Local NSAID gel (eltenac) in the treatment of osteoarthritis of the knee. A double blind study comparing eltenac with oral diclofenac and placebo gel.

In a randomized, double blind, multicentre study with 4 weeks follow-up of 290 patients with osteoarthritis of the knee joint, a topical NSAID (eltenac) was compared with oral diclofenac and placebo. The main outcome, Lequesne's Index and pain by VAS showed no statistically significant differences between neither of the active treatments and placebo for the total study population. However, in patients with more severe symptoms, both active groups showed statistically significant differences to placebo. No severe adverse drug reactions were seen but the number of GI reactions were three times higher in the diclofenac group compared to the topical treatment. Local skin reactions were twice as frequent in the eltenac than in the placebo group. Taking into account the nature of the treatment for a chronic disease like OA, our results indicate that eltenac gel could be a safe alternative to oral NSAIDs.

Glycosaminoglycan polysulfate injections in lateral humeral epicondylalgia: a placebo-controlled double-blind trial.

The purpose of this study was to investigate the therapeutic benefit of local Glycosaminoglycan polysulfate (GAGPS) injections in the treatment of chronic epicondylalgia. The study was conducted as a prospective, placebo-controlled double-blind trial. Sixty patients with a typical history of pain for at least 3 months who attended two private orthopaedic clinics in Stockholm received 50 mg GAGPS or placebo injections, one injection a week, for five weeks. The main outcome measures were the patients' evaluation of pain in connection with daily activities with a visual analogue scale and the number of treatment failures. The follow-up period was six months. The difference in reduction of painscore (VAS) ranging between 11.1 percentage units at the half-year follow-up and 20.9 percentage units 2 weeks after the treatment period is clinically good. The number of treatment failures in the GAGPS treatment groups at the 6 week follow-up was only 4 (13%) compared with 12 (40%) of the placebo treated patients. At the half-year follow-up 5 of those who received GAGPS had experienced a recurrency. The recurrency rate is thus smaller than most of those reported in controlled studies with corticosteroids. In the GAGPS treated group 13 patients reported on local pain after some injections, 2 cases combined with local haematomas, compared with 5 cases of local pain in the placebo group. The results confirm previous good results of GAGPS injection therapy in subchronic and chronic peritendinitis.

Effect of glycosaminoglycan polysulphate on the human intervertebral discs based on stature measurements.

Glycosaminoglycan polysulphate has been shown to protect against loss of glycosaminoglycans in experimental osteoarthritis and has been used in humans to achieve the same result. It was assumed that if glycosaminoglycan polysulphate generally affects human connective tissues its use would increase or maintain intervertebral disc height by preventing water loss. Stature was measured during a resting-loading-resting period of 1.5 h. Four baseline measurements were taken of six subjects during a 4-week period. Thereafter each subject was given glycosaminoglycan polysulphate for 3 weeks and stature was measured once a week until a stable condition was reached; no less than three measurements were obtained. No effect of glycosaminoglycan polysulphate on the stature could, however, be seen in the mean values for all six subjects.

Topical indomethacin in overuse injuries in athletes. A randomized double-blind study comparing Elmetacin with oral indomethacin and placebo.

In this double-blind trial in 70 athletes with superficial overuse injuries, the effect of topically and systemically administered indomethacin was compared with a placebo control. The treatment period was 2 weeks and blindness was secured by the double-dummy technique. The basic data of the patients showed no significant differences on entry to the study. The majority of cases were acute or subacute, the mean duration of symptoms being 7.4 weeks. The results showed a marked therapeutic effect after 3-7 days of treatment and statistically significant differences between the topical formulation and the placebo were reached in the parameters patients assessment of improvement and pain in connection with daily activity within the first week of treatment. However, during the second week the statistical significances were lost. Only in the topically treated patients local adverse reactions were observed. In the oral indomethacin group all reactions were systemic, GI- and CNS-complaints being predominant. The results on efficacy as well as adverse reactions favour the use of topical indomethacin in superficial overuse injuries in athletes.

Local glycosaminoglycan polysulphate injection therapy in osteoarthritis of the hand. A placebo-controlled clinical study.

In this placebo-controlled double-blind trial in 30 patients suffering from disabling osteoarthritis of the hand, the long-term effect of periarticular injections of glycosaminoglycan polysulphate (GAGPS) on symptoms, hand function and life quality was investigated. The overall effect of the half-year follow-up was clinically good in 46% of the GAGPS-treated cases, compared with 14% of the controls. Significant differences in grip- and pinch strength were also found between the treatment groups. Significant differences were still seen at the one-year follow-up, as 13 patients (87%) in the GAGPS group reported improvement in their most restricted activity, compared with 6 (43%) of the controls. Nine periarticular injections of GAGPS over a period of 13 weeks gave a clinically good and long-lasting effect, with improved life quality for most of the patients.

A promising novel therapy for Achilles peritendinitis: double-blind comparison of glycosaminoglycan polysulfate and high-dose indomethacin.

In this double-blind trial in 60 recreational athletes suffering from Achilles peritendinitis, we compared the effect of local injections of glycosaminoglycan polysulfate (GAGPS) with oral indomethacin (IM) administered over a 2-week period. Orthotic devices were prescribed in 66% of the cases to control biomechanical errors. The results after 1-year follow-up showed that GAGPS had a good overall therapeutic effect on two-thirds of the patients compared to one-third of the IM treated. In the patients with symptoms lasting longer than 3 months, IM had an effect in only 12% while GAGPS was beneficial in 59%. Twenty-five cases of non-responders and relapses underwent a crossover treatment. Those who received IM in this second period did not benefit from this treatment while those who received GAGPS showed a moderate to good effect in 8/17 (47%) after a 2-week follow-up. A different mode of action is suggested as an explanation of the encouraging results.

Percutaneous treatment with a mucopolysaccharide polysulphate of experimentally induced subcutaneous haematomas in man.

In a double blind trial on ten healthy volunteers, the efficacy of a topically applied mucopolysaccharide polysulphate in the treatment of subcutaneous haematomas was assessed. Standardized haematomas were induced by subcutaneous injection of a mixture of autogenous blood and 125I-fibrinogen. The absorption of the haematoma, expressed as the removal of the labelled fibrin(ogen), could thus be objectively measured by the decrease in radioactivity. The results show an exponential absorption of these haematomas. The absorption time was reduced to about half compared with placebo, when treated topically with mucopolysaccharide polysulphate. The difference is statistically highly significant and is also considered clinically relevant.

A randomized study of a semisynthetic heparin analogue and heparin in prophylaxis of deep vein thrombosis.

The prophylactic effect of a semisynthetic heparin analogue (SSHA) on deep vein thrombosis was investigated in a prospective double-blind multicentre trial. 440 major general surgical and gynaecological patients were randomized to one of three treatment groups: 50 mg SSHA, 37.5 mg SSHA and 5000 units sodium heparin subcutaneously 12-hourly. Deep venous thrombosis (DVT) was diagnosed with the fibrinogen uptake test and verified with phlebography. Bleeding complications and other side-effects were carefully monitored. There were no significant differences between the three treatment groups of patients in age, sex, type of operation or risk factors. A DVT was diagnosed in 16 patients (12 per cent) in the SSHA 50 mg group, in 21 patients (15 per cent) in the SSHA 37.5 mg group and 21 patients (14 per cent) in the heparin-treated group. No significant differences were found in the number of patients who bled unexpectedly in the postoperative period, required transfusion or developed wound haematomas. Blood loss at operation was similar in all three groups. Three pulmonary emboli were diagnosed by pulmonary scintigraphy, one in each group.

Effects of heparin and a semi-synthetic heparin analogue on platelet aggregation, lipoprotein lipase and other laboratory tests in surgical patients.

Platelet aggregation, lipoprotein lipase activity, coagulation parameters and routine blood chemistry were measured in a randomised study of 21 surgical patients before, immediately after and 3 months after operation. Sodium heparin 5000 IU was given subcutaneously to 11 patients every 12 hours for 7 days, the first injection 2 hours preoperatively; 10 patients received a semi-synthetic heparin analogue (SSHA 75 mg) in the same manner. The groups were sex and age matched. No conclusive changes were found in platelet aggregation. The increase in lipoprotein lipase activity in SSHA patients 2 hours after injection was significantly greater than in heparin patients. Neither of the two drugs induced significant changes in coagulation parameters or routine blood chemistry. The results indicate a difference in the effect on lipoprotein lipase release between heparin and SSHA at the used dosage schedules.