A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Adjuvant Treatment With Compound Cranberry Extract Tablets (UmayC) in Acute Bacterial Cystitis.

Introduction

Acute bacterial cystitis is a common and bothersome disease with a rapid onset nature. Uncomplicated cystitis occurs in patients without anatomical or physiological anomaly in the lower urinary tract. Although the infection is not life threatening in immuno-competent patients, the associated lower urinary tract symptoms cause massive impact on the quality-of-life of the victims. The voiding symptoms, such as urinary frequency, urgency, dysuria and suprapubic pain, were associated with the inflammatory response to microbial invasion. In most clinical scenario, 3-day empirical oral antimicrobial treatment could eradicate the pathogen efficiently.1,2 However, the lower urinary tract symptoms were not eradicated effectively by antibiotics only. In daily clinical practice, several symptomatic relieving treatments were applied while acute infection presented, including pyridine and anticholinergic agents. However, several side effects were complained according to the medication.

In lower urinary tract infection, the virulence of the pathogen was the major factor associated with colonization and invasion in the urinary tract mucosa. The adherence of the pathogen to the urothelium is the crucial step in the urinary tract infection.3 Several studies revealed good anti-adherence effect of the cranberry juice.4-7 In several clinical studies, cranberry juice has been proven to be an protective effect in bacterial cystitis8 and the role of cranberry juice in preventing urinary tract infection was well established.9,10 Cranberry is a rich source of bioactive compounds, such as phenolic acid and several organic acids, which have been proven playing major anti-bacterial effect.11

In literature reviewing, the clinical application of cranberry juice or extract tablet was focusing on the preventive role on chronic or repeated urinary tract infection. The effect to reduce bacteriuria and pyuria has been mentioned.12 However, the effect on lower urinary tract symptom relieving effect of the food supplement cranberry was not established. In this study, we try to evaluate the clinical efficacy of a commercial compound cranberry extract in treating acute uncomplicated cystitis as an adjunctive role. The compound tablet contained 900mg per tablet, including 600% concentrated cranberry extract 150mg, vitamin C 70mg, Rhizoma extract (Acrobio TS®) 150mg, Flos extract (Acrobio GL®) 60mg, lactose and mannitol 490mg. The compound has been on the market in Taiwan as a food supplement and was well tolerable. We conducted a double-blind, randomized, placebo-controlled trial to evaluate the adjuvant effect of compound cranberry extract on the symptomatic relieving effect.

Material and Methods