[Randomized, double blind, multicentre, parallel group study to compare efficacy and safety of acemetacin and indometacin in patients with activated osteoarthrosis of the knee]. / Wirksamkeit und Verträglichkeit einer Behandlung mit Acemetacin bei Patienten mit aktivierter Gonarthrose - Ergebnisse einer doppelblinden Vergleichsstudie mit Indometacin.

137 patients with active osteoarthritis of the knee joint were randomized in the ratio 2:1 to be treated with either one of the non-steroidal anti-inflammatory drugs acemetacin (180 mg/day) or indomethacin (150 mg/day). After 4 weeks of treatment, the complaints, as assessed by the patients by means of the Lequesne Index, decreased in both groups to a comparable extent. However, the overall assessment of the therapeutic success, both by patients and by physicians, showed a trend in favor of acemetacin: 70% of the patients in this group reported that their complaints were markedly improved or had subsided entirely, as opposed to 51% of the patients under indomethacin. As for adverse events, gastrointestinal complaints were dominant in both treatment groups, but significantly more patients interrupted the treatment in the indomethacin group (22.2%), than in the acemetacin group (5.4%). 83% of the patients declared the tolerance of acemetacin to be good or very good, in comparison to only 56 % of the patients in the indomethacin group, a highly significant difference (p = 0.0009). This significantly better tolerance of acemetacin in comparison to indomethacin confirms results from previous clinical studies.

Diclofenac epolamine is effective in the treatment of acute migraine attacks. A randomized, crossover, double blind, placebo-controlled, clinical study.

Hydrosoluble diclofenac epolamine (DHEP) represents an interesting approach to acute migraine attacks, where gastrointestinal motility and drug absorption are often reduced. Its efficacy was investigated in a randomized, crossover, double-blind trial on 155 patients who treated four consecutive mild-to-moderate migraine attacks, either with DHEP (65-mg sachet) or placebo. If pain was not relieved within 1 h, a second dose was given. The total number of treated attacks was 481. A pain-free condition was achieved within 2 h in 45.8% and 25.1% of attacks treated, respectively, with DHEP or placebo (P < 0.0001), with a therapeutic gain of 20.7%. Time to attack resolution, light and noise sensitivity and impact on working ability were significantly reduced by DHEP compared with placebo. Moreover, significantly fewer patients required a second drug dose or a rescue medication when treated with DHEP than with placebo. No adverse reaction was recorded. In conclusion, DHEP was effective and safe for pain relief in patients with an acute mild-to-moderate migraine attack.

Diclofenac patch for topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study.

OBJECTIVES: To investigate the clinical efficacy and safety of a newly developed diclofenac patch in the topical treatment of blunt impact injuries. METHODS: This was a randomised, placebo controlled, double blind, multicentre study in 120 patients with traumatic blunt soft tissue injury. Within 3 h of the injury participants of sport competitions and training camps were enrolled and treated twice daily with the diclofenac or a placebo patch over a period of 7 days. Patients were randomised (1:1) to two parallel groups. Tenderness produced by pressure was measured twice daily during the first 3 days after enrollment as well as at day 7. Tenderness was defined as the amount of pressure (measured by a calibrated caliper at the centre of the injury) that first produced a pain reaction as reported by the patient. RESULTS: The primary efficacy variable was the area under the curve for tenderness over the first 3 days. The diclofenac patch was significantly more effective than placebo (p<0.0001). The treatment effect was 64.7 kp h/cm2 (95% confidence interval 48.7 to 80.9) between diclofenac and placebo patches. These results were supported by all secondary efficacy variables. The diclofenac patch produced rapid pain relief as reflected by the time to reach resolution of pain at the injured site which was significantly shorter compared to placebo (p<0.0001). The diclofenac patch was well tolerated. The most frequently observed adverse events were local cutaneous adverse reactions (pruritus, rash) of minor severity occurring with the same frequency as in the placebo group. CONCLUSIONS: A newly developed diclofenac patch is effective and safe for the treatment of blunt impact injuries.

[Algorithm for diagnosis and therapy of pain]. / Algorithmus der Schmerzdiagnostik und -therapie.

Certain basic principles are applicable to all forms of pain treatment when the aims are pain relief and the avoidance of chronicety. Such algorithms, as guidelines are even more important when pain is becoming chronic. The use of the described algorithms is necessary in the diagnosis and therapy of acute pain and also to avoid the establishment of chronic pain due to the changes of neuroplasticity in the central nervous system. The most important basic principles in the form of algorithms are first of all that therapies should be simultaneously applied and not sequentially. Secondly, the challenge should be met to create a concept where by various therapies can be preformed in a parallel fashion, without compete one another and being effective on different aspects and causes of the pain.

[Topical treatment of blunt-impact soft tissue injuries]. / Die topische Therapie stumpfer Weichteilverletzungen.

Studies have shown that topical NSAIDs, e.g. diclofenac, easily penetrate the skin barrier to exert local therapeutic activity. In contrast to oral administration, plasma levels after application of topical formulations are by several magnitudes lower thus explaining the lack of systemic side effects. We discuss the clinical relevance of patches containing an NSAID by demonstrating the efficacy and safety of a newly developed diclofenac patch in the topical treatment of blunt impact soft tissue injuries in a randomised, placebo controlled, double blind, multicentre study. The results showed that the diclofenac patch was significantly more effective than placebo (p < 0.0001) with a significantly faster pain relief. The diclofenac patch was well tolerated. It might be used in indications with similar pathomechanisms.

Pharmacokinetics of diclofenac hydroxyethylpyrrolidine (DHEP) plasters in patients with monolateral knee joint effusion.

The aim of this study was the assessment of blood and synovial levels of diclofenac after repeated epicutaneous dosing with DHEP plasters in patients with joint effusion. To eight volunteers suffering from monolateral knee joint effusion, DHEP plasters containing 180 mg DHEP each, were applied on the affected knee b.i.d. (at 8 a.m. and 8 p.m.) for 4 consecutive days (8 doses) and only at 8 a.m. of the 5th day (9th dose). Plasters were left on the affected area until the following application or for 12h the 5th day. Venous blood samples were collected immediately before the first dosis and 1, 4 and 8 hours after the 9th application, while synovial fluid (SF) from the affected knee joint was collected at the beginning of the study and at 4 hours after the 9th DHEP plaster application. Unchanged diclofenac was measured in plasma and SF by means of a GLC-mass spectrometry technique. Low but durable levels of diclofenac were obtained at each collection after dosing in plasma. Detectable SF concentrations of diclofenac at the 4th hour of the 9th application were obtained, thus indicating the diffusion of diclofenac into the synovial liquid. The authors conclude that the topical application of DHEP plaster b.i.d. for 4 days allows measurable levels of diclofenac to be obtained in the underlying affected joint, without producing elevated circulating blood concentrations of diclofenac, thus greatly reducing the risk of possible systemic side effects.

[The place of apatite in rheumatic diseases. Study of 25 cases by x-ray microanalysis and scanning electron microscopy]. / Place de l'apatite dans les maladies rhumatismales. Etude de 25 cas par microanalyse à rayons X en microscopie életronique à balayage.

The importance of "apatite deposition disease" among the arthropathies has been recognized for some years: it is well known that X-ray microanalysis (XRMA) is an efficient method of determining the elemental constitution of microcrystalline deposits obtained from synovial fluids or from tendon washing solutions during examination in scanning electron microscopy. In all 25 patients studied (11 intraarticular and 14 extraarticular samples), alizarine red S staining was positive and XRMA confirmed the diagnosis of apatite deposition by determination of the phosphorus/calcium (P/Ca) ratio in the deposits. In the 25 patients the mean values obtained for the P/Ca ratios were situated between 0.362 and 0.450, with a general mean value of 0.411, i.e. a ratio clearly lower than the P/Ca ratio of pure hydroxyapatite specimens (0.438) measured in identical conditions. This apparent discrepancy seems to be related to the probable presence of carbonated apatites. The study confirmed the presence of apatite microcrystals in intra- and extraarticular location; in the first condition, these were generally found in patients with severe destructive arthrosis, whereas in the second condition the calcifications derived from supraspinatus tendons.

[Pigmented villonodular synovitis]. / Beitrag zur pigmentierten villonodulären Synovitis.

Pigmented villonodular synovitis (PVNS) is a comparatively rare disease of which some 2000 case reports are found in the international literature. PVNS should nevertheless be considered in the differential diagnosis of mono- and oligoarthritis. Three further cases of PVNS are presented in which the diagnosis was confirmed histologically. The clinical, X-ray, laboratory and histologic findings in PVNS, and the differential diagnosis and aetiology are discussed.

Clinical evaluation of 'Osmosin' versus piroxicam.

A single-blind, randomized trial was carried out in 30 out-patients with osteoarthritis to compare the efficacy and tolerability of the new osmotic-release formulation, 'Osmosin' (7 mg indomethacin per hour over a period of approximately 10 hours), with that of piroxicam. Patients received a single dose of one 'Osmosin' or 20 mg piroxicam per day for 4 weeks. The results of objective and subjective assessments of disease symptoms showed that both treatments produced statistically significant improvements from baseline and no significant differences between the groups were observed. Three patients in the piroxicam group experienced moderate to severe gastro-intestinal problems and 1 patient dropped out after 2 weeks because of lack of efficacy. No side-effects were reported in the group on 'Osmosin' and all 15 patients completed the study. Data on the incidence of indomethacin-related side-effects from two open multi-centre studies involving large numbers of patients with osteoarthritis are discussed.

[Synoviorthese]. / Die Synoviorthese.

Among the various possibilities for local treatment of rheumatoid synovitis, intra-articular injection of corticosteroids has only a very temporary effect. The same can be said of local treatment with cytostatics, though the effect is somewhat longer-lived. After intra-articular treatment with 1% osmic acid, joint effusions in particular remain under control over a lengthy period of time. The most effective conservative local treatment appears to be radionuclide therapy, and in older patients it may be a true alternative to surgical synovectomy. Radionuclides with varying physical properties are administered according to the size of the joint. The dosage of these substances also depends on the size of the joint. If precautions are taken, side effects are rare.

[Acupuncture and laser treatment in cervical and lumbar syndrome]. / Akupunktur- und Laserstrahlbehandlung beim Zervikal- und Lumbalsyndrom.

Eight random groups, each of 15 patients with tendomyotic cervical and lumbar syndrome, underwent acupuncture, one group receiving needle acupuncture at the "correct" sites according to Chinese medicine and another receiving placebo needles at the same sites. In a third group, acupuncture needles were applied at sites which were wholly inconsistent with Chinese practice. The remaining 5 groups took part in a single blind trial involving various types of radiation at the correct acupuncture sites, using an apparatus emitting either laser rays, red light, mixed light, infrared or no radiation at all, without interference from the therapist. All the groups showed improvement, but an analysis according to Kruskal and Wallis revealed no significant differences between type and site of treatment.