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HerbalGram. 2004;63:16-17 © American Botanical Council by Donald J. Brown, N.D. Reviewed: Zakay-Rones Z, Thom E, Wollan T, et
al. Randomized study of the efficacy and safety of oral
elderberry extract in the treatment of influenza A and B
virus infections. J International Med Res. 2004;32:132–140. Summary: In a randomized, double-blind, placebo
controlled trial, 60 male and female patients (18-54
years old; mean 30 years old) were recruited from four
primary care sites in Norway to study the efficacy of a
standardized elderberry syrup for the treatment of
influenza. Patients were screened for participation
between December and February, when influenza infection
is most prevalent. All volunteers selected for the study
had a fever ?38.00C (100.40F) and
at least one respiratory influenza symptom. Influenza
type A virus was isolated from 54 patients and influenza
type B from 6 patients. Patients were randomized to
receive either a standardized black elder (Sambucus
nigra L., Caprifoliaceae) berry syrup preparation
(containing 38% elderberry extract plus small amounts of
raspberry extract, glucose, citric acid, and honey;
Sambucol®, Razei Bar, Jerusalem, Israel) or a
placebo syrup (same as above but with no elderberry).
Patients were instructed to take 15 ml of elderberry or
placebo 4 times per day. Study medication was started
within 48 hours (mean 27.2 hours) of the onset of the
influenza-like symptoms and continued for 5
days. Patients were also allowed to take a “rescue
medication” (oral paracetamol and/or a dose-metered
nasal spray [Otrivin®, Novartis, Basel,
Switzerland]) if necessary during the study. The primary
study outcomes included visual analogue scores (VAS) for
aches and pains, frequency of coughing, quality of
sleep, mucus discharge in the respiratory tract, and
nasal congestion. The VAS used a 10-point rating scale
with 0 = no improvement and 10 = pronounced improvement.
A self-evaluation score measuring overall personal
well-being was also completed. Patients scored their
symptoms on diary cards at baseline, four times a day
during treatment, and twice daily for 5 days after the
treatment had finished. Baseline VAS scores did not
differ significantly between the elderberry and placebo
groups. There was a significant difference (p <
0.001) between the two groups in the development of mean
VAS scores. By days 3-4 of treatment, most of the VAS
scores in the elderberry group were close to 10
(pronounced improvement), while the placebo group
reached this level after 7-8 days. A significant
difference (p < 0.001) in the global evaluation
scores for the two groups was noted after a mean of 3.1
± 1.3 days, while a similar score was obtained after 7.1
± 2.5 days in the placebo group. Mean VAS scores for
aches and pains, quality of sleep, mucus discharge in
the respiratory tract, and nasal congestion were all
greater than 9.0 by day 4 in the elderberry group and
were ? 1.0 in the placebo group. The mean VAS score for
aches and pains was 10.0 at day 5 in the elderberry
group and at day 8 in the placebo group. Taking rescue
medication was significantly less (p < 0.001) in the
elderberry group (7 used paracetamol and 5 the nasal
spray) versus the placebo group (26 and 21,
respectively). Patients from both groups were fully
recovered after 8 days. None of the patients reported
any adverse events during the study. While the active constituents in this extract have not been clearly disclosed, it is thought that anthocyanins such as cyanidin 3-glucoside and cyanidin 3-sambuboside may be the key constituents in the extract.2 Both are detectable in the plasma after oral ingestion of the extract.3 Possible mechanisms of action suggested for the extract include immunomodulatory actions as well as possible inhibition of viral adhesion to cell receptors. One ex vivo study found that incubation of human monocytes with Sambucol increased cytokine production—most notably tumor necrosis factor alpha (TNF-a) but also various interleukins (IL-1?, IL-6, IL-8).4 An in vitro study found Sambucol inhibited the replication of common human and animal influenza A and B strains as well as prevention of viral adhesion to cell receptors.1 Practice Implications: The results of this clinical trial support the use of a standardized elderberry syrup extract for the treatment of symptoms associated with influenza in otherwise healthy adults. Although based on small clinical trials, the data suggests a 50% reduction in both the severity and duration of symptoms in persons (adults and children) using the extract for 3 to 5 days. Based on the cost effectiveness of elderberry extract, future trials should focus on its potential value in preventing influenza and also its safety and efficacy in high risk populations such as immunocompromised patients, young children and infants, as well as the elderly. References: 1. Zakay-Rones Z, Varsano N, Zlotnik M, et al. Inhibition of several strains of influenza virus in vitro and reduction of symptoms by an elderberry extract (Sambucus nigra L.) during an outbreak of influenza B Panama. J Altern Complement Med. 1995;1(4):361-–369. 2. Abuja PM, Murkovic M, Pfannhauser W. Antioxidant and prooxidant activities of elderberry (Sambucus nigra) extract in low density lipoprotein oxidation. J Agric Food Chem. 1998;46:4091–4096. 3. Cao G, Prior RL. Anthocyanins are detected in human plasma after oral administration of an elderberry extract. Clin Chem. 1999;45(4):574–576. 4. Barak V, Halperin T, Kalickman I. The effect of Sambucol, a black elderberry-based, natural product, on the production of human cytokines: I. Inflammatory cytokines. Eur Cytokine Netw. 2001;12(2):290–296. Phone: (512) 926-4900 | Fax: (512) 926-2345 | Email: abc@herbalgram.org Israel's elderberry remedy Sambucol provides solution to U.S. flu vaccine shortage By David Brinn October 31, 2004 Americans are nervously bracing for the expected flu vaccine shortage as health experts predict people will begin feeling the effects of the flu by next month. But as the hundreds of thousands of Americans who use Israel's elderberry extract Sambucol will tell you, vaccines aren't the only answer to the flu's debilitating symptoms. Nicknamed 'nature's flu fighter', Sambucol, which is produced by Jerusalem company Razei Bar, has been clinically proven to eliminate flu symptoms within one to two days. A standardized extract, the 100% natural Sambucol contains a potent antiviral compound, AntiVirin as well as a high amount of three flavonoids, naturally occurring plant antioxidants. Developed by world renowned Israeli virologist Dr. Madeleine Mumcuoglu, SAMBUCOL is derived from the black elder tree, Sambucus nigra L. Beginning in the 1970s, Mumcuoglu began research that led to her discovery of the key active ingredient in elderberry. "I became interested in the natural healing elements of elderberry when I did by PHD on it in Switzerland," Mumcuoglu told ISRAEL21c. "I isolated the active substances from the elderberry and tested them against the flu virus, and found them to be effective. After finishing my studies, I came back to Israel and continued to work on research for another 10 years or so at the Hadassah Medical Center in Jerusalem." According to Mumcuoglu, the black elderberry has been known since the 5th century BCE and was mentioned in the writings of Hippocrates, Dioscurides and Plinius. It can be found in every pharmacopoeia. Elderberry wine was traditionally used for influenza and the ill effects of the chills, and the juice of the black elderberry has historically been an invaluable remedy. After assessing its effectiveness against the flu during her research, which was conducted in collaboration with the Department of Virology, Hebrew University School of Medicine, Mumcuoglu decided to commercialize an elderberry supplement she named Sambucol, and founded Razei bar in 1992. Mumcuoglu was able to test her products on actual patients during a flu epidemic in souther Israel in the winter of 1992-93. The results were very encouraging. Within 24 hours, 20% of those patients taking Sambucol had dramatic improvements in symptoms like fever, muscle aches and pains and coughing. By the second day, 73% were improved and by day three, 90%. In the untreated group, only 16% felt better after two days. The majority of that group took almost a week to begin feeling better. Another double-blind placebo-controlled clinical study was conducted using Sambucol during an outbreak of influenza B Panama. A significant improvement of the symptoms, including fever, was seen in 93.3% of the cases in the Sambucol treated group within 2 days. A complete cure was achieved within 2 to 3 days in nearly 90% of the Sambucol treated group and within at least 6 days in the placebo group. And most recently, in a randomized, double blind, placebo-controlled study conducted in Norway, Sambucol was shown to significantly reduce the duration of the flu by approximately four days. The use of rescue medication (pain relievers, etc.) was significantly less in the group receiving Sambucol than in the placebo group. The study concluded that Sambucol stimulates the healthy immune system by increasing production of inflammatory cytokines. Cytokine production was measured using monocytes derived from the blood of 12 healthy volunteers, which were incubated with four different Sambucol products: Sambucol Black Elderberry Extract, Sambucol Black Elderberry Syrup, Sambucol Immune System, and Sambucol for Kids. Mumcuoglo refused to divulge the exact makeup of Sambucol and what makes it different from other elderberry extracts, but stressed that Sambucol stands alone among elderberry extracts. "I was the first to introduce the elderberry in the U.S., and now there are about 70 copycats. But to our credit, we still have about 80% of the market. We have a very special recipe. It's very easy to destroy the active element, that's most of those other products aren't effective," she said. Even though the product is produced and manufactured in Israel, the elderberries are imported from Europe, as the Middle East does not offer the proper climate for growing them. Sambucol costs $12 for 30 lozenges, and it can be found in just about any health food store throughout the U.S. It's distributed by Nature's Way Products. Besides the U.S., Sambucol is currently sold in Canada, United Kingdom, Holland, Belgium, Norway, Denmark, Israel, South Korea, Singapore and New Zealand. "I think that Sambucol has a great role to play - it really can save lives. To my knowledge, it's the only product that can cut the flu in half, before complications have a chance of setting in. At least 30,000 deaths are reported due to flu complications every year in the US.," Mumcuoglo said. "I'm very concerned over what is going to happen there. Half the population that has been receiving the vaccine will not get it this year, and a lot of them will get sick, transfer the flu to their families and friends. It's important to pass the message on - You need to stem the flu immediately, as soon as your experience a symptom." Research data from studies
conducted around the world have proven Sambucol®
to be effective in shortening the duration and
lessening symptoms of influenza A and B. Below are
some research highlights:
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