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Biomedical subjects

T Johannessen

Publications and source records attributed to T Johannessen.

32 records · Page 2Linked to original sources

Effect of pancreatic enzymes in non-ulcer dyspepsia. A pilot study.

The symptomatic effect of pancreatic enzymes was examined in 37 patients with non-ulcer dyspepsia (NUD) recruited from general practice by means of a 24-day multicrossover model (MCOM) including six treatment periods and five regular interchanges between pancreatic enzymes and placebo. The evaluation was based on a comparison of the enzyme- and placebo-associated symptoms and on the number of times pancreatic enzymes were associated with less symptoms than the preceding or following placebo period in individual patients. No evidence of a short-term effect of pancreatic enzymes in NUD was found.

Adult↗

[Endoscopy or trial treatment of patients with dyspepsia?].

The predictive value of dyspeptic symptoms is low. Upper GI endoscopy is the diagnostic gold standard, giving optimal basis for adequate drug treatment and may have a positive influence on the prognosis of non ulcer dyspepsia. Accordingly, endoscopy tends to be recommended at an early stage of chronic dyspepsia. Age above 40 years, pains relieved by food or antacids, night pains, smoking and male sex enhances the probability of an organic disease and thus the need for endoscopy. Trial treatment is recommended if the waiting period for endoscopy exceeds two weeks. Patients previously endoscoped may often be treated in accordance with earlier diagnosis and drug experience when relapsing. Drug choice when there is no firm diagnosis, should be determined by the symptom pattern. Two weeks of treatment failure necessitates endoscopy. Individual trial packages containing both the active drug and placebo could improve decision making in clinical practice.

Adult↗

Cimetidine responders in non-ulcer dyspepsia.

The effect of cimetidine and placebo was examined in 123 patients with non-ulcer dyspepsia (NUD) by means of a 12-day multi-crossover model with 5 regular interchanges between cimetidine and placebo. The evaluation of effect in individual patients was based on the number of times cimetidine was associated with less symptoms than the preceding or following placebo period. If cimetidine had no effect, the probability of being defined as a cimetidine responder was 25%. In general, cimetidine was associated with less symptoms than placebo (p less than 0.0001). Forty patients were identified as cimetidine responders (R) and the remaining patients were termed non-responders (NR). Symptoms compatible with gastroesophageal reflux were significantly more frequent in R than in NR, whereas the opposite was true for symptoms of the irritable colon syndrome. The ability of symptoms selected by stepwise logistic regression to predict response to cimetidine showed at best a sensitivity of 75% and a specificity of about 65%. No differences were found between R and NR with regard to acid secretion, endoscopic and histologic findings, or the result of an acid perfusion test. The present study supports the existence of a subgroup of cimetidine responders among patients with NUD characterized by symptoms suggestive of gastroesophageal reflux disease in the absence of confirmatory objective evidence.

Adult↗

Do we need to listen to the patient? The predictive value of symptoms.

We have previously shown that the endoscopist is able to predict the endoscopic diagnosis in about two thirds of the patients. We report some preliminary findings from two different studies on the ability of symptoms to predict endoscopic findings. Comparison with similar studies in Glasgow and Huddinge suggests that the predictive value of symptoms probably varies between countries and depends on the population dealt with as well as on the methods used for symptom evaluation. Predictive models for peptic ulcer or endoscopic esophagitis based on symptoms showed at best an about 60-70% sensitivity and specificity. We strongly feel that future studies on the predictive value of symptoms should be more focused on the first step in the decision process in general practice.

Esophagitis, Peptic↗

Experience with a multi crossover model in dyspepsia.

A multi cross over model (MCOM) has been designed for single case studies. The model which is only partly randomized, implies regular interchanges between treatment periods with active drug and placebo. The individual evaluation is based on the number of times the active drug is associated with less symptoms than the preceding or following placebo period (X-score), while the effect in a group is evaluated according to the X-score distribution and a paired t-test. The advantages of the single case approach and the impact of the MCOM is illustrated by the results from a study of the effect of cimetidine in non ulcer dyspepsia. Although there are several statistical objections to the model, the results from the study are reasonable and demonstrate a small degree of violence of preassumptions.

Cimetidine↗

Dyspepsia: Therapeutic response as a diagnostic tool.

Non-ulcer dyspepsia (NUD) is a poorly defined heterogenous condition less well suited for the conventional randomized and placebo controlled parallel type trials. We have designed a multi cross-over model (MCO-model) with the facility of providing information about drug responses in individual patients. A pilot study suggested that the model may identify individual cimetidine responders among patients with dyspepsia. Preliminary findings from an ongoing study in patients with NUD supports the existence of a subgroup of cimetidine responders characterized by gastroesophageal reflux symptoms and possibly an increased basal acid secretion.

Cimetidine↗

1- and 4-week cimetidine treatment for duodenal ulcer.

Forty-eight patients with symptomatic duodenal ulcer were randomized to 4 weeks' treatment with cimetidine, 1 g/day (C4), or 1 week of cimetidine treatment followed by 3 weeks of placebo (C1 + P). The study was performed double blind. The symptoms were recorded daily on a visual analogue scale. Endoscopy was performed after 4 weeks. Two patients receiving C1 + P dropped out during the 2nd week because of worsening symptoms. With the two dropouts being recorded as 'unhealed ulcers', the 4-week healing rates were 16 of 24 (67%) and 15 of 24 (63%), with C4 and C1 + P, respectively (p greater than 0.05). Even without including the two dropouts, the patients treated with C1 + P had significantly more symptoms during the 2nd and 3rd treatment week than those treated with C4. The present study indicates that 1 week of cimetidine treatment is not sufficient in patients with duodenal ulcer.

Cimetidine↗

The effect of cimetidine in non-ulcer dyspepsia. Experience with a multi-cross-over model.

The symptomatic effect of cimetidine was examined in 27 patients with non-ulcer dyspepsia (NUD) by means of a multi-cross-over model (MCO model) for testing the symptomatic effect of drugs in individual patients. None of the patients showed an ulcer at the time, but 20 patients had evidence of previous peptic ulcer disease. The variant of the MCO model used included six treatment periods and three regular interchanges between cimetidine and placebo. Treatment periods lasted 2 or 4 days. The individual results were evaluated on the basis of the number of times (X score) cimetidine was associated with less symptoms than the preceding or following placebo. In general, cimetidine was associated with significantly (p less than 0.02) less symptoms than placebo. The X-score distribution was therefore skew in favour of high scores. Five patients showed the maximal X score of 5. The chance of getting an X score of 5 when cimetidine is not better than placebo is about 9%. Accordingly, the risk of being wrong when defining these five patients as cimetidine responders is 9%. The present study confirms that the MCO model may identify individual cimetidine responders among patients with NUD.

Adult↗

Clinical significance of upper abdominal symptoms.

Upper abdominal symptoms are frequent in the healthy population. The clinical significance of upper abdominal symptoms appears to be slight when evaluated singly but more satisfactory when taken together. There is an urgent need for an improved data base of information with regard to the relationship between upper abdominal symptoms and disease.

Abdomen↗

Controlled trials in gastrodyspepsia: a methodological aspect.

Non-ulcer dyspepsia (NUD) is a poorly defined condition that is not very suitable for conventional randomised double-blind studies. A multi cross-over model (MCO-model) has been designed allowing identification of individual drug responders with a defined degree of certainty. The model involves regular interchanges between periods with active drug and placebo, and the evaluation is based on the number of times the active drug is associated with fewer symptoms than the preceding or following placebo period (X-score). A drug responder may be defined by a certain minimum value for the X-score. The risk of being wrong may then be easily calculated from the probability distribution of the X-score. The effect of cimetidine in patients with NUD has been studied using a variant of the MCO-model including 6 treatment periods of 2 or 4 days' duration. So far, the conclusion that the MCO-model is able to identify individual cimetidine responders among patients with NUD appears to be justified. The preliminary findings furthermore suggest that cimetidine responders among patients with NUD are characterised rather by symptoms suggestive of reflux esophagitis than by hypersecretion of acid.

Cimetidine↗

On-demand therapy in gastroesophageal reflux disease: a comparison of the early effects of single doses of fast-dissolving famotidine wafers and ranitidine tablets.

In this double-masked, double-dummy, randomized, single crossover study, we compared single doses of a fast-dissolving wafer formulation of famotidine with a conventional tablet formulation of ranitidine in patients with gastroesophageal reflux disease (GERD). Patient preference time until symptomatic relief, and predictive characteristics of early responders were assessed. Eligible patients had a clinical diagnosis of GERD and symptoms of GERD of sufficient severity to require relief. The study treatment was one dose of famotidine (20-mg wafer) and one dose of ranitidine (150-mg tablet), which were given in a randomized order and taken as needed. The patients were instructed to measure the symptomatic effects on a seven-point categorical scale (1 = worse to 7 = free of symptoms) at 15, 30, 45, 60, 120, and 180 minutes. After the clinical phase of the trial, the patients indicated their global assessment of efficacy and their preference for the wafer or the tablet. Of the 829 patients who completed the study, significantly more preferred the wafer to the tablet. While there was no significant difference in the global assessment of efficacy, the famotidine wafer provided significantly better relief than the ranitidine tablet during the first hour after dosing. However, at 120 and 180 minutes, the degree of relief was similar for the two drugs. The time until a clinically significant effect was also similar for the two drugs, and approximately one half of the patients experienced such improvement within 3 hours. Multivariate analyses disclosed no predictive characteristics of early symptomatic effect.

Adult↗