Use of natural and homeopathic remedies in children ailments

16 Pages·2016·1.74 MB·English

Clinical Management Issues
Clinical Management
Use of natural and homeopathic
remedies in children ailments
Stephen Buskin 1, María Pilar Riveros Huckstadt 2, Silvia Salatino 3
Abstract
In recent decades the use of CAM (Complementary and Alternative Medicine) has increased
significantly, not only among adults but also in the pediatric population. Perceived efficacy of
homeopathic or natural treatments, fear of drug adverse effects, dissatisfaction with conventional
medicine, and the need for more personal attention are the main reasons given by parents who
treat their children with homeopathy.
In the present paper the use of natural and homeopathic remedies for the treatment of children
ailments are considered. In particular we focus on minor disorders of early childhood with a major
impact on the well-being of the whole family, namely infant colic, teething, upper respiratory
tract infections (URTIs) and tonsillopharyngitis. The results of recent studies on homeopathic
1 International Health
products for the treatment of these disorders are presented and discussed. Centre, The Hague,
Netherlands
Keywords: Homeopathy; Children; Infant colic; Teething; Upper respiratory tract infections 2 Servicio Andaluz de
Salud, Marbella, Spain
(URTIs); Tonsillopharyngitis 3 Deutsche Homöopathie-
CMI 2016; 10(2): 33-48 Union, DHU-Arzneimittel
http://dx.doi.org/10.7175/cmi.v10i1.1252 GmbH & Co. KG,
Karlsruhe-Germany
INTRODUCTION
alized by combining data published in inter-
national journals, data from local or national
The National Institutes of Health (NIH) surveys in original language conveyed by
has defined complementary and alternative local experts, and expert perspectives about
medicine (CAM) as “a group of diverse med- CAM availability, quality, use and popularity
ical and health care systems, practices, and in their countries. According to this study,
products that are not presently considered conducted in 20 European countries, 56% of
to be part of conventional medicine” [1,2]. the European population in general has used
The National Center for Complementary CAM at least once during the year preced-
and Alternative Medicine (NCCAM) clas- ing the survey. For the pediatric population
sifies CAM therapies into five categories: the rate was similar (52%), confirming the
alternative medical systems (homeopathic growing interest in CAM reported by pe-
and naturopathic, Chinese, and Ayurvedic diatricians and institutions. Homeopathy
medicine), mind-body interventions, bio- and herbal medicine was identified as the
logically based therapies (herbs, foods, etc.), most popular CAM therapies in Europe [3]. Corresponding author
Silvia Salatino
manipulative and body-based methods, en- In the United States the percentage of [email protected]
ergy therapies [1,2]. healthy children seen in outpatient pediatric
Disclosure
In recent decades the use of CAM (Com- clinics that uses CAM is between 20-40% Stephen Buskin and
plementary and Alternative Medicine) has and rises to values above 50% in the case of María Pilar Riveros
Huckstadt are members
increased significantly, not only among children with chronic diseases, almost always
of the DHU Advisory
adults but also in the pediatric population. in conjunction with mainstream care [4]. Board. Silvia Salatino is
Zuzak et al. recently conducted a pan-Eu- An interesting analysis on the extent of an employee of DHU.
The writing of this article
ropean review about CAM in pediatrics, re- homeopathic prescriptions in children was was supported by DHU
33
Use of natural and homeopathic remedies in children ailments
conducted by Ekins-Daukes and colleagues Despite the long tradition of homeopathy,
in Scotland. Majority of these prescriptions and its spread around the world, the debate
were made for children under 1 year of age on this issue is always very heated. In recent
(8.0/1000 registered children) and the most years a number of studies have been pub-
common conditions for which homeopathic lished on the effectiveness of homeopathy
medicines were prescribed were colic (85%), in children. For example, several studies
cuts and bruises (52%), teething (49%), conducted in different countries on the man-
dermatological conditions (32%), earache agement of acute respiratory infections and
(21%), influenza and upper respiratory acute otitis media showed a significant rapid
tract infections (16%), cough (16%), vom- improvement upon homeopathic medica-
iting (16%), irritability (15%) and diarrhea tions compared to conventional treatment
(12%) [5]. and less use of antibiotics [10-12].
Recently an international survey was Some researchers have highlighted an
performed in order to provide insights interesting peculiarity: publication bias in
into physician’ attitude towards the use of CAM research is «opposite that of conven-
homeopathy and natural remedies in pe- tional medicine; that is, negative studies are
diatric practice. 582 general pediatricians more likely to be published in well-known
and general practitioners treating pediatric journals, and positive studies are more likely
conditions in 6 countries (Germany, Spain, to be published in non-English language
Russia, Bulgaria, Colombia, Israel) were in- and often complimentary medicine jour-
volved. Herbal medicine and homeopathic nals» [13].The most controversial aspect of
products amounted to 17% and 15% of to- homeopathy is the ultra-dilutions and the
tal prescriptions in pediatrics, respectively. lack of reliable data on the mechanism of
Upper respiratory tract infections (URTIs), action. Theories on the possible explana-
infant colic, sleep disturbances and recurrent tion of mechanism of action of homeopathy
infections were the main causes for which within the context of nanomedicine have
natural remedies and homeopathic products been recently published, although still hotly
were used. In the majority of cases they are debated [14]. A recent publication by Rut-
used as complementary treatment together ten et al. explores the current evidence for
with conventional drugs. The study confirms homeopathy reporting three meta-analyses
high interest of physicians in natural rem- by Kleijnen, Linde and Cucherat published
edies and homeopathy, however their knowl- from 1991-2000 that reached positive con-
edge level is heterogeneous. The concern clusions and a review by Shang in 2005 that
about side effects and the use for themselves reached negative conclusions [15-19].
are the main factor that drives parents to the In the present paper the use of natu-
use of homeopathy and natural remedies [6]. ral and homeopathic remedies for the
Perceived efficacy of homeopathic or natu- treatment of children ailments are consid-
ral treatments, fear of drug adverse effects, ered. In particular we focus on minor dis-
dissatisfaction with conventional medicine, orders of early childhood with a major im-
and the need for more personal attention are pact on the well-being of the whole family
the main reasons given by parents who treat namely infant colic, teething, upper respira-
their children with homeopathy [4]. tory tract infections (URTIs) and tonsillo-
Recognizing the increasing use of CAM pharyngitis. The results of recent studies on
in children, many institutions, like the homeopathic products for the treatment of
American Academy of Pediatrics (AAP), these disorders are presented and discussed
have decided to provide information and [20-24].
support for health professionals. In the
2001 AAP Periodic Survey of Fellows, 73%
INFANT COLIC
of pediatricians agreed that it is the role of
pediatricians to provide patients/families
Definition
with information about all potential treat-
ment options for the patient’s condition,
A common definition of infantile colic
and 54% agreed that pediatricians should
comes from Morris A. Wessel and col-
consider the use of all potential therapies,
leagues, the so-called “rule of 3”: a condi-
not just those of mainstream medicine, when
tion of a healthy, well-fed baby in which it
treating patients [7].
shows periods of intense, unexplained cry-
Efforts to include education and training
ing lasting more than at least 3 hours a day,
for CAM therapies in medical school pro-
grams have also become popular in some
European countries [8,9].
©SEEd Tutti i diritti riservati
34 Clinical Management Issues 2016; 10(2)
S. Buskin, M. P. Riveros Huckstadt, S. Salatino
on at least 3 days (per week), of at least 3
Active ingredient Therapeutic action / characteristics
weeks [25].
The prevalence of infantile colic given in Chamomilla D6 y Infant colic with flatulence (infant gaseous colic)
the scientific literature widely varies and y Hypersensitivity to pain
ranges from 5-40%, depending on the study y Restlessness together with dissatisfaction
methodology, the population and the defini- Cina D6 y Spasms of the gastrointestinal tract
tion of infantile colic used [26]. y Aversion to breast-milk (ingestion causes colic and
Although benign and self-limiting, it is diarrhoea; the baby frequently spits up sour milk)
associated with higher levels of maternal y Marked irritability, physical and mental
stress and anxiety: the impact of prolonged Colocynthis D6 y Colic / colicky pain better by pressure and heat (warm
and inconsolable crying in children with in- applications)
fantile colic causing sleepless nights, stress, y Griping pain around the navel
frustration and exhaustion, especially in Lac defloratum D6 y Digestive disorders due to intolerance of milk
first-time parents [27-29]. y General aggravation of symptoms from drinking milk
Despite being a very common disorder, Magnesium y Constipation with dry, pellet-like stool
the causes are not yet completely clarified. chloratum D6 y Problems to digest milk (especially during difficult
Etiopathology of this condition includes dentition)
both gastrointestinal and non-gastrointes-
tinal factors, such as hypersensitivity to baby
formula, alteration in gut microflora, exces-
Table I.
search is now targeting the promising role Colikind®
sive gas in the intestine, intestinal hypo- /
of Lactobacillus reuteri in the treatment of active ingredients and
hypermotility, immature digestive system,
infantile colic [37,38]. therapeutic action
over-stimulation and (hyper-)sensitivity to
Nutritional interventions are closely re-
the environment, reflection of problems in
lated to the type of feeding received by the
parent-infant interaction, maternal smoking.
child. In case of breast-fed infants, a moni-
Treatment tored low allergen maternal diet avoiding
cow’s milk and dairy food with appropri-
The above possible causes of infantile colic ate intake of vitamins and minerals may be
have led to a variety of available treatments, suggested, while the first-line for bottle-fed
ranging from pharmaceutical therapies, di- infants is represented by formulas based on
etary interventions, behavioral strategies, partially hydrolyzed whey proteins with pre-
and physical remedies. At first, the most biotic oligosaccharides [39].
commonly recommended approach is to A considerable number of behavioral
discuss the usually natural and self-limiting strategies and physical remedies resulting
character of infantile colic with parents and from tradition and practical experience are
to offer some methods to parents for calm- suggested, such as offering an atmosphere of
ing the baby. security to the baby, decreasing stimulation,
Pharmaceutical therapies includes simeth- offering “white noise”, massaging or rock-
icone, dicyclomine hydrochloride and cime- ing the baby. Despite the lack of evidence
tropium bromide, but results from literature published in the literature, this type of rem-
on simethicone and dicyclomine for infantile edies may be useful for some children [39].
colic do not suggest these to be effective or In the absence of standard of care for
appropriate treatment options [30-33]. A treatment of infant colic, CAM has assumed
trial by Savino et al. found cimetropium an increasingly important role in the man-
bromide more effective than placebo in re- agement of infantile colic. In particular, it
ducing the duration of crying in children is recognized the use of herbal supplements
with infantile colic but there were reported (i.e. containing chamomile, fennel, vervain,
side effects in terms of increased sleepiness licorice, balm-mint) [40,41] and homeo-
[34,35]. Safety is a critical issues in infants, pathic products [42].
and a major concern for parents: in literature
there have been reports of infants who expe- Colikind® (use and dosage)
rienced serious adverse events, such as seri-
Colikind® (Deutsche Homöopathie
ous respiratory symptoms seizures, syncope,
Union, DHU, Karlsruhe, Germany) is natu-
pulse rate fluctuations and muscular hypo-
ral combined medication that is indicated
tonia after taking dicyclomine hydrochlo-
for the treatment of infantile colic and flat-
ride syrup; no causal relationship has been
ulence. It is composed of a combination of
established but dicyclomine hydrochloride is
5 single remedies: Chamomilla D6, Cina
now contraindicated in infants < 6 months
and in nursing mothers [35,36]. Recent re-
©SEEd Tutti i diritti riservati
Clinical Management Issues 2016; 10(2) 35
Use of natural and homeopathic remedies in children ailments
Colikind® group (n=100) Simethicone group (n=100)
Children 0-6 years
Acute symptoms: 3 drops / hour (max. 6 times a day) 1 measuring spoon of the emulsion taken 3-5 times
Afterwards: 3 drops 3 times a day a day during meals (from a baby bottle or mixed
Table II.
Treatment with food and drink)
options [20]
Subjective complaints y Unexplained restlessness
y Sleep and appetite disturbances
y Increased crying while feeding
y Regurgitation
y Vomiting
y Stool softening
y Constipation and flatulence
Objective symptoms y Abdominal bloating
y Intestinal rumbling
y Tenderness and intestinal spasm on palpation
y Changes in stool
Table III.
Subjective y Dryness of the skin and mucosa
complaints and objective y Skin pallor
symptoms assessed in the y Coating and geographism of the tongue
study [20]
In case of acute condition, Colikind® can
be administered at a dose of 3 drops up to
a max. of 6 times a day; after improvement,
treatment can be continued with 3 drops 3
times a day [43].
From literature
In 2010 an open, prospective, multicenter,
comparative study on Colikind® was pub-
lished by Ilyenko and colleagues [20]. Aim
of the study was the evaluation of the effec-
tiveness, safety and tolerability of Colikind®
compared to simethicone in children with
infantile colic and/or meteorism. The study
population was 200 pediatric patients aged
2 months to 6 years of both sexes. Table II
summarized the treatment options.
Comparative evaluation of the efficacies
of the study agents was performed in terms
of changes in the severity of subjective com-
Figure 1. Decrease D6, Colocynthis D6, Lac defloratum D6 plaints and objective symptoms at 3, 7, and
in total sum score and magnesium chloratum D6 [43]. In Ta-
10 day after the start of treatment. In Table
(subjective + objective ble I Colikind® active ingredients and ther-
III subjective complaints and objective
symptoms). Adapted apeutic action are reported.
symptoms are reported. Clinical symptoms
from [20] Colikind® is available in drops. The medi-
were assessed by the physician at each visit,
cation can be used on its own or in combina-
while overall outcome of treatment, treat-
tion with prescribed medication. Colikind®
ment satisfaction, safety and tolerability of
drops should be kept within the mouth be-
study medication were assessed both by phy-
fore swallowing. In babies and small chil-
sicians and parents.
dren, the drops can also be diluted in a little
On day 10, both treatment groups showed
bit of water and administered with a plas-
a significant improvement of their subjective
tic spoon. An interval of approximately 30
and objective symptoms, whereas Colikind®
minutes should be kept between the intake
showed to be significantly more effective
of Colikind® and eating or drinking [43].
(p < 0.0001). Consequently, the decrease
©SEEd Tutti i diritti riservati
36 Clinical Management Issues 2016; 10(2)
S. Buskin, M. P. Riveros Huckstadt, S. Salatino
Figure 2.
Overall
outcome of treatment
on day 10, assessed by
physicians. Adapted
from [20]
Figure 3.
Overall
outcome of treatment
on day 10, assessed by
parents. Adapted from
[20]
in total sum score (subjective complaints + Significantly more parents were “very sat-
objective symptoms) was more pronounced isfied / satisfied” with treatment in the Co-
in the group of children treated with Co- likind® group compared to the Simethicone
likind® (Figure 1). group (p < 0.001). In addition, none of the
After 10 days of treatment, 96 % of pa- parents in the Colikind® group was “dissatis-
tients treated with Colikind® showed a “re- fied” with treatment, whereas this applied to
mission” or a “significant improvement” of 22 % of parents in the Simethicone group.
symptoms according to the physicians’ as- Tolerability of Colikind® was rated “very
sessment (Figure 2). good” or “good” in all patients, whereas in the
Parents’ assessment of overall outcome Simethicone group, there were 6 % of par-
after 10 days of treatment with Colikind® ents and 7 % of physicians who rated toler-
was even better. ability only as “satisfied”. In the study group
In total, 98 % benefitted from the treat- treated with Colikind® 1 adverse event (AE)
ment with Colikind® - thereof 75 % of pa- but no drug-related AE (i.e. adverse drug re-
tients showed a “remission” of symptoms action (ADR)) was reported. In the control
(Figure 3). group 5 children (5/100, 5 %) treated with
Simethicone were observed to suffer from an
©SEEd Tutti i diritti riservati
Clinical Management Issues 2016; 10(2) 37
Use of natural and homeopathic remedies in children ailments
AE, whereas 1 event was assessed as being Non pharmacological remedies include
related to the intake of Simethicone (ADR). teething rings, pacifier, hard food like bread,
According to the results of this study, both frozen fruits and vegetables. The relief de-
medications (Colikind® and Simethicone) rived from the low temperature of the ob-
were effective and safe and can thus be rec- jects, that cause local vasoconstriction, and
ommended. However the Authors high- by the pressure exerted on the gums through
lighted that in the Colikind® group more the biting on hard objects [21,45]. These
benefits were reported, such as quicker re- remedies are widely used and have few con-
mission, faster decrease in the degree of the traindications. It is crucial, however, to be
severity of subjective complaints and objec- very careful to avoid the chocking risk. It
tive symptoms, the greater parents’ satisfac- is also recommended to use only sugar-free
tion, the tolerability and the excellent safety objects and not to add medicine to food or
profile of Colikind®, emphasized by the lack feeding bottles, as their dosage cannot be
of adverse drug reaction. checked.
Dentokind® (use and dosage)
TEETHING
Dentokind® (Deutsche Homöopathie-
Definition Union, DHU, Karlsruhe, Germany) is a
complex homeopathic product containing
Teething is known as a natural process
five individual homeopathic substances:
by which the first teeth appear in children.
Belladonna D6, Chamomilla D6, Ferrum
A variety of symptoms has been shown to
phosphoricum D6, Hepar sulfuris D12 and
accompany teething, including fever, pain,
Pulsatilla D6 [48]. It is indicated for the
irritability, sleep problems, mouthing/bit-
treatment of teething symptoms such as ir-
ing, drooling, decreased oral intake, gum
ritability, restlessness, earache, painful gums,
inflammation, runny nose, and diarrhea [44].
mild fever and softened stools in babies and
The onset of the primary incisors is usu-
children. It is available as tablets allowed to
ally around 6-12 months: in the same period
dissolve slowly in the mouth. For usage in
the circulating maternal humoral immunity
small children, tablets can be dissolved in a
decreases, and the child’s own humoral im-
little bit of water. For children < 1 year the
munity develops [45]. The simultaneous
suggested dosage is 1 tablet every hour, up
presence of these events often makes this
to a maximum of 6 tablets a day, in acute
period difficult and distressing for both the
condition; the treatment can be extended
child and their respective parents and ac-
after improvement at a dosage of 1 tablet, 3
companied by a number of relatively minor
times a day. For children 1-6 years the sug-
symptoms [45]. Teething symptoms in chil-
gested dosage is 2 tablets every hour, up to a
dren can create much distress in parents [21].
maximum of 12 tablets a day, in acute con-
dition; the treatment can be extended after
Treatment
improvement at a dosage of 2 tablet, 3 times
a day. An interval of at least half an hour to
There are many remedies used by parents
meals should be kept [48].
to relieve the symptoms of teething, often
derived from tradition or experience of
From literature
friends and family.
Pharmacological therapies include topical
In 2015 a prospective, multicenter, ran-
local anesthetics (i.e. lidocaine based prepa-
domized, open-label, comparative, con-
rations and topical benzocaine gel), topical
trolled clinical trial on the clinical use of
choline salicylate-based products, and sys-
Dentokind® was published by Jong and col-
temic analgesics. However, a standard of
leagues [21]. The study, required for Dento-
care is not established in the treatment of
kind® marketing authorization in Russian
teething disturbances, use of some medica-
Federation, compared Dentokind® to an-
tions might be associated with unwanted
other homeopathic product already autho-
side effects and for some topical teething
rized in the Federation. The study popula-
gels cases of potential life-threatening risks
tion consisted of 200 pediatric patients up
have been reported [21,46]. In 2011 the US
to 6 years of age.
Food and Drug Administration (FDA) has
Dentokind® was administered orally for
released a document to recommend not to
seven days. Children aged up to one year
used benzocaine products on children < 2
received Dentokind® tablets with a dos-
years without medical advice [47].
©SEEd Tutti i diritti riservati
38 Clinical Management Issues 2016; 10(2)
S. Buskin, M. P. Riveros Huckstadt, S. Salatino
age regime of one tablet every hour up to Subjective complaints y Unmotivated anxiety
six tablets per day (acute symptoms). After y Gingival tenderness and appetite disorder
symptoms reduced one tablet three times a y Otalgy
day was administered. Children aged 1-6 y Stool softening
y Sleep-onset insomnia and frequent awakenings
years received two tablets every hour up to
a maximum of twelve tablets per day (acute Clinical signs y Skin pallor
symptoms). After symptoms reduction the y Gingiva hyperemia
dosage was two tablets three times per day. y Gingiva swelling
y Hematoma and hyperemia around the mouth
The other homeopathic medication was
y Drooling and hyperthermia
administered rectally for a period of seven
days. For children aged up to six months the
maximum daily dose was two suppositories
a day. Children older than six months of age Table IV. Subjective
Improvement of individual complaints
received a maximum of four suppositories complaints (TSSC) and
and individual signs after 7 days of treatment
(at a body temperature of ≥ 37.5°C) a day. clinical signs (TSCS)
was observed in both treatment groups-ex-
When body temperature normalized one assessed in the study
cept for the complaint sleep-onset insom-
suppository was used for further 3-4 days [21]
nia. Compared to the other homeopathic
1-2 times per day (with preventive purpose).
medication improvement of the individual
Primary endpoints were changes in total
complaints gingival tenderness and appetite
severity scores of subjective complaints
disorder and of the signs gingival hyperemia
(TSSC) and changes in total severity scores
and gingival swelling was observed in sig-
of clinical signs (TSCS) after treatment with
nificantly more children of the Dentokind®
study medication for 3-5-7 days. In Table
group (Armitage Trend Test: p<0.05; FAS).
IV subjective complaints and clinical signs
After 7 days of treatment children treated
are reported.
with Dentokind® had a 5-times higher odds
In the Dentokind group the assessment of
of showing improvement in total severity
TSCC recorded a reduction from 7.0 (base-
score of subjective complaints than children
line median value) to 3.0 (Day 3-5) and 1.0
treated with the other homeopathic medica-
at Day 7, while in the control group TSSC
tion and a 2.5-times higher odds of showing
values decreased from 5.0 (baseline median
improvement in the total severity score of
value) to 3.0 (Day 3-5) and 1.0 at Day 7.
objective clinical signs.
The study showed a reduction also in the
After 7 days of treatment with Dento-
TSCS values, which decreased from 6.0
kind® almost all parents and investigators
(baseline median value) to 3.0 (Day 3-5) and
(n=99 out of 100 each) of the Dentokind®
1.0 (Day 7) in the Dentokind group, and
group rated “no complaints” or “major im-
from 5.0 (baseline median value) to 4.0 (Day
provements” (Figure 4). Almost all parents
3-5) and 1.0 (Day 7) in the control group.
(n=99 out of 100) of the Dentokind® group
were very satisfied or satisfied with the treat-
Figure 4.
Overall
outcome on day 7,
assessed by physicians.
Adapted from [21]
©SEEd Tutti i diritti riservati
Clinical Management Issues 2016; 10(2) 39
Use of natural and homeopathic remedies in children ailments
Figure 5.
Treatment
satisfaction on day 7,
assessed by parents.
Adapted from [21]
ment. In comparison with the other product, days from work and school, with a relevant
the treatment satisfaction in Dentokind® economic burden [49].
group was significantly better (Armitage Sore throat, runny nose, general malaise,
Trend Test: p<0.0001; FAS) (Figure 5). fever, nasal congestion and cough are most
During the treatment period 1.5% chil- common symptoms [22].
dren experienced AEs. The AEs occurred The specific immune status of children in
in 3 children of the control group. In Den- the first years of life makes them especially
tokind® group no AEs occurred. Almost vulnerable to viral infections [50]. In litera-
all parents and investigators rated the tol- ture about 4-8 episodes of viral infection per
erability of Dentokind® as “very good” or year per child are recorded [50]. The major-
“good”. Compared to the control group ity of URTIs are caused by viral pathogens,
the outcome in the Dentokind® group was most commonly rhinoviruses, but also in-
significantly better (Armitage Trend Test: fluenza viruses [22].
p<0.0001; FAS). URTIs are even the most frequent cause
The study demonstrated that Dentokind® of antibiotic prescriptions in pediatric
reduced total severity scores of subjective outpatient care. This represents a serious
complaints, including individual symptoms health problem globally since inappropri-
such as unmotivated anxiety, gingival ten- ate use of antibiotics has a strong impact
derness, appetite disorders and otalgy in the increase of bacterial respiratory patho-
teething children after 7 days of treatment. gens [51,52].
Total severity scores of clinical signs also
lowered after 7 days of treatment in both Treatment
groups. Dentokind®seems therefore a “prag-
matic treatment alternative” to conventional Since there is no approved specific therapy
OTC teething gels for symptoms relief of for URTIs, treatment is mainly symptom-
painful teething in children [21]. atic. The most common pharmacological
treatments are antipyretics, anti-inflamma-
tory drugs, expectorants, decongestants, and
UPPER RESPIRATORY TRACT cough suppressants [21]. A number of other
INFECTIONS (URTIs) remedies are available, such as vitamins,
herbal supplements and homeopathic medi-
Definition cine. Data relating to the Germany showed
that about 7% of all pediatric prescriptions
Upper respiratory tract infections (UR- for the respiratory tract system are not offi-
TIs) or common colds represent the most cially licensed for use in children [53].
frequently occurring illness in the world. As mentioned above, a key issue con-
Although they are usually self-limiting con- cerns the prescription of antibiotics, that
ditions, they are a leading cause of missed are widely prescribed, but often inappro-
priate; overuse can lead to the development
©SEEd Tutti i diritti riservati
40 Clinical Management Issues 2016; 10(2)
S. Buskin, M. P. Riveros Huckstadt, S. Salatino
of community-acquired resistant pathogens 8 tablets per day, until improvement occurs;
which are an increasing and serious health for subsequent treatment the dose is 1 tablet
burden [50]. The results of a nationwide US 3 times per day. The same dosage (1 tablet 3
survey published in 2004 showed 38% of times per day) is suggested for prevention of
more than 6.5 million visits (primary prac- infections. Tablets should be dissolved slowly
tice, outpatient, and emergency department) in the mouth: for small children, they can be
by children and adults with a sole diagnosis dissolved in a little bit of water. An interval
of influenza were associated with antibiotic of at least half an hour to meals should be
prescriptions. Studies limited to children kept [56].
demonstrated even higher rates of antibiotic Efficacy and safety of Influcid® (IFC) in
treatment in children diagnosed with viral the treatment of flu-like infections and UR-
infections [54]. TIs were demonstrated in several studies: in
There are many factors that contribute the multicenter open study conducted by
to an inappropriate antibiotic prescription, Heger on a total of 600 patients (333 adults
including diagnostic uncertainty, lack of and 267 children) with URTIs, about 90%
knowledge, socio-cultural and economic of patients reported an improvement after
pressures, meeting parental expectations 3 days [57].
[51].
Natural remedies, and homeopathy in From literature
particular, can be used in the management
of URTIs. An integrative approach to these In 2015 a randomized, standard-treat-
infections may help reduce excessive antibi- ment controlled, parallel group, open, mul-
otic prescription [55]. ticenter and multinational clinical trial was
published by Thinesse-Mallwitz and col-
Influcid® (use and dosage) leagues [22]. Aim of the study was to evalu-
ate the effectiveness and safety of IFC as an
Influcid® (Deutsche Homöopathie- add-on to symptomatic standard treatments
Union, DHU, Karlsruhe, Germany) is a of URTIs. A total of 523 patients presenting
homeopathic preparation containing a fixed with clinical signs and symptoms of an
combination of 6 homeopathic singles sub- URTI with a duration up to 24 h, accom-
stances: Aconitum D3, Bryonia D2, Eupa- panied by fever were randomized. The stan-
torium perfoliatum D1, Gelsemium D3, dard treatment (ST) group received
Ipecacuanha D3 and Phosphorus D5 [56]. paracetamol, ambroxol and/or oxymetazo-
Launched in Germany in 1928, now it is line; the IFC group received the same symp-
marketed in 22 countries worldwide [22]. tomatic treatment plus IFC for 7 days. Pa-
In acute conditions, the suggested dose is tients evaluation was performed by investi-
1 tablet every 2 hours, up to a maximum of gators at baseline (day 1), and on day 4, 8,
Figure 6.
Between-
group differences in the
percentage of treatment
responders (IFC minus
ST) by study day
(including 95% CIs)
Adapted from [22]
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Clinical Management Issues 2016; 10(2) 41
Use of natural and homeopathic remedies in children ailments
Figure 7.
Ability to
perform normal daily
activities. Adapted
from [22]
Figure 8.
Cumulated
intake of standard
symptomatic
medication. Adapted
from [22]
15. During the first 72 hours, patients ≥ 12 Considering the entire study period of
years took 12 tablets a day (1 tablet every 14 days, data highlighted a more prompt
hour) while patients < 12 years took 8 tablets occurrence of “treatment response” in the
per day (1 tablet every 2 hours); during the IFC group (Figure 6).
following 96 hours the IFC dosage was 2 As a consequence to the significantly bet-
tablets 3 times a day for patients ≥ 12 years ter response to treatment, patients in the
and 1 tablet 3 times a day for children. IFC group showed a shorter time to symp-
The primary outcome was “treatment re- tom alleviation (1-2 days), a faster resump-
sponse” defined as a combination of mean tion of normal activities (IFC 48% vs ST
axillary body temperature ≤ 37.2° C and 28%) and a significantly lower median dis-
absence or very mild degree of symptoms. ease severity (Figure 7). Simultaneously,
Patients in the IFC group showed an at- significantly less standard symptomatic
tenuated and shortened course of illness: medication was needed in the IFC group
at day 4 a percentage of 76.8% in the IFC (Figure 8). Safety results confirmed the good
group was free of fever vs 56.7% in the ST tolerability of IFC.
group and 17.0% had absence or very mild According to authors’ conclusions, IFC
symptoms vs 7.5% of ST group. as an add-on therapy improved response,
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42 Clinical Management Issues 2016; 10(2)