This obscure herb works for the common cold

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This obscure herb works for the common cold

J Fam Pract. 2008 March;57(3):157-160

References

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STUDY SUMMARY: Duration and severity of symptoms are reduced

This was a multicenter, prospective, double-blind, placebo-controlled randomized trial to evaluate the effectiveness of a liquid herbal preparation from the roots of Pelargonium sidoides for decreasing the duration and severity of symptoms of the common cold.

Patient characteristics. Patients were recruited from 8 outpatient departments in Ukraine between December 2003 and May 2004. Two hundred and seven (207) patients were eligible. The number of ineligible and excluded patients was not stated. These 207 patients were randomized into 1 of 4 groups:

52 received 30 drops 3 times daily vs 51 patients who received placebo
52 patients received 60 drops 3 times daily vs 52 patients who received a higher-dose placebo.

The report gives the outcomes of the low-dose arm only. Two-thirds of the participants were women; all were Caucasian. Patients in the treatment and placebo groups were similar in terms of recurrent disease, prior use of medication for the common cold, smoking, and alcohol and caffeine consumption. All had a negative Group A beta-hemolytic strep test.

Inclusion criteria. Patients included men and women 18 to 55 years of age; able to provide written informed consent; with 2 major cold symptoms (nasal discharge, sore throat) and at least 1 minor cold symptom (nasal congestion, sneezing, scratchy throat, hoarseness, cough, headaches, muscle aches, or fever) or presence of 1 major cold symptom and at least 3 minor cold symptoms; duration of symptoms 24 to 48 hours.

Exclusion criteria were any acute ear, nose, throat and respiratory tract disease other than the common cold; positive rapid strep test; 6 or more episodes of recurrent tonsillitis, sinusitis, or otitis within the past 12 months or any chronic ear, nose, throat or respiratory tract disease; treatment with antibiotics, glucocorticoids, or antihistamine drugs during the 4 weeks prior to enrollment in the trial; treatment with cold medications that might impair the trial results (eg, decongestants, local anesthetics); and use of cough or pain relief medications, or any other treatment for the common cold within 7 days prior to enrollment in the trial.

Treatment regimen. Patients were assigned to take 30 drops of either the study herbal preparation or 30 drops of placebo 3 times daily, at least 30 minutes before or after a meal, from day 1 continuing to day 10. The investigational drug and placebo were supplied by Dr. Willmar Schwabe GmbH & Co. (Karlsruhe, Germany). The investigational medication is a preparation of the roots of P sidoides, extraction solution: ethanol 11% (1:8-10) (wt/wt). The placebo was matched for color, smell, taste, and viscosity. Paracetamol (acetaminophen) tablets were allowed for all patients for fever greater than 39°C.

Primary endpoint. Severity of cold symptoms was evaluated using the Cold Intensity Score (CIS), a validated scale derived from the sum of scores for 10 cold-related symptoms (nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headaches, muscle aches, and fever) on a scale of 0 to 4, where 0=not present and 4=very severe, to a maximum of 40 points. At baseline, the mean total CIS was comparable in both treatment and placebo groups (17.8±4.0 vs 16.9±3.4). From baseline to day 5, the mean total CIS decreased by 10.4±3.0 in the treatment group vs 5.6±4.3 in the placebo group (P<.0001).

FAST TRACK

To get the benefits, treatment must start early. Patients could be advised to buy the medication, to have on hand

Secondary endpoints. The number of patients achieving clinical cure (defined by CIS ≤1) by day 10 was significantly higher in the treatment group (78.8% vs 31.4%, P<.0001). The mean duration of days absent from work was significantly lower in the treatment group (6.9±1.8 vs 8.2±2.1, P<.0003), as was number of days with less than 100% usual activity level (7.1±1.5 vs 8.7±1.3, P<.0001). Data for both the primary and secondary endpoints were evaluated according to an intention-to-treat analysis. Both the intervention and placebo sides each had 4 patients that became ineligible after initial randomization. No patients were lost to follow-up.

Safety and tolerability. Patients in the low-dose arm experienced 3 nonserious adverse events, and 1 experienced mild epistaxis. Two additional patients (1 in the treatment and 1 in the placebo group) experienced moderate to severe tracheitis, not attributable to the study medication. Tolerability was rated slightly better in the treatment than placebo group on day 5. Forty-nine of 52 patients (94%) in the treatment group rated the preparation as good or very good tolerability vs 42 of 51 patients (82%) in the placebo group.

WHAT’S NEW?: A first

This is the first study that demonstrates the efficacy and safety of P sidoides in the treatment of the common cold. More importantly, this degree of improvement in cold symptoms is dramatically better than other common OTC treatments, including vitamin C, echinacea, and zinc preparations.