Double-blind study comparing the long-term efficacy of the COX-2 inhibitor nimesulide and naproxen in patients with osteoarthritis.

This double-blind one-year study compares the long-term efficacy and safety of nimesulide with naproxen in patients with osteoarthritis (OA) of the knee or hip. Patients were randomised to nimesulide 100 mg twice daily (n = 183) or naproxen 250 mg morning, 500 mg evening (n = 187). The primary efficacy variable was change in pain intensity (WOMAC A scale) at 6 months. Nimesulide tablets showed at least equivalent efficacy to naproxen tablets in reducing pain intensity at 6 and 12 months (nimesulide -22.5% at 6 and 12 months; naproxen -22.4% at 6 months, -19.9% at 12 months; non-inferiority proven). At 6 months the investigator assessed efficacy as 'good' or 'excellent' in 59.3% of nimesulide and 56.4% of naproxen-treated patients, with corresponding values for patient assessment of 57% and 52.7%. Both treatments were well tolerated, with fewer related gastrointestinal adverse events reported with nimesulide (77 cases, 47.5%) than with naproxen (96 cases, 54.5%). This study shows nimesulide to be as effective as naproxen in the long-term treatment of OA and to be associated with fewer gastrointestinal side-effects.

[Outcome measurement in musculoskeletal diseases: recommendation for a core set of scales for use in rehabilitation]. / Outcome-Messung bei muskuloskelettalen Krankheiten: Vorschlag für ein Core-Set von Instrumenten zum Einsatz in der Rehabilitation.

By application of a standardized core set of outcome measurement instruments, comparison between studies as well as meta-analyses in rehabilitation research can be facilitated. The German Society for Rheumatology has commissioned its working group on rehabilitation with the development of a proposal for such a core set of outcome measurement instruments. In a first step, dimensions for outcome measurement in rehabilitation were defined by a group of experts which represented rehabilitation hospitals, acute care hospitals, and research groups specialized in outcome measurement. The Delphi method was used in a multiple step consensus process. In a second step, instruments and procedures to operationalize the relevant dimensions were chosen. Reliability, validity, sensitivity to change, and practicability were used as criteria for selecting measurement instruments. The main intention of the proposed core set of outcome measurement instruments is to facilitate the processes of planning and carrying out rehabilitation research studies. Furthermore, the proposed instruments can be used for clinical documentation systems as well as for internal or external quality assurance programs.

The social environment and health in rheumatoid arthritis: marital quality predicts individual variability in pain severity.

OBJECTIVE: To examine prospective relations between a wide array of measures of social functioning and pain, while controlling for disease duration and activity and functional grade. METHODS: As part of a larger study on health care utilization, longitudinal data were collected from 136 Dutch and 98 German outpatients on clinical status and pain. Social data included information on sexual handicap, spouse behavior, loneliness, daily emotional support, and the maintenance of pleasurable life domains. Pain severity was assessed at baseline and 12 months later with standard measures of pain and analyzed with hierarchical regressions. RESULTS: Social measures obtained at baseline were consistently associated with pain at followup. Depression was a moderate correlate of pain in the Dutch and German samples. The regressions revealed that patient reports of negative spouse behavior (such as avoidance and critical remarks) and baseline depression predicted worse pain outcome, and this association remained significant in analyses controlling for baseline pain. The level of formal education was a weak correlate of disability, emotional support, and pain. Daily emotional support and social life domains associated with positive affect had an indirect influence on outcome. The absence of strong rather than weak social ties was the component of the loneliness construct linked to pain. These associations between social prognostic factors and pain severity, however, were mediated by psychological functioning at baseline. CONCLUSION: The social environment was found to operate on the core health outcome, pain severity, via several pathways. Social functioning may be affected by rheumatoid arthritis (RA) progression, but it also appears to form a determinant of future health outcome. Not only the status of being married but also the quality of the relationship in terms of long-term stress and emotional support may be useful prognostic factors in RA.

[Patient self-management and stabilization as a contribution to process quality]. / Selfmanagement des Patienten und seine Stabilisierung als Beitrag zur Prozessqualität.

Self-management is described as a pattern of patient behavior dealing with chronic disease. It encompasses self-assessment, decision making, self-care and treatment as well as documentation. The self-management behavior has to be encouraged and supported by health care professionals.

["State of the art" in epidemiology of arthroses. An overview of important studies of etiology and sequelae]. / "State of the Art" in der Arthrosenepidemiologie. Ein Uberblick über wichtige Studien zur Atiologie und zu den Krankheitsfolgen.

The term "Osteoarthrosis" encompasses a group of joint disorders characterized by pain and restriction of mobility. Currently, considerable confusion prevails with respect to the definition of the disease entity and the classification criteria to be utilized in epidemiologic research. Despite these methodological difficulties, it is discernible from the international rheumatology journals that during the past decade this emerging field of research has become firmly established in several European countries and in North America. Researchers have focused their attention on four major facets of the disease: 1. etiological or risk factors with respect to the initiation and clinical course of disease, 2. the impact of illness on the individual and his family, 3. the statistical estimation of incidence and prevalence rates in the total population or in selected at-risk groups of individuals, 4. health care utilization patterns and their costs and benefits. This survey article aims at providing a critical overview of this emerging field of research, as well as at suggesting to the reader future lines of development useful for public health and health promotion researchers in Germany.

[Special problems of young rheumatic patients with occupational placement]. / Besondere Probleme junger Rheumakranker bei der beruflichen Eingliederung.

In a study initiated by the German League against Rheumatism, 433 young patients with rheumatic disorders (mean age 27 years, disease duration 7.5 years, 60% female, 40% male) were questioned in 1989 for the first time to ascertain disease-related problems encountered at school or during professional training. Their self-reported diagnoses were 68.2% chronic arthritis and 23.6% Ankylosing spondylitis (definite or probable diagnosis). From 181 patients who had been affected at school age, 84.5% reported the following main problems: absence related to illness, exclusion from excursions and school-related activities. Nevertheless, a majority of the patients (60.5%) reached a qualified graduation. 25.3% of the study sample was still attending school, 50.3% were employed, 8.6% were unemployed, and 4.5% had been retired early. Only 37.7% of the Arthritis patients and 22.3% of the Spondylitis patients had sought advice and help from the labour exchange services; 26.9% of the arthritis patients and 21.9% of the Spondylitis patients assessed this advice to be helpful. Regarding vocational guidance, the patients main criticism was a lack of knowledge about rheumatic disorders. There is a demand for an adjustment of the individual physical abilities and the requirements of the respective jobs, and continuous supervision by a rheumatologist is necessary.

[The "Emmerich Arthritis Record", function and acceptance within the scope of an integrated treatment concept]. / Der "Emmericher Arthritispass", Funktion und Akzeptanz im Rahmen eines integrierten Behandlungskonzepts.

For a comprehensive model of rheumatoid arthritis treatment, we designed an arthritis manual for continuous treatment of chronic illness. One goal of introducing the manual to the patients was the improvement of communication between patient and different doctors and therapists. The first part includes of a doctor's documentation sheet and a patient calendar (6 months each) for daily self-documentation of drug compliance. The second part is a daily pain-rating scale. The 3-year evaluation of 655 patient manuals for 286 patients was analyzed to estimate the compliance in using the manual. Overall, 87% of diagnoses, 83% of disease-modifying anti-rheumatic drugs (DMARDs), 87% of non-steroidal anti-rheumatic drugs (NSAIDs) had been documented in the manual. Data indicates that the general practitioner and the rheumatologist accepted the manual form. In addition, 85% of the documented patients used the DMARDs, 74% used the daily pain score, and 43% the daily physiotherapy. Subgroup data (n = 130 RA patients) suggest additional results: 1) there was no difference in sociodemographic data between the patient manual user group and the non-user group; 2) the user group consisted of patients with higher disease activity (ARA-criteria), higher pain score, and negative mood pattern. Furthermore, the user group was more active in daily physiotherapy, ergotherapy, and balneotherapy.

[A case of osteopoikilosis combined with dermal changes and compression syndromes of peripheral nerves]. / Ein Fall von Osteopoikilie kombiniert mit dermalen Veränderungen und Kompressionssyndromen peripherer Nerven.

In the case of combination of osteopoikilosis with dermal alterations we wanted to know if the hereby discussed general mesenchymal lesions are the cause of the additional entrapment syndromes of peripheral nerves present in our case. For this purpose we recorded the pressure at the distal median and ulnar nerves within and out of the entrapment location. The results of the pressure recording of not point to a primary nerve lesion by a elevated pressure susceptibility or a pressure elevation at the peripheral nerve out of a defined entrapment location e.g. by an increase of connective tissue. Because of a hypertrophic scar formation in this case it should be paid attention to the wound healing of all patients with osteopoikilosis. The histologically verified nevoid mesenchymal alterations of the connective tissue found in this case, are to be delineated from the disseminated lenticular dermatofibrosis of the Buschke-Ollendorff syndrome.

Oral gold therapy with auranofin (SK&F 39162). A multicenter open study in patients with rheumatoid arthritis.

One hundred and fifty patients with rheumatoid arthritis received 6 mg of auranofin daily for 2-24 months. Thirty patients were withdrawn from the study, and 82 patients were observed for 12 months. Statistical evaluation was available for 74 patients at weeks 24, 38, and 48, respectively. The major side effects observed were diarrhea, rash, and alopecia. Significant improvement was noted in the articular index, ESR, pain, and morning stiffness.

[Clinical trial in couples of effectiveness and side-effects of gold and D-penicillamine in long term treatment of rheumatoid arthritis (author's transl)]. / Untersuchung von Wirksamkeit und Nebenwirkungen der Medikamente Gold und D-Penicillamin bei der Basisbehandlung der chronischen Polyarthritis im paarweisen Vergleich.

A prospective clinical trial in couples was done to compare effectiveness and toxicity of gold and D-penicillamine (D-Pen.) in treatment of rheumatoid arthritis (r.A.). Respecting defined criteria 70 patients were put to couples according to a random list and were treated with gold or D-Pen. alternatively. Physical and laboratory indices of inflammatory activity were checked every 3 months, X-rays every 12 months. Dropouts (side effects, missing compliance, uneffectiveness) were replaced by the nextcoming fitting patient. Thirty-two of 147 totally recruited patients stopped treatment because of side effects, three because of unsatisfying efficiency. Forty-two patients shuned the necessary controls. The clinical course was better in 16 couples with gold, only in sex couples with D-Pen. Thirteen pairs showed no difference in this respect (p = 0.05). Looking to the laboratory parameters separately D-Pen. tends to be superior (p < 0.05), radiografic deterioration seems to be more seldom with gold (< 0.05). Side effects occur with both drugs in comparable frequency (15/44 with D-Pen., 17/52 with gold), but the complications with D-Pen. are more serious. Altogether this trial shows gold superior to D-Pen. in the long-term treatment of r.A.

[Effect of D-penicillamine and 2-mercaptoethanol on human IgM in normal serum]. / Wirkung von D-Penicillamin und 2-Mercaptoäthanol auf humanes IgM in Normalseren

Serum from healthy blood donors (O Rh+) was fractionated on a Sephadex-G-200 column before and after incubation with equal volumes of either 0.2 m 2-Mercaptoethanol or D-Penicillamine. Immunoelectrophoretic analyses revealed that addition of these two sulphhydryl-containing compounds resulted in disappearance of the typical IgM-precipitate within the first peak. A new precipitate specific for M-chains appeared within the second peak. The data indicate that the smaller subunits with M-chain specificity result from splitting of disulphide bonds of the IgM molecules by the D-Penicillamine and the 2-Mercaptoethanol.

[Effect of D-penicillamine on the humoral primary response (author's transl)]. / Wirkung von D-Penicillamin auf die humorale Primärantwort

The influence of D-penicillamine (Pen) on the humoral primary response was studied systematically. Inbred rats are sensitized with erythrocytes of mice of one strain. Pen given at various schedules (dosage: 3 X 100 resp. 3 X 1000 mg/kg at 24 h intervals) showed no effect on antibody titer 7 days after sensitization. When Pen is given before the antigen the slope of the titer after day 7 is accelerated. Compared to experiments with alkylating drugs and antimetabolites in the same model Pen does not show immunosuppressive potency.