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Elderberry Extract Outpatient Influenza Treatment for Emergency Room Patients Ages 5 and Above: a Randomized, Double-Blind, Placebo-Controlled Trial.

  • 2020-09-14
  • Journal of general internal medicine 35(11)
    • Michael Macknin
    • Kathy Wolski
    • Jeffrey Negrey
    • Sharon Mace

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 87
Population
87 consecutive, consenting patients, over age four, with < 48 h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test
Methods
FDA-approved, investigator-initiated, Investigational New Drug, double-blind, randomized, placebo-controlled trial. 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.
Blinding
Double-blind
Duration
5 days

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.

Research Insights

  • American Elder→Reduced Influenza Symptom Duration

    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).

    Effect
    Neutral
    Effect size
    Small
    Dose
    5-12 years: 15 ml (5.7 g) orally twice a day for 5 days; >12 years: 15 ml 4 times a day for 5 days
  • American Elder→Reduced Time to Symptom Resolution

    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).

    Effect
    Neutral
    Effect size
    Small
    Dose
    5-12 years: 15 ml (5.7 g) orally twice a day for 5 days; >12 years: 15 ml 4 times a day for 5 days
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