Wirksamkeit und Verträglichkeit eines homöopathischen Komplexmittels (Sinusitis Hevert SL) bei akuter, unkomplizierter Rhinosinusitis: Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie an erwachsenen Patienten

Michalsen, Andreas; Palm, Jürgen; Samer, Holger; Wollmann, Jan-Christoph; Tausend, Sieglinde; Klein, Isabel; Schnitker, J

doi:10.1159/000471922

Cited by 4 publications

(6 citation statements)

References 9 publications

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“…An effective treatment for uncomplicated, acute rhinosinusitis is of great interest since there is a high prevalence and the disease is associated with increased costs due to prescription of antibiotics, doctor's visits and absences due to sickness (7). ARS is often treated with antibiotics even though watchful waiting and symptomatic treatment are recommended while the use of antibiotics is considered in severe cases of ARS (5).…”

Section: Discussionmentioning

confidence: 99%

“…The MSS (Major symptom score) is widely used to evaluate efficacy in clinical trials (7). This study used a MRSS, which is based on the MSS and comprised the five most relevant ARS symptoms namely, anterior and posterior secretion, congested nose, headache and facial pain or pressure.…”

Section: Discussionmentioning

confidence: 99%

“…Further assessment is not necessary even though techniques such as nasal culture or sinus puncture may be used to analyze specific pathogens involved in ARS. In case of severe ARS, imaging techniques like CT (computed tomography) are considered (7) .…”

Section: Introductionmentioning

confidence: 99%

“…With affecting 6 to 15% of the population, ARS is a very common condition and thus, causes significant direct and indirect costs. The former involves costs due to prescriptions, visits and imaging techniques while employees suffering from ARS indirectly create costs due to absence and reduced productivity (7) .…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of The Herbal Combination Containing Tropaeoli Majoris Herba and Armoraciae Rusticanae Radix in Patients Suffering from Uncomplicated, Acute Rhinosinusitis: A Randomized, Double-Blind, Placebo Controlled, Two-Arm, Parallel Group, Phase

Albrecht¹,

Stangeb

Schermuly³

2020

J Current Med Res Opinion

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Objectives: Demonstration of the efficacy and safety of an herbal combination containing horseradish root and nasturtium herb for the treatment of uncomplicated, acute rhinosinusitis. Design: Randomized, double-blind, placebo-controlled, two-arm, parallel group, multicenter, phase IV clinical study. Setting: Sixteen centers in Germany, from October 2017 to March 2018. Participants: Adult patients (≥18 – 75 years, male and female) diagnosed with uncomplicated, acute rhinosinusitis. Interventions: Participants received the herbal combination or placebo (3 x 4 per day) for 14 days. Clinical trial registration: EudraCT 2017-002081-40. Endpoints: Primary endpoint was MRSSinv/MRSSpat documented between day 6 and day 10, computed as AUC, assessed by ANCOVA with day 3 as covariate. MRSSinv/MRSSpat, responder rates, efficacy assessment and SNOT-20 GAV were used as secondary endpoints. Results: Out of 380 randomized participants, 238 were included in the FAS for statistical analysis. Treatment with the herbal combination revealed a significant smaller AUC (14.99) compared to placebo (18.52, p=0.0003). Moreover, MRSSinv/MRSSpat was significantly lower after administration of the herbal combination in comparison to placebo (3.60 herbal combination vs. 4.40 placebo, p=0.0018). Responder rates were significantly higher at visit 3 of patients receiving the herbal combination compared to placebo (92.1% herbal combination vs. 83.3% placebo, p=0.0418). Adverse events occurred in 21.9% and 18.6% of participants receiving the herbal combination and placebo, respectively. Most common adverse events were headaches and gastrointestinal complaints. Conclusion: Efficacy and safety of the herbal combination in comparison to placebo were confirmed while the treatment was well tolerated.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of The Herbal Combination Containing Tropaeoli Majoris Herba and Armoraciae Rusticanae Radix in Patients Suffering from Uncomplicated, Acute Rhinosinusitis: A Randomized, Double-Blind, Placebo Controlled, Two-Arm, Parallel Group, Phase

Albrecht¹,

Stangeb

Schermuly³

2020

J Current Med Res Opinion

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“…The non-existent pharmacological efficacy of homoeopathy was also shown (Michalsen et al 2017) as well as the dangers of using homoeopathic medication instead of antibacterial drugs (episodes 1141, 1095). Meningitis can also develop from a harmless bacterial infection which is shown in episode 1141.…”

Section: Department Of Health and Human Services 2021)mentioning

confidence: 97%

Systematic analysis of the pharmacological content of the Tatort (scene of crime) TV series from 2019 to 2021

Borchert

Seifert

2023

Naunyn-Schmiedeberg's Arch Pharmacol

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Tatort (scene of crime) is a must-see programme on Sunday evenings for many Germans. With its enormous reach, the crime series also deals in more than half of its episodes with active pharmacological substances, surprisingly most of them are used curatively. There are lots of ways representing the active pharmacological substances: simply naming the preparation to details such as information on how to take it or how it is manufactured illegally. Diseases of great interest to the public such as hypertension or depression are taken up. In addition to the correct presentation, in 20% of cases the active pharmacological substances were presented incorrectly or implausibly. But even with correct presentation, it may yield a harmful influence on viewers: Stigmatisation of preparations occurred in 14%, especially in the case of active pharmacological substances that are used in psychiatric therapies; presentations that could be considered dangerous occurred in 21% of the mentions. In 29%, content was presented positively to the audience beyond the correct presentation. Analgesics and active pharmacological substances used in psychiatry are frequently titled. But drugs such as amiodarone, insulin or "cortisone" are also mentioned. The potential for misuse is also presented. Tatort also educates the audience about common diseases and their treatment, for example hypertension, depression or the use of antibacterial drugs. However, the series does not educate the general public on the mechanism of action of commonly used drugs. There is a natural dilemma between informing the public and guiding them to misuse medicines. Finally, we discuss how future episodes could be improved with respect to pharmacological content.

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Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis

Leemhuis,

Seifert

2024

Naunyn-Schmiedeberg's Arch Pharmacol

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The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers’ claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

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Wirksamkeit und Verträglichkeit eines homöopathischen Komplexmittels (Sinusitis Hevert SL) bei akuter, unkomplizierter Rhinosinusitis: Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie an erwachsenen Patienten

Cited by 4 publications

References 9 publications

Efficacy and Safety of The Herbal Combination Containing Tropaeoli Majoris Herba and Armoraciae Rusticanae Radix in Patients Suffering from Uncomplicated, Acute Rhinosinusitis: A Randomized, Double-Blind, Placebo Controlled, Two-Arm, Parallel Group, Phase

Efficacy and Safety of The Herbal Combination Containing Tropaeoli Majoris Herba and Armoraciae Rusticanae Radix in Patients Suffering from Uncomplicated, Acute Rhinosinusitis: A Randomized, Double-Blind, Placebo Controlled, Two-Arm, Parallel Group, Phase

Systematic analysis of the pharmacological content of the Tatort (scene of crime) TV series from 2019 to 2021

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis

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