Pelargonium Sidoides (Umckaloabo)

1. Phytomedicine. 2007;14 Suppl 6:40-5. doi: 10.1016/j.phymed.2006.11.026. Epub 2006 Dec 22. Treatment of rats with the Pelargonium sidoides extract EPs 7630 has no effect on blood coagulation parameters or on the pharmacokinetics of warfarin. Koch E(1), Biber A. Author information: (1)Preclini

BACKGROUND: Pelargonium sidoides DC. (Geraniaceae) has a long history of traditional use among indigenous peoples of Southern Africa for treating respiratory and gastrointestinal disorders. Its transformation into the modern pharmaceutical product Umckaloabo (EPs® 7630) exemplifies the transition from traditional medicine to evidence-based therapeutics. PURPOSE: To provide a systematic analysis of P. sidoides, spanning from its botanical characteristics and ethnobotanical roots to its development as a regulated phytomedicine. The review focuses on the plant's unique phytochemical profile and provides a detailed synthesis of its molecular and systems-biological mechanisms of action, cultivation sustainability, and clinical efficacy in managing respiratory tract infections. STUDY DESIGN AND METHODS: A systematic search was conducted across PubMed, Scopus, and Cochrane Library up to December 2025 following PRISMA guidelines. Sources included scientific articles, pharmacopoeias, patents, and ethnobotanical records in English and Ukrainian. RESULTS: The systematic synthesis of identified records characterizes the chemical diversity of P. sidoides, focusing on specialized metabolites such as highly substituted benzopyranones, prodelphinidins, and unique coumarin sulfates. The review discusses modern cultivation practices, sustainability issues, and comparative extraction techniques, while analytical methods such as HPLC, LC-MS, and TLC for standardization are summarized. The pharmacological profile is defined by multi-target activity, encompassing immunomodulatory, antibacterial, and antiviral effects, including studies on SARS-CoV-2 and other respiratory pathogens. Analysis of available clinical data validates the therapeutic use of P. sidoides root preparations for managing acute bronchitis, rhinosinusitis, and tonsillopharyngitis. CONCLUSION: This study demonstrates that the integration of P. sidoides into modern healthcare is supported by the synergy between traditional knowledge and molecular and clinical validation. By mapping the developmental trajectory - from wild harvesting to systems-biological evidence - this review identifies P. sidoides as a model for th

Herbal medicine is a promising alternative in the treatment of acute rhinosinusitis (ARS). We performed a systematic review for phytopharmaceutical treatments of ARS. A computerized search of databases (Cochrane Library, PubMed, and Scopus) up to 16 September 2015 was performed. Randomized controlled trials (RCTs) and controlled trials (CTs) were included and assessed using the Cochrane risk of bias tool. Seven trials on Pelargonium sidoides (EPs 7630, Umckaloabo®), Myrtol (GeloMyrtol® forte), BNO 1016 (Sinupret® extract), BNO 101 (Sinupret®), Cyclamen europaeum (Nasodren®), and Esberitox® were included. Risk of bias was heterogeneous. EPs 7630 appeared to be useful in the treatment of ARS. Myrtol showed benefits against a placebo compound, and BNO 1016 and BNO 101 might be helpful; however, there was little evidence for the effectiveness of Cyclamen europaeum and Esberitox®. Herbal medicine might be effective for the treatment of ARS, but given the low number of clinical trials and the heterogeneous methodological quality, further research is necessary. © 2016 S. Karger GmbH, Freiburg.

BACKGROUND: Pelargonium sidoides (P. sidoides), also known as Umckaloabo, is a herbal remedy thought to be effective in the treatment of acute respiratory infections (ARIs). OBJECTIVES: To assess the efficacy and safety of P. sidoides for the treatment of ARIs in children and adults. SEARCH METHODS: In April 2013 we searched MEDLINE, Journals@Ovid, The Cochrane Library, Biosis Previews, Web of Science, CINAHL, CCMed, XToxline, Global Health, AMED, Derwent Drug File and Backfile, IPA, ISTPB + ISTP/ISSHP, EMBASE, Cambase, LILACS, PubMed component "Supplied by Publisher", TRIPdatabase, the publisher databases: Deutsches Ärzteblatt, Thieme, Springer, ScienceDirect from Elsevier. We conducted a cited reference search (forward) in Web of Science of relevant papers for inclusion. In addition we searched the study registries ClinicalTrials.gov, Deutsches Register klinischer Studien DRKS (German Clinical Trials Register), International Clinical Trials Registry Platform (ICTRP) - WHO ICTRP, Current Controlled Trials and EU Clinical Trials Register. SELECTION CRITERIA: Double-blind, randomized controlled trials (RCTs) examining the efficacy of P. sidoides preparations in ARIs compared to placebo or any other treatment. Complete resolution of all symptoms was defined as the primary outcome; in addition, we examined resolution of predefined key symptoms. DATA COLLECTION AND ANALYSIS: At least two review authors (AT, JG, WK) independently extracted and quality scored the data. We performed separate analyses by age group and disease entity. Subanalysis considered type of preparation (liquid, tablets). We examined heterogeneity using the I(2) statistic. We calculated pooled risk ratios (RR) using a fixed-effect model if heterogeneity was absent (I(2) < 5%; P > 0.1), or a random-effects model in the presence of heterogeneity. If heterogeneity was substantial (I(2) > 50%; P < 0.10), a pooled effect was not calculated. MAIN RESULTS: Of 10 eligible studies eight were included in the analyses; two were of insufficient quality. Three trials (746 patients, low quality of evidence) of efficacy in acute bronchitis in adults showed effectiveness for most outcomes in the liquid preparatio

An evidence-based systematic review, including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

BACKGROUND: Pelargonium sidoides (P. sidoides), also known as Umckaloabo, is a herbal remedy thought to be effective in the treatment of acute respiratory infections (ARIs). OBJECTIVES: To assess the efficacy and safety of P. sidoides for the treatment of ARIs in children and adults. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 4) which includes the Cochrane Acute Respiratory Infections Group's Specialised Register; MEDLINE (1966 to November 2007); EMBASE (1974 to December 2007); and other electronic databases. SELECTION CRITERIA: Randomized controlled trials (RCTs) examining the efficacy of P. sidoides preparations in ARIs compared to placebo, no treatment or any other treatment. Complete resolution of all symptoms was defined as a primary outcome. DATA COLLECTION AND ANALYSIS: Three review authors (AT, JG, WK) independently extracted and quality scored the data. Separate analyses were performed by age group and disease entity. Heterogeneity was examined using the I-square (I(2)) statistic. Pooled relative risks (RR) were calculated using a fixed-effect model if heterogeneity was absent (I(2) < 5%; P > 0.1), or a random-effects model in the presence of heterogeneity. If heterogeneity was substantial (I(2) > 50%; P < 0.10), a pooled effect was not calculated. MAIN RESULTS: Three trials (746 patients) of efficacy in acute bronchitis in adults showed substantial heterogeneity for all relevant outcomes. and three trials (819 children) were similarly inconsistent for acute bronchitis in children. Type of preparation was a potential cause of heterogeneity (not effective in tablet form). One unpublished study in patients with sinusitis (n = 103 adults) showed significant treatment effects (complete resolution at day 21; RR 0.43, 95% CI 0.30, 0.62). One study in the common cold demonstrating efficacy after 10 days, but not five days. Four trials were excluded because of excessive risk of bias. There were no valid data for the treatment of other acute respiratory tract infections. Adverse events were more common with P. sidoides, but none were serious. AUTHORS' CONCLUSIONS: P. sidoides may be

BACKGROUND: A dietary supplement containing Pelargonium sidoides extract, propolis, zinc, and honey has been recently developed and proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders. OBJECTIVE: This trial aims to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis (ATR). METHODS: The trial includes children aged between 3 and 10 years with ATR ≤48 h, a negative rapid test for beta-hemolytic streptococcus or culture identification of nasal and/or pharyngeal exudates, and SARS-CoV-2 infection. The dietary supplement tested is an oral solution already on the market based on Pelagon P-70 (equivalent to Pelargonium sidoides d.e. 133.3 mg/100 ml), propolis, zinc, and honey. The product is administered at 5 ml 3 times a day for 6 days for children younger than 6 years and 10 ml 3 times a day for 6 days for children older than 6 years. The study design is open label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from 3 sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary end points. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 (SD 3.85) points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children. RESULTS: Patient enrollment began on June 3, 2021 (first patient's first visit), and ended on August 12, 2021 (last patient's last visit). The data collection period was from June 3, 2021, to September 16, 2021. The study was funded in February 2023. Data analysis is currently ongoing (April 2024). We expect the results to be published in a peer-reviewed clinical journal in the third quarter of 2024 and presented at scientific meetings in the last quarter of 2024. CONCLUSIONS: The data from this trial

PURPOSE OF REVIEW: To analyze and compare the effects of herbal medicines (HMs) for treating different forms of rhinosinusitis. RECENT FINDINGS: Forty-seven randomized controlled trials evaluating 18 HMs in six different rhinosinusitis populations were included in the network meta-analysis. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. For the common cold, Pelargonium sidoides offered the most beneficial effect on symptom improvement (moderate certainty of evidence). For acute post-viral rhinosinusitis, Cineole and Pelargonium sidoides were the most effective treatments for controlling symptoms (moderate certainty), while Spicae aetheroleum was most effective for health-related quality of life (HRQoL) improvement (moderate certainty). For chronic rhinosinusitis without nasal polyps (CRSsNP), Origanum vulgare was the most beneficial treatment for improving symptoms and HRQoL (low certainty). Evidence of HMs for acute bacterial rhinosinusitis, chronic rhinosinusitis with nasal polyps, and unclassified chronic rhinosinusitis was restricted to a limited number of studies. Adverse events should be of concern in some HMs, such as Spicae aetheroleum or Mytorl. Several HMs improved patient-important outcomes, above minimal clinically important differences, in treating common cold, acute post-viral rhinosinusitis, and CRSsNP. Further studies with adequate sample sizes and long-term follow-ups are warranted to support the current evidence. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: PROSPERO ID: CRD42022328265 May 10, 2022. © 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

We aimed to assess whether Pelargonium sidoides extract (EPs®7630) reduces symptom duration or antibiotic use compared with usual care in adults with acute bronchitis. We conducted a pragmatic randomised-controlled trial across 36 primary care practices and five walk-in clinics in Switzerland. Adults ( ≥ 18 years) consulting a general practitioner for the first time for a new episode of acute bronchitis, with a cough of up to eight days' duration, were eligible for inclusion. The co-primary outcomes were (1) number of days required to achieve a 50% reduction in symptoms from the peak value, assessed using the Acute Bronchitis Severity Score (ABSS), and (2) the proportion of participants who used antibiotics. Missing data in intention-to-treat (ITT) analyses were multiply imputed. 332 participants were enrolled and randomly assigned: 155 to EPs®7630 and 177 to usual care. Neither co-primary outcomes showed a statistically significant difference between groups. No significant difference in time to 50% reduction of symptoms between the EPs®7630 and usual care groups was observed (adjusted regression coefficient 0.05 [95% CI - 0.13-0.23]; p = 0.578). Antibiotic use was 7 percentage points lower (31% relative reduction) in the EPs®7630 group (17.4%, 20 of 155) than in the usual care group (25.2%, 33 of 177), although the difference was not statistically significant (adjusted risk ratio 0.78 [95% CI 0.49-1.26]; p = 0.309). Adverse events were reported more frequently in the EPs®7630 group (32.3%, 50 of 155) than in the usual care group (21.5%, 38 of 177; hazard ratio 1.40 [95% CI 1.03-1.89]; p = 0.030); all adverse drug events were mild. EPs®7630 did not reduce symptom duration or antibiotic use significantly and was associated with more frequent events, that were all mild and previously described. Despite the absence of statistical significance, the observed reduction in antibiotic use warrants further investigation in larger trials to clarify its potential role within antimicrobial stewardship strategies. © 2026. The Author(s).

BACKGROUND: Acute bronchitis is the most common respiratory disease. Mixture of Ivy Leaf Extract and Coptidis rhizome syrup has shown good treatment efficacy against chronic bronchitis and acute respiratory infections. This study aimed to evaluate the efficacy and safety of Mixture of Ivy Leaf Extract and Coptidis rhizome compared with those of Pelargonium sidoides extract, for the treatment of acute bronchitis. METHODS: We performed a multicenter, randomized, double-blind, active-controlled, parallel phase III study in 220 patients with acute bronchitis. The participants were offered either Mixture of Ivy Leaf Extract and Coptidis rhizome syrup (AGS) and placebo of P. sidoides tablet or placebo syrup and active tablet of P. sidoides (AGU) for 7 days. The primary endpoint was the change in the Bronchitis Severity Score (BSS) from the baseline visit (visit 2) to day 7 (visit 3). RESULTS: For the primary outcome, there was no significant difference in the change of total BSS between visits 2 and 3 (-4.10 ± 1.93 vs. -4.24 ± 1.85, p = 0.5125), and since the upper limit of the confidence interval (1.00) was smaller than the predetermined non-inferiority margin (1.17), it was confirmed that the AGS group was non-inferior to the AGU group. The changes in each symptom in the BSS between visits 2 and 3 also showed no significant differences. The overall improvement rate measured by the investigator (91.7 vs. 89.7%; p = 0.3506) and the satisfaction rate of the participants at visit 3 also showed no significant differences (97.2 vs. 94.4%; p = 0.4388). Regarding safety issues, adverse reactions were noted in both groups similarly, with no serious adverse events (4.55 vs. 3.64%, p > 0.999). CONCLUSION: Mixture of Ivy Leaf Extract and Coptidis rhizome syrup is as effective and safe as P. sidoides in controlling symptoms of acute bronchitis.

BACKGROUND/AIMS: DW1601, an oral fixed dose combination syrup composed of DW16011 and Pelargonium sidoides, was developed to enhance the symptom relief effect in patients with acute bronchitis. We evaluated the efficacy and safety of DW1601 compared to DW16011 or P. sidoides for treatment of acute bronchitis using a randomized, double-blind, placebocontrolled, multi-centre trial design. METHODS: A total of 204 patients with acute bronchitis was randomized 1:1:1 to receive DW1601 (n = 67), DW16011 (n = 70), or P. sidoides (n = 64) for 7 days. The primary outcome was efficacy of DW1601 compared to DW16011 or P. sidoides in reducing the total bronchitis severity score (BSS) at day 4 of treatment. Secondary endpoints were changes in total and symptomspecific BSS, response rate and patient satisfaction rate. Safety analysis was assessed at day 7. RESULTS: At 4 days after medication, decrease of total BSS from baseline was significantly greater in the DW1601 group than in the DW16011 group (-3.51 ± 0.18 vs. -2.65 ± 0.18, p = 0.001) or P. sidoides group (-3.56 ± 0.18 vs. -2.64 ± 0.19, p &lt; 0.001). In addition, the BSS total score at day 7 and the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or P. sidoides group. Participants treated with DW1601 showed higher rates of response and satisfaction than control groups (response rate, DW1601, 100% vs. DW16011, 85.7% vs. P. sidoides, 85.9%; satisfaction rate, DW1601, 92.6% vs. DW16011, 82.9% vs. P. sidoides, 81.2%). Significant adverse events were not observed in the DW1601 group. CONCLUSION: DW1601 is superior to DW16011 or P. sidoides in improving symptoms of acute bronchitis.

Upper respiratory tract infections (URTIs) are a condition characterized by upper airway inflammation often caused by viruses in humans. The present study aimed to assess the effectiveness of the liquid herbal drug preparation from the root extracts of Pelargonium sidoides in improving symptoms of uncomplicated URTIs. One hundred sixty-four patients with URTI were randomized and given either verum containing the root extracts of Pelargonium sidoides (n = 82) or a matching placebo (n = 82) in a single-blind manner for 7 days. The median total scores of all symptoms (TSS) showed a significant decreasing trend in the group treated with the root extracts derived from Pelargonium sidoides compared to the placebo group from day 0 to day 7 (TSS significantly decreased by 0.85 points in the root extract group compared to a decrease of 0.62 points, p = 0.018). "Cough frequency" showed a significant improvement from day 0 to day 3 (p = 0.023). There was also detected a significant recovery in "sneezing" on day 3 via Brunner-Langer model, and it was detected that the extract administration given in the first 24 h onset of the symptoms had provided a significant improvement in day 0 to day 3 (difference of TSS 0.18 point, p = 0.011).Conclusion: The findings of the study revealed that the Pelargonium sidoides extracts are effective in relieving the symptom burden in the duration of the disease. It may be regarded as an alternative option for the management of URTIs. What is Known: • Upper respiratory tract infections (URTIs), an inflammation on the upper airways, are the most common infectious disease in children. • Pelargonium sidoides, a traditional medicinal plant native to South Africa, is one of the ornamental geraniums that is thought to be effective in treating URTIs What is New: • It may be revealed that the dried root extract of Pelargonium sidoides compared with placebo might be an alternative treatment in improving the symptoms such as dry cough, sneezing, and relieving cough frequency. • The administration of the root extract at the onset of URTIs' signs may be regarded as an adjunctive option for the management of URTIs due to its effectiveness in decreasing the

BACKGROUND: Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. STUDY DESIGN: Feasibility double-blind randomised placebo-controlled clinical trial. METHODS: We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. RESULTS: Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. CONCLUSION

OBJECTIVE: Previous investigations suggest the use of extract from the root of Pelargonium sidoides (EPs 7630) for the therapy of uncomplicated acute upper airway inflammations, due to its strong antimicrobial and immunomodulatory effect. We aimed to compare clinical efficacy, safety and bactericidal effect of EPs 7630 and amoxicillin monotherapy in treatment of patients with mild to moderate acute bacterial rhinosinusitis (ABRS). METHODS: Fifty ABRS patients were divided into two groups by randomization. Group 1 (n = 25) received EPs 7630 tablets, 3 × 20 mg/day per os for 10 days. Group 2 (n = 25) received amoxicillin tablets 3 × 500 mg/day per os, for 10 days. We assessed total symptom score (TSS), individual symptom scores for each symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, loss of the sense of smell), endoscopic findings, including total endoscopic score (TES) and individual endoscopic signs (mucosal edema, mucopurulent secretion), before and after treatment. Samples of discharge taken from the middle meatus of all patients were cultivated for bacteria before and after therapy. RESULTS: Higher absolute improvement after treatment was found for TSS, nasal obstruction, facial pain/pressure, impaired sense of smell, TES, mucosal edema and mucopurulent secretion in EPs 7630 group compared to amoxicillin group (P < .001 for all parameters). However, there were no differences in absolute improvement of rhinorrhea score and postnasal drip score between groups (P = .248; P = .679, respectively). Fewer types of bacteria grew on culture from middle meatal samples in EPs 7630 group compared to amoxicillin group. There were no reported adverse events from patients from either group. CONCLUSION: Our results demonstrated better clinical and antimicrobial efficacy of EPs 7630 than amoxicillin. EPs 7630 was shown as a potent agent and good alternative to antibiotic treatment of uncomplicated ABRS.

OBJECTIVE: Our review summarizes published literature of complementary and alternative medicine (CAM) used for the treatment of acute bronchitis in children. BACKGROUND: Acute bronchitis is one of the most frequent pediatric diseases and has high prevalence for in- and outpatient care. Acute bronchitis is mainly a viral-caused infection, but a high and inappropriate use of antibiotics has been demonstrated in many countries. As CAM therapies might reduce the use of antibiotics and can complement conventional therapies in children, they could be an appropriate treatment option. METHODS: A systematic literature search was conducted using general and complementary and alternative medicine (CAM)-specific databases. A search term including 65 CAM-associated definitions was applied. RESULTS: Literature search revealed 309 articles, whereby 18 articles hit search criteria. These clinical trials were subgrouped into the categories herbal medicine, anthroposophic medicine and homeopathy. The most often studied approaches are herbal remedies, in particular the Pelargonium sidoides extract, EPs® 7630. Its efficacy was demonstrated in three placebo-controlled trials and two observational studies. Anthroposophic approaches (mainly ribwort-containing remedies) were investigated in two controlled trials and three observational studies. Two studies were found investigating the homeopathic remedies Monapax® and Droperteel®. CONCLUSION: Study results indicate a favorable effect of investigated CAM approaches. However, only three of 18 studies were randomized controlled trials (RCTs), so a reliable statement on effectiveness was not possible and further RCTs are indispensable.

OBJECTIVE: Patient-reported outcomes (PRO) such as health-related quality-of-life (HRQoL) belong to the most important criteria for the evaluation of medical therapies in clinical trials or practice-based benefit assessments. This study, therefore, revisited results of an earlier published clinical trial investigating the effects of the herbal drug preparation from the roots of Pelargonium sidoides EPs 7630, administered as add-on therapy in patients suffering from chronic obstructive pulmonary disease (COPD), with respect to HRQoL and other PRO. METHODS: A total of 199 adults diagnosed with COPD stages II/III and receiving standard treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) were randomly assigned to add-on therapy with EPs 7630 or placebo for 24 weeks. HRQoL (disease-specific St. George's Respiratory Questionnaire, SGRQ; current HRQoL state according to the EuroQuol visual analog scale, EQ VAS) and PRO (Integrative Medicine Outcomes Scale, IMOS; Integrative Medicine Patient Satisfaction Scale, IMPSS; symptom severity score of cough, sputum production and sternal pain while coughing; duration of inability to work) were assessed at each study visit or documented daily by the patient in a patient diary, respectively. RESULTS: At week 24, all HRQoL and PRO measures showed a more pronounced improvement under EPs 7630 than under placebo (EQ VAS, p < .001; SGRQ total score, p < .001; symptom severity score of cough, sputum production, and sternal pain while coughing, p = .021; duration of inability to work, p = .004; two-sided t-test each; IMOS, p < .001, IMPSS, p < .001, two-sided Mantel-Haenszel test each). Moreover, the difference seen for the SGRQ exceeded the SGRQ minimal clinically important difference (MCID) threshold of 4 points. CONCLUSIONS: Add-on therapy with EPs 7630 led to an improvement in HRQoL and other PRO in adult patients with COPD compared to placebo while showing a good long-term tolerability.

OBJECTIVE: Pelargonium sidoides preparation EPs 7630 has been proven safe and effective in acute respiratory tract infections (aRTIs), but data for young children have not been presented separately. This study reviewed clinical studies and presents an overview of known and newly analyzed data from children <6 years. METHODS: MEDLINE and EMBASE were searched for interventional and non-interventional studies which investigated the effects of EPs 7630 in aRTIs and included children <6 years of age. Sub-group analyses for this age range were performed for symptom scales, global efficacy or effectiveness assessments, and safety outcomes. RESULTS: Seven studies with 1067 children <6 years exposed to EPs 7630 were identified. Efficacy of EPs 7630 was significantly superior to placebo in reducing symptom intensity and time until complete recovery in two randomized, double-blind trials in patients with acute bronchitis (AB). Similar symptom time courses were observed in two non-comparative observational studies in AB. One non-comparative, open-label study was identified in acute tonsillopharyngitis (ATP), and one in acute rhinosinusitis (ARS). In both indications, nearly all children showed complete recovery or major symptom improvements during the treatment period, with changes that were similar to those observed in controlled trials investigating older patient populations. The results were supported by an additional observational study including children with various diagnoses of aRTIs. EPs 7630 was safe and well-tolerated. CONCLUSIONS: EPs 7630 is efficacious in children <6 years suffering from AB. The analyses also support the effectiveness of the product in ATP and in ARS. No safety concerns were identified.

12. Altern Ther Health Med. 2018 Mar;24(2):16-26. Efficacy and Tolerability of High-dose Pelargonium Extract in Patients With the Common Cold. Riley DS, Lizogub VG, Zimmermann A, Funk P, Lehmacher W. Context • The common cold (CC) is usually caused by a viral infection. Antibiotics are often prescribed unnecessarily for it, although no evidence exists for any benefit in the CC. Effective alternatives are needed. Objective • The study intended to evaluate the efficacy of 7630, a proprietary extract of Pelargonium sidoides, the active ingredient in umckaloabo, compared with a placebo for the treatment of the CC. Design • This was a prospective, double-blind, parallel-group, placebo-controlled, phase 3 clinical trial (RCT), with an adaptive group-sequential design with 2 parts, both of which were 2-arm trials. The first used a standard dose (SD) of 3 × 30 drops per day of the active medication and the second used a high dose (HD) of 3 × 60 drops per day of the active medication, against 3 × 30 drops per day and 3 × 60 drops per day of a placebo, respectively. Setting • The study took place in 8 outpatient departments affiliated with hospitals. Participants • For the entire study, 207 adults with predefined cold symptoms that had been present for 24 to 48 h prior were included in the study, with 103 participating in the SD part and 104 participating in the HD part. Intervention • In the HD part, as covered in this article, the intervention group received treatment with 3 × 60 drops per day of the active medication and the control group received a placebo (control group), for a maximum period of 10 d. Outcome Measures • The primary outcome measure was the sum of differences in the cold intensity score (CIS) from day 1 to day 3 and from day 1 to day 5, defined as the sum of the symptom intensity differences (SSID). The criteria for the secondary outcome, efficacy, were (1) diverse response criteria according to the total CIS; (2) changes in individual CIS symptoms; (3) changes in further cold-relevant symptoms; (4) ability to work; (5) activity level; (6) general well-being; (7) health-related quality of life-the EuroQol questionnaire with 5 dimensions (EQ-5D), inc

OBJECTIVES: To elucidate the benefits, pitfalls and risks of phytotherapy in the clinical practice of otorhinolaryngology. MATERIAL AND METHODS: The PubMed and Cochrane databases were searched using the following keywords: phytotherapy, phytomedicine, herbs, otology, rhinology, laryngology, otitis, rhinitis, laryngitis and otorhinolaryngology. Seventy-two articles (18 prospective randomized studies, 4 Cochrane analyses, 4 meta-analysis and 15 reviews of the literature) devoted to clinical studies were analyzed. Articles devoted to in vitro or animal studies, biochemical analyses or case reports (including fewer than 10 patients) and articles dealing with honey, aromatherapy or minerals were excluded. RESULTS: Per os ginkgo biloba has no indications in tinnitus, presbycusis or anosmia following viral rhinitis. Traditional Asian medicine has no proven benefit in sudden deafness or laryngeal papillomatosis. Per os mistletoe extracts associated to conventional treatment for head and neck squamous cell carcinoma does not increase 5-year survival. Extracts of various herbs, notably echinacea, eucalyptus, petasites hybridus, pelargonium sidoides, rosemary, spirulina and thyme, show superiority over placebo for rhinosinusitis and allergic rhinitis, as does gingko biloba for selected vertigo. There have been encouraging preliminary results for intratumoral injection of mistletoe in head and neck carcinoma and acupoint herbal patching for allergic rhinitis. Herb intake should be screened for in case of certain unexplained symptoms such as epistaxis, headache or dizziness, or signs suggesting allergy. Phytotherapy should be interrupted ahead of surgery and/or chemotherapy. CONCLUSION: Scientific proof of the benefit of phytotherapy in otorhinolaryngology remains to be established but, given its widespread use and the reported data, knowledge of this form of treatment needs to be developed.

OBJECTIVE: Diagnosis and assessment of response to treatment in acute bronchitis depends on clinical findings. We evaluated published data on the Bronchitis Severity Score (BSS) used to diagnose acute bronchitis and to evaluate the impact of treatment in clinical studies. METHODS: We conducted a literature search using PubMed (search terms: acute bronchitis, treatment, score, and BSS; publication date April 2012 or earlier) and asked the manufacturer for relevant publications. Articles were reviewed and relevant studies were classified according to author, study design, measurements made and duration of study, study drug(s), outcome, and statistical significance. RESULTS: The medication most frequently evaluated by the BSS is a herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630). The BSS consistently demonstrated statistically significant differences between active treatments and placebo as well as between different doses of active treatment. The proportion of responders was considerably higher in the EPs 7630 group than in the placebo group. Because of the subjective components of the BSS, inter-individual differences in results may exist. However, the BSS outcome was supported by the results of secondary outcome measures, such as the Integrated Medicine Patient Satisfaction Scale (IMPSS), documenting that patients were more often 'satisfied' or 'very satisfied' with EPs 7630 than placebo. CONCLUSIONS: We recommend further use of the BSS as a reliable and convenient clinical trial tool for selecting and evaluating patients in studies of acute bronchitis. Improvement in the BSS correlates with outcomes reported by these patients.