A Review of the Medical Literature: Pelargonium sidoides (Part 2 of 6)
Russell H. Greenfield, MD
Medical Director, Greenfield Integrative Healthcare, PLLC
President, Greenfield Consulting, LLC
Charlotte, NC
Clinical Assistant Professor
University of North Carolina at Chapel Hill
School of Medicine
Chapel Hill, NC
To read other newsletters on this topic, please visit the Seasonal viral update: A 6-part series resource center. Click here.
This e-newsletter represents the second installment in a series focusing on the symptomatic treatment of upper respiratory infections (URIs). The first installment described such issues as the ineffectiveness of antibiotic use, the challenge of addressing concerns of patients who want symptom relief, and a review of a recent Journal of Family Practice Priority Update from the Research Literature (PURL). This installment presents evidence from the medical literature concerning Pelargonium sidoides (marketed in the United States as Zucol and Umcka ColdCare), an agent that is widely used in many countries but may be unfamiliar to clinicians in the United States. Future installments will provide additional information on over-the-counter options.
2007: Effect on cold symptoms
A study published in the indexed journal Explore presented partial results of a multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled phase 3 clinical trial.1 The study enrolled 207 patients aged 18 to 55 years who, for the previous 24 to 48 hours, had experienced a significant number of common cold symptoms. The investigators assessed the efficacy of a liquid P sidoides formulation in comparison with placebo. Patients received either 30 drops (1.5 mL) of P sidoides or a placebo 3 times daily for 10 days.
Ten cold symptoms were evaluated: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, and fever. The P sidoides group had a significant diminution of symptoms. Secondary end points also improved, including mean duration of absence from work (6.9 +/- 1.8 days vs 8.2 +/- 2.1 days; P = .0003). Most patients tolerated it extremely well; 3 nonserious adverse events (AEs) were reported: 2 of 52 patients in the active treatment arm and 1 of 51 patients in the placebo group. In 2 patients, the AE was deemed unrelated to the study drug (moderate tracheitis in 1 treated patient and severe tracheitis in 1 placebo patient). A causal relationship of mild epistaxis due to the study drug could not be excluded in 1 patient. On day 10, all of the patients in the active treatment group noted tolerability of the agent as good or very good.
Among the challenges to interpretation of the study was the fact that no information regarding individuals who were excluded from the study was provided. Although not methodologically perfect, the data are clearly compelling, particularly given the lack of safe and effective products available for the management of cold symptoms.
2007: Effect on bronchitis
This randomized, double-blind, placebo-controlled, multicenter study evaluated 217 adults aged 18 to 66 years with acute bronchitis.2 Participants in the active arm (n=108) received P sidoides, 30 drops (1.5 mL) or placebo 3 times daily, for 7 days. Changes in bronchitis severity score (BSS), individual symptoms, patient satisfaction, and AEs were assessed. At the end of treatment, the BSS decreased by 7.6 +/- 2.2 points in the active treatment group and by 5.3 +/- 3.2 points in the placebo group. A total of 45% of individuals who received the active treatment reported complete recovery, compared with 6.5% of those taking the placebo. Overall, patients were satisfied. Minor and transitory AEs were noted by 23 of 108 patients in the active treatment group and by 24 of 109 patients in the placebo group. In both groups, AEs included laboratory abnormalities related to the underlying infectious disease, such as increases in the erythrocyte sedimentation rate (10 patients in each group) and changes in leukocyte count (5 patients in the active treatment group and 4 in the placebo group).
2005: Effect on bronchitis
Six outpatient clinics served as the setting for this randomized, double-blind, placebo-controlled trial that enrolled 124 adults with acute bronchitis present for < 48 hours, with symptoms of > 5 points on the BSS.3 Participants received P sidoides (30 drops [1.5 mL]) or placebo 3 times daily for 7 days; changes in the BSS were assessed on day 7. In the active treatment group, the BSS improved in 95% of participants vs 58% in the placebo group.
2003: Effect on bronchitis
This randomized, double-blind, placebo-controlled trial studied 468 outpatient adults with acute bronchitis who were treated by 36 primary care physicians.4 All patients had a BSS >5 points, and symptoms had been present for > 48 hours. Patients (n=233) in the active treatment group (30 drops [1.5 mL], 3 times daily for 7 days) showed a decrease in BSS from baseline to day 7 of 5.9 +/- 2.9 points vs 3.2 +/- 4.1 points for the placebo group (P < .0001). The duration of illness was significantly shorter in the active treatment group (P < .001). On average, these participants were able to return to work 2 days earlier. Nonserious AEs occurred in 20 of 233 active treatment patients and 16 of 235 patients receiving placebo. However, the intensity of most AEs for the P sidoides-treated patients was only mild. The number of moderate AEs did not differ between treatment groups. These events most frequently affected the following organ systems: gastrointestinal, nervous system, respiratory/thoracic and mediastinal, and ear and labyrinth. The number of patients with ear and labyrinth disorders was slightly higher in the active treatment group (5 of 233 patients vs 1 of 235 patients). Gastrointestinal disorders were slightly more frequently reported in the placebo group (7 of 235 patients vs 4 of 233 patients).
Additional findings
Trials have also been done to evaluate the safety and efficacy of P sidoides in children; results were very similar to those shown in adult populations, featuring similar efficacy and side effect profile.5,6
At present, the total number of studies and patients enrolled is not sufficient to provide authoritative evidence, and many of the studies available have not been conducted in Western industrialized countries. However, the results are compelling, both as individual research reports and as described in a recent Cochrane review meta-analysis.7 P sidoides represents a promising treatment for the management of viral URIs for which there are presently no good options and which can cause significant patient discomfort and time lost from work and school.
Duration and cost of treatment
Course of treatment is 6 to 10 days (3 doses/day). The user/patient should continue to take the full course of treatment, even after symptoms cease, to preclude secondary infection. Typical retail cost is $7.99 for 1 package containing an 18-dose course of treatment.
References
- Lizogub VG, Riley DS, Heger M. Efficacy of a Pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial. Explore (NY). 2007;3:573-584.
- Matthys H, Heger M. Treatment of acute bronchitis with a liquid herbal drug preparation from Pelargonium sidoides (EPs 7630): a randomised, double-blind, placebo-controlled, multicentre study. Curr Med Res Opin. 2007;23:323-331.
- Chuchalin AG, Berman B, Lehmacher W. Treatment of acute bronchitis in adults with a Pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial. Explore (NY). 2005;1:437-445.
- Matthys H, Eisebitt R, Seith B, Heger M. Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial. Phytomedicine. 2003;10(suppl 4):7-17.
- Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation (EPs 7630) in the treatment of acute bronchitis in adults and children. Phytomedicine. 2007;14(suppl 6):69-73. Epub 2006 Dec 20.
- Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial. Altern Ther Health Med. 2003;9:68-79. 7. Timmer A, Günther J, Rücker G, Motschall E, Antes G, Kern WV. Pelargonium sidoides extract for acute respiratory tract infections. Cochrane Database Syst Rev. 2008(3):CD006323.
Disclosure
Dr Greenfield reports that he has no conflict of interest to disclose.
This e-newsletter is supported by a grant from Nature's Way, manufacturer of the only products containing the active P sidoides extract used in the clinical trials that are available in the United States—as a rapid melt tablet (Zucol™ ColdCare) as well as in liquid and chewable tablet forms (Umcka® ColdCare).
|
