[Comparative epidemiological study in patients with rheumatic diseases illustrated in a example of a treatment with non-steroidal anti- inflammatory drugs versus an oral enzyme combination preparation]. / Vergleichende epidemiologische Studie bei Erkrankungen des rheumatischen Formenkreises am Beispiel der Therapie mit nichtsteroidalen Antiphlogistika versus einem oralen Enzymkombinationspräparat.

To establish the safety and efficacy of an oral enzyme-combination product (OE; Phlogenzym, containing trypsin, bromelain and rutin) in the treatment of rheumatic diseases a retrolective cohort study with parallel groups was undertaken as an epidemiological study, in which the enzyme combination was compared with non steroidal anti-inflammatory drugs (NSAID). Data of 3326 patients treated for rheumatic diseases between January 1993 and the end of March 1995 were registered by 380 physicians. From the patient file age, gender, indication for treatment (diagnostic group), anamnestic data (especially pre-treatment), complaints at the beginning and end of treatment, treatment duration, prescribed drugs (OE, NSAID), additional treatment and adverse events were transferred into case report forms (CRFs). The quality of the data was monitored and additionally checked by internal and external quality audits. Included in the efficacy analysis were 2139 patients which were treated either only with OE or only with NSAID and could be classified unambiguously into one of the following diagnostic groups: joint diseases, spinal diseases, rheumatic soft tissue diseases. As clinically relevant and reliably evaluable criterion freedom from rheumatic complaints at the end of treatment was considered. For evaluation of safety the documented adverse events of all patients were considered. Two thirds of the OE patients received the recommended dose of 6 tablets/day, taken for 23 to 35 days. The respective mean values for NSAID patients were 16 to 25 days, and the patients were treated with the recommended symptomatically effective doses of NSAID. As the allocation of the compared treatment options (OE or NSAID) to the patients was not randomized, a mixing of treatment effects with other factors cannot be excluded. For adjustment of these confounding factors two methods were applied: a) logistic regression of the relative ratio of the main criterion and all confounding factors and b) stratification of data according to the propensity score i.e. the probability of a treatment with OE. Both methods yielded similar results: A 50% higher success rate can be expected in total for OE than for NSAID at comparable initial and treatment situations (95% confidence interval with logistic regression = 1.218-1.96, with stratification according to propensity score = 1.16-1.84). As significant negative indicators for response age over 50 years, pre-treatment with antirheumatic or analgetic drugs, treatment duration more than 30 days and joint diseases or fibromyalgias could be revealed. Since there was no interaction between these indicators and the type of treatment also in patients presenting with these indicators a treatment success (freedom from symptoms) with OE can be expected with a higher probability than with NSAID. OE were well tolerated showing much less adverse events when compared with conventional doses of NSAID.

[Effectiveness of vitamin E in comparison with diclofenac sodium in treatment of patients with chronic polyarthritis]. / Wirksamkeit von Vitamin E im Vergleich zu Diclofenac-Natrium in der Behandlung von Patienten mit chronischer Polyarthritis.

In a randomized, double blind parallel group comparison the antiphlogistic and analgetic efficacy of high-dosed vitamin E (3 x 400 mg RRR-alpha-Tocopherolacetat/d) versus diclofenac-sodium has been investigated in hospitalized patients with established chronic rheumatoid arthritis. After 3 weeks of treatment the vitamin E group (n = 42) as well as the diclofenac group (n = 43) showed a significant improvement of all assessed clinical parameters. Duration of morning stiffness could be reduced under vitamin E treatment from 90 min to 68 min and under diclofenac treatment from 68 min to 30 min. The joint index according to Richie declined from 56 to 46 (vitamin E) and 49 to 34 (diclofenac). Grip strength increased in the vitamin E group as well as in the diclofenac group. In addition, the degree of pain, assessed by a 10 cm visual analogue scale, reduced significantly under vitamin E as well as under diclofenac. Regarding the therapeutical result both, physicians and patients, considered both drugs to be similarly effective. Especially regarding the risk profile of NSAR in long-term treatment of chronic rheumatoid arthritis intake of high-dosed vitamin E is a possible alternative in the treatment of inflammatory rheumatoid diseases.

[Rheumatoid disorders in Crohn disease and ulcerative colitis. Dominance of non-inflammatory factors]. / Rheumatische Beschwerden bei Morbus Crohn und Colitis ulcerosa. Dominanz nicht entzündlicher Faktoren.

82 consecutive outpatients with Crohn's disease (n = 52) and ulcerative colitis (n = 30) were examined ambulatory. Rheumatic complaints, objective results and diagnosis were correlated to the activity of the underlying illness and the extent of the bowel affected. 61% of the examined patients complaint about rheumatic pains. In two thirds this could be attributed to noninflammatory causes (30% insertion tendinitis. 16% degenerative arthritis, 16% wrong carriage), which appeared to be independent of the activity and severity of the underlying disease. One fourth of the rheumatic complaints was caused by inflammation (21% arthritis, 5% sacroileitis). In these cases a dependency on the disease activity and the extent of the colon involvement could be found. No cause was found for 12% of the rheumatic complaints. In patients with ulcerative colitis suffering from arthritis a significant increase of disease activity (Rachmilewitz index) could be shown as compared to ulcerative colitis patients without arthritis (p < 0.02). For patients with Crohn's disease no significant correlation between arthritis and disease activity could be established. In these cases the occurrence of arthritis was associated with the colon involvement (Chi2 = 8.48). The data indicate the high frequency of rheumatic complaints in inflammatory bowel diseases due to noninflammatory causes.

[Circumscribed venous ectasia of the upper esophagus and "downhill" varices in primary disorders of esophageal motility]. / Umschriebene Venektasien im oberen Osophagus und "Downhill"-Varizen bei primären Störungen der Osophagusmotilität.

Felson and Lessure 1964 (1) described varicosities involving the upper third of the esophagus in patients without portal hypertension. Several etiological factors causing these "downhill" varices, e.g. bronchogenic carcinoma, retrosternal thyroid adenoma or mediastinal fibrosis, have been described. Since September 1989 ectatic esophageal veins or "downhill" varices were diagnosed in nine patients with dysphagia and/or non cardiac chest pain. Intrathoracic masses as a possible cause of "downhill" varices could not be diagnosed in any of these patients. Endoscopy of the upper gastro-intestinal tract revealed spiral esophageal contractions as a potential sign of a esophageal motor disorder in seven patients. By means of esophageal manometry "nutcracker"-esophagus was seen in two patients and diffuse esophageal spasm in three patients. On the basis of these findings primary esophageal motor disorders should be considered as a possible cause of ectatic veins in the proximal esophagus and "downhill" varices.

[Immunomodulating therapy in chronic polyarthritis with thymopentin. A multicenter placebo-controlled study of 119 patients]. / Immunmodulierende Therapie der chronischen Polyarthritis mit Thymopentin. Eine multizentrische placebokontrollierte Studie an 119 Patienten.

In a multicenter, placebo-controlled and randomized double-blind trial 119 patients with rheumatoid arthritis were treated with thymopentin, an immunoregulating drug. The data of 107 patients were complete enough to be evaluated: 51 were given intravenous injections over ten minutes of 50 mg thymopentin three times weekly, 56 were similarly treated with a placebo solution. Significant improvement of five among nine clinical criteria were obtained with thymopentin after the third week of treatment. The response rate (improvement of a clinical parameter by at least 40%) was significantly greater for all clinical parameters in the thymopentin group. Regression to a functionally more favourable class (Steinbrocker's classification) occurred in seven thymopentin-treated, but in none of the placebo-treated patients. The improvement gradually subsided over four weeks after the end of treatment. There were no changes during the trial with respect to immunological, biochemical or haematological findings. Except for one systemic allergic reaction there were no side effects.

The involvement of the liver in Sjögren's syndrome.

Liver involvement in Sjögren's syndrome is little known in oral medicine. The involvement of the oral cavity and salivary glands is often diagnosed as an additional symptom during a general internal examination. This study shows that, even in the case of extensive liver involvement with considerable hepatic enzyme alterations, complaints in the mouth and jaw region can initially lead the patient to seek the advice of a dentist.

[False diagnosis of phlebothrombosis (author's transl)]. / Fehldiagnose Phlebothrombose.

Clinical signs of deep vein thrombosis of the calf in diseases of the knee joint may lead to a false diagnosis. Two examples illustrate how bursae or herniated cysts at the back of the knee may resemble acute phlobothrombosis when they increase in size or rupture. Sonographic investigations are the method of choice for diagnosis and differentiation of cysts as well as for the follow-up.

Immunological and functional characteristics of peripheral blood and synovial fluid lymphocytes from patients with rheumatoid arthritis.

Spontaneous (SCMC) and antibody dependent cellular cytotoxicity (ADCC); mitogenic responsiveness (PHA, Con A, PPD, dextran and pokeweed) as well as lymphocyte subpopulations (E-, EA-, EAC-rosettes, S-Ig) were studied simultaneously in peripheral blood (PBL) and synovial fluid lymphocytes (SFL) of fifteen patients with rheumatoid arthritis. Marked differences were observed in the cytotoxic activity of SFL and PBL. Whereas SCMC activity of SFL was always significantly elevated above the cytotoxic levels of PBL, the reverse was true for the ADCC reaction; here, 50% of the patients showed a decreased cytotoxicity of SFL compared to PBL. Synovial fluid neutrophils (SFN) were found to be inactive in both cytotoxic assays. No differences were found in ADCC activity of PBL between normal controls and RA patients. In SCMC assays a significantly increased activity of control PBL was only observed at L/T ratios of 100:1. Overnight incubation of PBL from RA patients and normal controls resulted in a marked decrease in SCMC and, to a smaller extent, in ADCC activity. SFL from three out of four patients lost less SCMC activity after overnight incubation than the corresponding PBL. In one patient even an increased activity in both cytotoxic systems was obtained. Regarding lymphocyte populations, T-cells were significantly decreased in PBL of RA patients. With the exception of a significantly lowered percentage of C3 receptor positive cells in SFL, no significant differences were recorded in the lymphocyte distribution between the patients' PBL and SFL. In the RA patients, the response to T-cell mitogens was significantly depressed in SFL while PPD and pokeweed reactivity was equal to that of PBL.