| Title |
Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis
|
|---|---|
| Published in |
Research and Reports in Urology, March 2017
|
| DOI | 10.2147/rru.s121203 |
| Pubmed ID | |
| Authors |
Rainer Stange, Berthold Schneider, Uwe Albrecht, Valentina Mueller, Joerg Schnitker, Andreas Michalsen |
| Abstract |
To demonstrate non-inferiority of an herbal combination (horseradish root and nasturtium herb) to an antibiotic (co-trimoxazole) in acute uncomplicated cystitis. Randomized, prospective, double-blind, double-dummy, multicenter, phase III clinical study, using block randomization of 4 blocks (size 2). Twenty-six centers in Germany, from May 2011 to June 2013. Adult patients (median age, 38.5 years; 90% female) with acute uncomplicated cystitis confirmed via urinalysis and bacterial counts. Patients received the herbal combination (five tablets, four times per day) or the antibiotic (two tablets daily) for a period of 7 or 3 days, respectively, followed by a 21-days without drug treatment. Placebos ensured blinding. The primary endpoint was the percentage of responders, expressed as reduction of germ count from >10(5) to <10(3) CFU/mL of pathogens between visit 1 (day 0) and 3 (day 15). Secondary endpoints included change of symptom scores, duration of symptoms, efficacy assessments, relapse frequency, and safety. A sample size of 178 patients per group was estimated. Of the 96 randomized patients (intent-to-treat; 45 in the phytotherapy group, 51 in the antibiotic group), 51 were considered per-protocol patients (22 in the phytotherapy group, 29 in the antibiotic group). Responder rates were 10/22 (45.5%) for the phytotherapy group and 15/29 (51.1%) for the antibiotic group (group difference: -6.27% [95% CI: -33.90%-21.3%]). The study was terminated prematurely due to slow recruitment rates. Non-inferiority could not be assumed by predefined criteria. During the follow-up period, one relapse occurred in each group. Both treatments were well tolerated. This clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of future trials. Issues that led to the premature trial discontinuation were considered. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Australia | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 34 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 34 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 9 | 26% |
| Student > Bachelor | 5 | 15% |
| Student > Doctoral Student | 5 | 15% |
| Other | 3 | 9% |
| Researcher | 2 | 6% |
| Other | 6 | 18% |
| Unknown | 4 | 12% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 11 | 32% |
| Biochemistry, Genetics and Molecular Biology | 4 | 12% |
| Nursing and Health Professions | 4 | 12% |
| Agricultural and Biological Sciences | 3 | 9% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 6% |
| Other | 5 | 15% |
| Unknown | 5 | 15% |
Attention Score in Context
This research output has an Altmetric Attention Score of 10. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 16 January 2021.
All research outputs
#3,839,854
of 25,584,565 outputs
Outputs from Research and Reports in Urology
#33
of 251 outputs
Outputs of similar age
#67,283
of 324,971 outputs
Outputs of similar age from Research and Reports in Urology
#2
of 3 outputs
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