Spicae aetheroleum in uncomplicated acute bronchitis: a double-blind, randomised clinical trial

Abstract

SummaryBackground The trial aimed to evaluate the efficacy and safety of Spicae aetheroleum (Spicae ae.), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients with acute bronchitis. Methods Patients with uncomplicated acute bronchitis (bronchitis severity score [BSS] ≥ 5 score points) were randomly assigned to treatment with Spicae ae. or placebo in a double-blind, parallel-group design. No additional treatment was admitted. The primary objective was the mean difference of a defined total BSS of 25% between the Spicae ae. and the placebo group after 7 days of full medication dose. Secondary endpoints included the BSS at day 10, additional signs and symptoms of bronchitis, quality of life (QoL) and safety. Results The mean decrease in BSS at day 7 and day 10 was significant with 4.79 vs. 3.20 (p < 0.005 for a 25% difference) and 6.47 vs. 4.32 (p < 0.009 for a 25% difference) score points respectively in the Spicae ae. (n = 119) vs. placebo group (n = 110). Accordingly, most additional signs and symptoms of acute bronchitis as well as the patients' QoL improved significantly with Spicae ae. as compared to placebo. In all, 258 patients were eligible for safety analysis. The treatment with Spicae ae. was well tolerated; no serious adverse events occurred. Conclusion The defined objectives both for the primary and secondary endpoints have been met. The results of this study provide evidence that Spicae ae. is well tolerated, effective and superior to placebo in the symptomatic treatment of uncomplicated acute bronchitis in adult patients.

Tavipec® in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial

“…In a double-blind, placebo-controlled RCT cineole was significantly more effective for timely treatment of nonpurulent rhinosinusitis in 150 patients (24) . To date, one placebocontrolled RCT examined the efficacy and safety of Tavipec® in acute RTIs: Kähler et al administrated 300 mg Tavipec® three times daily to 256 patients with uncomplicated acute bronchitis (28) . The treatment with Tavipec® exhibited a significant mean difference of 25% of a defined total bronchitis severity score (BSS) between verum and placebo after 7 (p<0.005) and 10 days (p<0.009) of full medication as well as a significant amelioration of the patients' QoL (p<0.001) as compared to placebo.…”

“…The anti-inflammatory properties and mode of action (MoA) of plant derived monoterpenes as well as their efficacy to control signs and symptoms of RTIs including viral ARS have been thoroughly investigated (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) . Monoterpenes are resorbed in the gastrointestinal tract and enter the circulation and reach the mucosal secretory glands, where they have secretolytic effects by enhancing mucus production and ciliary beat frequency (CBF) as well as stimulating ciliary cell differentiation, thus supporting the cleaning function and the recovery process of the mucosa (14,15,22,30,31) .…”

“…Being rich in linalool and 1,8-cineole, Spicae aetheroleum is extensively used for its mucolytic, anti-inflammatory and spasmolytic activity (38,39) . Recently, Kähler et al demonstrated the efficacy and tolerability of Spicae aetheroleum (Tavipec®) for symptom relief in patients with acute bronchitis in a double-blind, placebo-controlled RCT (28) . However, equivalent data evaluating Tavipec® in the treatment of viral ARS are still lacking.…”

Effects of essential oils on symptoms and course (duration and severity) of viral respiratory infections in humans: A rapid review

“…The risk of bias (RoB) of study findings was assessed using the revised Cochrane RoB tool for randomised trials (RoB 2) https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool/current-version-of-rob-2 (see Supplement 2). In the first domain (randomisation process), all trials were rated as low risk of bias [ [1] , [2] , [3] , [4] , [5] , 7 , 8 ]. For domain 2 (treatment assignment), all trials were rated as low risk of bias [ [1] , [2] , [3] , [4] , [5] , 7 , 8 ].…”

“… Verdict Clinical evidence from published clinical trials identified in this rapid review suggests that oral administration of blends of certain essential oils (EO) can reduce symptoms of acute respiratory infections of viral origin in humans, namely acute sinusitis and acute bronchitis. There is clinical evidence for orally administered Lavandula latifolia essential oil (Tavipec®) (n = 2) and a blend of essential oils of Eucalyptus globulus , Citrus sinensis , Myrtus communis and lemon Citrus limonum (Myrtol® and its successors GeloMyrtol® and GeloMyrtol®Forte) (n = 3) to reduce symptoms of acute sinusitis and acute bronchitis of viral origin(s) [ [1] , [2] , [3] , [4] , [5] ]. All five clinical trials relied mostly on (subjective) symptom scores to determine the treatment effect.…”