Michael Macknin1,2, Kathy Wolski3, Jeffrey Negrey4, Sharon Mace5. 1. Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA. macknim@ccf.org. 2. , Beachwood, USA. macknim@ccf.org. 3. C5 Research, Cleveland Clinic, Cleveland, OH, USA. 4. Clinical Research Unit, Cleveland Clinic, Cleveland, OH, USA. 5. Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA.
Abstract
BACKGROUND: Black elderberry, used medicinally for centuries, decreased influenza duration by 4 days in three previous peer-reviewed trials. US elderberry sales, possibly related to a "high severity" and "high activity" influenza season from January to March 2018, more than doubled from 2017 to 2018 to > $100 million. OBJECTIVE: To determine whether elderberry extract decreases influenza's duration and severity. DESIGN: FDA-approved, investigator-initiated, Investigational New Drug, double-blind, randomized, placebo-controlled trial. Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System. PATIENTS: Eighty-seven consecutive, consenting patients, over age four, with <; 48 h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test. INTERVENTION: Patients from age 5 to 12 years receivedplacebo or 15 ml (5.7 g) elderberry extract orally twice a day for 5 days; those > 12 years received 15 ml 4 times a day for 5 days. Patients were permitted to choose to also receive the standard dosage of oseltamivir. MEASUREMENTS: Primary: days until all symptoms were none or mild for 21.5 h. Secondary: days to complete symptom resolution for 24 h. RESULTS: The 87 participants were randomized to receive placebo (n = 44) or elderberry (n = 43). The average age was 25 ± 20 years, and 56% were male. The average number of days to reach all symptoms none or mild for 21.5 h in the placebo group was 4.9 ± 2.8 days compared to 5.3 ± 3.6 in the elderberry group (p = 0.57). The average number of days to complete resolution was 8.7 ± 3.8 and 8.6 ± 3.9 in the placebo and elderberry group, respectively (p = 0.87). LIMITATIONS: Small sample size, but powered > 0.90 to detect 2-day benefit of elderberry versus placebo. CONCLUSIONS: We found no evidence that elderberry benefits the duration or severity of influenza. Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone. Our results contradict previous studies and demonstrate the need for further studies. TRIAL REGISTRATION: NCT03410862.
RCT Entities:
BACKGROUND: Black elderberry, used medicinally for centuries, decreased influenza duration by 4 days in three previous peer-reviewed trials. US elderberry sales, possibly related to a "high severity" and "high activity" influenza season from January to March 2018, more than doubled from 2017 to 2018 to > $100 million. OBJECTIVE: To determine whether elderberry extract decreases influenza's duration and severity. DESIGN: FDA-approved, investigator-initiated, Investigational New Drug, double-blind, randomized, placebo-controlled trial. Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System. PATIENTS: Eighty-seven consecutive, consenting patients, over age four, with < 48 h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test. INTERVENTION: Patients from age 5 to 12 years received placebo or 15 ml (5.7 g) elderberry extract orally twice a day for 5 days; those > 12 years received 15 ml 4 times a day for 5 days. Patients were permitted to choose to also receive the standard dosage of oseltamivir. MEASUREMENTS: Primary: days until all symptoms were none or mild for 21.5 h. Secondary: days to complete symptom resolution for 24 h. RESULTS: The 87 participants were randomized to receive placebo (n = 44) or elderberry (n = 43). The average age was 25 ± 20 years, and 56% were male. The average number of days to reach all symptoms none or mild for 21.5 h in the placebo group was 4.9 ± 2.8 days compared to 5.3 ± 3.6 in the elderberry group (p = 0.57). The average number of days to complete resolution was 8.7 ± 3.8 and 8.6 ± 3.9 in the placebo and elderberry group, respectively (p = 0.87). LIMITATIONS: Small sample size, but powered > 0.90 to detect 2-day benefit of elderberry versus placebo. CONCLUSIONS: We found no evidence that elderberry benefits the duration or severity of influenza. Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone. Our results contradict previous studies and demonstrate the need for further studies. TRIAL REGISTRATION: NCT03410862.
Authors: Z Zakay-Rones; N Varsano; M Zlotnik; O Manor; L Regev; M Schlesinger; M Mumcuoglu Journal: J Altern Complement Med Date: 1995 Impact factor: 2.579
Authors: Mark G Thompson; Nevil Pierse; Q Sue Huang; Namrata Prasad; Jazmin Duque; E Claire Newbern; Michael G Baker; Nikki Turner; Colin McArthur Journal: Vaccine Date: 2018-08-01 Impact factor: 3.641