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
Özet
Amaç. Meme kanserinin cerrahi tedavisinde uygulanan yöntemlerden modifiye radikal mastektomi ve meme koruyucu cerrahi sonrasında görülen önemli komplikasyonlardan birisi lenfödemdir. Mikronize Flavanoid Fraksiyon (MFF) (diosmin %90, hesperidin %10) venöz akımı ve lenfatik akımı hızlandıran bir ajan olarak günümüzde kullanılmakta olan bir ilaçtır. Biz bu çalışmada MFF 500 mg'ın lenfödem üzerine etkisini araştırmayı amaçladık. Yöntem. Bu amaçla kliniğimizde Temmuz 2001-Temmuz 2004 tarihleri arasında meme kanseri nedeniyle modifiye radikal mastektomi ya da meme koruyucu cerrahi uygulanan hastalar çalışmaya dahil edildi. Operasyon sonrasında aksiller radyoterapi endikasyonu koyulan hastalar çalışma dışı bırakıldı. Hastalar 2 gruba randomize edildi. Grup 1: Kontrol: Bu hastalara operasyon sonrasında 6 ay plasebo verildi. Grup 2: MFF 500 mg: Bu hastalara operasyon sonrasında 6 ay MFF 500 mg 2x1 verildi. Hastaların tamamının preoperatif ve postoperatif 1. ay, 3. ay ve 6. aylarında kol çapları ve kol hacimleri ölçülerek kaydedildi. Operasyon tarafındaki % 10’luk hacim ve/veya çap artışı lenfödem olarak kabul edildi. Sonuçlar Mann Whitney U testi ile değerlendirildi. Bulgular. Grup 1'de 30 hasta grup 2'de ise 24 hasta vardı. Gruplar arasında preoperatif kol çapları ve kol hacimleri açısından istatistiksel olarak anlamlı fark yoktu. Diseke edilen lenf nodu sayıları her iki grupta istatistiksel olarak farksızdı. Postoperatif lenfödem gelişimine baktığımızda grup 1'de 5 hastada (%16,6), grup 2'de ise 4 hastada %10,7 oranında lenfödem geliştiği görüldü. Bu oranlar arasında istatistiksel olarak anlamlı fark yoktu. Gruplar arasında postoperatif 1. 3. ve 6. ay yapılan hacim ve çap ölçümleri değerlendirildiğinde çap değişimi ve hacim değişimi açısından anlamlı fark saptanmadı. Sonuç. Sonuç olarak aksiller diseksiyon sonrasında gelişen lenfödemin önlenmesinde MFF etkisinin olmadığı ancak daha kesin sonuca varılması için daha büyük grupları içeren çalışmaların gerektiği kanaatine varıldı.
Anahtar sözcükler: Post-operatif lenfödem, aksiller diseksiyon, mikronize flavonoid fraksiyonu
Keywords
References
- Browning C. Lymphedema: prevalence, risk factors and management: a review of research. Sydney: NHMRC National Breast Cancer Center, 1997.
- Pertek J, Helen M. Incidence of breast Carcinoma-related lymphedema Cancer 1998; 83: 2776-81.
- Purushotham AD, Bennett Britton TM, Klevesath MB, Chou P, Agbaje OF, Duffy SW. Lymph node status and breast cancer-related lymphedema. Ann Surg 2007; 246: 42-5.
- McLaughlin SA, Wright MJ, Morris KT, Sampson MR, Brockway JP, Hurley KE, Riedel ER, Van Zee KJ. Prevalence of lymphedema in women with breast cancer 5 years after sentinel lymph node biopsy or axillary dissection: patient perceptions and precautionary behaviors.J Clin Oncol 2008; 26: 5220-6.
- Kwan W, Jackson J, Weir LM, Dingee C, McGreggor G, Olivotto IA. Chronic arm morbidity after curative breast cancer treatment: prevalence and impact on quality of life. J Clin Oncol 2002; 20: 4242-8.
- Foldi E, Foldi M, Weissleder H. Conservative treatment of lymphedema of the limbs. Anjiology 1985; 36: 171-80
- Micke O, Bruns F, Mücke R, Schäfer U, Glatzel M, DeVries AF, Schönekaes K, Kisters K, Büntzel J. Selenium in the treatment of radiation-associated secondary lymphedema. Int J Radiat Oncol Biol Phys 2003; 56: 40-9.
- Bollinger A, Herrig I, Fischer M, Hoffmann U, Franzecck UK. Intravital capillaroscpy in patients with chronic venous insufficiency and lymphedema: relevance to Daflon 500 mg. Int J Microcirc Clin Exp 1995; 15 Supple 1: 41-4.
- Katsenis K.Micronized purified flavonoid fraction (MPFF): a review of its pharmacological effects, therapeutic efficacy and benefits in the management of chronic venous insufficiency. Curr Vasc Pharmacol 2005; 3: 1-9.
- Pecking AP, Fevrier B, Wargon C, Pillion G. Efficacy of daflon 500 mg in the treatment of lymphedema (secondary to conventioal therapy of breast cancer). Angiology 1997: 48: 93-8.
- Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: Results from a prospective International Cooperative Group trial. Ann Surg Oncol 2006; 13: 491-500.
- Lucci A, McCall LM, Beitsch PD, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol 2007; 25: 3657-63.
- Engler HS, Sweat RD. Volumetric arm measurements: technique and results. Am Surg 1962; 28: 465-8.
- Stanton AW, Levick JR, Mortimer PS. Current puzzles presented by postmastectomy edema (breast cancer related lymphedema). Vasc Med 1996; 1: 213-25.
- Engel J, Kerr J, Schlesigner-Raab A, Sauer H, Holzel D. Axilla surgery severely affects quality of life: results os a 5-year prospective study in breast cancer patients. Breast Cancer Treat 2003; 79: 47-57.
- Pertek JA,Senie RT, Peters M, Rosen PP. Lymphedema in a cohort of breast carcinoma survivors 20 years after diagnosis. Cancer 2001: 92: 1368-77.
- Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg 1999; 177: 184-7.
- Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J,Peckitt C, Woods M, Yarnold J. Doubled-blind placebo-controlled randomized trial of vitamin E and pentoxifylline in patients with chronic arm lymphedema and fibrosis after surgery and radiotherapy for breast cancer. Radither Oncol 2004; 73: 133-9.
- Cluzan RV, Alliot F, Ghabboun S, Pascot M. Traetment of secondary lymphedema of the upper limb with CYCLO 3 FORT. Lymphology 1996; 29: 29-35.
- Berlin E, Gjores JE, Ivarsson C, Palmqvist I, Thagg G, Thulesius O. Post mastectomy lymphedema. Treatment and a five year follow-up study. Int Angiol 1999; 18: 294-8.
- Pecking AP. Evaluation by lymphoscintigraphy of the effect of a micronized flavonoid fraction (Daflon 500 mg) in the treatment of upper limb lymphedema. Int Angiol 1995; 14: 39-43.
- Olszewski W. Clinical efficacy of micronized purified flavonoid fraction (MPFF) in edema. Angiology 2000; 51: 25-9.
- Campisi C, Boccardo F, Zilli A, Maccio A, Napoli F, Ferreira Azevedo W Jr, Fulcheri E, Taddei G. Lymphedema secondary to breast cancer treatment: possibility of diagnostic and therapeutic prevention. Ann Ital Chir 2002; 73: 493-8.
- Panobianco MS, Mamede MV. Complications and incidents associated with arm edema in the first 3 months after mastectomy. Rev Lat Am Enfermagem 2002; 10: 544-51.
Abstract
Amaç. Meme kanserinin cerrahi tedavisinde uygulanan yöntemlerden modifiye radikal mastektomi ve meme koruyucu cerrahi sonrasında görülen önemli komplikasyonlardan birisi lenfödemdir. Mikronize Flavanoid Fraksiyon (MFF) (diosmin %90, hesperidin %10) venöz akımı ve lenfatik akımı hızlandıran bir ajan olarak günümüzde kullanılmakta olan bir ilaçtır. Biz bu çalışmada MFF 500 mg'ın lenfödem üzerine etkisini araştırmayı amaçladık. Yöntem. Bu amaçla kliniğimizde Temmuz 2001-Temmuz 2004 tarihleri arasında meme kanseri nedeniyle modifiye radikal mastektomi veya meme koruyucu cerrahi uygulanan hastalar çalışmaya dâhil edildi. Operasyon sonrasında aksiller radyoterapi endikasyonu koyulan hastalar çalışma dışı bırakıldı. Hastalar 2 gruba randomize edildi. Grup 1: Kontrol: Bu hastalara operasyon sonrasında 6 ay plasebo verildi. Grup 2: MFF 500 mg: Bu hastalara operasyon sonrasında 6 ay MFF 500 mg 2x1 verildi. Hastaların tamamının preoperatif ve postoperatif 1. ay, 3. ay ve 6. aylarında kol çapları ve kol hacimleri ölçülerek kaydedildi. Operasyon tarafındaki % 10’luk hacim ve/veya çap artışı lenfödem olarak kabul edildi. Sonuçlar Mann Whitney U testi ile değerlendirildi. Bulgular. Grup 1'de 30 hasta grup 2'de ise 24 hasta vardı. Gruplar arasında preoperatif kol çapları ve kol hacimleri açısından istatistiksel olarak anlamlı fark yoktu. Diseke edilen lenf nodu sayıları her iki grupta istatistiksel olarak farksızdı. Postoperatif lenfödem gelişimine baktığımızda grup 1'de 5 hastada (%16,6), grup 2'de ise 4 hastada %10,7 oranında lenfödem geliştiği görüldü. Bu oranlar arasında istatistiksel olarak anlamlı fark yoktu. Gruplar arasında postoperatif 1. 3. ve 6. ay yapılan hacim ve çap ölçümleri değerlendirildiğinde çap değişimi ve hacim değişimi açısından anlamlı fark saptanmadı. Sonuç. Sonuç olarak aksiller diseksiyon sonrasında gelişen lenfödemin önlenmesinde MFF etkisinin olmadığı ancak daha kesin sonuca varılması için daha büyük grupları içeren çalışmaların gerektiği kanaatine varıldı
References
- Browning C. Lymphedema: prevalence, risk factors and management: a review of research. Sydney: NHMRC National Breast Cancer Center, 1997.
- Pertek J, Helen M. Incidence of breast Carcinoma-related lymphedema Cancer 1998; 83: 2776-81.
- Purushotham AD, Bennett Britton TM, Klevesath MB, Chou P, Agbaje OF, Duffy SW. Lymph node status and breast cancer-related lymphedema. Ann Surg 2007; 246: 42-5.
- McLaughlin SA, Wright MJ, Morris KT, Sampson MR, Brockway JP, Hurley KE, Riedel ER, Van Zee KJ. Prevalence of lymphedema in women with breast cancer 5 years after sentinel lymph node biopsy or axillary dissection: patient perceptions and precautionary behaviors.J Clin Oncol 2008; 26: 5220-6.
- Kwan W, Jackson J, Weir LM, Dingee C, McGreggor G, Olivotto IA. Chronic arm morbidity after curative breast cancer treatment: prevalence and impact on quality of life. J Clin Oncol 2002; 20: 4242-8.
- Foldi E, Foldi M, Weissleder H. Conservative treatment of lymphedema of the limbs. Anjiology 1985; 36: 171-80
- Micke O, Bruns F, Mücke R, Schäfer U, Glatzel M, DeVries AF, Schönekaes K, Kisters K, Büntzel J. Selenium in the treatment of radiation-associated secondary lymphedema. Int J Radiat Oncol Biol Phys 2003; 56: 40-9.
- Bollinger A, Herrig I, Fischer M, Hoffmann U, Franzecck UK. Intravital capillaroscpy in patients with chronic venous insufficiency and lymphedema: relevance to Daflon 500 mg. Int J Microcirc Clin Exp 1995; 15 Supple 1: 41-4.
- Katsenis K.Micronized purified flavonoid fraction (MPFF): a review of its pharmacological effects, therapeutic efficacy and benefits in the management of chronic venous insufficiency. Curr Vasc Pharmacol 2005; 3: 1-9.
- Pecking AP, Fevrier B, Wargon C, Pillion G. Efficacy of daflon 500 mg in the treatment of lymphedema (secondary to conventioal therapy of breast cancer). Angiology 1997: 48: 93-8.
- Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: Results from a prospective International Cooperative Group trial. Ann Surg Oncol 2006; 13: 491-500.
- Lucci A, McCall LM, Beitsch PD, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol 2007; 25: 3657-63.
- Engler HS, Sweat RD. Volumetric arm measurements: technique and results. Am Surg 1962; 28: 465-8.
- Stanton AW, Levick JR, Mortimer PS. Current puzzles presented by postmastectomy edema (breast cancer related lymphedema). Vasc Med 1996; 1: 213-25.
- Engel J, Kerr J, Schlesigner-Raab A, Sauer H, Holzel D. Axilla surgery severely affects quality of life: results os a 5-year prospective study in breast cancer patients. Breast Cancer Treat 2003; 79: 47-57.
- Pertek JA,Senie RT, Peters M, Rosen PP. Lymphedema in a cohort of breast carcinoma survivors 20 years after diagnosis. Cancer 2001: 92: 1368-77.
- Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg 1999; 177: 184-7.
- Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J,Peckitt C, Woods M, Yarnold J. Doubled-blind placebo-controlled randomized trial of vitamin E and pentoxifylline in patients with chronic arm lymphedema and fibrosis after surgery and radiotherapy for breast cancer. Radither Oncol 2004; 73: 133-9.
- Cluzan RV, Alliot F, Ghabboun S, Pascot M. Traetment of secondary lymphedema of the upper limb with CYCLO 3 FORT. Lymphology 1996; 29: 29-35.
- Berlin E, Gjores JE, Ivarsson C, Palmqvist I, Thagg G, Thulesius O. Post mastectomy lymphedema. Treatment and a five year follow-up study. Int Angiol 1999; 18: 294-8.
- Pecking AP. Evaluation by lymphoscintigraphy of the effect of a micronized flavonoid fraction (Daflon 500 mg) in the treatment of upper limb lymphedema. Int Angiol 1995; 14: 39-43.
- Olszewski W. Clinical efficacy of micronized purified flavonoid fraction (MPFF) in edema. Angiology 2000; 51: 25-9.
- Campisi C, Boccardo F, Zilli A, Maccio A, Napoli F, Ferreira Azevedo W Jr, Fulcheri E, Taddei G. Lymphedema secondary to breast cancer treatment: possibility of diagnostic and therapeutic prevention. Ann Ital Chir 2002; 73: 493-8.
- Panobianco MS, Mamede MV. Complications and incidents associated with arm edema in the first 3 months after mastectomy. Rev Lat Am Enfermagem 2002; 10: 544-51.
Details
| Primary Language | English |
|---|---|
| Journal Section | Medical Science Research Articles |
| Authors | |
| Publication Date | June 1, 2011 |
| Published in Issue | Year 2011Volume: 33 Issue: 3 |