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| Date: 06-15-2016 | HC# 051661-546 |
Tiralongo E, Wee SS, Lea RA. Elderberry supplementation reduces cold duration and symptoms in air-travellers: a randomized, double-blind placebo-controlled clinical trial. Nutrients. March 24, 2016;8(4). pii: E182. doi: 10.3390/nu8040182.
Air travelers are often subject to stressors such as fatigue, travel stress, and correlated compromised immune function. Close proximity to other travelers also may result in elevated risk of contracting or spreading communicable diseases such as the common cold. European elderberries (Sambucus nigra, Adoxaceae) have been shown, in previous clinical studies, to lessen the symptoms and duration of both colds and influenza infections.1,2 This randomized, double-blind, placebo-controlled trial focused on whether an European elderberry extract (BerryPharma®; Iprona AG; Lana, Bolzano, Italy) helped prevent respiratory symptoms and had a positive impact on the physical and mental health of air travelers.
The trial was conducted between April 2013 and December 2014 and study subjects were recruited from the Gold Coast region of Australia. Included subjects were at least 18 years old and healthy. Criteria for exclusion were participation in another clinical trial at the time of the study or within the past 30 days; presence of plant allergies, respiratory problems, or other diseases; an influenza vaccine within 10 days of the study; use of medications such as antibiotics or antivirals; or lactation, pregnancy, or intention of pregnancy.
Subjects were economy-class travelers, traveling for at least 7 hours overseas from Australia, with a layover of less than 12 hours and at least 4 days spent at the final destination. Subjects began the treatment 10 days prior to their flight and continued until 5 days after arrival. This resulted in a total treatment duration of 15 or 16 days. Subjects completed questionnaires addressing cold symptoms and duration, quality of life, and stress levels at baseline, 2 days before travel, and 4 to 5 days after travel.
The BerryPharma extract was packaged into capsules by Plantafood Medical GmbH; Leiningen, Germany. Capsules contained 300 mg of extract standardized to 22% of polyphenols, 15% anthocyanins, and 150 mg of rice (Oryza sativa, Poaceae) flour. Placebo capsules were considered to be matched. Manufacturer and exact description of placebo content are not given. The dosage was 2 capsules daily from 10 days until 2 days prior to travel, and 3 capsules daily starting 1 day prior to travel and continuing until 4 to 5 days after arrival. Remaining capsules were counted to gauge compliance.
To assess the presence and severity of cold symptoms, subjects completed the Jackson Score questionnaire. Symptoms (nasal obstruction, sore throat, cough, etc.) were assessed in this questionnaire using 0 for absence of symptoms to 3 for severe symptoms. Daily use of cold medications, as well as whether subjects thought they had a cold, were recorded. Colds were classified with a total aggregate symptom score of > 14 over 6 days with the belief of the presence of a cold for ≥ 3 days. Also assessed were the number of colds, duration, and cold symptoms that required medication.
To assess the impact of colds on quality of life, the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) was used. This survey uses a 7-point Likert scale, where a lower score indicates better health. Symptom severity, functional impairment, and global severity and change over the prior 24 hours were gauged. Another assessment for quality of life was the Short Form Health Survey (SF-12). This questionnaire measured physical and mental health based on 12 questions; the score ranged from 0 (worst health) to 100 (optimum health). To gauge stress, the Perceived Stress Scale (PSS) was employed. The PSS addresses how subjects experience stress in their lives, with higher scores indicating greater stress. A score of > 14 was considered indicative of a large degree of stress.
In total, 325 subjects were randomly assigned to either the elderberry or placebo group. Of these, 13 subjects did not take the treatments due to loss of material in the mail, pneumonia, alteration in travel or decision, or family emergency. The intention-to-treat analysis included 312 subjects, with 158 in the elderberry group and 154 in the placebo group. Most subjects were women (66%), did not smoke, were around 50 years old, and conducted holiday air travel of over 16 hours. The PSS scores were > 14 at baseline, and around half the subjects had an influenza vaccination. Demographics were not significantly different between groups at baseline.
During the study, 12 subjects in the elderberry group and 17 in the placebo group had a cold, according to the Jackson Score (this difference was not significant). Symptoms were detectable in 11 subjects prior to travel, in 3 during travel, and 15 upon arrival at their destination. The number of days with a cold in the elderberry group was less than the placebo group, bordering on significance (57 days vs. 117 days, P=0.05). The [assumed aggregate] cold symptom score over these days was significantly less in subjects in the elderberry group as compared with the placebo group (247 vs. 583, P=0.02).
Half of the subjects with colds took medications to treat cold symptoms, but there was no significant difference between groups. The WURSS-21 scores were not significantly different between the groups at any time point; however, those in the elderberry group reported less cold symptoms prior to travel than the placebo group, approaching significance (P=0.07). According to the SF-12 questionnaire, physical health composite scores significantly decreased in the placebo group across the study (P=0.005), while no change in scores was observed in the elderberry group. In total, 90% of subjects were 90% compliant with the protocol. Adverse side effects such as itchy throat, "cold-like" symptoms, and fatigue were reported in both groups (4 subjects), while kidney pain was reported by 1 subject in the placebo group.
Based on the data shown here, the authors conclude that taking European elderberry extract may result in a shorter duration of a cold with less symptom severity. The beneficial effects of elderberry extract on colds agree with previous studies. The authors mention that many subjects used additional medications to treat their colds, and this may have confounded symptom reporting. In general, this study suggests European elderberry extract to be efficacious in alleviating colds associated with travel. Future studies will ideally include a broader population, other stressful environments, and elucidate potential mechanisms of action. The study was funded by Iprona AG, which also provided the European elderberry and placebo capsules and was partially involved in the design of the study..
—Amy C. Keller, PhD
References
1Vlachojannis JE, Cameron M, Chrubasik S. A systematic review of the sambuci fructus effect and efficacy profiles. Phytother Res. January 2010;24(1):1-8.
2Kong F. Pilot clinical study on a proprietary elderberry extract: efficacy in addressing influenza symptoms. Online Journal of Pharmacology and Pharmacokinetics. 2009;5:32-43.
