith differential and platelet count. Cutaneous safety profiles,mainly injection site erythema and ain were assessed using aten-point scale. Subjects were also asked to report anyadverse events by answering a questionnaire during weeks 1,2, 3, and 4. All Data were analyzed using Univariate and

Multivariate Analysis of Variance at a 95% confidence level.The end of trial data and all adverse events reported duringthe study were summarized, with frequency counts of severi-ty and relationship to study treatment.

RESULTS

The PC-OS and Omeoformula 1 were found to be compara-ble in efficacy and were both superior to the PC+L formula indecreasing mid-arm circumference. There were no significantdifferences of abnormalities between treatments at differenttime intervals in terms of renal function, liver function, com-plete blood count, triglycerides, cholesterol and VLDL, butthere was a significant increase in HDL and decrease in LDLat the end of treatment in all groups. Injection site pain waspruritus, and heaviness. Rare adverse events were axillarylymphadenopathy, severe oedema and erythema, steatorrhea,and post-inflammatory hyperpigmentation. Least adverseevents were reported in the Omeoformula 1 group.

CONCLUSIONS

Overall, mesotherapy is safe and effective in the treatment oflocalized fat deposits in Filipino adult females and appears tohave some benefit in improving the HDL/LDL balance. �

Abstract presented in: Posters “Aesthetic dermatology: Cosmetic der-matology”, 21st World Congress of Dermatology. Buenos Aires -Argentina. Sept. 30th - Oct. 5th, 2007.

L.R.A. Intong, F.B. Kishi Generao,C.D. Villarama-Cellona

SAFETY AND EFFICACY OF MESOTHERAPYIN THE TREATMENT OF LOCALIZED FATDEPOSITS IN FILIPINO ADULT FEMALES:

A RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL

Corresponding Author

Dr. L.R.A. Intong, MDUniversity of the Philippines - Philippine General HospitalManila - Philippines

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6-Dermatology:Art. Milani 29-10-2008 9:28 Pagina 37