This trial is evaluating whether Mind-body therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Primary Biliary Cholangitis. Measurement will happen over the course of 12 Weeks.
This trial requires 34 total participants across 2 different treatment groups
This trial involves 2 different treatments. Mind-body Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
The prevalence of PBC in the US has not been known for many years. The increase in incidence of PBC seen in the past 20 years is likely related to the advent of liver biopsy in people suspected of having PBC.
Corticosteroid injections for PBC are considered curative therapy. If not received, such therapy is indicated as long-termed therapy that requires careful monitoring because of the risk of fibrosis. In regards to the remaining treatment modalities, the use of proton pump inhibitors, antibiotics, and/or immunosuppressants are recommended for PBC treatment. However, there is a strong need for new therapeutic options for PBC.
Primary biliary cholangitis is considered a primary immune-mediated cholangiopathy and presents with distinct clinical, biochemical, and histological features, indicating a different aetiology compared with the classical idiopathic primary biliary cholangitis (PBC). It affects women and, as PBC, can present with cholangitis and liver cirrhosis. However, PBC has also been detected in women who are menopausal, are postmenopausal, and do not have autoimmune liver disease, and PBC is frequently more severe than in men with autoimmune liver disease.
Persistent itching can indicate pancreatobiliary abnormalities, such as gallbladder cancer or primary sclerosing cholangitis, which may also cause itching. Jaundice, which may be associated with cholangiocarcinoma, is a less common finding and is not a definitive sign of cholangiocarcinoma. Patients with unexplained anemia or bone pain, particularly if associated with jaundice or in the elderly, may also have a diagnosis of cholangiocarcinoma.
It has not been proven that the clinical presentation of primary biliary cholangitis can be modified or reversed with specific treatment plans. The clinical course is usually progressive, and patients often present with symptoms which are refractory to the management of PBC.
The cause of PBC is unknown; however recent studies suggest it is not an autoimmune disease or a B cell disease. In many cases it is not well characterized and there is controversy within the medical community. PBC is a rare chronic inflammatory condition in the biliary tract, which causes progressive destruction of the liver and the biliary ducts. Patients tend to be Caucasian. PBC appears to be more common in the UK and Spain compared to North America. There is usually abnormal liver function tests, including cholesterol. The course of disease is unpredictable, with the disease running a variable time course. Prognosis is hopeful, and if the inflammation subsides a good outcome may be expected.
The severity of the disease may range significantly among patients from the same region, but may not differ between countries, or within a country. More research is needed to gather more representative data of PB patients from multiple regions and countries to investigate further the possible heterogeneity of the disease.
The MAST results were inconsistent and the differences were small. In summary there is no evidence to support mind-body therapy as a treatment for PBC.
A familial pattern of PBC has not been reported. Familial liability for PBC may be explained by either a role for environment in inducing PBC during childhood or by a common mode of inheritance.
PBC is a rare disease, especially in men under 60 years of age. Most patients develop PBC in the third to seventh decades of life. This is comparable to the timing of onset for autoimmune disease in general. The pathogenesis of the disorder is not well understood.
MBT (cognitive-emotional therapies) are being applied throughout the world in a variety of clinical circumstances and for psychological and somatic problems. This article discusses recently emerged treatments for the treatment of the physical components of MBT that have been studied extensively in a systematic and controlled way.
MBI improves HRQoL in PBC patients. However, the short-term effects of MBI are not maintained over time, and the clinical significance of an MBI effect has yet to be established. Further assessment of long-term improvements in HRQoL with MBI is needed in this patient population.