A multi-centre randomized, double-blind, parallel-group clinical trial was carried out in 63 patients with osteoarthritis of the knee to compare the efficacy and tolerability of a course of intra-articular injections of 20 mg sodium hyaluronate with a similar course of injections of placebo. Treatment consisted of up to 11 injections over a 23-week period. Evaluation was by means of subjective symptom and activity assessments, serially during the course of treatment and also 25 weeks thereafter. Ten patients (5 of 30 on active treatment; 5 of 33 on placebo) were withdrawn prematurely. Pain on movement, assessed by visual analogue scale (VAS) showed statistically significant (p less than 0.05 to p less than 0.0001) reductions in mean scores throughout the first 11 weeks of treatment with sodium hyaluronate but smaller, non-significant, reductions with placebo treatment. The difference between treatments was significant (p less than 0.05) at 5 weeks. Pain at rest, also assessed by VAS, showed little change in mean scores with placebo but with sodium hyaluronate there was a progressive reduction which was significant (p less than 0.01) throughout the period from 5 to 23 weeks. The difference between sodium hyaluronate and placebo was significant (p less than 0.05 to p less than 0.002) at Weeks 5, 11, 15, 19 and 23. 'Activities of daily living' were assessed using a standard scale. There were small improvements with both treatments, significant at some assessments and somewhat greater with sodium hyaluronate than placebo, but there were no statistically significant differences between the groups.(ABSTRACT TRUNCATED AT 250 WORDS)
In a single-blind trial, five treatments for painful stiff shoulder were compared for a 4-week assessment period in 60 patients. The treatments were acupuncture, steroid injection with placebo and with active tolmetin sodium, physiotherapy in the form of ultrasound and 'placebo' physiotherapy with placebo tolmetin sodium. Objective assessment was gained by use of goniometer readings to monitor shoulder abduction. Pain was measured by visual analogue scales and by a 4-point scale. Comparative assessment was also recorded and at the end of the study a success or failure was recorded for each patient's treatment. With very few exceptions all patients improved markedly, both in terms of the subjective and objective parameters. No differences between the treatments were detected. The incidence and severity of side-effects was low. It is suggested that the results show that the painful stiff shoulder may be a self-limiting condition and that any beneficial effect was really due to natural recovery. This is an important consideration because patients do not always receive immediate attention when referred to an out-patient department and the use of physiotherapy and acupuncture in such cases, perhaps, should be critically examined.
SUMMARY Thirty-seven patients with chronic back pain were entered into a randomised, 3-way, double-blind, cross-over comparison of naproxen sodium 550 mg twice daily, diflunisal 500 mg twice daily, and placebo. Each treatment was given for 14 days after a preadmission wash-out week during which only paracetamol was allowed. Patients were assessed on admission and at the end of each treatment with respect to global pain, night pain, pain on movement, and pain on standing. Both visual analogue scales and simple descriptive scales were used to measure pain. Side effects were elicited by a nonleading question. Both methods of pain measurement gave similar results and were highly correlated. Naproxen sodium was superior to placebo in relieving global pain and, depending on the method of measurement, in relieving night pain and pain on movement. Diflunisal showed no significant differences from placebo. Side effects were similar on all 3 treatments. The final preference of the patients was significantly in favour of the active treatments.Both naproxen sodium and diflunisal are analgesics with anti-inflammatory properties that are used primarily for their analgesic effect. Diflunisal has been heralded as the safer aspirin. In a controlled general-practitioner study1 it was reported that diflunisal had 3 advantages over aspirin in being more effective, more convenient (twice daily dosage), and less likely to cause gastric side effects in patients treated for acute pain. However, there has been some evidence23 to suggest that even this 'safe' drug may cause acute peptic ulcer. Naproxen sodium has been shown to produce significantly higher and earlier plasma levels of naproxen than an equivalent dose of the free acid, naproxen.4 It is therefore suited for use in acute conditions. Naproxen sodium has shown to be as effective as indomethacin in treating acute musculoskeletal disorders in general practice.5The present study was set up to compare diflunisal and naproxen sodium in chronic back pain in outpatients attending a hospital clinic. A placebo was included to try to resolve the problem of comparing 2 similar drugs which may be equally effective or ineffective. The study was also designed to compare the 2 main methods of measuring pain, the visual analogue scale (VAS) and the simple descriptive 4-point scale (SDS).Accepted for publication 20 February 1981 Correspondence to Dr H. Berry.
Patients and methodsStudy design. The study was a double-blind, 3-way, cross-over comparison of naproxen sodium, diflunisal, and placebo in patients with chronic back pain of at least 3 months' duration. Patients satisfying the admission criteria were randomly allocated to one of the 6 possible orders of treatment. Any existing drug treatment for back pain was replaced by paracetamol for 7 days, after which the 3 test preparations were given in turn for 2 weeks.Patients
1. Nineteen patients with classical rheumatoid arthritis complicated by severe subluxation of the cervical spine are reported. 2. Thirteen patients had atlanto-axial subluxation. This was the only level ofinvolvement in ten. 3. The next most frequent level to be involved was C.4-5. This occurred in five patients. 4. Eleven patients required surgery for symptoms or signs of spinal cord compression or vertebral artery insufficiency. 5. Operations included six posterior fusions, three anterior fusions and two laminectomies. 6. The differential diagnosis, the radiological findings, the indications for surgery and the results of treatment are discussed.
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