Efficacy of bile acid therapy for gallstone dissolution: a meta‐analysis of randomized trials

Abstract

To define better the efficacy of bile acid therapy for dissolution of radiolucent gallstones, we performed a meta-analysis of published trials from January 1966 to September 1992. Studies were identified using a MEDLINE computer search followed by an extensive manual search. The inclusion criteria used were: randomized trial, radiolucent gallstones in a visualizing gallbladder on oral cholecystography, and complete stone dissolution confirmed by oral cholecystography or ultrasound. Study results were pooled into 6 groups: placebo : high-and lowdose chenodeoxycholic acid (CDCA) ( 2 10 mg . kg/day and < 10 mg . kg/day); high-and low-dose ursodeoxycholic acid (UDCA) ( 2 7 mg . kg/day and < 7 mg . kg/day) and combined CDCA plus UDCA. Homogeneity calculations were performed and the percentage of complete stone dissolution calculated for each group with 95% confidence intervals. Of 66 trials identified, 23 comprising 1949 patients met the inclusion criteria. A total of 1062 patients were treated with CDCA, 819 with UDCA and 78 combination therapy. In studies > 6 months' duration, high-dose UDCA completely dissolved stones in 37.3 % of patients (95 % C.I.3 3 4 2 % ) , low-dose UDCA in 20.6%) and high-dose CDCA 18.2% (95% C.I. 1 5 2 1 % ) . Based on only two studies, combination therapy achieved dissolution in 62.8% (95% C.I. 51-74%) of patients. Stones less than 10 mm dissolved significantly more frequently than stones larger than 10 mm. This analysis shows that UDCA in doses greater than 7 mg . kg/day taken for greater than 6 months will dissolve radiolucent gallstones in 38% of patients. The combination of UDCA and CDCA may be more efficacious but this observation is based upon only 78 patients and requires confirmation in further randomized trials.

Evidence-based clinical practice guidelines for cholelithiasis 2016

“…The effectiveness of oral dissolution therapy of X-ray-negative cholesterol gallstones with bile acid formulations has been validated in a meta-analysis [54]. Treatment with a combination of UDCA and chenodeoxycholic acid (CDCA) for 6 months has been reported to achieve complete dissolution of gallstones with a diameter smaller than 15 mm in 52-62.8% of patients.…”

“…Treatment with a combination of UDCA and chenodeoxycholic acid (CDCA) for 6 months has been reported to achieve complete dissolution of gallstones with a diameter smaller than 15 mm in 52-62.8% of patients. A rate of 24-38% has been reported for treatment with UDCA alone [54,55]. Although UDCA and CDCA share a common mechanism of action (i.e., increasing the solubility of cholesterol in bile) [56], the safety and efficacy of UDCA are reported to be superior [57,58].…”

Ursodeoxycholic acid: A therapeutic niche in an internist’s practice

“…Работы по изучению эф-фективности УДХК при холелитиазе продолжаются и в настоящее время. Однако их результаты не опровергают данные метаанализа, опубликованные в 1993 г., согласно которым эффективность УДХК при калькулезном холецистите составила 38% [27].…”

Cholezystolithiasis – ein Wandel im interdisziplinären Vorgehen?

“…Aufgrund des diurnalen Rhythmus der Cholesterin-Sättigung der Galle wird empfohlen, die gesamte Dosis vor dem Schlafengehen einzunehmen [55]. Die Behandlungsdauer bis zur Steinauflösung beträgt in Abhängigkeit von der Steingröße -bei zirka 1 mm Größenabnahme pro Monat -meist 6-24 Monate [56]. Die Erfolgsraten liegen zwischen 30% (Steingröße bis 10 mm) und 70% (Steingröße unter 5 mm) nach 12 Monaten Therapie [54,[56][57][58][59].…”

“…Die Behandlungsdauer bis zur Steinauflösung beträgt in Abhängigkeit von der Steingröße -bei zirka 1 mm Größenabnahme pro Monat -meist 6-24 Monate [56]. Die Erfolgsraten liegen zwischen 30% (Steingröße bis 10 mm) und 70% (Steingröße unter 5 mm) nach 12 Monaten Therapie [54,[56][57][58][59]. Falls nach 6 Monaten Therapie sonographisch oder röntgenologisch keine Verkleinerung der Steine feststellbar ist, sollte die Therapie abgebrochen werden [60].…”