Saxena RC, Singh R, Kumar P, et al. A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmColdTM) in patients with uncomplicated upper respiratory tract infection. Phytomed. 2010;10: 178-185.
Andrographis (Andrographis
paniculata) is an annual herb
native to
Patients
(18-60 years old) suffering from 2 or more symptoms of the common cold (cough,
expectoration, running nose, headache, fever, sore throat, earache,
malaise/fatigue, and sleep disturbance) and who were sick for fewer than 3 days
participated in this randomized, double-blind, placebo-controlled study. Those
suffering from anything other than the common cold or using medicines that
might impact its symptoms were excluded. Participants were recruited from 4
centers in
Three patients
in the placebo group were lost to follow-up and excluded from analysis. No
KalmCold-treated patients discontinued from the study. At baseline, both
treatment groups had similar symptom severity scores. In both treatment groups,
the mean symptom scores decreased significantly from day 1 to day 3 (P <
0.05) and there was no significant difference between the 2 groups. However, in
the placebo group, from day 3 to day 5, no symptoms except expectoration improved
significantly. In contrast, in the KalmCold group, from day 3 to day 5, all symptoms
improved significantly (P < 0.05), except earache. At day 5, 14 of 108
placebo-treated patients reported that their symptoms were aggravated. This is
significantly more than the single KalmCold-treated patient that reported an
aggravation of symptoms at day 5 (P < 0.05). A total of 17 placebo-treated
patients and 2 KalmCold-treated patients had either an increase of overall
symptom scores or showed no response to treatment (P < 0.05).
Six
KalmCold-treated patients had minor adverse events (AEs): vomiting (n = 1), epistaxis
(nosebleed, n = 1), urticaria (itchy rash, n = 1), and
diarrhea (n = 3). Two of the 3 patients with diarrhea also had nausea or lethargy.
Three placebo-treated patients had AEs: diarrhea (n = 1), vomiting (n = 1), and
moderate rigor (stiffness, n = 1). There was no significant difference between
groups in the number of AEs. Except for vomiting and urticaria in the
KalmCold-treated patients, all other AEs spontaneously resolved without
treatment.
The authors
conclude that KalmCold was 52.7% more effective (based on the effect size) than
placebo at treating the common cold. The findings are in agreement with other
studies of andrographis. One parameter that was not included that would have
been an interesting addition would have been “patient satisfaction.” Patient
satisfaction questions, such as “Would you use this treatment again?”, are
commonly used in clinical trials of pharmaceuticals. It is an additional
indicator of whether the patient believes that the treatment provided a benefit.
Aside from this point, the study was well-designed and executed.