Gall stone recurrence and its prevention: the British/Belgian Gall Stone Study Group's post-dissolution trial.

Abstract

The British/Belgian Gall Stone Study Group (BBGSG) post-dissolution trial was a prospective, multicentre, randomised, double blind trial of: (i) low dose ursodeoxycholic acid, (ii) placebo, and (iii) a high fibre, low refined carbohydrate diet in the prevention of gall stone recurrence in patients with complete gail stone dissolution. Further aims included establishing the timing and frequency of recurrence and its association with biliary symptoms, a comparison of the sensitivity of ultrasonography v oral cholecystectography in detecting recurrent stones, and a search for risk factors predicting recurrence. Ninety three patients entered the study, and 82 were followed up for up to five years (mean (SEM) 28 (1-5) months) with six monthly ultrasonography and yearly oral cholecystectography. There were 21 recurrences (26 by oral cholecystectography or ultrasonography, or both), only two of which were symptomatic, which were detected between 12 and 42 months after trial entry. This corresponded to an actuarial recurrence rate of 33*9 (7.0%) by lifetable analysis at 42 months and subsequently. There were four recurrences in the ursodeoxycholic acid, six in the placebo, and 11 in the diet groups, corresponding to 21*9 (9.9)%, 27-4 (10.1)%, and 45*8 (12-4)% respectively at 42 months by lifetable analysis (NS). Variables including age, obesity, menopausal state, pregnancy, and oestrogen containing drugs were not shown to affect recurrence rate. Men had more frequent recurrence than women (NS). Patients who had had multiple stones experienced more recurrences than did those with single stones (NS). Recurrence did not occur in patients who took non-steroidal anti-inflammatory drugs (NSAIDs) (p<0.02). The stone free interval between stone dissolution and trial entry proved to be important -those stone free>nine months had a recurrence rate of only 12.7 (6.0)% at 42 months compared with 55*4 (12-5)% in those stone free<nine months (p<001). There was imbalance between the ursodeoxycholic acid and placebo groups for this factor, and after applying a statistical correction, the adjusted recurrence rate in the ursodeoxycholic acid group was 15% compared with 30% in both placebo and diet groups (NS). These data suggest that after medical dissolution, the risk of gall stone recurrence is not reduced by a high fibre, low refined carbohydrate diet: it may be lowered, but not abolished, by low dose ursodeoxycholic acid.

Food intake patterns and gallbladder disease in Mexican Americans

“…In this study population, the traditional food pattern was associated with a lower per cent of kilocalories from total fat, but a higher intake of cholesterol and ®bre (data not shown). It is notable, however, that one recent clinical trial found no reduction in gallstone recurrence in individuals given a high-®bre, low-re®ned-carbohydrate diet 65 . In additional analyses in our study population, we found no major differences in intake between those with and without disease for any single nutrients of a priori interest, including total fat, cholesterol and ®bre (data not shown).…”

Dietary intake and gallbladder disease: a review

“…It is notable that only one of 15 studies with information on fibre intake noted a positive association, and none of 10 studies with information on simple sugar intake noted an inverse association. Interestingly, however, one intervention study found that a diet high in fibre and low in refined carbohydrates did not reduce the risk of recurrence of gallstones after dissolution 87 . At the food level, positive associations have been found for sugar or sugar products 44,55,67,76 , dates 83 , and pastries and cakes 88 , although other researchers have not found positive associations for sugar-rich products 45,[71][72][73]76 .…”

Nonsteroidal Antiinflammatory Drugs and Gallstone Disease: Will an Aspirin a Day Keep the Gallstones Away?

“…In addition, epidemiological studies examining the effects of NSAIDs on gallstone incidence and prevalence have also yielding conflicting results. In the postgallstone dissolution studies conducted by the British-Belgian Gallstone Study Group, none of 12 regular NSAID users developed recurrent gallstones after oral bile salt therapy compared to 32% of patients who did not use NSAIDs on a regular basis (35,36). In contrast, treatment with aspirin did not reduce the incidence of new gallstone formation for patients participating in a very low-calorie, rapid weight loss diet program (25) and Kurata et al (37) could not demonstrate that regular use of aspirin reduced the hospitalization rate for symptomatic gallstones among 4500 patients who participated in the Aspirin Myocardial Infarction Study.…”