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By David Kiefer, MD, Editor
Clinical Assistant Professor, Department of Family Medicine, University of Wisconsin; Clinical Assistant Professor of Medicine, Arizona Center for Integrative Medicine, University of Arizona, Tucson
Dr. Kiefer reports no financial relationships relevant to this field of study.
SYNOPSIS: A cough syrup containing homeopathic remedies improved cold symptoms more than placebo during the first day of treatment only.
SOURCE: Jacobs J, Taylor JA. A randomized controlled trial of a homeopathic syrup in the treatment of cold symptoms in young children. Comp Ther Med 2016;29:229-234.
What to do when young children have an upper respiratory infection, and symptomatic relief seems hard to come by? This can be a difficult task for parents and healthcare providers alike. Into this quandary stepped two researchers from Seattle, whose aim was to test the efficacy of homeopathy.
In this study, participants were recruited from a pediatric outpatient clinic. These recruits included children 2-5 years of age with a diagnosis of an upper respiratory tract infection and symptoms less than seven days; they were randomized to receive a homeopathic cough syrup or placebo. Children were excluded if they had already taken a homeopathic remedy in the previous 48 hours, if they had asthma, or if they were prescribed medicines at that clinic visit or were taking medicine prescribed at a previous visit.
If the parents of the children elected to participate in the trial, they were asked to rate four of the child’s symptoms (runny nose, cough, sneezing, and congestion) each on a scale of 0 (none) to 4 (severe). The treatment group received Hyland’s Cold ‘n Cough 4 Kids containing the seven remedies listed in Table 1. As an aside, the product used in this clinical trial included 6X and 12X homeopathic remedies. A 6X homeopathic remedy contains a substance that was diluted in a ratio of 1:10 six consecutive times, and a 12X remedy was diluted in that way 12 times. The syrup was sweetened with a glycyrrhiza extract, as was the placebo syrup, rendering both indistinguishable. The syrups were dosed one teaspoon (5 mL) every 4-6 hours as needed to treat cold symptoms up to a maximum of six times daily for three days.
Information about the changes in symptoms were recorded by the parents. Table 2 shows the rating systems used and includes overall symptoms, symptom changes, and side effects for the three-day treatment period. A follow-up phone call was made 5-10 days after enrollment to re-assess some of the variables. (See Table 2.) In addition, parents were asked about the child missing school or daycare, or if the parent missed work, as well as if the child was administered any other treatments during the study period. From the data resulting from the first line of Table 2, overall severity, a composite cold score (CCS), was created by adding the four scores for a total ranging from 0-16.
From the enrollment period, 261 children were eligible for randomization to the homeopathic syrup (n = 128) or the placebo syrup (n = 133). Out of this group of 261, 154 returned information after the syrup dosages and 162 returned the other information about symptoms, overall health, and function. There was no statistical difference between the groups who returned information or who didn’t return information with respect to demographics and clinical characteristics. All told, 244 children “completed follow-up,” although the researchers didn’t specify what this meant.
The placebo and homeopathic groups did not differ significantly for any of the symptoms one hour after syrup dosage. However, for the twice-daily assessment of cold symptoms, some differences appeared. Compared to baseline, the homeopathic syrup group improved more than the placebo group for runny nose, cough, and sneezing (improvements ranged from -0.22 to -0.39; P = 0.05-0.001), but not congestion. Interestingly, this improvement occurred only for the first day, disappearing by day 3; that is, by the end of the treatment period, both groups had improved similarly. The CCS behaved similarly: For the first day, the homeopathic group had changed more from baseline than the placebo group. (See Table 3.) The CCS scores were not statistically significantly different for the other days.
Interestingly, 13 children in the homeopathy group were given ibuprofen the first morning after randomization, compared to only two in the placebo group (P = 0.04). Also, chest rubs were administered to 13 children in the homeopathy group but to only two in the placebo group the first morning (P = 0.002) and the second morning (P = 0.028). All functional outcomes were similar between the two groups for any day. When follow-up contact occurred at day 5-10, cough severity was worse for the homeopathy group compared to placebo (P = 0.009). More side effects (9/75) were noted in the homeopathy group compared to the placebo group (2/79) (P = 0.02). None of the side effects were serious, but rather involved mostly gastrointestinal symptoms.
There is a gap in treatments available for young children with cold symptoms who are not prescribed a medicine. What are parents supposed to do? Many over-the-counter medicines are not appropriate for this age group, and symptomatic measures might only partially alleviate coughing and congestion that compromise sleep, eating, and the ability to return to schools or daycares and, therefore, return to work for parents.
Does this study highlight an intervention that could fill this niche? Possibly, but the clinical ramifications of these findings are narrow. After three days of the use of a cough syrup with seven homeopathic remedies, there was a slight improvement in some cold symptoms for the first day, but not thereafter. For suffering children (and parents), that is at least something, but it wasn’t sustained for the rest of the trial, not to mention the fact that at day 5-10, the children’s coughs were actually worse in that group. The researchers posited that it might be because of a rebound in symptoms after stopping the therapy, but it could be considered actually a side effect — something worth factoring into our decision-making as clinicians until this study is replicated.
There are flaws in this trial that are worth keeping in mind. A large percentage of the study participants did not return the logs of symptoms after dosing nor the diaries with the other information about function and overall response to treatment. The authors mentioned this as a potential bias, even though the “returner” group and the “non-returner” group had statistically similar demographics and characteristics. Furthermore, no mention was made of the higher adverse effect rate in the homeopathy group. The conventional wisdom is that homeopathy either helps or doesn’t have any effect; it is thought to be quite safe. Of course, skeptics of this type of therapy would say that it’s safe because there is nothing actually in a homeopathic remedy. Regardless of the somewhat difficult-to-grasp mechanism of action, it’s worth noting the adverse effects as we counsel our patients. Perhaps these remedies aren’t as innocuous as previously thought.
There are not many clinical trials examining homeopathic remedies. From the landmark trial showing benefit in childhood diarrhea in Nicaragua1 to trials on arnica homeopathics perioperatively,2 this trial was a valiant effort. The authors mentioned other clinical trials using homeopathic remedies in upper respiratory tract infections to which this current study contributes some information. For those children suffering from colds, benefiting minimally from conservative treatment, perhaps a day of relief, even a little bit, might be just what the doctor ordered.
Financial Disclosure: Integrative Medicine Alert’s executive editor David Kiefer, MD, peer reviewer Suhani Bora, MD, AHC Media executive editor Leslie Coplin; editor Jonathan Springston; and editorial group manager Terrey L. Hatcher report no financial relationships relevant to this field of study.