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

Abstract

Background: This randomized clinical trial was designed to evaluate the efficacy and safety of Tavipec® (Spicae aetheroleum), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients suffering from acute viral rhinosinusitis. Methodology: Patients with acute viral rhinosinusitis were randomly assigned to treatment with 2 capsules Tavipec® 150 mg or placebo thrice daily over a period of 7 days in a double-blind, parallel-group design. No additional treatment was admitted. The efficacy endpoints comprised the improvement of the main rhinosinusitis symptoms as per Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) as well as of quality of life (QoL) by global assessment scale, evaluated at baseline, day 5 and day 8, respectively. Results: 288 patients were enrolled and randomized to treatment. At day 8 the patients in the Tavipec® group had a significantly lower MSS compared to placebo and the impact of rhinosinusitis symptoms on QoL was significantly reduced. A significantly higher proportion of Tavipec® treated patients experienced a change in SNOT-22 score ≥ 10 points at day 5 or day 8. No new safety signals were identified. Conclusions:The treatment with Tavipec® effectively reduced the symptoms of acute rhinosinusitis in adult patients.

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 ].…”

“…For domain 4 (measure of outcomes), all trials were rated as low risk of bias [ [1] , [2] , [3] , [4] , [5] , 7 , 8 ]. In domain 5 (selective reporting), one trial was identified as high risk of bias [ 2 ], with the remaining trials rated as having low risk of bias [ 1 , 3 , [2] , [3] , [4] , [5] , 7 , 8 ]. Overall, six trials were judged as having low risk of bias [ 1 , 3 , [2] , [3] , [4] , [5] , 7 , 8 ], whereas one trial was rated as having some concerns [ 2 ].…”

“…Essential oils (EO) are steam-distilled plant extracts containing volatile terpenoids and phenylpropanoid compounds with a molecular weight of less than 300 Daltons. The anti-inflammatory and anti-microbial properties, including mode of action (MoA) of EO, have been addressed in numerous pre-clinical ( in-vitro and in-vivo ) studies [ 1 ]. A recent review [ 6 ] of the antibacterial, anti-fungal and antiviral properties of EOs found evidence of in vitro anti-viral activity for several virus species, although none for the novel coronavirus (SARS-CoV-2).…”

“…Although essential oils are often inhaled or applied dermally, they can also be ingested in enteric coated or soft gel capsules. Orally administered EO are thought to be absorbed from the gastrointestinal tract, enter the blood circulation and reach the mucosal secretory glands whereupon they exert their secretolytic effects [ 1 ].…”

“… 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.…”