Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain.

Abstract

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

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

“…Comments 1.In many of the studies used to formulate these recommendations, the sample size was low (N=37 (Berry et al 1982); N=30 (Hickey 1982); N=459, but in the subgroup with chronic LBP N=81 ; N= 28 (Videman and Osterman 1984)) and the follow-up was short (2-6 weeks). …”

“…One low quality study from the systematic review compared diflunisal vs. placebo vs. naproxen sodium (Berry et al 1982). Naproxen was superior to placebo in relieving global pain and, depending on the method of measurement, in relieving night pain and pain on movement.…”

“…In a 3-way, doubleblind, cross-over study, diflunisal (500 mg twice daily) was compared with naproxen sodium (550 mg twice daily) and each was compared with placebo (Berry et al 1982). Whilst naproxen showed significantly better results than placebo, diflunisal did not, indicating that naproxen was superior to diflunisal.…”

Lumbar Degenerative Disc Disease: Clinical Presentation and Treatment Approaches

“…There is adequate data demonstrating efficacy in pain reduction in the context of chronic low back pain [63][64][65][66], with use most commonly limited by gastrointestinal (GI) complaints. COX2 inhibitors offer modest relief in chronic LBP and improved function in the long-term set-ting.…”

Untitled

“…It is envisaged that this information would appear adjacent to the summary or abstract and would be categorized under the headings Design, Measurement and Analysis. Contained within these three components there are 19 subcom- (Brooks et al, 1982;Martinez et al, 1980;Melton et al, 1978), gout (Douglas & Thompson, 1970;Sturge etal., 1977), rheumatoid arthritis (Atkinson et al, 1980;de Silva & Hazleman, 1981), chronic back pain (Berry et al, 1982), ankylosing spondylitis (Bird et al, 1980) and Raynaud's phenomenon (Rodshaffer et al, 1983). They were selected to illustrate the applicability and versatility of the coding system when applied to different disease states and different trial designs.…”