Can a patient take ursodiol (ursodeoxycholic acid) alone for the treatment of gallstones?

From the Guidelines

Ursodiol can be used alone to treat certain types of gallstones, but its effectiveness depends on specific factors, such as small, cholesterol-based gallstones in patients with a functioning gallbladder. The decision to use ursodiol alone for gallstone treatment should be based on a thorough assessment of the patient's condition, including the type and size of the gallstones, as well as the patient's overall health and treatment goals. According to the guidelines for the treatment of gallstones by the American College of Physicians 1, the effort and minor risks of surgical and nonsurgical intervention still outweigh their corresponding benefits for many patients, making expectant management a viable option until a perfectly safe, effective, convenient, and inexpensive treatment is developed.

Some key considerations for using ursodiol alone include:

• The size and composition of the gallstones: Ursodiol works best for small, cholesterol-based gallstones.
• The patient's gallbladder function: The gallbladder should be able to contract normally for ursodiol to be effective.
• The patient's treatment goals and attitudes: Patients who want to prevent another episode of pain may opt for treatment, while those who primarily want to reduce the risk for death from gallstones may choose expectant management.
• The potential risks and benefits of treatment: Patients should be aware of the potential side effects of ursodiol, such as diarrhea or stomach upset, as well as the risk of stone recurrence after stopping treatment.

It is essential to note that ursodiol is not suitable for all patients with gallstones, particularly those with larger stones, calcified stones, or acute symptoms, for whom surgery (cholecystectomy) remains the standard treatment 1. Regular follow-up ultrasounds are necessary to monitor stone dissolution progress during treatment.

From the FDA Drug Label

Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces. The overall effect of ursodiol is to increase the concentration level at which saturation of cholesterol occurs The various actions of ursodiol combine to change the bile of patients with gallstones from cholesterol-precipitating to cholesterol-solubilizing, thus resulting in bile conducive to cholesterol stone dissolution. On the basis of clinical trial results in a total of 868 patients with radiolucent gallstones treated in 8 studies (three in the U.S. involving 282 patients, one in the U. K. involving 130 patients, and four in Italy involving 456 patients) for periods ranging from 6 to 78 months with ursodiol doses ranging from about 5 mg/kg/day to 20 mg/kg/day, an ursodiol dose of about 8 mg/kg/day to 10 mg/kg/day appeared to be the best dose With an ursodiol dose of about 10 mg/kg/day, complete stone dissolution can be anticipated in about 30% of unselected patients with uncalcified gallstones < 20 mm in maximal diameter treated for up to 2 years

Ursodiol can be taken alone for gallstone dissolution. The patient should have radiolucent gallstones, and the size of the stones should be less than 20 mm in maximal diameter. The chance of gallstone dissolution is increased up to 50% in patients with floating or floatable stones. However, patients with calcified gallstones, radiopaque stones, or radiolucent bile pigment stones are not candidates for ursodiol therapy 2, 2.

• The dose of ursodiol for gallstone dissolution is about 8-10 mg/kg/day.
• Complete stone dissolution can be anticipated in about 30% of unselected patients with uncalcified gallstones < 20 mm in maximal diameter treated for up to 2 years.
• Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered 2.

From the Research

Gallstone Treatment with Urosodiol

• Urosodiol, also known as ursodiol, is a medication used to dissolve gallstones, particularly those made of cholesterol 3.
• The efficacy of urosodiol in dissolving gallstones depends on the size and number of stones, with smaller stones being more responsive to treatment 3.
• Studies have shown that urosodiol can be effective in dissolving gallstones, but its effectiveness is increased when combined with extracorporeal shock-wave lithotripsy (ESL) 4, 5, 6.

Comparison of Urosodiol Alone and Combination Therapy

• Research has compared the efficacy of urosodiol alone versus combination therapy with ESL, and the results suggest that combination therapy is more effective in achieving stone-free gallbladders 4, 5, 6.
• For example, one study found that 47% of patients treated with ESL plus urosodiol were stone-free, compared to 22% of patients treated with urosodiol alone 4.
• Another study reported that 85% of patients with single stones treated with ESL plus urosodiol were stone-free at 12 months, compared to 0% of patients treated with urosodiol alone 5.

Safety and Efficacy of Urosodiol

• Urosodiol is generally considered safe and well-tolerated, with few side effects reported, such as transient diarrhea 3, 7.
• The medication has been shown to be effective in reducing biliary cholesterol secretion and promoting gallstone dissolution 3, 7.
• However, the recurrence rate of gallstones after treatment with urosodiol is relatively high, with approximately 50% of patients experiencing recurrence within 5-7 years 3.