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Introduction

Description of the herbal substance(s), herbal preparation(s) or combinations therefore.

Herbal substance(s)

The herbal substance consists of the dried, ripe berries of Sambucus nigra L. (elderberry). The wrinkled, more or less spherical dropes are dark violet-black and slightly glossy with a size around 0.5 cm. Usually, they contain three, somewhat elongated stones, each of which has a seed inside the hard endocarp. Fruit stalks are occasionally present. Elderberry belongs to the family Caprifoliaceae (Wichtl 2004). Elder berries taste sweet and sourish with a characteristic aroma (Bisset and Wichtl 2001, Wichtl 2004, Hiermann 2010).

Clinical studies (case studies and clinical trials)

Two clinical studies have been conducted by Zakay-Rones et al. (1995, 2004) studying the safety and efficacy of a syrup containing a standardised elderberry extract in the treatment of influenza and its symptoms. The first study was conducted on 27 people (15 receiving treatment and 12 receiving an undefined placebo preparation). Improvement of flu symptoms including fever was obtained in 93.3% of the patients within 2 days after initial dosing, while 91.7% in the placebo group (P<0.001) showed signs of improvement after 6 days. Immunological tests found a higher level of influenza virus antibodies in patients who received elderberry than those who received the placebo, suggesting an enhanced immune activity. None of the patients reported any adverse reactions related to the medication(Zakay-Rones et al. 1995).

In vivo experiments

Antioxidative activityBobek et al. (2001) also studied antioxidative activity:

Rats with acute colitis were fed for a month with a diet containing 4% black elderberry extract (extraction solvent 70% ethanol, concentrated to the 50-60% content of dry matter.) Colitis was induced by intraluminal instillation of 4% acetic acid. Long-term feeding with a diet containing black elderberry extract showed increased resistance to experimentally induced colitis. Lower levels of oxidative stress in the experimental group compared with the control group who received laboratory control diet (without black elderberry extract) was observed. In addition, neutrophil infiltration caused by myeloperoxidase activity was significantly lower, while higher activity of lysosomal enzymes (acid phosphatase and cathepsin D) that are released during inflammation was observed in colonic tissue in the experimental group. Both macroscopic damage to the colon and myeloperoxidase activity was 50% lower in the treatment group compared with the control diet group. The results suggest that a diet containing black elderberry extract can increase the level of antioxidative defense of the organism and thus lead to increased resistance to induction of colitis. Rats with acetic acid-induced colitis placed on an elderberry diet had significantly less macroscopic damage and 50% lower myeloperoxidase activity scores than did rats in the control diet group. The antioxidative effects of glutathione are considered to be detoxification of degradation products resulting from lipid peroxidation and DNA damage. Elderberry extract with abundant content of beneficial flavonoids is thought to prevent damage to cellular components caused by reactive oxygen species.

Source: https://www.ema.europa.eu/documents/herbal-report/final-assessment-report-sambucus-nigra-l-fructus_en.pdf