Background: Current recommendations for the self-management of SARS-Cov-2 disease (COVID-19) include self-isolation, rest, hydration, and use of NSAID in case of high fever only. It is expected that many patients will add other symptomatic/adjuvant treatments, such as herbal medicines. Aims: To provide a benefits/risks assessment of selected herbal medicines traditionally indicated for ‘respiratory diseases’ within the current frame of the COVID-19 pandemic as an adjuvant treatment. Method: The plant selection is primarily based on species listed by the WHO and EMA, but some other herbal remedies are considered due to their widespread use in respiratory conditions. Preclinical and clinical data on their efficacy and safety were collected from authoritative sources. Target population: adults with early flu symptoms without underlying conditions. These were evaluated according to a modified PrOACT-URL method with paracetamol, ibuprofen, and codeine as reference drugs. The benefits/risks balance of the treatments was classified as positive, promising, negative, and unknown. Results: A total of 39 herbal medicines were identified as very likely to appeal to the COVID-19 patient. According to our method, the benefits/risks assessment of the herbal medicines was found positive in 5 cases (Althaea officinalis, Commiphora molmol, Glycyrrhiza glabra, Hedera helix and Sambucus nigra), promising in 10 cases (Allium sativum, Andrographis paniculata, Echinacea angustifolia, Echinacea purpurea, Eucalyptus globulus essential oil, Justicia pectoralis, Magnolia officinalis, Pelargonium sidoides, Salix sp, Zingiber officinale), and unknown for the rest. On the same grounds, only ibuprofen resulted promising, but we could not find compelling evidence to endorse the use of paracetamol and/or codeine. Conclusions: Our work suggests that several herbal medicines have safety margins superior to those of reference drugs and enough levels of evidence to start a clinical discussion about their opportunity as adjuvants in the treatment of early/mild common flu in otherwise healthy adults within the context of COVID-19. While these herbal medicines will not cure or prevent the flu, they may both improve general patient well-being and offer them an opportunity to personalize the therapeutic approaches.

/pdf/covid-19-is-there-evidence-for-the-use-of-herbal-medicines-1yj81g4t50.pdf

COVID-19: Is There Evidence for the Use of Herbal Medicines as Adjuvant Symptomatic Therapy?

Acute cough due to viral upper respiratory tract infections (URTIs) and bronchitis is a common reason for patients to seek medical care. Non-antibiotic over-the-counter cough medications such as ivy leaf extract are frequently used but their efficacy is uncertain. Our purpose was to update our previous systematic review and evaluate the effectiveness and tolerability of ivy leaf in the treatment of acute URTIs in adult and pediatric populations. We searched MEDLINE, EMBASE, the Cochrane Library, and clinical trial registries from December 2009 to January 2020. Randomized controlled trials (RCTs), controlled clinical trials (CCTs), and observational studies (OSs) investigating ivy leaf mono- or combination preparations were included. Two independent reviewers assessed records for eligibility and risk of bias and performed data extraction. Six RCTs, 1 CCT, and 4 OSs were identified. Since the publication of our previous review, the number of RCTs has increased. All studies concluded that ivy leaf extract is an effective and safe option for the treatment of cough due to URTIs and bronchitis. Three RCTs reported a more rapid reduction in cough severity and/or frequency under ivy leaf treatment. The clinical significance of these effects appears to be minimal. No serious adverse effects were reported. The overall quality of reporting was low and the risk of bias was high. Ivy leaf preparations are safe for use in cough due to acute URTIs and bronchitis. However, effects are minimal at best and of uncertain clinical importance.

/pdf/ivy-leaf-hedera-helix-for-acute-upper-respiratory-tract-3qepxelynx.pdf

Ivy leaf (Hedera helix) for acute upper respiratory tract infections: an updated systematic review

Introduction. Acute bronchitis is defined as a sudden inflammation of the bronchial tubes in the lung mainly caused by viral infection. It is characterized by a persistent cough which can be productive or dry. It is the most common disease in industrialized countries, and thus herbal expectorants enjoy a high popularity in many European countries due to their favorable risk-benefit ratio. Objective. The present noninterventional study was intended to gain further data on the application of a cough syrup containing ivy leaf extract EA 575® by evaluating its efficacy and safety in children and adults with symptoms of acute bronchitis. Acetylcysteine (ACC) was chosen as comparator drug (common mono preparations). Material and Methods. The study was conducted at 25 medical practices throughout Switzerland as prospective, open, noninterventional study. Results. At entry visit, all clinical assessments including coughing fits, sputum, dyspnoea, rales, severity of the diseases, and coughing quality were rated with moderate intensity in both groups. At the final visit after seven days of treatment, there was a comparable improvement in both groups for all assessments except dyspnoea and number of cough attacks which showed a higher improvement in the EA 575® group compared with ACC. Further, cough-associated sleeping disorders improved more in the EA 575® group. Both, physicians and patients described the efficacy of EA 575® comparable with acetylcysteine. Observations of the tolerability were comparable for both products. The study results indicate that ivy leaf extract might be an effective alternative to acetylcysteine with respect to the improvement of respiratory function in children and adults at a slightly better evaluation of efficacy.

/pdf/assessment-of-the-efficacy-and-safety-of-ivy-leaf-hedera-wcsck39g4h.pdf

Assessment of the Efficacy and Safety of Ivy Leaf (Hedera helix) Cough Syrup Compared with Acetylcysteine in Adults and Children with Acute Bronchitis.

Brief overview Based on the evidence identified in this rapid review, Hedera helix preparations and herbal complex preparations including H. helix may be a therapeutic option for treating early symptoms of respiratory tract infections. The best effectiveness for H. helix preparations has been proven for coughing, as an expectorant and to reduce the frequency and intensity of cough. Only weak evidence was found for all other researched symptoms. Both adults and children tolerate H. helix well. Currently, there is insufficient evidence to recommend the use of this supplement in the treatment or prevention of COVID-19. However, the current evidence justifies further research to better understand its applicability in coronavirus infections. Verdic tCurrent evidence suggests H. helix may improve the frequency and intensity of cough associated with viral respiratory infection. The overall applicability of additional findings is limited by the poorly defined outcome measures employed. However, studies focused explicitly on expectoration did report an increased conversion from dry to productive cough, and an improvement in expectoration amount, consistency and colour. These effects may be explained by a related finding of reduced oropharyngeal congestion and improved inflammatory markers (erythrocyte sedimentation rate and c-reactive protein). A decrease in frequency of night cough and respiratory pain was also reported, as was improved sleep quality and reduced cough-related sleep disturbance. Some studies also measured general respiratory tract infection symptoms and identified clinical improvement or resolution of fever, fatigue, sore throat, sneezing, wheezing, nasal congestion, post-nasal drip and body-ache. A reduced need for antibiotic prescriptions was also identified. While not consistently reported, the majority of studies also found H. helix reduced the overall severity of viral bronchitis and related conditions. Tolerability was rated as between ‘good’ and ‘high’. Adverse events were rare or non-existent in almost all studies, and those that were reported were defined as non-serious and not drug-related.

The effects of Hedera helix on viral respiratory infections in humans: A rapid review.

Herbal medicines are becoming increasingly popular among patients because they are well tolerated and do not exert severe side effects. Nevertheless, they receive little consideration in therapeutic settings. The present article reviews the current state of research on the clinical benefits of herbal medicines on five indication groups, psychosomatic disorders, gynecological complaints, gastrointestinal disorders, urinary and upper respiratory tract infections. The study search was based on the database PubMed and concentrated on herbal medicines legally approved in Europe. After applying defined inclusion and exclusion criteria, 141 articles were selected: 59 for psychosomatic disorders (100% randomized controlled trials; RCTs), 20 for gynecological complaints (56% RCTs), 19 for gastrointestinal disorders (68% RCTs), 16 for urinary tract infections (UTI, 63% RCTs) and 24 for upper respiratory tract infections (URTI) (79% RCTs). For the majority of the studies, therapeutic benefits were evaluated by patient reported outcome measures (PROs). For psychosomatic disorders, gynecological complaints and URTI more than 80% of the study outcomes were positive, whereas the clinical benefit of herbal medicines for the treatment of UTI and gastrointestinal disorders was lower with 55%. The critical appraisal of the articles shows that there is a lack of high-quality studies and, with regard to gastrointestinal disorders, the clinical benefits of herbal medicines as a stand-alone form of therapy are unclear. According to the current state of knowledge, scientific evidence has still to be improved to allow integration of herbal medicines into guidelines and standard treatment regimens for the indications reviewed here. In addition to clinical data, real world data and outcome measures can add significant value to pave the way for herbal medicines into future therapeutic applications.

Current state of research on the clinical benefits of herbal medicines for non-life-threatening ailments

This randomized, placebo-controlled, double-blind trial was conducted to assess the efficacy and safety of ivy leaves cough liquid in the treatment of acute cough. A total of 181 adult patients with acute cough were treated with either ivy leaves cough liquid containing EA 575® or with placebo three times a day for one week. The primary efficacy outcome was cough severity (CS) assessed by Visual Analogue Scale (VAS) over the whole treatment period (area-under-the-curve (AUC0-168 h) over 7 days (visit (V)1, V2, V3, V4, and V5). The secondary endpoints were defined as the CS assessed by VAS over the whole observation period (V1 - V6) and by Bronchitis Severity Score (BSS) and Verbal Category Descriptive (VCD) score. The evaluation of the VAS, BSS and VCD score revealed that subjects treated with ivy leaves cough liquid showed statistically significant and clinically relevant reductions in CS, severity of symptoms associated with cough and bronchitis compared to the placebo group. Furthermore, a remarkable early onset of efficacy was observed as significant reductions of cough severity were detected within 48 hours after the first drug intake. At all following visits and even 7 days after the end of treatment (V6) this significant treatment advantage was detected in comparison to placebo. All adverse events (AEs) in this clinical trial were non-serious, mild or of moderate severity and not drug-related. This clinical trial proved consistent superiority of the ivy leaves cough liquid treatment versus placebo and confirmed the EA 575® preparation to be a safe and efficacious option for the treatment of acute cough.

A randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract (EA 575®) vs. placebo in the treatment of adults with acute cough.

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A randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract (EA 575®) vs. placebo in the treatment of adults with acute cough.