Short-term outcome of painful bone marrow oedema of the knee following oral treatment with iloprost or tramadol: results of an exploratory phase II study of 41 patients.

OBJECTIVES: To compare the therapeutic effects of oral iloprost and tramadol on the outcome of bone marrow oedema (BME) of the knee by MR imaging and clinical assessment. METHODS: Forty-one patients with painful ischemic or mechanical BME of the knee were enrolled in a double-blind, randomized controlled study. Patients were randomized either to iloprost (n = 21, group 1) or tramadol (n = 20, group 2). The treatment duration was 4 weeks. The Larson knee score was used to assess function before treatment and then 3 days, 1, 2, 3, 4 weeks and 3 months after the start of treatment. Short tau inversion recovery and T1-weighted MR images of the affected knees were obtained before and 3 months after the start of treatment. Bone marrow oedema was assessed visually and by computer-assisted quantification for baseline and follow-up MR examinations. RESULTS: Thirty-three patients completed the study as scheduled. The mean Larson score improved from 58.6 points to 81.8 points in group 1, and from 59.6 points to 86.8 points in group 2, after 3 months (no significant difference between the treatment groups). On MR images, complete BME regression in at least one bone was observed in nine patients (52.9%) in group 1, as opposed to three patients (18.7%) in group 2, after 3 months (P = 0.034). Correspondingly, the median BME volume decreased by 58.0% in group 1, and by 47.5% in group 2. CONCLUSIONS: The analgesic effect of iloprost and tramadol was similar. BME regression on MR images was more pronounced under iloprost treatment.

Cost-effectiveness of adjuvant treatment with acamprosate in maintaining abstinence in alcohol dependent patients.

An open prospective cohort study was performed in Germany in order to evaluate the costs of treating alcohol dependence under real-world conditions. Eight hundred and fourteen recently detoxified alcohol-dependent patients were provided with psychosocial rehabilitation support. In addition, 540 alcohol-dependent patients treated with adjuvant acamprosate therapy were compared with 274 patients without pharmacotherapy. Real costs were assessed over a period of one year. Of the patients who were treated with acamprosate, 33.6% remained abstinent compared to only 21.1% in the standard cohort. The mean total costs per patient treated with acamprosate were EUR 1,631.49 per year. In the standard cohort, total costs were EUR 2,068.83. This difference is highly significant (p = 0.012). Direct costs amounted to 76.9% of the total costs, with a 27% difference between the cohorts (p < 0.001). There was no difference in indirect costs between the two groups (p = 0.324). This real-cost study confirms the favourable cost-effectiveness of acamprosate previously suggested by pharmaco-economic modelling studies.

[St. John's wort extract WS 5572 in minor to moderately severe depression. Effectiveness and tolerance of 600 and 1200 mg active ingredient daily]. / Johanniskrautextrakt WS 5572 bei leichten bis mittelschweren Depressionen. Wirksamkeit und Verträglichkeit von 600 und 1200 mg Wirkstoff täglich.

BACKGROUND AND METHOD: In this multi-centre study, the effectiveness and tolerability of an extract of herba hyperici WS 5572 were examined. The total of 2,166 participating patients, all suffering from mild to moderate depression, were prescribed to take 600 mg (one tablet) or 1,200 mg (two tablets) daily. Four-hundred-forty-six general practitioners, psychiatrists and neurologists conducted the survey. Three quarters of the participating patients were female at an average age of 50 years. Most of the patients suffered from a depression which was diagnosed for the first time. Approximately in one third of the patients, a recurrent depression was diagnosed. RESULTS: The average severity of the depression was "moderate" (basing on CGI; Clinical Global Impression Scale) at the beginning of the survey and was reduced to less than "mild" after an average observation time of seven weeks. 83.7% patients (600 mg) and 88.6% (1,200 mg) responded respectively. During this observation period, an improvement in symptoms, measured in 17 items, was of clinical relevance. The treating physicians described the drug tolerance as being good or very good for 99% in all cases. This observation was confirmed by adverse drug reactions, which amounted to 0.41%. The low ratio of adverse drug reactions of 0.41% confirmed the physicians' judgement. CONCLUSION: The results obtained from this observational study were similar to those of an equally designed observation performed in 1998, where St. John's wort was observed in a dosage of 300 mg per tablet (standard dosage 3 x 300 mg/d). This is a good proof of the effectiveness and the tolerability of this drug in patients who are suffering from mild and moderate depressive episodes.

[Medical and economic aspects of early microbiological diagnosis in patients with severe infections]. / Medizinische und ökonomische Aspekte einer frühzeitigen mikrobiologischen Diagnose bei Patienten mit schweren Infektionen.

OBJECTIVE: The decision tree analysis is based on a study of v. Doern comparing the medical costs of a diagnosis by means of a traditional method (ONAST) to a new and quicker method (RAST). The conclusion is that, the traditional method proofs to be more expensive regarding different types of costs. A goal of this analysis was to prove the results of this US study for an application in the German health care system. METHODS: A cost efficacy analysis by means of a decision tree was carried out measuring the costs using the surviving of patients as a parameter. As in the RAST group 24 out of 273 and in the ONAST group 46 in 300 persons died, the efficacy rates amount to 0.912 and 0.847, respectively. Finally, sensitivity analyses were performed. RESULTS: Results of total (direct and indirect) costs per surviving patient showed an advantage of the RAST procedure amounting to DM 3,653 (28.3%) compared to the ONAST procedure. From the perspective of a German sickness fund, the RAST procedure leads to a saving potential of about DM 2,671 (13.0%) in comparison to the ONAST procedure. As a result, a minimum of 10 patients a year are required to save costs from the perspective of the hospital. If costs for drugs in the RAST procedure amount to DM 8,764.93, equality of total costs is obtained. This case is rather unlikely. CONCLUSION: From both perspectives of the payer as well as that of the hospital it can be concluded that the rapid method is more cost-effective than the overnight method.