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- Pelargonium sidoides
- Common Cold
| Date: 09-30-2008 | HC# 040384-361 |
Re: Pelargonium sidoides Root Liquid Extract Recommended for Common Cold
Patrick G, Hickner J. This obscure herb works for the common cold. J Fam Pract. March 2008;57(3): 157-161.
The term "common
cold" refers to a collection of symptoms, including sore throat,
rhinorrhea, nasal congestion, cough, low-grade fever, and malaise, usually
self-limited and lasting 10 to 14 days, caused by a number of viruses, most
commonly by a rhinovirus.1 Although Americans spend about $2.9
billion annually on over-the-counter (OTC) cold preparations and $1.1 billion
on unnecessary antibiotics,2 evidence for the efficacy of the
various cold remedies is inconclusive and contradictory.
The authors report on a
previously published 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.3
Between December 2003 and May
2004, 207 patients were recruited from 8 outpatient departments in Ukraine. The
patients (two-thirds were women) were aged 18 to 55 years, with 2 major cold
symptoms (nasal discharge and sore throat) and at least 1 minor cold symptom
(nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache,
muscle aches, or fever) or with 1 major cold symptom and at least 3 minor
symptoms. Duration of their symptoms ranged from 24 to 48 hours.
Exclusion criteria included
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 antihistaminic drugs during the 4 weeks before the trial; treatment with
cold medications that might impair the trial results; and use of cough or pain
relief medications or any other treatment for the common cold within seven days
before the trial.
The patients were randomized
into 1 of 4 groups: 52 received 30 drops of the investigational medication 3
times daily vs. 51 who received placebo; and 52 patients received 60 drops of
the medication 3 times daily vs. 52 patients who received a higher-dose
placebo. The drops were taken at least 30 minutes before or after a meal, from
day 1 through day 10.
The authors reported that the
investigational medication was 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. Both treatments were supplied by Dr. Willmar Schwabe GmbH &
Co. (Karlsruhe, Germany).
The study report gives the
outcomes of the low-dose arm only.
The severity of cold symptoms
was evaluated by using the validated Cold Intensity Score (CIS), derived from
the sum of scores for 10 cold-related symptoms (sore throat, nasal congestion,
nasal drainage, sneezing, hoarseness, scratchy throat, cough, muscle aches,
headaches, fever) on a scale of 0 to 4 (0 = not present and 4 = very severe).
At baseline, the mean total CIS was comparable in both treatment and placebo
groups. 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<0.0001).
The number of patients
achieving clinical cure by day 10 was significantly higher in the treatment
group (78.8% vs. 31.4%, P<0.0001). The average number of days absent from
work was significantly lower in the treatment group than in the placebo group
(6.9 ± 1.8 vs. 8.2 ± 2.1, P<0.0003), as were the days with less than 100% of
usual activity (7.1 ± 1.5 in the treatment group vs. 8.7 ± 1.3 in the placebo
group, P<0.0001).
Patients in the low-dose arm
experienced 3 nonserious adverse events, and 1 experienced mild epistaxis.
Tolerability was rated slightly better in the treatment than placebo group on
day 5: of the 52 patients in the treatment group, 49 (94%) rated the
tolerability of the preparation as good or very good vs. 42 of 51 patients
(82%) in the placebo group.
"We recognize that this
is only 1 clinical trial, and the results may not be replicated in future
trials," write the authors. However, they were impressed by the effect
size of the study. Of concern are the facts that one of the study authors is an
employee of the pharmaceutical company that manufactures the P. sidoides preparation and that the
results of the high-dose arm were not reported. However, "in the final
analysis, we think that these findings justify recommending this…to our
patients," write the authors.
One of the challenges in
doing so, however, is that the efficacy of Pelargonium
may be less when started later in the course of the illness (and not within 48
hours of the onset of symptoms as reported in this trial). "Our conclusion
is that patients could be advised to purchase the medication to have on hand at
home at the start of the cold season," write the authors.
The authors report that their
Internet search failed to yield a distributor of the German preparation used in
the study that would be available in the United States. However, P. sidoides root liquid extract is
available in the United States
under the brand name Umcka™ Cold Care (Nature's Way, Springville, Utah).
—Shari Henson
References
1Heikkinen T, Jarvinen A. The common cold. Lancet. 2003;361:51-59.
2Fendrick AM, Monto AS, Nightengale B, Sarnes M. The
economic burden of non-influenza related viral respiratory tract infection in
the United States.
Arch Intern Med. 2003;163:487-494.
3Lizogub
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. |