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Ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic use in children by preventing respiratory infections: a randomized, blinded, controlled clinical trial.Eur J Med Res. 2021;26(1):33.
Study objective
To determine whetherEchinacea purpureaExtract may prevent viral respiratory tract infections (RTIs), secondary bacterial complications, and/or reduce antibiotic use in children compared to placebo.
Draft
Randomized, blinded, controlled clinical trial in 13 clinics in Switzerland.
Participant
Out of a total of 203 participants, 187 healthy children (aged 4–12 years) completed this study, with 35.7% of participants being under 6 years old. Men and women were in equal proportions in each group, with no clinically significant differences between the two groups. One patient in each group discontinued the study due to an adverse event.
A total of 95% of study participants had not taken echinacea or vitamin C for at least 3 months before treatment. Approximately 4% of patients in each group had previously received influenza vaccines, and 48.5% and 40.8% of participants in the echinacea and vitamin C groups, respectively, received the pneumococcal vaccine.
The exclusion criteria for this study included those “who are taking antimicrobial substances, salicylates or immunosuppressants or if they had diabetes mellitus, actively treated atopy or asthma, metabolic, autoimmune, degenerative or malabsorption disorders, liver or kidney disease or other serious health problems (cystic fibrosis or bronchopulmonary dysplasia) or allergy to the ingredients of the investigational products.”
intervention
Healthy children were randomized 1:1 to receive either the intervention or placebo. The intervention was 400 mgEchinacea purpureaExtract (Echinaforce®) 3 times daily, for a total of 1,200 mg daily. The echinacea extract comprised fresh aerial plant parts and roots, plant parts and roots, 380 mg and 20 mg of ethanolic extract, respectively (plant to ethanol ratio = 1:12 and 1:11, respectively, using 65% ethanol). volume per volume).
The placebo consisted of 50 mg vitamin C (20 mg ascorbic acid and 36 mg calcium ascorbate) with natural orange flavor to make it indistinguishable from the intervention agent. This was also given 3 times daily, for a total intake of 150 mg of vitamin C daily.
The researchers distributed both echinacea and the placebo in two-month allotments. The average treatment duration was 4.1 months.
Study parameters assessed
The researchers instructed parents to record in a daily log the presence or absence of signs/symptoms in their children, including "runny nose," "stuffy nose," "sneezing," "headache and body aches," "sore throat," "cough," "chills," "impaired child's sleep quality," "malaise," "need for additional care." These were rated as “not present” [0], “mild” [1], “moderate” [2], “severe” [3] or “severity cannot be assessed.”
If they had symptoms, they were also instructed to call the clinic and given a throat swab to detect pathogens in acute infections.
Primary outcome measures
The primary endpoint was the cumulative number of days with reported cold symptoms. This included any days that had anything other than “missing” symptoms marked in the participant’s log.
Secondary outcome measures
Secondary endpoints included: total cumulative number of RTI symptoms and complications, total cumulative number of adverse events while taking echinacea or vitamin C, total cumulative number of adverse events potentially related to echinacea and vitamin C, and days with fever and other flu-like symptoms.
Key insights
This study showed that echinacea extract appears to be effective and well tolerated as a prophylactic treatment for RTIs and may help reduce antibiotic consumption in children compared to vitamin C 50 mg 3 times daily.
The vitamin C group (n = 98) had 47% more days (602 days) with RTI symptoms than the echinacea group (429 days; n = 103;P<0.0001).
The echinacea group had 32.5% fewer RTI events (61 cumulative cold episodes) compared to vitamin C (86 cold episodes; OR = 0.52 [95% CI 0.20-0.91, P = 0.021]).
The number needed to treat (NNT) was 4 to prevent 1 RTI with echinacea.
Fever: The number of days with fever decreased from an average of 4.9 ± 6.61 days in the vitamin C group to 1.6 ± 4.34 days in the echinacea group (P<0.001).
Subjective observation: More parents (89.8%) of children in the echinacea group reported that they believed the treatment resulted in improved resistance than in the vitamin C group (70.8%) (P = 0.010).
Viral load/pathogen test: Significantly fewer viruses were detected in nasopharyngeal samples in the echinacea group (57) compared to the vitamin C group (72; P = 0.0074). There were 20 influenza samples found in the vitamin C group compared to 3 samples in the echinacea group (P = 0.012).
RTI complications: There were 11 patients (10.7%) with RTI complications in the echinacea group compared to 30 patients (30.6%) in the vitamin C group (P < 0.0030), with an absolute risk reduction of 65.0% for the echinacea group and 19.9% for the vitamin C group.
Antibiotic use: In the echinacea treatment group, 6 children (5.8%) took antibiotics for a total of 45 days, compared to 15 children (15.3%) who took vitamin C for a total of 216 days. This resulted in a relative risk reduction for antibiotic use of 76.3% and an absolute risk reduction of 18.7% (P = 0.0012) over a 4-month period. There were 1.67 days less antibiotic treatment in the echinacea group compared to the vitamin C group over 4 months, resulting in 4.98 days less antibiotic use for each child over an entire year. The NNT=5 with Echinacea to reduce antibiotic use and RTI complications compared to vitamin C.
From the perspective of parents and investigators, there were no significant differences in tolerability between the echinacea group and the vitamin C group, and most rated both agents as “very good.”
Side effects: Two patients in the vitamin C group (2.0%) and 3 patients in the echinacea group (2.9%) reported a possible treatment-related side effect. Side effects in the echinacea group included diarrhea, urticaria, and suffocation.
Practice implications
Echinacea species are commonly used in the Western world to prevent and treat colds.1Determining effectiveness is challenging due to the high risk of bias in many of these studies.1including this one. Previous studies have shown that echinacea has no statistically significant results over placebo in treating colds, although it has been shown to be more beneficial when used early (prophylactically), with a low risk of side effects.1
The results of this recent study by Ogal et al. are promising, but due to the high risk of bias and small sample size, more research needs to be done to be conclusive. That being said, the study suggests that echinacea (Echinaforce) is a relatively safe and effective prophylactic treatment for children who are not immunocompromised, are taking steroids (e.g. for asthma), or have allergies to echinacea and/or ragweed.2
Researchers conducted a small study over a 10-day period on 11 children with recurrent upper RTIs. In it, they received echinacea extract (2.5 ml three times daily for the age group 2-5 years and 5 ml twice daily for the age group 6-12 years), and the results showed reduced severity of symptoms and confirmed safety and tolerability.3These are promising results, but due to the small sample size and short duration, the results are not as meaningful as they could be. Regular follow-up visits with thorough patient intake, medical history and physical examinations should be performed to reduce the risk of possible side effects.
Although it is important to reduce the risk of RTIs along with their associated complications and antibiotic use, it may not be feasible, convenient, or safe to recommend an herb such as echinacea to every child for long-term prophylaxis.
In the current study, researchers used an ethanol-based echinacea extract for the treatment group, which has previously been shown to be effective in preventing recurrent RTIs as well as reducing the risk of associated complications.4This is of utmost importance as water-based extracts such as pressed juices have not shown significant effectiveness.4
A systematic review and meta-analysis was published in 2019 that collected data on the effectiveness and safety of echinacea for treating or preventing upper respiratory tract infections (URTIs) in people of all ages.5They concluded that it may help in prevention, and short-term use is recommended because it reduces the risk of side effects compared to long-term use.5
When treating children, safety is the top priority. Although it is important to reduce the risk of RTIs along with their associated complications and antibiotic use, it may not be feasible, convenient, or safe to recommend an herb such as echinacea to every child for long-term prophylaxis. With this in mind, there are a number of other naturopathic modalities for cold and flu prevention that are much less likely to cause harm, such as: B. Hydrotherapy, nutrition and homeopathy. All of these may be recommended to otherwise healthy pediatric patients before recommending any herb for long-term use. Long-term prophylactic use of echinacea in children may be indicated for individuals at increased risk of recurrent RTI, with due consideration of the benefit-risk ratio of such a recommendation. That being said, Echinacea may be indicated for children at the first sign of cold/flu symptoms until they no longer occur, as long as there is no obvious allergy or hypersensitivity reaction.