Clinical studies

Indication A (cough associated with cold, oral application):

In an open, multicentre study (Dentinox 1997, cited in ESCOP (2003)), 154

children aged 2 months to 14 years (mean 4.4 years) with bronchial catarrh or
bronchitis were treated daily with 15 – 30 ml of thyme syrup, containing 97.6 mg
of thyme liquid extract (2 – 2.5: 1) per ml, for a period of 7-14 days (mean 7.9
days); 46 patients did not receive any co-medication. Compared to the start of the
treatment an improvement in the intensity of coughing was reported in 93.5 % of
patients.

This company report is typical for an open study sponsored by the marketing
authorization holder. The extract is stated to be a liquid extract but this seems
unlikely in view of the DER. It is assumed that the liquid extract according to the
DAB (with a DER of 1: 2-2.5) has been tested. Nevertheless this open study on the
use of thyme syrup in young children contributes to the documentation of the safe
use of thyme syrup as traditional herbal medicinal product in general.

Relaxant Effect of Thymus Vulgaris on Guinea-Pig Tracheal Chains and Its

Possible Mechanism(s)

Thymus vulgaris for the treatment of respiratory diseases is indicated widely, and
relaxant effects on smooth muscle have been shown previously. In the present
study, the relaxant effects of macerated and aqueous extracts of Thymus vulgaris
on tracheal chains of guinea-pigs were examined using cumulative concentrations
of macerated and aqueous extracts in comparison with saline (as the negative
control) and theophylline (as the positive control).

The relaxant effects of four cumulative concentrations of macerated and aqueous

extracts (0.25, 0.5, 0.75 and 1.0 g %) in comparison with saline (as the negative
control) and four cumulative concentrations of theophylline (0.25, 0.5, 0.75 and 1.0
mm; as the positive control) were examined for their relaxant effects on
precontracted tracheal chains of guinea-pig by 60 mm KCl and 10 micron
methacholine in two different conditions: non-incubated tissues and incubated
tissues with 1 micron propranolol and 1 micron chlorphenamine.
There were significant correlations between the relaxant effects and the
concentrations for both extracts and theophylline in all experimental groups (p <
0.01 to p < 0.001). These results demonstrated a potent relaxant effect of Thymus
vulgaris on guinea-pig tracheal chains that was comparable to theophylline at the
concentrations used.

Bronchitis, Cough

Thyme has traditionally been used for the treatment of respiratory conditions
including cough and bronchitis. Animal studies have identified spasmolytic
properties of thyme constituents. The German expert panel, the Commission E,
has approved thyme for use in bronchitis. However, due to a lack of data regarding
thyme as a mono therapy for any specific respiratory indication, there is currently
insufficient scientific evidence to recommend for or against thyme as a treatment
for bronchitis or coughs.

Evidence: Ernst et al. conducted a multi-center post-market surveillance study

comparing Bronchipret®(combination of thyme and primula root) with other
pharmaceutical options for acute bronchitis.

The study was designed as a matched-pair comparison of 7,783 patients. Patients

received Bronchipret, “other herbals” pooled into one treatment group
(Bronchoforton-eucalyptus, peppermint, Hedelix-ivy extract, Prospan-ivy extract,
Sinupret-Rad. Gentianae, Flos Primulae cum calycibus, Herba Rumicis, Flos
Sambuci, Herba Verbenae, Soledum-extract of thyme) or the synthetic agents N-
Acetylcysteine (NAC) or Ambroxal.

Clinical outcomes of bronchitis and adverse reactions were documented. Data were
evaluated by comparing the treatment success of the test medication and 3 control
groups using ordinal regression. The authors reported that the clinical effectiveness
of Bronchipret was not less than the synthetic drugs. There was a trend towards
better results with Bronchipret, particularly in adults. Bronchipret was associated
with a favorable adverse effects profile compared to controls. The authors
concluded a possible risk/benefit advantage of Bronchipret over these controls for
the management of acute bronchitis. This preliminary finding may merit follow-up
with a prospective controlled trial with both a placebo arm, and a control
medication with established evidence of efficacy.

In a double blind, randomized trial, 60 patients with productive

cough as a result of an uncomplicated respiratory infection received ei
-
ther syrup of thyme or bromhexine for a period of 5 days.
67
Both groups
made similar gains from day zero to day five. The authors reported no
significant difference between the two groups based on self-reported
symptom relief. The study concluded that bromhexine may be no better
in alleviating coughing complaints than syrup of thyme. However, no
power calculation was conducted prior to the study, and it is conceiv
-
able that the sample size was too small to detect significant differences
between groups. Without a placebo arm, these results cannot be dis
-
criminated from the natural course of disease.
In a double blind, randomized trial, 60 patients with productive
cough as a result of an uncomplicated respiratory infection received ei
-
ther syrup of thyme or bromhexine for a period of 5 days.
67
Both groups
made similar gains from day zero to day five. The authors reported no
significant difference between the two groups based on self-reported
symptom relief. The study concluded that bromhexine may be no better
in alleviating coughing complaints than syrup of thyme. However, no
power calculation was conducted prior to the study, and it is conceiv
-
able that the sample size was too small to detect significant differences
between groups. Without a placebo arm, these results cannot be dis
-
criminated from the natural course of disease.
In a double blind, randomized trial, 60 patients with productive
cough as a result of an uncomplicated respiratory infection received ei
-
ther syrup of thyme or bromhexine for a period of 5 days.
67
Both groups
made similar gains from day zero to day five. The authors reported no
significant difference between the two groups based on self-reported
symptom relief. The study concluded that bromhexine may be no better
in alleviating coughing complaints than syrup of thyme. However, no
power calculation was conducted prior to the study, and it is conceiv
-
able that the sample size was too small to detect significant differences
between groups. Without a placebo arm, these results cannot be dis
-
criminated from the natural course of disease.
In a double blind, randomized trial, 60 patients with productive
cough as a result of an uncomplicated respiratory infection received ei
-
ther syrup of thyme or bromhexine for a period of 5 days.
67
Both groups
made similar gains from day zero to day five. The authors reported no
significant difference between the two groups based on self-reported
symptom relief. The study concluded that bromhexine may be no better
in alleviating coughing complaints than syrup of thyme. However, no
power calculation was conducted prior to the study, and it is conceiv
-
able that the sample size was too small to detect significant differences
between groups. Without a placebo arm, these results cannot be dis
-
criminated from the natural course of disease.