Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis. DESIGN: Randomised, placebo-controlled study with a 24-week, blinded follow-up period without any treatment. SETTING: Three gastroenterology clinics in Denmark. PATIENTS: Forty-two patients with histologically confirmed collagenous colitis and diarrhoea (more than three stools/day). INTERVENTIONS: Patients in clinical remission after 6 weeks' open-label therapy with oral budesonide (Entocort CIR capsules, 9 mg/day) received 24 weeks' double-blind maintenance therapy with budesonide 6 mg/day or placebo. Thereafter, patients entered the 24-week, blinded follow-up period. MAIN OUTCOME MEASURE: The proportion of patients in clinical remission (three or fewer stools/day) at the end of maintenance therapy. FINDINGS: A total of 34 patients in remission at week 6 were randomly assigned to budesonide 6 mg/day (n = 17) or placebo (n = 17). After 24 weeks' maintenance treatment, the proportions of patients in clinical remission were 76.5% (13 of 17) with budesonide and 12% (2 of 17) with placebo (p<0.001). At 48 weeks (the end of the follow-up period, without any treatment) these values were 23.5% (4 of 17) and 12% (2 of 17), respectively (p = 0.6). The median times to relapse after stopping active treatment (6 plus 24 weeks in the budesonide group; 6 weeks in the placebo group) were 39 and 38 days, respectively. Long-term treatment with budesonide was well tolerated. CONCLUSIONS: Long-term maintenance therapy with oral budesonide is efficacious and well tolerated for preventing relapse in patients with collagenous colitis. The risk of relapse after 24 weeks' maintenance treatment is similar to that observed after 6 weeks' induction therapy.

Collagenous colitis: a long-term follow-up study.

OBJECTIVE: Collagenous colitis was first described in 1976. It is a rare disorder and the long-term course and prognosis of the disease are unknown. The aim of this study was to evaluate the course of the disease more than 5 years after the diagnosis. DESIGN: A retrospective follow-up of patients with collagenous colitis diagnosed during the period 1979-1990. METHODS: All examinations performed at the time of diagnosis were reviewed and the clinical courses of the patients were determined by evaluation of the medical records. At a follow-up visit in 1996 complete histories were obtained and conventional laboratory tests were performed. RESULTS: Two men and 22 women aged 20-82 years with collagenous colitis were identified. At the time of diagnosis, extensive investigation did not reveal other gastrointestinal diseases. At the time of follow-up, six patients had died from diseases unrelated to collagenous colitis, 10 patients suffered from chronic or intermittent diarrhoea, and four patients had been without gastrointestinal symptoms for the last 2-10 years. None of the patients developed colorectal cancer or chronic inflammatory bowel disease. Four patients were lost to follow-up. CONCLUSION: Collagenous colitis is a benign disease, most often with a chronic course. No association with other gastrointestinal diseases was found.

[Transmission of hepatitis B from an adopted child to an adult]. / Hepatitis B-smitte fra et adoptivbarn til en voksen.

A case of acute hepatitis B infection in a 43 year-old male is presented. Seven months before admission the family had adopted a two year-old boy from India, and the child was later found to be seropositive for HBsAg. The patient had no other risk factors of hepatitis B infection and transmission of hepatitis B virus from the adopted child is suspected. It is recommended that children who are adopted from countries with high hepatitis B virus prevalence should be examined for HBsAg, and adoptive family members be vaccinated if the child is found to be HBsAg seropositive.

Microscopic colitis: Current status, present and future challenges: statements of the European Microscopic Colitis Group.

Microscopic colitis (MC) is an inflammatory bowel disease presenting with chronic, non-bloody watery diarrhoea and few or no endoscopic abnormalities. The histological examination reveals mainly two subtypes of MC, lymphocytic or collagenous colitis. Despite the fact that the incidence in MC has been rising over the last decades, research has been sparse and our knowledge about MC remains limited. Specialists in the field have initiated the European Microscopic Colitis Group (EMCG) with the primary goal to create awareness on MC. The EMCG is furthermore a forum with the intention to promote clinical and basic research. In this article statements and comments are given that all members of the EMCG have considered being of importance for a better understanding of MC. The paper focuses on the newest updates in epidemiology, symptoms and diagnostic criteria, pathophysiology and highlights some unsolved problems. Moreover, a new treatment algorithm is proposed on the basis of new evidence from well-designed, randomized control trials.

Axillary sampling and the risk of erroneous staging of breast cancer. An analysis of 960 consecutive patients.

Axillary nodal status was analysed in 960 consecutive cases of primary invasive breast cancer operated in two Danish hospitals. After stratification according to the number of nodes removed, the rate of node positivity in each subgroup was calculated. We found that the probability of finding at least one metastatic node increased continuously up to about 10 removed nodes. In lymph node negative patients, who did not receive any adjuvant treatment, there was a significant association between the recurrence-free survival and the number of nodes removed, provided that less than 8-10 nodes had been collected. The percentage of node positivity in each subgroup seemed to level off above 10 nodes at about 64%, suggesting that this represents the true rate of node positivity at the time of primary surgery. We conclude that about 10 axillary nodes should be removed in order to minimize the risk of erroneous classification of the axilla.

The prognostic value of estrogen and progesterone receptors in female breast cancer. A single center study.

In the period from September 1980 to December 1987, our laboratory measured estrogen (ER) and progesterone receptor (PgR) levels in 960 patients with primary breast cancer. At presentation, 918 of these had no distant metastases. ER as well as PgR were considered positive at values above 10 fmol/mg cytosol protein. All the patients included had been operated on at one of two participating hospitals in the country of North Jutland, and all patients had been checked up in a uniform way at one oncological out-patient department. By applying test for interaction, the PgR was found to be dependent on nodal status. Separate multivariate analyses were carried out for node positive and node negative patients. By this method, size of tumor, histologic grading, and age turned out to be independent prognostic factors for the node negative patients. Independent prognostic parameters for the node positive patients were histologic grading, PgR and postoperative x-ray therapy. The results support the theory that PgR is a better predictor of disease-free survival than ER.

Budesonide treatment of collagenous colitis: a randomised, double blind, placebo controlled trial with morphometric analysis.

BACKGROUND: Collagenous colitis is characterised by diarrhoea, lymphocytic inflammation, and a thickened subepithelial collagen layer in the colorectal mucosa. No standard treatment of the disease is established. AIMS: To investigate the clinical and histological effect of oral budesonide (Entocort, AstraZeneca) in the treatment of collagenous colitis. PATIENTS: Twenty patients with collagenous colitis (collagen layer >10 micro m) and diarrhoea (>4 stools/day and/or stool weight >200 g/day). METHODS: A randomised, double blind, placebo controlled trial of budesonide treatment. Patients were randomised to placebo or budesonide for eight weeks. Stool frequency and stool weight were registered before and after treatment. Sigmoidoscopy was performed before and after treatment, and biopsies at fixed locations were obtained for morphometric analysis. RESULTS: Ten patients were randomised to budesonide and 10 to placebo. All 10 patients receiving budesonide had a clinical response compared with two in the placebo group (p<0.001). In the budesonide group, stool weight was reduced from 574 g/day to 200 g/day and stool frequency was reduced from 6.2/day to 1.9/day (p<0.01). The histological inflammation grade in the sigmoid mucosa and the thickness of the collagen layer were significantly reduced. A correlation between the grade of inflammation as well as collagen layer thickness and stool weight was found. No side effects were reported. Eight of 10 patients had relapse of symptoms within eight weeks after stopping treatment. CONCLUSIONS: Budesonide is a highly effective and well tolerated treatment of collagenous colitis. There is a high risk of relapse after stopping eight weeks of treatment.