Forty patients with acute mechanical low-back pain were treated in a double-blind manner with either Rado-Salil or placebo for 14 days. Statistically significant improvements in spontaneous pain, muscular contracture and in both the patient's and physician's opinions occurred by day 3. These improvements persisted at day 14 and, in addition, there were statistically significant improvements in the finger-floor distance and the degree of lumbar extension. Treatment with Rado-Salil also allowed significant reduction in the use of oral analgesics. Only a few localized transient side-effects, requiring no specific treatment, were observed.
Two double-blind studies were carried out to compare the effectiveness and tolerance of a slow-release tablet formulation of 300 mg fentiazac, given once daily, with the standard tablet formulations of 100 mg, given 4-times daily, or 200 mg, given twice daily. A total of 60 patients suffering from acute bicipital tendinitis and/or subdeltoid bursitis was studied, 15 patients on the slow-release and 15 on one of the two standard tablets in each of the two trials. Patients were assessed on entry and at Days 7 and 14 of treatment. The results in both studies showed that there was significant improvement in tenderness, pain on movement, overall pain and in the range of movement after treatment, there being no significant difference between those receiving the slow-release form or the standard tablets. Tolerance was good in all groups and only a few minor or moderate side-effects, mainly of a gastro-intestinal type, were reported.
Eighty out-patients (50 F, 30 M), aged 58 +/- 12 years (range: 26-84) and weighing 72 +/- 10 kg (range: 50-97), presenting with an acute or subacute (< 3 months) episode of rotator cuff tendinitis without (n = 28) or with movement restriction (n = 52) of the shoulder and having a pain intensity of at least 4 on VAS for pain at rest or on active movement, were treated at random and in double blind conditions for 1 to 4 weeks with 1 weekly periarticular anterior injection of tenoxicam 20 mg or placebo. Tenoxicam treated patients improved more than placebo-injected patients in a statistically highly significant manner with regard to clinical index, pain on VAS during active movement and at rest, active mobility (degrees), pain or pressure and clinical global impression (assessed by investigator and patient). There was a nonsignificant opinion that placebo treated patients consumed more rescue medication. Safety assessments were not significantly better in the placebo-treated patients through local tolerability tended to be better in that group. These results indicate that tenoxicam 20 mg injected locally is effective in alleviating pain and in improving shoulder mobility in patients with a painful shoulder episode and suggest that such a treatment is safe and well tolerated. Local injection of tenoxicam seems to be a promising new treatment of acute, painful, local inflammatory processes in Rheumatology, Orthopaedics, Physical Medicine and Sports Medicine. Further studies in other pathologies are warranted.
Summary264 patients experiencing pain related to osteoarthritis of the hip and/or knee were enrolled in a double-blind randomised multicentre study. Those who reported moderate or severe pain despite taking paracetamol 4g daily during a I-week lead-in period were randomised to treatment with tramadol Hel 100mg 3 times daily or dextropropoxyphene napsylate 100mg 3 times daily for 2 weeks. At the end of the second week of therapy, 71.6 and 70.4% of tramadol-treated patients and 53.2 and 50.5% of dextropropoxyphene-treated patients had symptom improvement during daily activities (p = 0.01) and on walking (p = 0.006), respectively. A larger proportion of tramadol-treated patients also reported improvement of pain during sleep as compared with patients administered dextropropoxyphene (tramadol: 44.3%; dextropropoxyphene: 30.3%; p = 0.04). Numerically, tramadol was also more effective than dextropropoxyphene for improvement of pain relief as measured on a visual analogue scale, but the difference did not reach statistical significance (tramadol: 48, dextropropoxyphene: 42; p = 0.12). No potentially serious adverse events were reported. Tramadol was associated with a significantly higher number of reported adverse events; the most commonly reported events were nausea, dizziness and vomiting, and more patients taking tramadol were withdrawn due to adverse events.In conclusion, tramadol was more effective than dextropropoxyphene in treating osteoarthritic pain, but tramadol was more often associated with adverse events. However, considering the nonserious nature of the events and the high number of fatal overdoses reported in the literature with dextropropoxyphene, tramadol appears to be a better alternative.Osteoarthritis is a painful condition that affects up to 80% of the population)l] The diagnosis of osteoarthritis is based on clinical observations, but also includes destruction of joint cartilage. The role of inflammation in the disease progress is somewhat controversial. It is probably responsible for the intermittent symptoms of pain in association with tenderness, swelling, warmth and redness, but its role in the breakdown of cartilage is questionable. Thus, in some countries the condi-
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