The efficacy of micronized flavonoid fraction (450 mg diosmin plus 50 mg hesperidin) in the treatment of lymphedema after axillary dissection

Abstract

Abstract Aim. Lymphedema is one of the most important complications that occurs secondary to modified radical mastectomy and breast conserving surgery in breast cancer treatment. micronized flavonoid fraction (MFF) (diosmin 90%, hesperidin 10%) is a well known chemical agent used for the acceleration of the flow of lymphatic and venous drainage. Our goal was to evaluate the efficacy of MFF in the treatment of lymphedema. Method. Fifty-four patients who underwent modified radical mastectomy or breast conserving surgery, because of breast cancer between July 2001 and July 2004 in our clinic were included in the trial. The patients who required post operative axillary radiotherapy were excluded. Patients were randomized into two groups. Groups were allocated as follows: Group I (30 patients): Placebo treatment for six months was performed. Group II (24 patients): Patients were treated with 2x1 .500 mg/day/p.o MFF for six months. The diameters and the volumes of the patients’ arms were measured and recorded preoperatively and postoperatively at the 1st, 3rd and 6th months. The 10% increase of diameter and/or volume in the arm at the operation side was accepted as lymphedema. The results were evaluated by using Mann Whitney U test. Results. There were 30 patients in group 1 and 24 patients in group 2. No statistically significant difference was detected between the groups by means of preoperative diameter and volume of the arms. Post operative dissected numbers of the lymph nodes were also not different among groups. Postoperative lymphedema was detected in 5 (16.6%) and 4 (10.7%) patients in Group I and in Group II respectively. These results similarly showed no statistically significance. And also we detected no statistically difference between the two groups in the measurements of the arms at the1st, 3rd and 6th month control visits. Conclusion. As a result, the MFF in the treatment of lymphedema can be accepted as ineffective but further investigations with larger number of patients are required to confirm this conclusion. Keywords: Postoperative lymphedema, axillary dissection, micronized flavonoid fraction Ozet Amac. Meme kanserinin cerrahi tedavisinde uygulanan yontemlerden modifiye radikal mastektomi ve meme koruyucu cerrahi sonrasinda gorulen onemli komplikasyonlardan birisi lenfodemdir. Mikronize Flavanoid Fraksiyon (MFF) (diosmin %90, hesperidin %10) venoz akimi ve lenfatik akimi hizlandiran bir ajan olarak gunumuzde kullanilmakta olan bir ilactir. Biz bu calismada MFF 500 mg'in lenfodem uzerine etkisini arastirmayi amacladik. Yontem. Bu amacla klinigimizde Temmuz 2001-Temmuz 2004 tarihleri arasinda meme kanseri nedeniyle modifiye radikal mastektomi ya da meme koruyucu cerrahi uygulanan hastalar calismaya dahil edildi. Operasyon sonrasinda aksiller radyoterapi endikasyonu koyulan hastalar calisma disi birakildi. Hastalar 2 gruba randomize edildi. Grup 1: Kontrol: Bu hastalara operasyon sonrasinda 6 ay plasebo verildi. Grup 2: MFF 500 mg: Bu hastalara operasyon sonrasinda 6 ay MFF 500 mg 2x1 verildi. Hastalarin tamaminin preoperatif ve postoperatif 1. ay, 3. ay ve 6. aylarinda kol caplari ve kol hacimleri olculerek kaydedildi. Operasyon tarafindaki % 10’luk hacim ve/veya cap artisi lenfodem olarak kabul edildi. Sonuclar Mann Whitney U testi ile degerlendirildi. Bulgular. Grup 1'de 30 hasta grup 2'de ise 24 hasta vardi. Gruplar arasinda preoperatif kol caplari ve kol hacimleri acisindan istatistiksel olarak anlamli fark yoktu. Diseke edilen lenf nodu sayilari her iki grupta istatistiksel olarak farksizdi. Postoperatif lenfodem gelisimine baktigimizda grup 1'de 5 hastada (%16,6), grup 2'de ise 4 hastada %10,7 oraninda lenfodem gelistigi goruldu. Bu oranlar arasinda istatistiksel olarak anlamli fark yoktu. Gruplar arasinda postoperatif 1. 3. ve 6. ay yapilan hacim ve cap olcumleri degerlendirildiginde cap degisimi ve hacim degisimi acisindan anlamli fark saptanmadi. Sonuc. Sonuc olarak aksiller diseksiyon sonrasinda gelisen lenfodemin onlenmesinde MFF etkisinin olmadigi ancak daha kesin sonuca varilmasi icin daha buyuk gruplari iceren calismalarin gerektigi kanaatine varildi. Anahtar sozcukler: Post-operatif lenfodem, aksiller diseksiyon, mikronize flavonoid fraksiyonu