Complementary and Alternative Medicine for Upper-Respiratory-Tract Infection in Children

Roxane R. Carr; Milap C. Nahata

Disclosures

Am J Health Syst Pharm. 2006;63(1):33-39. 

In This Article

Herbal Medicine

Echinacea

Echinacea (Echinacea purpura) is a commonly used herb thought to prevent and treat common colds by stimulating the immune system. The evidence of efficacy in adults is conflicting. In a randomized, double-blind, parallel-group study of echinacea's efficacy and safety in 407 children (mean ± S.D. age, 5.6 ± 2.9 and 5.4 ± 2.5 years in the echinacea and placebo groups, respectively) with 707 URTIs, investigators found no benefit in duration and severity of symptoms and an increased rate of rash in the echinacea group compared with placebo (7.1% versus 2.7%, p = 0.008).[21] Pediatric dosage guidelines (in milligrams per kilogram) for echinacea do not currently exist. However, dosage in the study was based on age range and extrapolated from the adult dosage. The pharmacokinetics of echinacea in children are also unclear. Thus, echinacea may have been ineffective in part because of a subtherapeutic dosage. A different species of echinacea (Echinacea angustiflora or Echinacea pallida) may have had different effects.

The age ranges on which the dosage was based may have led to large variations in the milligram-per-kilogram dosage between patients at the upper and lower limits of each range. Furthermore, a volume-based dosage (7.5 mL/day for patients 2−5 years old and 10 mL/day for patients 6−11 years old) of echinacea was used. The milligrams of echinacea per milliliter were not reported.

A randomized, double-blind, multicenter study examined the use of a herbal preparation containing echinacea 50 mg/mL, propolis 50 mg/mL, and ascorbic acid 10 mg/mL (Chizukit, Hadas Corp. Ltd., Yokneam, Israel) in 430 children one to five years old.[22] Propolis, also known as bee glue, is a resinous substance collected by bees from a variety of plants to build and maintain hives. Children ages one to three years received 5 mL twice daily, and those ages four to five years received 7.5 mL twice daily. Mean ± S.D. age was 38.3 ± 18.6 and 38.9 ± 20.6 months in the Chizukit and placebo groups, respectively. Propolis is thought to have antimicrobial activity, anticancerous properties, antiinflammatory effects, and antiviral effects.[23] Twenty-three percent of the participants dropped out of the study within the first week, most commonly because of the unpalatability of both the herbal and placebo preparations. Study enrollment was adjusted to allow a 50% dropout rate; therefore, power was maintained. The authors concluded that the herbal preparation decreased the rate of URTI, including acute otitis media, tonsillopharyngitis, and pneumonia. They also found a decrease in the total number of days of fever, antipyretic use, antibiotic use, unscheduled visits to the physician, and absence from daycare or kindergarten in the herbal preparation group (p < 0.001). Adverse drug reactions were reported as mild transient gastrointestinal and palatability symptoms and were similar in the treatment and placebo groups. Rash was not reported.

Spasov et al.[24] conducted a three-group study in 133 children (mean ± S.D. age, 6.89 ± 0.18 years) comparing echinacea, Andrographis paniculata (kan jang), and standard treatment. A. paniculata is a herb believed to reduce symptoms of common colds and viral URTI. Standard treatment for the control group consisted of "lavish" warm drinks, throat gargles with matricaria (chamomile) infusion, antiseptic nose drops of silver nitrate colloid p.r.n., and acetaminophen 500 mg three times daily if fever or severe headache was present. Typical administration of acetaminophen on a milligram-per-kilogram basis was not used. The standard treatment did not reflect typical treatment of children with a cold in North America.

The A. paniculata was administered as two tablets three times daily for 10 days (30 mg of andrographolide and deoxyandrographolide per day), which was in accord with the dosage recommendations of the Swedish Herbal Institute. The echinacea group received 10 drops three times daily for 10 days. Echinacea administration was expressed as milligrams of echinacea pressed juice per 100 mL of oral solution; the milligram dosage was not reported. The echinacea product contained 20% alcohol.

An improvement in URTI symptoms by days 2−3 was reported in all groups. The authors reported a faster improvement in symptoms in the A. paniculata group (p < 0.002) and a decrease in nasal secretions in the A. paniculata and echinacea groups compared with the standard treatment on day 5 (p < 0.01) of five drops to the affected ear canal of either.

Herbal Ear Drops

Herbal ear drops (Otikon otic solution, Healthy-On Ltd., Petach-Tikva, Israel, containing Allium sativum [garlic], Verbascum thapsus [a homeopathic remedy], Calendula flores [marigold], and Hypericum perforatum [St. John's Wort] in olive oil) were compared with anesthetic ear drops (Vitamed Pharmaceutical Ltd., Benyamina, Israel, containing ametocaine and phenazone in glycerin) for the relief of pain from acute otitis media in a randomized, double-blind trial enrolling 110 children (median age, 8.1 years for girls and 8.3 years for boys).[25] Pain was measured on a 10-point Likert scale, with 1 representing no pain and 10 the worst pain possible; a facial pain scale; and a color pain scale. The groups were unbalanced with regard to bilateral acute otitis media: 28 children (77.8%) in the herbal-ear-drop group and 8 children (22.2%) in the anesthetic-ear-drop group had bilateral infection.

Reduction in pain by day 3 was seen in both groups. The difference in mean pain levels between the two groups was also similar. The only significant difference was the mean pain score on day 1 at 30 minutes after administration. The herbal-ear-drop group had less pain (mean pain score, 3.1, versus 4.3 in the anesthetic-ear-drop group; p = 0.07). Children in the study also received acetaminophen, so pain reduction may be attributed at least in part to acetaminophen and not ear drops. The authors concluded that the two drop preparations were equivalent; however, no power or sample-size analysis was provided to interpret the data clearly.

A four-group study comparing naturopathic herbal extract ear drops (NHED, M. Pharm Co., Petah Tiqwa, Israel), NHED plus high-dose amoxicillin (80 mg [as the trihydrate]/kg/ day divided three times daily), anesthetic otologic drops, and anesthetic otologic drops plus high-dose amoxicillin for the treatment of ear pain secondary to acute otitis media was performed in 180 children (mean ± S.D. age, 6.81 ± 3.88 years).[26] NHED contained A. sativum, V. thapsus, C. flores, H. perforatum, lavender, and vitamin E in an olive oil base. All four treatment groups had a decrease in ear pain within 15 minutes of initial administration and a 77.8−95.9% decrease in pain over three days, with mean pain scores decreasing from ranges of 7.8−9.1 to 0.3−2.0 (no p values provided). Concomitant antibiotic treatment did not affect outcomes. No comparison with placebo was made, so pain may have been self-limited. No adverse reactions were documented. These data suggest that otologic drops (either herbal or anesthetic) may decrease ear pain in children with acute otitis media during the first three days, even if antibiotics are not administered. It is unknown whether the drops would have a benefit over watchful waiting or acetaminophen.

Chinese Herbal Medicines

Allergina, a traditional Oriental medicine and a herbal combination medication used in Asia to enhance immune response and inhibit allergic inflammation,[27] was studied for the treatment of otitis media with effusion.[28] Allergina contained a decoction of Schizonepetae herba, Forsythiae fructus, Ledebouriellae radix, Angelicae radix, Cnidii rhizome, Paeoniae radix alba, Angelicae dahuricae radix, Bupleuri radix, Auratinii fructus, Scutellariae radix, Frucuts angelicae, Platycodi radix, Glycyrrhizae radix, Trichosanthis radix, Taraxaci herba, and Lonicerae flos.

Allergina was compared in a prospective, parallel-group trial with unspecified antibiotics for symptom resolution and effects on immune mediators and interleukin (IL) levels in 17 children (mean age not reported) with otitis media with effusion.[28] The IL-2 and IL-4 levels were significantly higher in the allergina treatment group, and clinical signs of otitis media with effusion were greatly diminished after patients received allergina. The method of treatment allocation, power and sample-size calculations, outcome measures for clinical signs of otitis media, and criteria for evaluating treatment success were not stated. Thus, the efficacy and safety of allergina in the management of otitis media with effusion are unclear.

Liu and Douglas[29] published a review of Chinese herbal medicines for the treatment of URTI. Twenty-six of the 27 studies reviewed were published in Chinese, and only 1 was in English (and it involved adult patients). Although a majority of the studies found Chinese herbal medicines to be superior to antibiotics for the treatment of URTI, the quality of the studies was generally poor. Therefore, no conclusions could be made about efficacy and safety.

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