Level 1: Likely reliable evidence
A liquid herbal solution containing Pelargonium sidoides (EPs), an extract of the South African geranium, was evaluated in a randomized, placebo-controlled trial (Explore [NY]. 2007;3:573-584). EPs is the active ingredient in Umcka ColdCare and Zucol products in the United States. Patients aged 18-55 years in the Ukraine with cold symptoms (N=207) were randomized to one of four treatments administered orally three times daily, ≥30 minutes before or after meals, for 10 days: EPs 30 drops vs. placebo 30 drops vs. EPs 60 drops vs. placebo 60 drops. The outcome was measured as change in the cold intensity score (CIS), which is based on 10 symptoms (0-4 points each) for a total range of 0-40 points.
In analyses limited to 103 patients randomized to EPs 30 drops or placebo 30 drops, the mean reduction in CIS score was -10.4 vs. -5.6 at day 5 (P<.05). Comparing EPs vs. placebo, 42.3% vs. 3.9% had CIS <7 points on day 5 and 94.2% vs. 43.1% had reduction in CIS ³7 points on day 5. Clinical cure, defined as CIS score of 0, was achieved by 63.5% vs. 11.8% of patients on day 10. The median time to “onset of treatment effect” was five to six days vs. seven to eight days (estimated from graph). More than twice as many EPs patients were satisfied or very satisfied as placebo patients (86.5% vs. 41.2%). EPs was also associated with significantly higher rates of remission and improvement for limb pain, overall weakness, exhaustion, and fatigue. There were no significant differences in adverse effects (two treated patients, one placebo patient), and none of the adverse events was considered serious.
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Results for the high-dose group will be published elsewhere. Although the study appears valid for the product tested in the Ukraine, it is not clear that products in the United States are equivalent. Also, there is insufficient information to report on interactions with other medications.
