The Effectiveness and Safety of a Homeopathic Medicinal Product in Pediatric Upper Respiratory Tract Infections With Fever

Glob Pediatr Health. 2016; 3: 2333794X16654851.

Published online 2016 Jul 4. doi:  10.1177/2333794X16654851

PMCID: PMC4959794

A Randomized Controlled Trial

Robert van Haselen, MSc,¹ Manuela Thinesse-Mallwitz, MD,² Vitaliy Maidannyk, MD,³ Stephen L. Buskin, MBBCh,⁴ Stephan Weber, MSc,⁵ Thomas Keller, PhD,⁵ Julia Burkart, MSc,⁶ and Petra Klement, MSc⁶

¹International Institute for Integrated Medicine, Kingston, UK

²General Practitioner, Private Practice, Munich, Germany

³Bogomolets National Medical University, Kiev, Ukraine

⁴International Health Center of the Hague, The Hague, The Netherlands

⁵Acomed statistik, Leipzig, Germany

⁶Deutsche Homöopathie-Union, Karlsruhe, Germany

Robert van Haselen, International Institute for Integrated Medicine, 22 Eden Street, Suite 467, Kingston KT1 1DN, United Kingdom. Email: 

Abstract

We investigated the clinical effectiveness of a homeopathic add-on therapy in a pediatric subpopulation with upper respiratory tract infections (URTI) in a randomized, controlled, multinational clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey–21 (WURSS-21). A total of 261 pediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, symptoms resolved significantly earlier (P = .0001), had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less (P < .0001) during the entire URTI episode. One adverse event (vomiting) was possibly related to IFC. IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use.

Keywords: upper respiratory tract infections, fever, pediatrics, randomized controlled clinical trial, homeopathy, Influcid^®

Go to:

Introduction

Children are frequently affected by upper respiratory tract infections (URTI) or common colds, causing a lot of missed days from kindergarten or school,¹ as well as missed days off work for parents who have to take leave to take care of their child.^2,3 Each year young children may have as many as 6 to 8 or even more episodes.^4-6 The German Health Interview and Examination Survey for Children and Adolescents found that the 1-year average prevalence of URTI among children and adolescents amounts to 88.5%, with the highest prevalence of almost 94% among children aged 3 to 6 years.⁷ Symptoms usually include sore throat, runny nose, general malaise, and low-grade fever at onset, followed by nasal congestion and cough, and peak at around day 3 or 4 after the onset of symptoms. Recovery is typically complete after about 7 to 10 days.^1,8 Viral pathogens like rhinoviruses,^6,9-11 and also influenza viruses,¹² are the major causes of URTI.

Since no universally accepted specific therapy for URTI exists, treatment is mainly symptomatic.¹³ Antiviral drugs are only recommended in confirmed influenza cases in children under 2 years of age, immunocompromised and chronically ill children, and in cases with severe symptoms.¹⁴ In all other cases antipyretics, anti-inflammatory drugs, expectorants, decongestants, and cough suppressants either alone or in combination can be used.¹³ In Germany, medicines are used to treat the common cold and URTI in about 14% of children (7% prescribed and 7% over-the-counter), and about 12% of the prescribed medicines are antibiotics.¹⁵ In general, antibiotics are widely prescribed.^16,17 Since URTI are mainly caused by viruses,⁶ an antibiotic treatment is often inappropriate, and only indicated if there is a bacterial infection or to prevent superinfections.^13,18 Overuse further spreads the problem of antibiotics resistance, which is of significant concern from a public health point of view.^19,20

Homeopathy is increasingly popular.²¹ For instance in Germany, 60% of the population has used homeopathy. The great majority (87%) of these users report positive experiences, and the common cold and flu is the most frequently mentioned indication.²² Homeopathy is the most commonly used complementary medicinal treatment in German children. It is estimated that around 16% of all homeopathic medicines used in children are for flu or rhinopharyngeal complaints.²³ One homeopathic preparation for the treatment of flu-like infections with fever and other acute viral URTI is Influcid^® (IFC), which was marketed in its first form as a solution in Germany in 1928, and is currently available in 26 countries worldwide. Preliminary studies indicate that IFC is an effective and safe treatment of typical cold-related symptoms in both adults and children.^24,25

Since there is no approved specific therapy for URTI and because conventional medicines sometimes lead to side-effects and inappropriate use of antibiotics, there is an interest in the identification and evaluation of alternative therapies with a beneficial risk-benefit profile. We therefore evaluated the effectiveness and safety of IFC as an add-on to symptomatic standard treatment in a randomized controlled trial in adult and pediatric URTI with fever. The primary outcome measure in this trial, “symptom and fever resolution” at day 4, was significantly superior in the IFC-group compared to the standard treatment group. For full results of this trial, see the publication by Thinesse-Mallwitz et al.²⁶ Given the wide use of homeopathy in children, we aimed to better distinguish and differentiate the effects in preadolescent children. This article reports the findings in this subpopulation.