Original Articles
Vol. 14 (2025)
https://doi.org/10.4081/vl.2025.13189

Mesotherapy versus oral medical treatment of chronic venous insufficiency in a general practitioner setting - A randomized controlled trial

Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Received: 2 October 2024
Accepted: 17 March 2025
Published: 27 March 2025
703
Views
353
Downloads
Mesotherapy, chronic venous insufficiency, edema, varicose veins

Authors

Silvia Rossetto
https://orcid.org/0009-0008-4413-8390
Medical Student, University of Ferrara, Italy.
Giulia Baldazzi
giulia01.baldazzi@edu.unife.it
https://orcid.org/0000-0001-8589-5154
Department of Translational Medicine, School of Vascular Surgery, University of Ferrara, Italy.
Alessandra Gallo
https://orcid.org/0009-0007-5034-1187
General Practitioner, Fossalta di Piave (VE), Italy.
Paolo Zamboni
Professor and Chairman, Department of Translational Medicine, School of Vascular Surgery, University of Ferrara, Italy.

Mesotherapy involves the introduction of drugs through dermal microinjections for preventive, therapeutic, or rehabilitative purposes. This study evaluates the safety, tolerability, and effectiveness of mesotherapy in treating Chronic Venous Insufficiency (CVI) compared to traditional oral treatments. Sixty-one patients with CVI (CEAP stage C3-C4) were randomized into two groups. The primary outcome was the measurement of bilateral ankle circumferences. Secondary outcomes included the evaluation of bilateral circumferences and subcutaneous ultrasound thicknesses at the thigh, calf, and medial ankle, and Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) stage variation. The treatment group (30 patients) received mesotherapy with a complex homeopathic product every 15 days for 3 months, and the control group (31 patients) was treated with oral flavonoids for 3 months. With no recorded adverse effects, mesotherapy led to significant reductions in bilateral ankle circumferences (right p=0.0008, left p=0.0075), CEAP stage (p=0.0212), ankle ultrasound thicknesses (right p=0.0037, left p=0.0015) and calf thicknesses (right p=0.0131, left p=0.0137). Mesotherapy was found to be safe, well tolerated, and more effective with respect to oral drugs in CVI patients; however, further randomized, controlled, and blind trials with wider sample sizes are mandatory to confirm our results.

Downloads

Download data is not yet available.
Lee BB, Nicolaides AN, Myers K, et al. Venous hemodynamic changes in lower limb venous disease: the UIP consensus according to scientific evidence. Int Angiol 2016;35:236-52.
Zamboni P, Traina L, Gianesini S. In: Dionigi R, Dionigi Chirurgia. Settima edizione. Edra, Perignano, Italy, 2023.
Apollonio A. In: Frullini A, Manuale di flebologia ambulatoriale. Officina Editoriale Oltrarno, Firenze, Italy, 2023.
White JV, Ryjewski C. Chronic venous insufficiency. Perspect Vasc Surg Endovasc Ther 2005;17:319-27. DOI: https://doi.org/10.1177/153100350501700406
Azar J, Rao A, Oropallo A. Chronic venous insufficiency: a comprehensive review of management. J Wound Care 2022;31:510-9. DOI: https://doi.org/10.12968/jowc.2022.31.6.510
Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assessment and quality of life improvement with micronized Flavonoids. Angiology 2002;53:245-56. DOI: https://doi.org/10.1177/000331970205300301
Mammucari M, Vellucci R, Mediati D, et al. What is mesotherapy? Recommendations from an international consensus. Trend in Medicine 2014;14:1-10.
Mammucari M, Maggiori E, Cresta P, et al. Trattato di intradermo terapia distrettuale. EMSI, Roma, Italy, 2022.
Mammucari M, Maggiori E, Lazzari M, et al. Should the general practitioner consider mesotherapy (intradermal therapy) to manage localized pain? Pain Ther 2016;5:123-6. DOI: https://doi.org/10.1007/s40122-016-0052-3
Maggiori S. L'intradermoterapia distrettuale. La mesoterapia in Italia. EMSI, Roma, Italy, 2013.
+ Mammucari M, Mercandante S. Norme di buona pratica clinica in mesoterapia. EMSI, Roma, Italy, 2022.
Mammucari M, Russo D, Maggiori E, et al. Evidence-based recommendations on mesotherapy: an update from the Italian Society of Mesotherapy. Clin Ter 2021;171:e37-45.
PASCOE Lymdiaral. Injectable vials, package leaflet.
Zamboni P, Lanzara S, Mascoli F, et al. Inflammation in venous disease. International Angiology 2008;27:361-9.
Rizzi A, Quaglio D, Zamboni P, et al. Effects of vasoactive agents in healthy and diseased human saphenous veins. J Vasc Surg 1998;28:855-61. DOI: https://doi.org/10.1016/S0741-5214(98)70061-8
Zamboni P, Tisato V, Menegatti E, et al. Endothelial PDGF-BB produced ex vivo correlates with relevant hemodynamic parameters in patients affected by chronic venous disease. Cytokine 2013;63:92-6. DOI: https://doi.org/10.1016/j.cyto.2013.04.018
Ligi D, Croce L, Mannello F. Inflammation and compression: the state of art. Veins and Lymphatics 2016;5:5980. DOI: https://doi.org/10.4081/vl.2016.5980
Albergati F, Farina M, Bacci PA. Valutazione dell’attività di Lymdiaral sull’omeostasi endoteliale nella stasi circolatoria: studio clinico pilota in doppio cieco, randomizzato, controllato con placebo ed in cross-over. Campisi C, Zilli A, Eretta C. Efficacia di Lymdiaral nel trattamento del linfedema cronico degli arti: studio caso controllo. Linfologia Italiana 2004
Maggiori E., Bartoletti E., Mammucari M. Intradermal therapy (mesotherapy) with lymdiaral in chronic venous insufficiency and associated fibrosclerotic edema damage: a pilot study. J Altern Complement Med 2013;19:777-81. DOI: https://doi.org/10.1089/acm.2012.0734
Davids MR, Edoute Y, Jungas RL, et al. Facilitating an understanding of integrative physiology: emphasis on the composition of body fluid compartments. Can J Physiol Pharmacol 2002;80:835-50. DOI: https://doi.org/10.1139/y02-114
Viscido R, Ferrara PE, Ljoka C, et al. Mesotherapy as a treatment of pain and disability in patients affected by neck pain in spondylartrosis. Ig Sanita Pubbl 2018;74:95-101.
Ferrara PE, Ronconi G, Viscito R, et al. Efficacy of mesotherapy using drugs versus normal saline solution in chronic spinal pain: a retrospective study. Int J Rehabil Res 2017;40:171-4. DOI: https://doi.org/10.1097/MRR.0000000000000214
Paolucci T, Russo D, Maggiori E, et al. A call to action by the Italian Mesotherapy Society on Scientific Research. Drug Des Devel Ther 2021;15:3041-7. DOI: https://doi.org/10.2147/DDDT.S321215
Pavei P, Ferrini M, Spreafico G, et al. Ultrasound guided foam sclerotherapy of recurrent varices of the great and small saphenous vein: 5-year follow up Veins and Lymphatics 2014;3:4655. DOI: https://doi.org/10.4081/vl.2014.4655
Ricci S. The sapheno femoral junction involvement in the treatment of varicose veins disease Veins and Lymphatics 2017;6:6822. DOI: https://doi.org/10.4081/vl.2017.6822
Tessari M, Menegatti E, Zamboni P, et al. Elastic stockings effect on leg volume variability in healthy workers under prolonged gravitational gradient exposure Veins and Lymphatics 2015;4:5182. DOI: https://doi.org/10.4081/vl.2015.5182
De Maeseneer MG, Kakkos SK, Aherne T, et al. European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg 2022;63:184-267. DOI: https://doi.org/10.1016/j.ejvs.2022.06.022
Palmieri. Trattamento dell’edema flebolinfatico con Lymdiaral. In: Medicina Funzionale, 2011.
Gasbarro V, Cataldi A, Poverini R, et al. Modificazioni morfologiche dei linfonodi in corso di trattamento con Lymdiaral. Trattamento topico e mesoterapico con Lymdiaral in pazienti affetti da PEFS 3-2011. In: Medicina Funzionale, 2011.
Sukhareva M, Egorova O, Belov B. Lipodermatosclerosis as a type of lobular panniculitis: the effectiveness of non-pharmacological treatment methods. Annals of the Rheumatic Diseases 2020;79:1821. DOI: https://doi.org/10.1136/annrheumdis-2020-eular.1443

How to Cite



Mesotherapy versus oral medical treatment of chronic venous insufficiency in a general practitioner setting - A randomized controlled trial. (2025). Veins and Lymphatics, 14. https://doi.org/10.4081/vl.2025.13189
Copyright (c) 2025 the Author(s) Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.