A double-blind one year clinical trial comparing alclofenac with gold in rheumatoid arthritis.

Twenty-seven patients with rheumatoid arthritis entered and 20 completed a one year double blind trial in which the effects of alclofenac 1 g 3 or 4 times daily were compared with gold injections 50 mg weekly intramuscularly to 1 g then 50 mg monthly. Previous anti-inflammatory medication was continued. Assessments were done every 3 months. On both drugs there was a delayed continued improvement over at least the first 6 months in mean pain scores, morning stiffness, grip strength, articular index and an overall grading system. The mean ESR fell markedly in patients on gold, but in those on alclofenac it showed no consistent change. Several measurements showed improvements statistically compared with initial values in both groups after 6 months. Rheumatoid factor, and hand and feet X-rays, were not influenced by either treatment. Side effects were rather similar on both drugs, and 4 patients in each group developed a rash.

A new goniometer.

A simple new goniometer has been developed for measurement of the mobility of the cervical spine. It consists of a headgear with three rigid scales calibrated in degrees, mounted on a skull cap with straps around the chin, and it measures flexion/extension, lateral flexion and horizontal rotation. Its construction and use are described. Three observers each tested the same 10 subjects to determine inter-observer error. Two observers then each tested 10 different subjects on two occasions at intervals of 10 to 30 minutes to test intra-observer error. Statistical analysis of the inter-observer error data by analysis of variance, and the intra-observer error data by calculation of means and standard errors of the differences between the means, showed that acceptably reproducible results could be obtained with this new goniometer, and it is also shown that an experienced observer can obtain more consistently reproducible results. Reference is made to the successful use of this technique in a comparative study (published elsewhere) of two drugs in degenerative joint disease of the cervical spine.

A clinical trial of diflunisal against aspirin in osteoarthritis.

Thirty patients with osteoarthritis of knees or hips took part in a double-blind randomized 12-week inter-group clinical trial of diflunisal 250 mg to 375 mg twice daily against aspirin 500 mg to 750 mg four times daily using the double-placebo technique. Changes were assessed in weight-bearing pain and night pain, stiffness after rest, a specified activity, and overall judgements by patient and physician, all graded on a five-point scale. Intermalleolar distance or knee flexion were measured. Side-effects and safety tests were monitored. Diflunisal produced statistically significant responses for all the criteria, when numbers of patients better or worse after 12 weeks were compared using the sign test. Neither the figures for aspirin alone, nor a comparison between the two treatment groups, reached statistical significance. Side-effects and especially dropouts were less on diflunisal. Nine patients on diflunisal but only two on aspirin wanted to continue treatment beyond 12 weeks, though still 'blind' when deciding this. Diflunisal may be a useful, less toxic and longer acting alternative to aspirin in the management of osteoarthritis.

Two trials of diflunisal in osteoarthritis.

Two double-blind inter-group trials were carried out in which diflunisal was compared for 12 weeks against aspirin in 30 patients with osteoarthritis of knees or hips, and against naproxen for 8 weeks in 20 patients with osteoarthritic knees. Diflunisal appeared to be somewhat better than aspirin in terms of both effectiveness and tolerance, whilst it was similar in both repects to naproxen.

Antinative DNA antibodies as a reaction to pyrazole drugs.

A case history is presented of the occurrence of a high binding capacity for native DNA in the serum of a patient on phenylbutazone. This reverted to normal on stopping the drug. The patient also had a reversible neutropenia and leucopenia, and it is suggested that the high anti-DNA binding capacity was a feature of a drug-induced lupus-like phenomenon.

Indomethacin or amylobarbitone sodium for sleep in rheumatoid arthritis, with some observations on the use of sequential analysis.

1 A double blind crossover trial in patients with rheumatoid arthritis showed that indomethacin given at night was superior to a hypnotic in providing sleep and relieving morning stiffness. 2 In a second trial, the combination of a hypnotic with indomethacin was not superior to indomethacin alone as judged by patients' preference, but further analysis suggested that the combination improved sleep without affecting morning stiffness. 3 It is argued that the use of a small closed sequential design produced too small a sample in the first trial. In the second trial, the sample was relatively large but the result was inconclusive; measurement of the response in terms of preference alone obscured the effect of treatment on one aspect of the symptomatology studied.

Trial of an anti-inflammatory agent (indomethacin) in low back pain with and without radicular involvement.

A short-term double-blind sequential trial of indomethacin against placebo in the treatment of low back pain, with and without nerve root pain such as sciatica, showed that indomethacin was significantly more effective than placebo in the group with nerve root pain. On the other hand, no difference was found between the treatments in the patients with uncomplicated low back pain. This difference may result from an effect of indomethacin on the inflammatory process around the nerve root which has been shown to be present when this is compressed.