A reduction in antibiotic consumption in children with Echinacea

reference

ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic use in children through the prevention of respiratory infections: a randomized, blind, controlled clinical study. EUR J med res . 2021; 26 (1): 33.

Study goal

to determine whether echinacea purpurea extract can prevent viral respiratory infections (RTIs), secondary bacterial complications and/or reduce the use of antibiotics in children compared to placebo.

draft

randomized, blinded, controlled clinical study in 13 clinics in Switzerland.

participant

of a total of 203 participants completed 187 healthy children (at the age of 4–12 years), with 35.7 % of the participants under 6 years old. Men and women were in the same ratio in every group, without clinically significant differences between the two groups. A patient in every group broke off the study due to an undesirable event.

A total of 95 % of the study participants had not taken echinacea or vitamin C at least 3 months before the treatment. About 4 % of the patients in each group had previously received flu vaccines, and 48.5 % or 40.8 % of the participants in the Echinacea or Vitamin C group received the pneumococcal vaccination.

The exclusion criteria for this study included those "taking antimicrobial substances, salicylates or immunosuppressants or if they had diabetes mellitus, actively treated atopia or asthma, metabolic, autoimmune, degenerative or malabsorption disorders, liver or kidney disorders or other serious health problems ( Mukoviscidosis or bronchopulmonary dysplasia) or allergy against the ingredients of the test preparations. “

Intervention

Healthy children were randomized 1: 1 and received either the intervention or the placebo. The intervention was 400 mg Echinacea Purpurea extract (Echinaforce®) 3 times a day, for a total of 1,200 mg a day. The Echinacea extract included fresh, above-ground plant parts and roots, plant parts and roots, 380 mg or 20 mg ethanolic extracts (plant-to-ethanol ratio = 1:12 or 1:11 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 aroma so as not to distinguish it from the intervent. This was also given 3 times a day, for a total recording of 150 mg vitamin C daily.

The researchers distributed both Echinacea and the placebo in two months. The average treatment period was 4.1 months.

study parameters evaluated

The researchers instructed the parents to record the presence or non-existence of signs/symptoms in their children in a daily protocol, including "running nose", "clogged nose", "sneezing", headache "," sore throat "," cough "," shiver "," disturbed sleep quality of the child "," discipline "," need for additional care ". These were rated as "not available" [0] "light" [1] "moderate" [2] "heavy" [3] or "not assessable."

In the case of corresponding symptoms, they were also instructed to call the clinic and received a smell smear to detect pathogens in acute infections.

Primary result measurements

The primary endpoint was the cumulative number of days with reported cold symptoms. This included every day when the participant protocol was marked as "missing" symptoms.

Secondary result measurements

The secondary endpoints included: Cumulative total number of RTI symptoms and complications, overall cumulative number of side effects while taking Echinacea or vitamin C, total cumulative number of undesirable events that may have been reported in connection with Echinacea and vitamin C, and days with fever and other flu -like symptoms.

important knowledge

This study showed that Echinacea extract seems effective and well tolerated as a prophylactic treatment for RTIs and can help reduce the antibiotic consumption in children compared to 50 mg 3 times a day.

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 colds episodes) compared to vitamin C (86 colds; 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 the children in the Echinacea group stated that they believed that treatment had improved resistance than in the vitamin C group (70.8 %) (p = 0.010).

Test on virus load/pathogens: In the Echinacea Group (57), a significantly fewer viruses were demonstrated in the Echinacea Group (57) compared to the vitamin C group (72; p = 0.0074). 20 influenza samples were 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.

Use of antibiotics: In the Echinacea treatment group, 6 children (5.8 %) took antibiotics for a total of 45 days compared to 15 children (15.3 %), which took a total of 216 days of vitamin C. This led to a relative risk reduction for the use of antibiotics of 76.3 % and an absolute risk reduction of 18.7 % (p = 0.0012) over a period of 4 months. There were 1.67 days less antibiotic treatment in the Echinacea group compared to the vitamin C group over 4 months, which results in 4.98 days less antibiotic intake for every child over a year. The nnt = 5 with echinacea to reduce the antibiotic insert and RTI complications compared to vitamin c.

From the parent and examiner perspective, there were no significant differences between the tolerance between the Echinacea Group and the Vitamin C Group, and most rated both funds with "very good".

Side effects: Two patients from the vitamin C group (2.0 %) and 3 patients from the Echinacea Group (2.9 %) reported on a possibly treated side effect. The side effects in the Echinacea group included diarrhea, urticaria and suffocation.

practice implications

echinacea species are often used in the western world to prevent and treat colds. ^{1 The determination of the effectiveness is a challenge in many of these studies due to the high bias risk. Earlier studies have shown that Echinacea has no statistically significant results compared to placebo when treating colds, although it has proven to be more advantageous if it is used early (prophylactic), with a low risk of side effects.}

The results of this current study by Ogal et al. are promising, but due to the high bias risk and the small sample size, more research has to be operated to be conclusive. Apart from that, the study suggests that Echinacea (Echinaforce) is a relatively safe and effective prophylactic treatment for children who are not immunodized, have steroids (e.g. in asthma) or allergies against Echinacea and/or Ambrosia.

researchers carried out a small study over a period of 10 days with 11 children with recurrent upper RTIs. In it they received echinacea extract (2.5 ml three times a day for the age group of 2–5 years and 5 ml twice a day for the age group of 6–12 years), and the results showed a reduced severity of the symptoms as well as confirmed security and tolerance. ^{3 These are promising results, but due to the small sample size and the short duration, the results are not as meaningful as they could be. Regular follow -up examinations with thorough patient admission, anamnesis and physical examinations should be carried out in order to reduce the risk of possible side effects.}

Although it is important to reduce the risk of RTI together with the associated complications and the use of antibiotics, it may not be feasible, convenient or safe to recommend a herb like Echinacea for long -term prophylaxis.

In the current study, the researchers used an Echinacea extract based on ethanol for the treatment group, which has previously proven to be effective in preventing recurring RTIs and the reduction of the risk of complications. have. 4

2019 A systematic overview and meta -analysis was published that collected data on the effectiveness and safety of Echinacea for the treatment or prevention of infections of the upper respiratory tract (URTIS) in people of all ages. ^{5 You could help with the prevention, and a short -term application is recommended, since the risk of side effects compared to long -term use Reduced. 5}

In the treatment of children, security comes first. Although it is important to reduce RTI's risk together with the associated complications and the use of antibiotics, it may not be feasible, convenient or safe to recommend a herb like Echinacea for long -term prophylaxis. Against this background, there are a number of other naturopathic modalities for cold and flu prophylaxis with much less probability to cause damage, such as: B. hydrotherapy, nutrition and homeopathy. All of this can otherwise be recommended to healthy pediatric patients before any herb is recommended for long -term use. The long-term, prophylactic application of Echinacea in children can be indicated for people with an increased risk of recurrent RTI, while considering the benefit-risk relationship of such a recommendation. Apart from that, Echinacea can be indicated for children at the first signs of cold/flu symptoms until they no longer occur as long as there is no obvious allergy or hypersensitivity reaction.