What are the medical treatment options for Cholelithiasis (gallstones)?

From the Guidelines

Surgical removal of the gallbladder (cholecystectomy) is the most effective treatment option for symptomatic gallstones, as it prevents future pain, complications, gallstone recurrence, and gallbladder cancer. When considering treatment options for Cholelithiasis (gallstones), it is essential to weigh the benefits and risks of each approach.

Treatment Options

• Surgical removal of the gallbladder (cholecystectomy) is the standard treatment for symptomatic gallstones, as it provides a definitive solution and prevents future complications 1.
• Laparoscopic cholecystectomy is a preferred method, as it requires only small incisions and allows for faster recovery, although it is a relatively new technology (as of 1989) and its safety has not been fully assessed in large, comprehensive studies 1.
• For patients who cannot undergo surgery, medications like oral bile acids (e.g., ursodeoxycholic acid) may be used to dissolve cholesterol stones, but this approach is less effective and stones often recur when medication stops 1.
• Extracorporeal shock wave lithotripsy may be used in select cases to break up stones, but its use is limited and requires subsequent oral bile acid therapy to dissolve the fragments 1.

Considerations

• Asymptomatic gallstones typically do not require treatment, as they often cause no problems.
• During acute gallstone attacks, treatment includes pain management with NSAIDs or opioids, and antibiotics if infection is present.
• Dietary modifications, such as reducing fatty foods, maintaining regular meals, and gradual weight loss if overweight, can help manage symptoms. It is crucial to note that while nonsurgical therapies can bypass the risks and potential complications of surgery, they will neither prevent gallstone recurrence nor prevent gallbladder cancer 1.

From the FDA Drug Label

ALTERNATIVE THERAPIES Watchful Waiting Watchful waiting has the advantage that no therapy may ever be required. For patients with silent or minimally symptomatic stones, the rate of development of moderate-to-severe symptoms or gallstone complications is estimated to be between 2% and 6% per year, leading to a cumulative rate of 7% to 27% in 5 years Presumably the rate is higher for patients already having symptoms. Cholecystectomy For patients with symptomatic gallstones, surgery offers the advantage of immediate and permanent stone removal, but carries a high risk in some patients. About 5% of cholecystectomized patients have residual symptoms or retained common duct stones The spectrum of surgical risk varies as a function of age and the presence of disease other than cholelithiasis.

SPECIAL NOTE Gallbladder stone dissolution with Ursodiol Capsules USP, 300 mg treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.

The medical treatment options for Cholelithiasis (gallstones) are:

• Watchful waiting: for patients with silent or minimally symptomatic stones
• Cholecystectomy: for patients with symptomatic gallstones, which offers immediate and permanent stone removal but carries a high risk in some patients
• Ursodiol (ursodeoxycholic acid) therapy: for gallbladder stone dissolution, which requires months of therapy and has a recurrence rate of up to 50% within 5 years 2 2

From the Research

Medical Treatment Options for Cholelithiasis (Gallstones)

The medical treatment options for cholelithiasis (gallstones) include:

• Oral bile acids, such as ursodeoxycholic acid and chenodeoxycholic acid, which can dissolve radiolucent gallstones 3, 4, 5
• Lithotripsy, which uses shock waves to break up gallstones, often in combination with oral bile acids 4, 5
• Contact dissolution using methyltertbutylether, which can dissolve gallstones of any size and number 5
• Pharmacological agents that inhibit hepatic cholesterol synthesis, such as statins, or intestinal cholesterol absorption, such as ezetimibe 6

Patient Selection Criteria

Patient selection criteria for medical treatment of gallstones include:

• Gallstones must be cholesterol-rich and radiolucent 5
• The cystic duct must be patent, as indicated by gallbladder opacification on oral cholecystography 5
• Patients with small, uncalcified cholesterol gallstones in a functioning gallbladder with a patent cystic duct are considered for oral litholysis by hydrophilic ursodeoxycholic acid 6

Treatment Outcomes

Treatment outcomes for medical treatment of gallstones include:

• Complete or partial dissolution of radiolucent gallstones in about 40 to 55% of patients treated with ursodeoxycholic acid 3
• Annual dissolution rates of about 80 and 40% for single and multiple stones, respectively, with lithotripsy combined with oral bile acid 5
• Complete dissolution of gallstones in almost 100% of stones with direct contact dissolution using methyltertbutylether, but debris is frequently left behind in the gallbladder 5
• Recurrence of gallstones in about 50% of patients after dissolution using any form of treatment 5