Real-world data confirm effectiveness of a thyme-ivy extract combination

The evaluation of the study included data from a total of 730 adult participants who were suffering from acute cough and therefore sought advice at the pharmacy. The subjects were given 2.6 ml of a thyme-ivy extract combination (BNO 1200) three times a day until their symptoms subsided. Data were collected using a cough-specific questionnaire that patients were asked to complete before starting the first dose (day 0), on day 4 and on the last dose day (day 7 on average). The ‘Bronchitis Severity Score (BSS)’ was used to assess the symptoms. This is a validated questionnaire for acute bronchitis which, in addition to the main symptoms of cough and sputum, also records breathing sounds (rattles), chest pain during coughing, and dyspnea. Each of the five symptoms is rated on a scale from 0 (not present) to 4 (very strong) and the individual scores are added to create a total score (0 to 20). At the beginning of the observational study, the mean BSS was 8.7 ± 3.8, which corresponds to moderate acute bronchitis, as is typical in the realm of self-medication.

Response to the medication was calculated as an absolute and a relative change in the BSS compared to baseline. After a four-day treatment with the thyme-ivy extract combination, the reported BSS already decreased significantly to 5.8 ± 3.3, which corresponds to an absolute reduction of 2.9 points (p<0.0001) or a relative reduction of 31.0%. At the end of the treatment, the mean BSS was 2.4 ± 2.6, corresponding to a significant reduction of 6.3 points compared to baseline or a relative reduction of 70.0% (p<0.0001; cf. Fig. 1). Patients whose symptoms had been present for a longer period of time or were more severe before the start of treatment (BSS ≥ 8) showed a more significant BSS reduction during and after treatment. The data show that the thyme-ivy extract combination already significantly reduces the overall symptoms of acute bronchitis within seven days, while the main symptom of acute bronchitis, the cough, lasts an average of 18 days without treatment [2].

A post-hoc analysis of the study data [1] also showed that the thyme-ivy extract combination significantly reduced the number of daily coughing bouts. For example, the number of patients who self-reported “all of the time”, “most of the time” or “several times during the day” having coughing episodes in the previous 24 hours decreased by 67% in the first four days of treatment (p<0.0001; Fig. 2). This also had positive effects on sleep: while at the beginning of the study 56.7% of the subjects complained of cough-related sleep disturbances, at the end of the study 79.4% reported their sleep was disturbed either “hardly any of the time” or “none of the time” by coughing. Furthermore, after four days of treatment with the thyme-ivy extract combination, 68% (p<0.0001) fewer study participants reported having “all of the time”, “most of the time” or “a good bit of the time” suffered from cough-related sleep disturbances in the previous 24 hours compared to the start of treatment (Fig. 2). This is presumably due to the fact that, in contrast to most typical expectorants, the preparation studied can still be taken in the evening and thus can also alleviate cough irritation at night. The reduction in coughing episodes during the day and the reduced sleep disturbance at night are also reflected in an improved quality of life (QoL, determined using the Leicester Cough Questionnaire [LCQ]). On average, on a scale of 3 (lowest QoL) to 21 (highest QoL) at baseline, patients scored 12.2 ± 3.3 points and improved to 18.5% ± 2.7 points (p<0.0001) by the end of treatment. The minimum clinically important difference of at least two points in the LCQ questionnaire was achieved by 90.9% of patients at the end of the treatment.

In addition to the number of coughing bouts, their severity also decreased. Measured on a validated 100-mm Visual Analogue Scale (100-mm VAS), cough severity decreased in the patients’ assessment from 58.2 ± 20.4 mm at the beginning to 36.0 ± 18.9 mm (p<0.0001) on day 4 and to 14.9 ± 17.0 mm (p<0.0001) at the individual end of treatment (Fig. 3). Clinically relevant improvements, defined by changes of at least 17 mm on the 100-mm VAS, were reported by 87.2% of patients at the end of treatment. Within an average of seven days, the severity of the cough was reduced by 74%, which means significantly fewer painful coughing bouts for those affected.

_{Conflict of interest: Claudia B. Bittner is an employee of Bionorica SE.}

_{Disclosure: Medical writing and publication funded by Bionorica SE.}