Evidence map›Paper›PMID 32929634›Full record

Trial reportJournal of general internal medicine2020

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

Michael Macknin, Kathy Wolski, Jeffrey Negrey, Sharon Mace

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of general internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03410862 (Phase IV Study Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03410862 phase4completednot on this map

Phase IV Study Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza: A Randomized, Double-Blind Placebo-Controlled Trial

TypeinterventionalSponsormichael mackninRan2018 to 2019Enrolled87ConditionsInfluenza, HumanArmsElderberry Extract, Placebos
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Fruits of Wild-Grown Shrubs for Health Nutrition.Plant foods for human nutrition (Dordrecht, Netherlands) · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Michael MackninCleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA. macknim@ccf.org.ORCID 0000-0002-7492-0067
Kathy WolskiC5 Research, Cleveland Clinic, Cleveland, OH, USA.
Jeffrey NegreyClinical Research Unit, Cleveland Clinic, Cleveland, OH, USA.
Sharon MaceCleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA.
Cleveland Clinic · USCleveland Clinic Lerner College of Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlack 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.

objectiveTo determine whether elderberry extract decreases influenza's duration and severity.

designFDA-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.

interventionPatients 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.

resultsThe 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.

conclusionsWe 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 registrationNCT03410862.

Indexed as

Influenza, HumanSambucusAdolescentAdultAntiviral AgentsChildChild, PreschoolDouble-Blind MethodEmergency Service, HospitalFemaleHumansMaleMiddle AgedOutpatientsPlant ExtractsTreatment OutcomeAntiviral AgentsPlant ExtractselderberryinfluenzaSambucus nigratreatment

Identifiers

PMID32929634
PMCPMC7661609
OpenAlexW3085504341

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.