CAVEATS: How is this different from other cold remedies?
Patients are already spending a lot on cold remedies; this study suggests money would be better spent on having a ready supply of Pelargonium in the medicine cabinet, and it appears to be safe.
Other initially promising complementary and alternative therapies, such as zinc, echinacea, and vitamin C, have not been shown to be effective with more vigorous evaluation. We recognize that this is only 1 clinical trial, and the results may not be replicated in future trials. However, we are impressed by the effect size—twice the size as that seen for placebo, with a reduction in half of total cold symptom severity over 5 days and a reduction of missed time from work by more than a full day on average over placebo.
In vitro studies suggest a physiologic mechanism that is consistent with the study outcomes.
Similar findings are reported for symptom reduction in acute bronchitis.
Safety
There were no significant adverse events in this study, which is consistent with the findings of the studies of acute bronchitis.12-14P sidoides has been widely used in Germany since the 1980s, with an annual sale value in 2002 of $55 million or 4.1 million packages.
The Uppsala Monitoring Centre, in conjunction with the World Health Organization international pharmacovigilance program, received 34 case reports between 2002 and 2006 of allergic reactions to ethanolic herbal extract of Pelargonium root, 2 of which involved life-threatening circulatory collapse requiring emergency medical attention. Given the extremely rare occurrence of these events we believe the minimal risk is acceptable. The others involved rash and pruritus.
Also of note: contact dermatitis to Pelargonium houseplants has been reported. As a result, product information will be added to product packaging, warning of common reactions of gastrointestinal complaints (gastric pain, heartburn, nausea, and diarrhea) as well as the potential for serious allergic reaction. In addition, since some of the active compounds are plant coumarins, there is a theoretical risk of interaction with warfarin and aspirin but no serious bleeding events have been reported.16
It is also recommended that individuals with renal or hepatic disease or women who are pregnant or breastfeeding avoid use of this preparation, as safety studies have not been performed.
Other study design issues
A few other issues struck us as important when assessing the validity of this study. For example, 1 of the authors appears to be an employee of the pharmaceutical company that manufactures the preparation, raising the conflict of interest issue.
We were also curious about why the results of the high-dose arm were not reported in this manuscript. Could there have been a higher rate of adverse events in the high-dose arm? Knowing how many patients were ineligible or excluded, and the efficacy or safety in the high-dose arm would give us more confidence in the findings, but we decided that these were not necessarily fatal flaws.
Bottom line
Despite the above caveats, this was a well-designed randomized controlled trial that suggests that P sidoides is impressively efficacious in decreasing the duration and severity of the common cold. In the final analysis, we think that these findings justify recommending this to our patients.