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Acta Phlebologica 2017 April;18(1):29-35

DOI: 10.23736/S1593-232X.17.00382-4


language: English

Preliminary experience with a multicomponent nutraceutical (melilotus, rutin and bromelain) on phlebolymphedema of the lower limbs

Fausto CAMPANA 1 , Simone U. URSO 2, Stefania PACCASASSI 3, Galya DIMITROVA 4, Roberto COLUCCI 5, Attilio CAVEZZI 6

1 Ospedali Privati Forlì, Forlì, Italy; 2 Unit of Phlebology, Professor Nobili Hospital, Castiglione dei Pepoli, Bologna, Italy; 3 Eurocenter Venalinfa, San Benedetto del Tronto, Ascoli Piceno, Italy


BACKGROUND: The aim of our paper was to assess effectiveness and safety of supplementation with a nutraceutical composed of melilotus extract (coumarin), rutin and bromelain in patients with phlebolymphedema (PLE) of the lower limbs.
METHODS: A prospective observational clinical and instrumental study has been performed on a cohort of 100 patients, one limb per patient. 74 females and 26 males, mean age 58.6 years (SD±14.1), with an average Body Mass Index equal to 27.2 (±3.8) affected by venous and lymphatic insufficiency of the lower limbs, C3 or higher of CEAP clinical classification, were prospectively enrolled and investigated for three months. 3 patients (3%) were lost to follow-up or excluded from the final statistical analysis. Patients were daily administered for three months with one tablet of a multicomponent nutraceutical comprising: 1) 100 mg of melilotus; 2) 300 mg of rutin; 3) 100 mg of bromelain. Visual Analogue Scale (VAS) was used to assess symptoms before, 45 days and 90 days after the treatment. Edema in the lower leg was calculated through circumference measurement and relative derived volumetry. Bioimpedance spectroscopy (BIS) and its resistance (RES) and reactance (REA) parameter was used to assess fluid changes. Previously used compression stockings were allowed in all subjects throughout the study duration. No change of lifestyle was allowed during the 90 days of the protocol. Wilcoxon Test and Student’s t-test for paired data was used for statistical analysis of the results.
RESULTS: After 90 days of supplementation symptom analysis by means of VAS showed a general improvement (P<0.05) for all symptoms; more specifically mean figures of heaviness, pain and swelling sensation decreased from 5.33, 1.93 and 5.10 to 3.81, 0.75 and 3.53 respectively and the other symptoms showed a similar, slightly lower, reduction. Average volume in the lower leg (in cc) decreased from 2521.71 (±495.92) to 2467.07 (±474.43) (P<0.01). BIS data of the lower leg showed an increase in the average value of the resistance from 143.39 (±27.81) to 149.61 (±28.24) (P<0.01) and an increase in the reactance from 10.37 (±3.23) to 11.11 (±3.56) (P<0.04), which attests to a mild improvement of the fluid content and of tissue composition. Lower improvement of RES and REA values for the total limb were recorded. Very few patients experienced mild nausea or epigastralgia.
CONCLUSIONS: This prospective observational study proved an overall good efficacy and safety of a multicomponent nutraceutical (melilotus+rutin+bromelain) in patients affected by PLE of the lower limbs. Further studies on larger cohorts and possibly with a control group are needed to support the results of this preliminary study.

KEY WORDS: Dietary supplements - Melilotus - Lower extremity - Edema

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