Modafinil in the treatment of debilitating fatigue in primary biliary cirrhosis: a clinical experience.

Modafinil may be a potentially effective treatment for primary biliary cirrhosis (PBC)-related fatigue. About 42 patients were given a 3-day trial of 100-200 mg modafinil. Response was defined as increased energy, decreased somnolence and sleep requirements, and improved daily function. Patients with positive responses were continued indefinitely on the medication. During the initial trial period, 31 (73%) patients had complete response and continued to take the medication. Eleven (26%) had no response. In long-term follow-up (average 17.7 months), 25 (81%) patients continued to take 100-200 mg modafinil daily. Some required an increased dosage and some took the medication as needed. Four (12%) patients stopped the medication because of side-effects or reduced efficacy; one patient (3%) stopped due to medication cost and one (3%) due to resolution of fatigue. Side-effects included insomnia, nausea, nervousness, and headaches. Modafinil appears to be a safe, effective treatment for PBC-related fatigue.

Use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications. A consensus report based on clinical evidence.

BACKGROUND: Probe-based confocal laser endomicroscopy (pCLE) provides microscopic imaging during an endoscopic procedure. Its introduction as a standard modality in gastroenterology has brought significant progress in management strategies, affecting many aspects of clinical care and requiring standardisation of practice and training. OBJECTIVE: This study aimed to provide guidance on the standardisation of its practice and training in Barrett's oesophagus, biliary strictures, colorectal lesions and inflammatory bowel diseases. METHODS: Initial statements were developed by five group leaders, based on the available clinical evidence. These statements were then voted and edited by the 26 participants, using a modified Delphi approach. After two rounds of votes, statements were validated if the threshold of agreement was higher than 75%. RESULTS: Twenty-six experts participated and, among a total of 77 statements, 61 were adopted (79%) and 16 were rejected (21%). The adoption of each statement was justified by the grade of evidence. CONCLUSION: pCLE should be used to enhance the diagnostic arsenal in the evaluation of these indications, by providing microscopic information which improves the diagnostic performance of the physician. In order actually to implement this technology in the clinical routine, and to ensure good practice, standardised initial and continuing institutional training programmes should be established.