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Efficacy of Naturopathic Extracts in the Management of Ear Pain Associated With Acute Otitis Media
E. Michael Sarrell, MD;
Avigdor Mandelberg, MD;
Herman Avner Cohen, MD
Arch Pediatr Adolesc Med. 2001;155:796-799.
ABSTRACT
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Objective To determine the efficacy and tolerance of Otikon Otic Solution (Healthy-On
Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (containing Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum perforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical Ltd,
Benyamina, Israel) ear drops (containing ametocaine and phenazone in glycerin)
in the management of ear pain associated with acute otitis media (AOM).
Design Children between the ages of 6 and 18 years who experienced ear pain
(otalgia) and who were diagnosed with eardrum problems associated with AOM
were randomly assigned to be treated with Otikon or Anaesthetic ear drops,
which were instilled into the external canal(s) of the affected ear(s). Ear
pain was assessed using 2 visual analog scales: a linear scale and a color
scale. Pain assessment took place throughout the course of 3 days. The mean
score of pain reduction was used to measure outcome.
Setting Primary pediatric community ambulatory centers.
Participants One hundred three children aged 6 to 18 years who were diagnosed with
otalgia associated with AOM.
Results Each of the 2 treatment groups were comparable on the basis of age,
sex, laterality of AOM, and the effectiveness of ameliorating symptoms of
otalgia. The 2 groups were also comparable to each other in the initial ear
pain score and in the scores at each application of Otikon or Anaesthetic
drops. There was a statistically significant improvement in ear pain score
throughout the course of the study period (P = .007).
Conclusions Otikon, an ear drop formulation of naturopathic origin, is as effective
as Anaesthetic ear drops and was proven appropriate for the management of
AOM-associated ear pain.
INTRODUCTION
ACCORDING TO the United States Department of Health and Human Services,1 otitis media is the most common condition for which
children are seen in a physician's office, with more than 31 million physician
visits reported each year.2 The majority of
children with acute otitis media (AOM) experience an earache.3
Acute otitis media is one of the most frequently diagnosed infections in the
pediatric population, with a peak incidence in children aged between 6 and
18 months. By age 7 years, 93% of all children in the United States have had
a least 1 diagnosed episode of AOM.4
Adequately addressing reports of ear pain early in the course of AOM
will improve the patient's level of comfort and parental anxiety during the
acute episode, as well as the healing process. Hoberman et al5
reported that topically applied ear drops were proven effective in the relief
of ear pain within 30 minutes of treatment.5
A mixture of ametocaine and phenazone dissolved in dehydrated glycerine, Anesthetic
(Vitamed Pharmaceutical Ltd, Benyamina, Israel) ear drops are designed for
instillation into the external auditory canal. The preparation has no known
systemic effects, but it reputedly induces an analgesic effect on the tympanic
membrane (TM). The mechanisms of action of topical ear drops have been postulated
to be the following: (1) anesthetic action of ametocaine; (2) the anti-inflammatory
and analgesic actions of phenazone; (3) hygroscopic activity of glycerin,
which may result in decreased middle ear pressure via fluid osmosis through
the TM; and (4) decompression of an edematous TM by osmotic properties.6
The use of herbal medicine is widespread and growing, with an increasing
number of herbal products available in conjunction with, or as replacement
for, conventional medicine. The clinical purpose of the present study was
to compare the efficacy of Otikon (Healthy-On Ltd, Petach-Tikva, Israel),
a naturopathic herbal extract (consisting of Allium sativum, Verbascum thapsus, Calendula
flores, and Hypericum peroforatum in olive
oil), with Anaesthetic ear drops in the management of ear pain associated
with AOM.
PATIENTS AND METHODS
The study was conducted between January 1998 and October 1999. Children
aged 6 to 18 years experiencing ear pain associated with AOM were eligible
for enrollment. The study was conducted in a double-blind, randomized manner.
The study was approved by the Edith Wolfson Medical Center (Holon, Israel)
Human Rights Committee. The diagnosis of AOM required the presence of middle
ear effusion, ear pain, and at least one other indicator of acute inflammation.
Indicators of acute inflammation were marked redness of the TM and/or distinct
fullness or bulging of the TM. Determination of the presence of middle ear
effusion was based on the presence of at least 2 of the following: decreased
or absent TM mobility by pneumatic otoscopy, an "A" flat or "B" curve revealed
in tympanogram images, visible bubbles or air fluid level behind the TM, or
opacification of the TM other than that secondary to scarring.
Children were excluded from the study if any of the following conditions
were present at the initial examination: prior use of any kind of ear drops
or analgesic within the preceding 4 hours; known allergy to herbal medication,
ametocaine, phenazone, glycerine, or acetaminophen; presence of otorhea, eardrum
perforation or ventilation tube(s); known immune deficiency; past history
of complication of AOM; history of treated or untreated ear disease in the
2 weeks prior to enrollment in the study; and inability to reliably use a
visual analog pain scale.
INSTRUMENT FOR EAR PAIN ASSESSMENT
The first data point (TA0) was assessed at the diagnosis
of AOM. After installation of the Otikon or Anaesthetic ear drops, the patients
and parents, under the guidance of the physician, recorded the pain scores
at 15 and 30 minutes (TA15, TA30, respectively).
At day 2 and day 3, patients and parents used the pain evaluation scale
at home. Telephone interviews with the parents were then conducted 24 and
48 hours after the treatment period. The frame of reference for each data
point was the time before the first ear drops were installed (at TA0 [1-day evaluation], TB0 [2-day evaluation], and TC0 [3-day evaluation]).
On entering the study, all children were treated with acetaminophen
(a single dose of 15 mg/kg), and parents were instructed not to use any analgesic
for the remainder of the study.
The Observational Scale of Behavioral Distress (the Pain-O-Meter) was
used to assess ear pain. On one side of the Pain-O-Meter is a linear scale
(1-10) and a color scale (ranging from blue to red). The color scale begins
with blue, indicating no pain, and darkens to the color red, indicating the
elevated level of pain experienced. On the reverse side of the card is the
face scale, which is composed of 5 facial representations ranging from a broad
smile, indicating no pain, to a sad and crying child, indicating the worst
possible pain.
The parents and children were educated in the use of the pain scale.
Eligibility for study participation required a T0 score of 3 or
more out of 10. Measurements of both the facial and linear scales were recorded
seperately for each time evaluation, and then averaged to determine an overall
ear pain score.
Success was determined if, after 48 hours, the child had a reduction
in ear pain of at least 75%, if there was improvement in the child's appearance,
and if there was improvement in activity level and quality of sleep as reported
by patients and parents.
STUDY DESIGN
Informed consent was obtained from one of the parents of each child,
and the children were randomly assigned to 1 of 2 treatment groups. Group
A was administered 5 drops of Otikon, and group B was given 5 drops of Anaesthetic
ear drops, applied to the affected ear canal 3 times daily.
ANALYSIS
Survey responses were analyzed using SPSS for Windows (Statistical Product
and Services Solutions 9.01b; SPSS Inc, Chicago, Ill). Data are reported using
the  2 test or the Fisher exact test. Comparisons for abnormal
distribution of continuous data were assessed using the repeated-measures
analysis and paired t test. A 2-tailed test with
a P value of .05 was used to define statistical significance
for differences observed between groups, and to calculate confidence intervals
around differences in sample means and odds ratios.
RESULTS
A total of 110 children were enrolled in the study. Seven children were
excluded: 5 due to noncompliance (those who could not be reached by telephone
for the interview or those who forgot to take the medication), and the 2 additional
children were overcome by the smell of the ear drops. One hundred three children
completed the study. Sixty-one children (59.3%) received Otikon, and 42 children
(40.7%) received Anaesthetic ear drops. Fifty-four children (52.4%) were girls.
Of those, 22 (40.7%) received Anaesthetic ear drops, and 32 (59.3%) received
Otikon. Forty-nine of the participating children (47.6%) were boys. Of those,
20 (40.8%) received Anaesthetic ear drops, and 29 (59.2%) received Otikon.
The median age of the girls was 8.1 years, and the median age of the boys
was 8.3 years (Table 1).
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Demographic Variables by Group Members*
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Evaluation of laterality of AOM revealed that 67 (65%) of the participants
had unilateral ear infections; 34 (50.7%) of them received Anaesthetic, and
33 (49.3%) received Otikon ear drops. Of the 36 patients who had bilateral
AOM, 8 (22.2%) received Anaesthetic and 28 (77.8%) received Otikon ear drops.
No adverse events were documented.
The main emphasis of this study was based on the evaluation of the severity
of pain experienced by patients in each of the groups. The pain was graded
on a scale from 1 to 10, with 1 signifying no pain, and 10 signifying excruciating
pain. The mean pain score was evaluated for 3 days. The reduction in the pain
score was apparent in both groups (Figure
1). The difference in the mean pain levels between the 2 groups
was not statistically significant, although there was less pain at TA30 in the group receiving the Otikon (P =
.007) (Figure 1).
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Regression of pain with treatment. Error bars represent standard
deviation. Subscripted letters A, B, and C indicate days 1, 2, and 3, respectively,
of pain evaluation; subscripted numbers 0, 15, and 30, administration of eardrops,
15-minute pain evaluation, and 30-minute pain evaluations, respectively.
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Comparison of the ear pain evaluation between the 2 groups revealed
a reduced score on repeated measurements in the Otikon groups. All children
with AOM were effectively treated with Otikon or Anaesthetic ear drops, and
we observed no complications secondary to abstention from the use of systemic
antibiotics.
COMMENT
Ear pain is a common problem associated with AOM that frequently leads
to a child's requiring medical evaluation. Pain may result from receptor stimulation
via various mechanisms, such as stretch and pressure, or from a release of
toxic products of inflammation. The pain may originate from the TM, the periostium
of the mastoid, or the mucoperiostium.6 The
responses to pain may vary, depending on the source of pain and the mechanism
of relief. Anaesthetic ear drops, which are sold over the counter, have analgesic,
anesthetic, and hygroscopic properties.5 Otikon
solution, produced from herbal extract in an olive oil base, has analgesic,
anti-inflammatory, hygroscopic, and occlusive effects, as well as anti-infective
properties.7
Self-reporting is considered the most reliable means of pain measurement,
since pain is subjective and related to many variables. Children are limited
in their ability to accurately describe their pain experience. The Pain-O-Meter
provides a desirable tool in the measurement of pain. Although the younger
children were not able to use the numerical symbols to quantify pain, they
understood the concepts of "more" or "less," and "higher" or "lower,"and they
applied them to the facial representations. A possible limitation of the Pain-O-Meter
is that the color may reflect only anger and fear and not the intensity of
pain.8
The ear pain evaluation comparing the 2 groups showed that topically
applied drops of the herbal extract (Otikon) seem to provide the analgesic
equivalent of Anesthetic ear drops.
The complete absorption rate of acetaminophen ranges from 23 to 60 minutes.9 It is possible that in both treatment groups, at 30-minute
pain evaluations, pain reduction may have been influenced by the onset of
analgesia induced by acetaminophen.
Although AOM is often a mild, self-limiting infection, most clinicians
recommend use of antibiotics to avoid suppurative complication, to prevent
progression to chronic otitis media, and to reduce the risk of mastoiditis,
meningitis, and bacteremia. Diagnostic criteria for AOM used by practicing
physicians in the United States and in other countries are inconclusive, and
the rates of misdiagnosis are uncertain.
Antibiotic treatment of AOM in older children is controversial. There
is little evidence that routine use of antimicrobials is necessary or more
effective than selective use in preventing mastoiditis and meningitis.9, 10, 11, 12, 13
All the children participating in this study recovered without requiring systemic
antibiotic treatment, and no complications were observed during the study
period.
Decreased use of antimicrobial agents might delay the development of
antimicrobial resistance in both the individual child and the community. Naturopathic
herbal extract medications may offer significant benefits in the management
of ear pain associated with AOM. Primary care physicians should be aware that
a least one tenth of their patients may have tried one or more forms of alternative
or complementary medicine. Herbal extracts have the potential to meet all
the requirements of an appropriate medication that could be used routinely
in the pediatric population.14, 15
They have been shown to stimulate the immune response,16
serve as an antioxidant,17 and have anti-inflammatory
effects.18 They are of natural origin and well
absorbed, with good penetration to the tissue surrounding the TM; furthermore,
they work via local enhancement of anti-inflammatory17, 18
and immunological activity.
Shaparenko et al19 described the possible
bactericidal and immunologic abilities of plant extracts in the treatment
of AOM.19 These herbal extracts were well tolerated,
had a long half-life, and were easy to administer. There were no documented
major adverse effects.
We are aware that the relatively small sample size and the fact that
the study did not include a control group are possible limitations. Furthermore,
the lack of standardization of herbal products may be a disadvantage to interpretation
of the study results. Additional studies on the efficacy and safety of herbal
products are required.
This study suggests that an ear solution of herbal extracts applied
in the affected ear canal may reduce the ear pain associated with AOM, and
that it is at least as effective as Anaesthetic ear drops. In children older
than 6 years, initial antibiotic treatment at the diagnosis of AOM may be
withheld; however, if at follow-up no improvement is observed, antimicrobial
treatment should be initiated. In this way, we may be able to avoid the development
of allergies, staggering costs, risk of overtreatment, and increasing bacterial
resistance to antibiotics. Larger studies on the efficacy of herbal extract
ear drops in reducing otalgia associated with AOM are necessary.
AUTHOR INFORMATION
Accepted for publication February 27, 2001.
This work was supported by David Naker, MPharm, from Healthy-On, who
created and supplied the herbal extract, naturopathic ear drops, Otikon.
We also thank Dorit Karsh, MA, from the Department of Epidemiology and
Statistics, Section of Information and Statistics at Klalit Health Maintenance
Organization, for assistance with statistical analysis. We thank the following
investigators for enrolling their patients: Monica Finkelstein, MD, Katusa
Karlnosca, MD, and Routh Senhav, MD.
From the Pediatric and Adolescent Ambulatory Community Clinic of General
Health Services (Drs Sarrell and Cohen) and the Department of Family Medicine
(Drs Sarrell, Mandelberg, and Cohen), Sackler School of Medicine, Tel-Aviv
University, Tel-Aviv, Israel; and the Department of Pulmonary Medicine and
Pediatrics, Edith Wolfson Medical Center, Holon, Israel (Dr Mandelberg).
Corresponding author: E. Michael Sarrell, MD, Hairis 7 Moshav Gan-Haim,
44910 Israel (e-mail: sarrell{at}netvision.net.il).
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