Retreatment of hepatitis C non-responsive to Interferon. A placebo controlled randomized trial of Ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux [ISRCTN53821378]

BACKGROUND: Evidence based medicine depends on unbiased selection of completed randomized controlled trials. For completeness it is important to publish all trials. This report describes the first large randomised controlled trial where combination therapy was compared to placebo therapy and to ribavirin monotherapy, which has not been published untill now. METHODS: One hundred and twenty one patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy, were included from 16 centers in Belgium, the Netherlands and Luxembourg between 1992 and 1996. Patient poor-response characteristics were: genotype 1 (69%), HCV RNA above 2 × 10(6 )copies/ml (55%) and cirrhosis (38%). Patients were randomized to 6 months combination therapy with interferon alpha-2b (3 MU tiw) and ribavirin (1000–1200 mg / day), 6 months ribavirin monotherapy (1000–1200 mg / day) or 6 months ribavirin placebo. The study was double blinded for the ribavirin / placebo component. One patient did not fit the entry criteria, and 3 did not start. All 117 patients who received at least one dose of treatment were included in the intention to treat analysis. RESULTS: At the end of treatment, HCV RNA was undetectable in 35% of patients on combination therapy and in none of the patients treated with ribavirin monotherapy or placebo. The sustained virological response rate at 6 months after therapy was 15% for patients treated with interferon and ribavirin. During the 6 months treatment period 13% of patients on interferon ribavirin combination therapy, 13% of patients on ribavirin monotherapy and 11% of patients on placebo withdrew due to side effects or noncompliance. At 24 weeks of treatment the mean Hb level was 85% of the baseline value, which means a mean decrease from 9.1 mmol/l to 7.8 mmol/l. The Hb levels at the end of treatment were not significantly different from patients treated with ribavirin monotherapy (p = 0.76). End of treatment WBC was significantly lower in patients treated with combination therapy, compared to ribavirin (p < 0.01) as well as for patients treated with ribavirin monotherapy compared to placebo (p < 0.01). DISCUSSION: This belated report on the only placebo controlled study of interferon ribavirin combination therapy in non responders to standard doses of interferon monotherapy documents the effectiveness, be it limited, of this approach as well as the dynamics of the effects on blood counts

Evolution of gastroenterology training

There have been rapid developments in gastroenterology (GE) over the last decade. Up until the late 1980s, GE-training was incorporated in Internal Medicine training. The introduction of endoscopy has necessitated the need for additional training. Around the world different national boards have developed their own curricula which will be discussed in this paper. Emphasis will be placed on the curriculum recently introduced in The Netherlands. The internal medicine component has become a two-year requirement (Common Trunk) and the duration of training in GE has been extended to four years. Because of the growing complexity of GE, there are now four subspecialties: Interventional Endoscopy, Neuromotility, Oncology and Hepatology that trainees can choose from. These subspecialties each have predefined specific requirements. The World Gastroenterology Organization has drawn up a standard curriculum which can be of help to the boards in different countries. The curriculum emphasizes the knowledge and skill components. The curriculum also defines the training recommendations, the requirements of training facilities and competence evaluation of fellows and facilities, while less is said about research, finance and the number of gastroenterologists required. In the coming decades the curriculum will need to be revised continuously. Personalization of the curriculum will be the next challenge for the years to come

Gastroenterology training in private hospitals: India vs South Africa

In South Africa, nurses and doctors are emigrating in significant numbers. Job satisfaction, safety and ensuring career progression are important in retaining doctors to make a career in Republic of South Africa (RSA). Due to budgetary constraints many hospitals have not been upgraded. Coming home after overseas training seems difficult. In RSA it takes a minimum of 13 years for a young specialist to become registered and 15 years for subspecialists. Career progression, creating more specialist trainees in public and private hospitals and shortening the period of professional training are potential solutions to the problem. India, which has a population of more than 1 billion people, is struggling with similar problems. For the past 10-15 years, private hospitals have assisted in manpower development for medical specialist and subspecialist careers. Currently their private sector trains 60% of their recognised (sub)specialities fellows. A national task force for specialist training in RSA should be instituted. It should discuss, based on the current status and projected specialist and subspecialist personnel requirements, the future structure and logistics of training needs. This is required in all subspecialities including gastroenterology, as has been done in India. It is hoped that as a consequence well-trained doctors, similar to those in India, might move to provincial hospitals in rural areas, upgrading the medical services and keeping medical power in South Africa. South Africa should become a model for Sub-Saharan Africa, as India already is for South-East Asia

Digestive oncologist in the gastroenterology training curriculum

Until the late 1980s, gastroenterology (GE) was considered a subspecialty of Internal Medicine. Today, GE also incorporates Hepatology. However, Digestive Oncology training is poorly defined in the Hepatogastroenterology (HGE)-curriculum. Therefore, a Digestive Oncology curriculum should be developed and this document might be a starting point for such a curriculum. HGE-specialists are increasingly resisting the paradigm in which they play only a diagnostic and technical role in the management of digestive tumors. We suggest minimum end-points in the standard HGE-curriculum for oncology, and recommend a focus year in the Netherlands for Digestive Oncology in the HGE-curriculum. To produce well-trained digestive oncologists, an advanced Digestive Oncology training program with specific qualifications in Digestive Oncology (2 years) has been developed. The schedule in Belgium includes a period of at least 6 mo to be spent in a medical oncology department. The goal of these programs remains the production of well-trained digestive oncologists. HGE specialists are part of the multidisciplinary oncological teams, and some have been administering chemotherapy in their countries for years. In this article, we provide a road map for the organization of a proper training in Digestive Oncology. We hope that the World Gastroenterology Organisation and other (inter)national societies will support the necessary certifications for this specific training in the HGE-curriculum

Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation A Report From the GARFIELD-AF Registry

IMPORTANCE Congestive heart failure (CHF) is commonly associated with nonvalvular atrial fibrillation (AF), and their combination may affect treatment strategies and outcomes