Naturopathic Treatment for Ear Pain in Children

Abstract

ABSTRACT.Objective. Otitis media is 1 of the most frequent diseases of early infancy and childhood and 1 of the most common reasons for children to visit a physician. In the past 2 decades, there has been a substantial increase in the diagnosis of otitis media worldwide. In the United States, 93% of all children have had at least 1 episode of acute otitis media (AOM) by 7 years of age. Otalgia is the hallmark of AOM. Most affected children either complain of earache or manifest behavior that the parents interpret as indicating ear pain. Treatment of the ear pain early in the course of AOM decreases both parental anxiety and the child's discomfort and accelerates the healing process. The objective of this study was to determine the efficacy and tolerability of naturopathic versus traditional treatment for the management of otalgia commonly associated with AOM in children.Methods. The study was designed as a double-blind trial in an outpatient community clinic. A total of 171 children who were aged 5 to 18 years and had otalgia and clinical findings associated with middle-ear infection were studied. The children were randomly assigned to receive treatment with Naturopathic Herbal Extract Ear Drops (NHED) or anesthetic ear drops, with or without amoxicillin. On enrollment, the children were assigned by computer-numbered randomization to receive NHED (contents: allium sativum, verbascum thapsus, calendula flores, hypericum perfoliatum, lavender, and vitamin E in olive oil) 5 drops 3 times daily, alone (group A) or together with a topical anesthetic (amethocaine and phenazone in glycerin) 5 drops 3 times daily (group B), or oral amoxicillin 80 mg/kg/d (maximum 500 mg/dose) divided into 3 doses with either NHED 5 drops 3 times daily (group C) or topical anesthetic 5 drops 3 times daily (group D). A double-blind design was used, and all ear drops were placed in identical bottles. Treatment was initiated by the nurse in all cases. A single physician (M.S.) evaluated and treated all of the patients included in the study and recorded all of the data. The presence or absence of ear pain was assessed over 3 days with a visual analog scale. Ear pain was assessed by a specially devised observational instrument based on previous reports. One side of the instrument consisted of a linear numbered scale, from 1 (no pain) to 10 (worst possible pain), and a corresponding color scale, ranging from blue to dark red. The reverse side contained a scale of 5 facial expressions, ranging from broad smile (no pain) to a sad and crying face (worst possible pain), and a corresponding color scale, ranging from blue to dark red.Results. There were no significant between-group differences in patient age or gender, degree of fever, main symptoms, associated symptoms, and severity or laterality of acute otitis media. Each group had a statistically significant improvement in ear pain over the course of the 3 days. Patients who were given ear drops alone had a better response than patients who were given ear drops together with amoxicillin. Results...

Topical analgesia for acute otitis media

“…In the third trial by Sarrell (Sarrell 2003b), 90 children aged 5 to 18 years with ear pain were enrolled. The diagnosis and exclusion criteria were as outlined above.…”

Topical analgesia for acute otitis media

“…The studies were assessed independently by three authors (JD, ACJ and JW) and differences of opinion were resolved by discussion. Only four trials fulfilled the criteria (Hoberman 1997;Sarrell 2001;Sarrell 2003a;Sarrell 2003b), two trials were reported in one paper (Sarrell 2003a;Sarrell 2003b). An unpublished trial (Matz 2001a) was identified through personal communications but was excluded.…”

“…Four trials fulfilled the review inclusion criteria; of these, two were found in the same paper (Sarrell 2003a;Sarrell 2003b). One of the trials (Hoberman 1997) evaluated the efficacy of anaesthetic ear drops (antipyrine, benzocaine and glycerine) for treating ear pain in children with acute otitis media.…”

“…Method of randomisation was only mentioned in two of the trials (Sarrell 2003a;Sarrell 2003b) which reported the use of computer-generated randomisation. Allocation concealment was not discussed in either of the trials by Sarrell (Sarrell 2001, Sarrell 2003a, Sarrell 2003b).…”

“…Allocation concealment was not discussed in either of the trials by Sarrell (Sarrell 2001, Sarrell 2003a, Sarrell 2003b). All trials were double-blinded but no details were provided for the first trial (Sarrell 2001).…”