[Lymphedema of the upper extremity in patients operated for carcinoma of the breast: clinical experience with coumarinic extract from Melilotus officinalis].
OBJECTIVE
The aim of this clinical study was to verify the therapeutic activity of cumarinic extract of Melilotus officinalis (CEMO) in patients with chronic lymphedema of the upper arm caused by lymphadenectomy for breast cancer. Cumarine, in fact, has antiedemic properties due to macrophagic action that stimulates proteolysis in the tissues affected by chronic lymphedema.


METHODS
In an open clinical study we enrolled 24 patients with chronic upper arm lymphedema due to post-lymphadenectomy of the axilla for breast cancer. 21 patients were eligible to receive 400 mg of CEMO containing 8 mg of cumarine in a sole daily administration for 6 months. We measure the circumference of the upper arm at 3 and 6 months from treatment. We evaluated the symptoms and tolerability through a questionnaire given to the patients at every clinical control.


RESULTS
Of the 21 (87.5%) patients eligible, only 14 (66.6%) were treated with CEMO according to protocol. Of these 11 patients (52.3%) had a reduction of the circumference of the affected arm of 5% with respect to base values. Three patients (14.2%) had no change. In 12 patients (57.1%) symptoms improved. As for tolerability: 3 patients (14.2%) had transitory gastrointestinal side-effects. There was worsening of lymphedema and symptoms in 4 patients (19%) that did not receive CEMO and were followed as controls. Three patients (14.2%) were not evaluable because they were lost to follow-up.


CONCLUSIONS
Cumarinic extract of Melilotus officinalis (CEMO) was effective in reducing lymphedema in 79% of the pts treated for a period of six months. The median reduction of the upper arm circumference was modest (5% with respect to initial values) but statistically significant (p = 0.048). Treatment with CEMO for lymphedema could be associated to the physiotherapy given to these patients such as manual lymph drainage (MLD).
Pastura
G
G
IST (Istituto Nazionale per la Ricerca sul Cancro) Genova, Italia.
Mesiti
M
M
Saitta
M
M
Romeo
D
D
Settineri
N
N
Maisano
R
R
Petix
M
M
Giudice
A
A
D000328:Adult; D000368:Aged; D001132:Arm; D001943:Breast Neoplasms / Q000188:drug therapy / Q000601:surgery*; D003374:Coumarins / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008209:Lymphedema / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010592:Pharmaceutic Aids / Q000627:therapeutic use*; D010936:Plant Extracts / Q000627:therapeutic use; D011183:Postoperative Complications / Q000628:therapy*
D003374:Coumarins; D010592:Pharmaceutic Aids; D010936:Plant Extracts