J. Campbell

Circadian rhythm in pain, stiffness, and manual dexterity in rheumatoid arthritis: relation between discomfort and disability.

Fourteen patients with rheumatoid arthritis (RA) self rated their pain and stiffness on separate 10 cm visual analogue scales and performed bead intubation coordinometry (BIC) on six occasions each day for seven consecutive days. In addition, 14 healthy controls matched for age and sex also performed BIC measurements according to the same schedule. Data were analysed using least squares and cosine vector techniques. Significant circadian rhythms in patients with RA were detected in pain, stiffness, and BIC, and in controls in BIC. Pain was least in patients with RA at 1700 and stiffness at 1724. Peak BIC performance occurred almost simultaneously in RA (1544) and control (1528) subjects and for subjects with RA occurred within the 95% confidence interval of least pain and stiffness. These data suggest that the inferior performance of subjects with RA may be an accentuation of the normal physiological variation seen in healthy controls, but may be modulated by the patients level of pain or stiffness, or both.

Comparative Study of Self-rating Pain Scales in Osteoarthritis Patients

Although progress has been made in the clinical metrology of pain in osteoarthritis, much further work remains. The preferred methods of measurement remain debatable. In this longitudinal, open study, a comparison of eight self-rating pain scales has been conducted. A total of 333 patients entered the four-week study after completing a 3-7 day NSAID-free washout period. Patients were assigned to treatment with oxaprozin 1200 mg p.o. once daily with titration permitted between 600 mg and 1800 mg. Rescue analgesia with acetaminophen (paracetamol) 325 mg (maximum 2600 mg) was allowed. At the end of the washout and the treatment period, patients completed eight self-administered pain scales. All pain measures detected clinically important and statistically significant improvements in pain. The pain scales differed in their degree of responsiveness. The Likert and visual analogue scales and their primary variations (continuous chromatic analogue and numerical scales) were more responsive than more complex measures. A positive correlation between initial pain rating and subsequent pain relief was confirmed in this study. We conclude that, while pain is a subjective sensory phenomenon, its perceived severity can be evaluated using a variety of self-administered pain scales, all of which are capable of detecting improvements in health status following effective pharmacological intervention.

Relationship between severity and clinical importance of symptoms in osteoarthritis.

SummarySeventeen patients with primary osteoarthritis of the knee were evaluated with respect to the severity and clinical importance of pain, stiffness and physical function during the conduct of a double-blind randomized controlled trial of flurbiprofen SR versus diclofenac sodium SR using the WOMAC Osteoarthritis Index. Mean importance scores were similar for items within the same dimension as well as between items in different dimensions. In general, low levels of correlation were noted between the severity and importance of symptoms. Analysis of individual WOMAC items within a given subscale indicated that, although highly correlated, they differed from one another. Factor analysis further supported the contention that scores from items within a subscale could be summated into subscale scores. These observations are of importance in the weighting and aggregation of items within discrete dimensions and have the potential for reducing sample size requirements for clinical trials in osteoarthritis.

Comparative Study of Self-rating Pain Scales in Rheumatoid Arthritis Patients

Although progress has been made in the clinical metrology of pain in rheumatoid arthritis, much further work remains. The preferred methods of measurement remain debatable. In this longitudinal, open study, a comparison of eight self-rating pain scales has been conducted. A total of 124 patients entered the four-week study after completing a 3-7-day NSAID-free washout period. Patients were assigned to treatment with oxaprozin 1200 mg p.o. once daily with titration permitted between 600 mg and 1800 mg. Rescue analgesia with acetaminophen (paracetamol) 325 mg (maximum 2600 mg) was permitted. At the end of the washout and treatment period, patients completed eight self-administered pain rating scales. All pain measures detected clinically important and statistically significant improvements in pain. The pain scales differed in their degree of responsiveness. The Likert and visual analogue scales and their primary variations (continuous chromatic analogue and numerical scales) were more responsive than more complex measures. A positive correlation between initial pain rating and subsequent pain response was confirmed in this study. We conclude that, while pain is a subjective sensory phenomenon, its perceived severity can be evaluated using a variety of self-administered pain scales, all of which are capable of detecting improvements in health status following effective pharmacological intervention.

Efficacy and tolerability of enteric-coated naproxen in the treatment of osteoarthritis and rheumatoid arthritis: A double-blind comparison with standard naproxen followed by an open-label trial

One hundred and twenty-three patients with osteoarthritis (n = 50) or rheumatoid arthritis (n = 73) were enrolled in a 6-week, double-blind, randomized, controlled, parallel trial comparing enteric-coated naproxen with standard naproxen. Ninety-eight patients subsequently entered a 20-week, open-label trial of enteric-coated naproxen. The study demonstrated that naproxen in both its standard formulation and its new enteric-coated formulation is a highly effective form of therapy for osteoarthritis and rheumatoid arthritis. The tolerability profiles of the two formulations were similar in terms of the types of complaints reported. It is concluded that enteric-coated naproxen is an efficacious and well-tolerated formulation for the treatment of osteoarthritis and rheumatoid arthritis.

A Cochrane review (update 2004): Hylan G-F 20 vs placebo for knee OA

Aim of study: As part of a Cochrane review of viscosupplementation in knee OA, randomised controlled trials (RCT) were reviewed to evaluate evidence for the efficacy of viscosupplementation with Hylan G-F 20 compared to placebo. Methods: Electronic searches were conducted of MEDLINE, EMBASE, Premedline, Current Contents, and CENTRAL. Human, RCT involving Hylan G-F 20 compared to placebo, published prior to 1Q2004, were included. Trials were selected and data extracted by two independent reviewers. Methodological quality was assessed with the Jadad criteria by two reviewers. Data on the OARSI and OMERACT core set clinical outcome measures were extracted where possible. Weighted mean difference (WMD), based on post-test scores, and 95% confidence intervals (CI) were calculated for continuous outcome measures and relative risk (RR) for dichotomous outcome measures. Results: Seven RCT met the inclusion criteria. Median methodological quality was 4 (range 1–5). A further two studies were only reported in abstract form (Jadad score Z 1) and contained insufficient extractable data for inclusion in the analysis. Nine RCT, which compared Hylan G-F 20 to other interventions such as intra-articular corticosteroid, physiotherapy, NSAID, appropriate care, intra-articular gaseous oxygen and other hyaluronan, are not reported here. Twenty-three studies failed to meet inclusion criteria and were excluded. Hylan G-F 20 was more efficacious than placebo at 1–4 weeks post-injection for pain on weight-bearing WMD (random effects [RE]) 13 mm on a 0–100 mm VAS (P Z 0.002) based on 6 RCT. This difference was even greater at 5–13 weeks post-injection, 22 m (RE) (P Z 0.001) based on 5 RCT, and at 14–6 weeks postinjection, 21 m (RE) (P Z 0.006) based on 4 RCT. Hylan G-F 20 was more efficacious than placebo at 1–4 weeks post-injection for pain at night, WMD 7 mm on a 0–100 mm VAS (P Z 0.003) based on 5 RCT. This difference was even greater at 5–13 weeks post-injection, 11 mm (P Z 0.008) based on 4 RCT, and at 14–26 weeks post-injection, 17 mm (P ! 0.00001) based on 3 RCT. There was no significant difference (WMD 8 mm) between Hylan G-F 20 C oral placebo and arthrocentesis C oral placebo at 5–13 weeks post-injection for WOMAC Pain, but Hylan G-F 20 C oral placebo was more efficacious than arthrocentesis C oral placebo for WOMAC Function, WMD 9 mm on a 0–100 mm VAS (P Z 0.01) (Dickson, 2001). Hylan G-F 20 was more effective than placebo at 1–4 weeks postinjection for the variable designed treatment efficacy, WMD 22 mm on a 0–100 mm VAS (P ! 0.00001) based on improvement in 4 RCT. This difference was even greater at 5–13 weeks post injection, 35 mm (P ! 0.00001). Conclusions: Evidence from this updated Cochrane review supports the superior efficacy of Hylan G-F 20 compared to placebo on weight-bearing pain, night pain, function and treatment efficacy in the treatment of knee OA.

Open-label tolerability study of enteric-coated naproxen in the treatment of osteoarthritis and rheumatoid arthritis

Two hundred and ninety-six patients were enrolled in a 6-month, open-label tolerability study of enteric-coated naproxen in patients with rheumatoid arthritis (n = 174) and osteoarthritis (n = 122). Thirty percent of the patients were greater than 65 years of age. Under standard clinical prescribing conditions, enteric-coated naproxen 500 mg twice daily and 375 mg twice daily demonstrated an acceptable tolerability profile that was not different from what one would expect with standard naproxen.