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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

Research and Reports in Urology Aug 12, 2017

Stange R, et al. – The efficacy and safety of an herbal combination (horseradish root and nasturtium herb) were compared with an antibiotic (co–trimoxazole) in acute uncomplicated cystitis. Outcomes indicated comparable efficacy of the herbal combination and antibiotic. Whereas, non–inferiority of the herbal combination to co–trimoxazole was not proved. These findings were important for further research work.

Methods

  • This study included adult patients (median age, 38.5 years; 90% female) with acute uncomplicated cystitis confirmed via urinalysis and bacterial counts. 
  • In this study, 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 percentage of responders, expressed as reduction of germ count from >105 to <103 CFU/mL of pathogens between visit 1 (day 0) and 3 (day 15) was considered as the primary endpoint.
  • Change of symptom scores, duration of symptoms, efficacy assessments, relapse frequency, and safety were the secondary endpoints.
  • A sample size of 178 patients per group was estimated.

Results

  •  Out of 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%]).
  • Due to slow recruitment rates, the study was terminated prematurely.
  • By predefined criteria, non–inferiority could not be assumed.
  • During the follow–up period, one relapse occurred in each group.
  • Both treatments were well tolerated

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