| アブストラクト | Recent literature has assessed the potential of Echinacea products to reduce respiratory tract infections (RTIs) and antibiotic use but has not comprehensively evaluated safety within a risk-benefit framework. Our systematic review and meta-analysis reviewed relevant databases for adverse events (AEs) in clinical trials comparing oral Echinacea (all species and preparations) with placebo, active or no-treatment groups. AEs were classified by System Organ Class (SOC) and compared with individual case safety reports (ICRs) from EudraVigilance (EVDAS). Across 48 clinical studies (N = 10,115), 2,396 AEs were reported. AE occurrence was lower in Echinacea groups compared with any control (22.7% vs. 24.8%, p = 0.014) and to placebo control only (29.1% vs. 32.3%; p = 0.005). In therapeutic settings, after excluding pressed juice formulations, Echinacea significantly reduced AEs by up to 21.1% (19.8% vs. 25.1%; p < 0.0001). Preventive studies in healthy participants showed comparable AE rates between Echinacea and control groups (21.3% vs. 22.3%; p = 0.411). Serious AEs (SAEs) accounted for 0.09% and 0.08% of events for Echinacea and any control, respectively; no fatal SAEs were reported. Spontaneous EVDAS reports mostly concerned gastrointestinal (17.7%), general (13.1%), and nervous system disorders (10.3%, e.g. headache), whereas skin and subcutaneous tissue events (16.1%) were less prominent in clinical trials, which predominantly investigated high-quality pharmaceutical extracts.Principally, oral Echinacea products demonstrate a high level of safety, with preparation-dependent qualitative differences. Pharmaceutical-grade ethanolic extracts showed further reductions in AEs versus control, possibly reflecting clinical efficacy and supporting positive risk-benefit evaluation for RTI management and antibiotic stewardship. |
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| 投稿者 | Ogal, Mercedes; Willcox, Merlin; Bauer, Rudolf; Johnston, Sebastian L; Kreft, Samo; Booker, Anthony; Schapowal, Andreas; Roux, Danielle; Gancitano, Giuseppe; Stange, Rainer |
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| 組織名 | Integrative Medizin Innerschweiz AG, Pediatric Clinic, Switzerland, Brunnen.;University of Southampton, Primary Care and Population Science, United Kingdom of;Great Britain and Northern Ireland, Southampton.;University of Graz, Institute of Pharmaceutical Sciences, Austria, Graz.;Imperial College London, National Heart and Lung Institute, England, United;Kingdom of Great Britain and Northern Ireland, London.;University of Ljubljana, Faculty of Pharmacy, Slovenia, Ljubljana.;"Sodobna fitoterapija" phytotherapy school, Slovenia, Divaca.;University of Westminster, Research Centre for Optimal Health, United Kingdom of;Great Britain and Northern Ireland, London.;UCL School of Pharmacy, Research Group 'Pharmacognosy and Phytotherapy', England,;United Kingdom of Great Britain and Northern Ireland, London.;Schweizerische Medizinische Gesellschaft fur Phytotherapie, Schweizerische;Medizinische Gesellschaft fur Phytotherapie, ZH, Switzerland, Zurich.;Phytotherapie europeenne, Phytotherapie europeenne, France, Paris.;University of Florence, Department of Experimental and Clinical Medicine, Italy,;Florence.;Immanuel Krankenhaus Berlin, Department of Internal and Integrative Medicine,;Germany, Berlin. |
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