Studies of Sinupret reviewed in the monograph include 4 clinical trials regarding acute sinusitis, 2 clinical trials regarding chronic sinusitis, 1 meta-analysis of clinical trials evaluating treatment of sinusitis, 2 clinical trials regarding bronchitis, and a post-marketing surveillance study of patients with bronchitis.
Based on the review of the available scientific and clinical information from these studies, the monograph concludes that Sinupret has a relatively significant level of safety and efficacy data compared to many other natural products intended for use in maintaining the health of sinuses and the upper respiratory tract.
“Year after year, Sinupret is one of the top-selling herbal products in Germany, a country where the strong tradition of herbal preparations is combined with modern science,” said Mark Blumenthal, founder and executive director of ABC. “Extensive use by millions of people attests to this product’s overall safety and effectiveness in the area of upper respiratory tract health.
“The availability of this product, particularly the version for children, comes at a time when millions of parents are concerned about recent government advisories about the safety of conventional over-the-counter cough and cold medications in children,” he added. The US Food and Drug Administration has advised parents not to administer cold and flu remedies to young children under 2 years of age and is reviewing the safety of such products for older children. The Consumer Healthcare Products Association (CHPA), a leading over-the-counter drug industry trade association, has recommended that parents not administer such products to children under 4 years of age.
The ABC Sinupret monograph is published in 3 parts: The full monograph, a Clinical Overview containing condensed information from the full monograph, and a consumer/patient information sheet, consisting of essential information for consumer education about the responsible use of the product. Each of these elements is accessible separately on the ABC Web site (www.herbalgram.org).
The full monograph provides information on Sinupret’s popularity within the German market, the uses of the product, the chemistry of the product’s 5 herbal ingredients, dosage information, summaries of the product’s researched pharmacological actions, and safety data. The monograph also contains an extensive summary of human clinical research in both text and table form, among other data.
Sinupret contains extracts of 5 traditional European herbs: elder (Sambucus nigra, Caprifoliaceae) flowers, primrose (Primula veris, Primulaceae) flowers with calyx, common sorrel (Rumex acetosa, Polygonaceae) herb, European vervain (Verbena officinalis, Verbenaceae) herb, and gentian (Gentiana lutea, Gentianaceae) root.
Sinupret is manufactured by Bionorica, a 76-year-old company in Neumarkt, Germany with offices in San Clemente, California. Bionorica is widely considered one of Europe’s leading manufacturers of clinically tested herbal preparations.
According to Scott Bukow, president and CEO of Bionorica’s US division, Sinupret has a great deal of safety and efficacy data behind it, and Bionorica commissioned the ABC monograph so that this information would be readily available to the general public (oral communication to C. Cavaliere, February 3, 2009). Bukow noted that such information could be particularly important for consumers interested in safe and effective natural products for children.
“ABC is recognized as an outstanding organization with an excellent reputation that plays a key part in educating and informing all relevant target groups in the US,” said Dr. Harel Seidenwerg, head of corporate communications of Bionorica (e-mail to C. Cavaliere, February 3, 2009). “Bionorica wanted to perform an independent review about Sinupret and believes that with ABC it has chosen one of the most credible organizations to do so.”
The monograph was written by Heather S. Oliff, PhD, and ABC’s Blumenthal. It was formally peer reviewed by scientific and medical experts for its accuracy.
“This monograph is extremely valuable for the consumer and healthcare provider because it provides an unbiased review of the Sinupret literature,” said lead author Dr. Oliff, who is the principal in the Scientific Consulting Group, LLC, and holds a doctorate in toxicology and pharmacology (e-mail to C. Cavaliere, February 2, 2009). “The monograph includes numerous studies to which people in the US have limited access,” she continued, noting that some studies of Sinupret have been published only in German.
The publication of the Sinupret monograph is not an endorsement or recommendation of the product or manufacturer by ABC. “ABC has had a long history of documenting the specific herbal products and ingredients that have been clinically tested,” said Blumenthal. “As part of our nonprofit educational mission, we believe it is in the public interest to identify clinically tested natural plant-based products and ingredients which the scientific literature indicates are safe and beneficial.”
ABC’s Sinupret monograph is the third in a series of product-specific monographs that the organization has initiated. Previous product-specific monographs developed by ABC have focused on the scientific and clinical trial data regarding the health benefits of CVT-E002® (the active ingredient in the ginseng-based dietary supplement COLD-fX®) and of POM Wonderful® Pomegranate Juice. Additional monographs concerning specific researched commercial products and ingredients are being developed by ABC.