DOI: 10.24019/issn.2532-0831

Online ISSN 2532-0831

Journal of Theoretical and Applied Vascular Research

Journal website: http://www.vasculab.eu/jtavr.xml

JTAVR 2022;07(3)

Efficacy and safety of a Maqui berry-based nutraceutical in venous insufficiency of the lower limbs

E Mici¹, A Prifti¹, L Zikaj¹, A Kuraj¹

Abstract Aims: to assess effectiveness of supplementation with a nutraceutical containing an extract of Maqui berry on symptoms and signs of patients with venous insufficiency of the lower limbs

Patients and methods: a preliminary prospective cohort clinical and instrumental study was performed in a single center, on patients affected by venous insufficiency of the lower limbs related to varicose veins, C2-C4 of CEAP classification. All patients were prospectively enrolled and investigated for a two-month period and they took 2 tablets a day of a nutraceutical containing 500 mg of Maqui berry extract. Venous symptom assessment with visual analogue scale (VAS) was performed at T0 (baseline), T1 (30 days after T0) and T2 (60 days after T0). Short-form 12 questionnaire (SF12) for mental and physical condition was compiled at T0 and T2. Both blood C- reactive protein (CRP) and edema measurement in the lower leg (through circumferences and derived volumetry) were performed at T0 and T2. Compression stockings were allowed if previously used at least one month before T0. Maintenance of the previous lifestyle and nutrition was required throughout the study duration. Student’s test for paired data was used for statistical analysis.

Results: a cohort of 45 patients, 35 females and 10 males, mean age 56.4 ± 1,7, with an average body mass index of 26.5 ± 0,5, were investigated. At T0 CEAP C distribution was: 5 C2, 31 C3, 9 C4. No patient was lost to follow-up. VAS assessment showed a statistically significant (p <0.0001) improvement of all symptoms; mean value of heaviness, pain, swelling sensation and dysesthesia at T0 and T2 (T2/T0) were 8.8/5.3, 7.6/4.2, 8.7/5.5 and 6.3/3.3 respectively. The mental component of SF12 improved from 23.2 to 37.0 (p<0.0001), whereas the physical component did not show any relevant variation. CRP was statistically (p<0.01) lower at T2. Lower leg mean volumetry did not show any significant variation between T0 and T2, though ankle circumference decreased of 2 mm. No side effects were reported.

Conclusions: in this preliminary prospective cohort study the nutraceutical Maqui 500® proved to be effective and safe in patients affected by venous insufficiency of the lower limbs. A statistically significant improvement of venous symptoms, CRP and SF12 mental score was demonstrated in this clinical series; a lower though non-significant effect on edema was found. Larger cohort, randomized studies may possibly corroborate the outcomes of this preliminary study.