The efficacy and tolerability of Pelargonium sidoides DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.

In an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1-5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respiratory infection, general health status according to the Integrative Medicine Outcomes Scale (IMOS), and satisfaction with treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS).

591 children were randomized and treated with syrup (n = 403) or solution (n = 188) for 7 days. In both treatment groups, the number of adverse events was similarly low and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) or gastrointestinal disorders (syrup: 2.7%; solution: 3.2%). After one week’s treatment, more than 90% of the children experienced an improvement or remission of the symptoms of the BSS-ped. Further respiratory symptoms decreased similarly in both groups. At Day 7, more than 80% of the whole study population had completely recovered or showed a major improvement as assessed by the investigator and the proxy, respectively. Parents were “very satisfied” or “satisfied” with the treatment in 86.1% of patients in the combined syrup and solution group.

Both pharmaceutical forms, EPs 7630 syrup and oral solution, were shown to be equally safe and well tolerated in pre-school children suffering from AB. Improvement of health status and of complaints were similar in both groups.

Kamin, W., Behre, U., Helm, K., Reling, B., Funk, P., & Malek, F. A. (2023). Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis. Frontiers in Pediatrics, 11, 1107984.

Link: https://www.frontiersin.org/articles/10.3389/fped.2023.1107984/full

While favipiravir had been the standard anti-SARS-CoV-3 drug for COVID-19 treatment in Thailand, the efficacy of favipiravir treatment is controversial. Andrographis paniculata extract (APE) inhibits viral entry, exhibits immunomodulatory effects, and proposes to have the potential for early-stage COVID-19 treatment.

A randomized, double-blind, placebo-controlled trial was performed in Thailand during June – September 2021. Non-severe COVID-19 patients were randomized 1:1 to groups receiving 180 mg/day of APE plus favipiravir (APE-FPV group) or placebo plus favipiravir (placebo-FPV group). Efficacy in preventing disease progression to severe COVID-19 was assessed on day 4, using World Health Organization Clinical Progression Scale (WHO CPS) score and visual analog scale (VAS) for acute respiratory tract infection symptoms.

Of 146 patients, there were 73 patients in each group. Non-deterioration of WHO CPS scores on day 4 was 98.63% versus 97.26% of patients in the APE-FPV and placebo-FPV groups (p = 1.000). No difference in supplemental oxygen, hospitalization, and death was shown in both groups. The oxygen supplemental was 4.11% in the placebo-FPV group. The interleukin (IL)-1β was significantly lower in the APE than in the placebo-FPV group throughout the study. We found no difference in virologic outcomes between groups and no substantial adverse events.

APE treatment did not demonstrate additional clinical and virological benefits in patients with mild to moderate COVID-19 being treated with favipiravir. Early reduction of IL-1β with APE may be advantageous in preventing cytokine storms in severe COVID-19 and requires further study.

Siripongboonsitti, T., Ungtrakul, T., Tawinprai, K., Auewarakul, C., Chartisathian, W., Jansala, T., … & Mahidol, C. (2023). Efficacy of Andrographis paniculata extract treatment in mild to moderate COVID-19 patients being treated with favipiravir: A double-blind, randomized, placebo-controlled study (APFaVi trial). Phytomedicine, 119, 155018.

Link: https://www.sciencedirect.com/science/article/pii/S0944711323003793

Acute viral pharyngitis is a self-limited disease but the symptoms, a sore throat in particular, can affect one’s quality of life. Medicine for symptom relief is the main treatment. Recently, many studies have shown that Andrographis paniculata was efficacious in treating many diseases, including upper respiratory infections. However, adverse reactions to systemic intake are a concern. Therefore, A. paniculata spray is intended to reduce systemic adverse reactions and provide patients with more comfort as its local use.

This randomized, double-blind study enrolled 60 adult patients with acute viral pharyngitis. All patients were asked to score the severity of symptoms including a sore throat, difficulty swallowing, and coughing using an 11-point numeric rating scale from 0 to 10. A physical examination was performed to score the severity of erythematous and swollen mucosa using a 0-3 score (0 = no, 1 = mild, 2 = moderate, and 3 = severe). The patients were randomized to receive treatment with either an A. paniculata spray or a positive control chamomile spray.

Results revealed a significant reduction in the severity of all signs and symptoms in both groups (p < 0.05). The duration of treatment response in the A. paniculata spray group was 1.9 ± 0.7 days compared to 2.5 ± 1.2 days in the chamomile spray group (p = 0.049). No adverse events were noted in either group. A. paniculata spray is safe and highly efficacious in treating acute viral pharyngitis and can reduce symptoms more rapidly than a positive control spray.

Okonogi, R., Thampanya, V., & Okonogi, S. (2023). Efficacy of Andrographis paniculata spray in acute pharyngitis: A randomized controlled trial. Drug Discoveries & Therapeutics.

Link: https://www.jstage.jst.go.jp/article/ddt/advpub/0/advpub_2023.01053/_article

Reducing inappropriate antibiotic (AB) use by using effective non-antibiotic treatments is one strategy to prevent and reduce antimicrobial resistance (AMR). Andrographis paniculata (Burm. f.) Wall. ex Nees, Pelargonium sidoides DC., Echinacea species and a combination of ivy (Hedera helix L.), primrose (Primula veris L./Primula elatior L.) and thyme (Thymus vulgaris L./Thymus zygis L.) have promising clinical effects in uncomplicated, acute upper respiratory tract infections (URTI) treatment. However, mechanistic evidence of these herbal treatments is lacking.

The objective of this study is to provide an overview of mechanistic evidence for these effects. Thirty-eight databases were searched. Included studies were mechanistic studies (in vitro, animal, and human studies and reviews) on these herbs; published before June 2021. Non-mechanistic studies or studies on combinations of herbs other than ivy/primrose/thyme were excluded. Furthermore, three experts in traditional, complementary and integrative healthcare (TCIH) research and pharmacognosy were interviewed to collect additional expert knowledge.

The results show that A. paniculata acts through immunomodulation and antiviral activity, possibly supplemented by antibacterial and antipyretic effects. P. sidoides acts through antiviral, indirect antibacterial, immunomodulatory and expectorant effects. Echinacea species likely act through immunomodulation. The combination of ivy/primrose/thyme combines secretolytic and spasmolytic effects from ivy with antibacterial effects from thyme. Studies on primrose were lacking. This mechanistic evidence supports the difference-making evidence from clinical studies, contributes to evidence-based recommendations for their use in URTI treatment, and guides future mechanistic studies on URTI treatments.

Veldman, L. B., Belt-Van Zoen, E., & Baars, E. W. (2023). Mechanistic Evidence of Andrographis paniculata (Burm. f.) Wall. ex Nees, Pelargonium sidoides DC., Echinacea Species and a Combination of Hedera helix L., Primula veris L./Primula elatior L. and Thymus vulgaris L./Thymus zygis L. in the Treatment of Acute, Uncomplicated Respiratory Tract Infections: A Systematic Literature Review and Expert Interviews. Pharmaceuticals, 16(9), 1206.

Link: https://www.mdpi.com/1424-8247/16/9/1206