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A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty
Abstract
One hundred and seven patients whose gallbladder was normal at the time of vertical banded gastroplasty (VBG) were considered for entry into a randomized placebo-controlled double-blind study to determine the effectiveness of ursodeoxycholic acid (UDCA) in preventing cholelithiasis during the period of weight loss. Twenty-one patients (20%) developed gallstones in the six-week period post-VBG and prior to randomization and were therefore excluded. Eighty-six patients were randomized at 6 weeks to active medication or placebo. Of these, 61 patients (71 %) completed the study. Twenty-five patients (29%) failed to complete the study because of incompliance, intolerance to the medication or pregnancy; 17 of these were in the active treatment group and eight were in the placebo group. None of the 27 patients treated with UDCA developed gallstones, whereas eight of 34 (24%) patients taking placebo developed gallstones. This difference was statistically significant (p = 0.0061). These results suggest that UDCA is fully effective in preventing gallstone formation following VBG in patients who follow the prescribed regimen.
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Reducing the time of overnight fasting to less than 12 hours might mitigate gallbladder hypomotility, as suggested by observational data.
“Additionally, gallbladder hypomotility might be mitigated by reducing the time of overnight fasting to less than 12 h, as suggested by observational data [76].”
From Excess Body Weight and Gallstone Disease (2021) · cites this paper as [76]
The moderate overall compliance of 63% in our trial is consistent with compliance rates reported in other trials.
“The moderate overall compliance of 63% in our trial is consistent with compliance rates reported in other trials, 6,8,35,36 although higher rates have been reported as well.7,25,37,38”
A small Canadian double-blind study on 29 patients reported that 6 (43%) of the 14 subjects on placebo developed stones 3 months after the operation.
“A small Canadian double-blind study on 29 patients reported that 6 (43%) of the 14 subjects on placebo developed stones 3 months after the operation.23”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [23]
In prospective randomized studies, prophylactic administration of ursodeoxycholic acid has been shown to be effective in gastric bypass procedures, as well as in a small series with vertical banded gastroplasty.
“In prospective randomized studies, the prophylactic administration of ursodeoxycholic acid has been shown to be effective in gastric bypass procedures20–22, as well as in a small series with vertical banded gastroplasty.23”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [23]
Ursodeoxycholic acid administered during very low-calorie dieting and weight loss after bariatric surgery is effective in preventing gallstone formation.
“Ursodeoxycholic acid administered during VLCD and weight loss after bariatric surgery is effective in preventing gallstone formation19–23”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [23]
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Miller, K., Hell, E., Lang, B., & Lengauer, E. (2003) · Annals of Surgery · doi:10.1097/01.sla.0000094305.77843.cf · Cited by 200
Stokes, C. S., Gluud, L. L., Casper, M., & Lammert, F. (2014) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2013.11.031 · Cited by 118
Magouliotis, D. E., Tasiopoulou, V. S., Svokos, A. A., Svokos, K. A., Chatedaki, C., Sioka, E., & Zacharoulis, D. (2017) · Obesity Surgery · doi:10.1007/s11695-017-2924-y · Cited by 108
Haal, S., Guman, M. S. S., Boerlage, T. C. C., Acherman, Y. I. Z., de Brauw, L. M., Bruin, S., de Castro, S. M. M., van Hooft, J. E., van de Laar, A. W. J. M., Moes, D. E., et al. (2021) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(21)00301-0 · Cited by 82
Manatsathit, W., Leelasinjaroen, P., Al-Hamid, H., Szpunar, S., & Hawasli, A. (2016) · International Journal of Surgery · doi:10.1016/j.ijsu.2016.03.060 · Cited by 78
Excess Body Weight and Gallstone Disease
Stokes, C. S., & Lammert, F. (2021) · Visceral Medicine · doi:10.1159/000516418 · Cited by 58
Son, S.-Y., Song, J. H., Shin, H.-J., Hur, H., & Han, S.-U. (2022) · Journal of Metabolic and Bariatric Surgery · doi:10.17476/jmbs.2022.11.2.30 · Cited by 23
Metadata
- Authors
- Williams, C. N., Gowan, R., & Perey, B. J.
- Venue
- Obesity Surgery
- Published
- 1993-08-01
- Volume
- 3
- Issue
- 3
- Pages
- 257-259
- ISSN
- 1708-0428
- 0960-8923
- Cited by
- 41
- References
- 0
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