title: Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women.
abstract: BACKGROUND
  Overactive bladder syndrome (OAB) is a chronic disorder that often requires long-term treatment. There is a growing interest in new substances. In vitro experiments of Bryophyllum pinnatum (BP) on porcine bladder muscle have shown a muscle-relaxing effect. In this clinical trial we evaluated BP versus placebo regarding efficacy and safety.
  
  
  METHODS
  Prospective, double-blind randomized, placebo-controlled study with 20 patients (10 BP, 10 placebo); medication over 8 weeks; dosage 3×2 capsules BP 50% (350 mg)/day or placebo (lactose). Primary aim: reduction of the micturition frequency/24h. Secondary aim: change in quality of life, alterations of parameters in the bladder diary and adverse events (AE). Statistical analysis was performed with IBM SPSS Statistics 20. The groups were compared using Fisher's exact test and the Mann-Whitney test; the visits using the Wilcoxon signed ranks test.
  
  
  RESULTS
  Both groups did not differ significantly in demographical data. For the primary endpoint, a trend in the reduction of the micturition frequency/24h in the BP group was found: 9.5±2.2 before and 7.8±1.2 after BP versus 9.3±1.8 before and 9.1±1.6 after placebo, p=0.064. From visit 2 to visit 4, micturition frequency/24h improved in 8/10 patients in the BP group (p=0.037). In the placebo group, micturition frequency/24h improved in 5/9 patients (p=0.89). Improvement of the QoL did not differ between the two groups. The incidence of AE was similar in both groups, no SAE occurred.
  
  
  CONCLUSIONS
  The successful safety outcome and positive trend for efficacy permits BP to be further evaluated as a favorable treatment option for OAB.
authors.affiliation: Department of Gynecology, University Hospital Zurich, CH-8091 Zurich, Switzerland. cornelia.betschart@gmx.ch
authors.forename: Cornelia
authors.initials: C
authors.lastname: Betschart
authors.forename: Ursula
authors.initials: U
authors.lastname: von Mandach
authors.forename: Burkhardt
authors.initials: B
authors.lastname: Seifert
authors.forename: David
authors.initials: D
authors.lastname: Scheiner
authors.forename: Daniele
authors.initials: D
authors.lastname: Perucchini
authors.forename: Daniel
authors.initials: D
authors.lastname: Fink
authors.forename: Verena
authors.initials: V
authors.lastname: Geissbühler
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D031962:Kalanchoe; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D017698:Postmenopause; D011446:Prospective Studies; D011788:Quality of Life; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D010936:Plant Extracts