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Biomedical subjects

N Bellamy

Publications and source records attributed to N Bellamy.

At least 91 records · Page 5Linked to original sources
PubMed1993

A multicenter study of tenoxicam and diclofenac in patients with osteoarthritis of the knee.

OBJECTIVE: To conduct the first Canadian study of the comparative efficacy and safety of tenoxicam and diclofenac in patients with primary osteoarthritis (OA) of the knee. METHODS: Tenoxicam 20 mg per os once daily (po od) was compared to diclofenac (Voltaren) 50 mg per os 3 times a day (po tid) in a 12-week, double blind, randomized, controlled, multicenter, parallel trial. The primary outcome measure was the pain dimension of the WOMAC OA Index. Following an initial screening visit and a 3 to 7 day NSAID-free washout period (i.e., baseline), patients were assessed at Weeks 2, 4 and 12; assessments including some 15 efficacy variables and safety variables. RESULTS: Ninety-eight patients [tenoxicam (n = 48), diclofenac (n = 50)] participated in the trial. Statistically significant (p < or = 0.05) improvements in all 3 dimensions of the WOMAC OA Index and six efficacy variables were noted in both treatment groups. No significant between drug differences were noted on any efficacy variable. Significantly fewer patients reported adverse events in the tenoxicam group (21 vs 33, p = 0.03). CONCLUSION: Tenoxicam is efficacious and well tolerated in patients with OA of the knee. In this group of patients it was similar in efficacy and superior in tolerability to diclofenac 150 mg/day (50 mg tid). Thus the benefit/risk ratio of tenoxicam was superior to that of diclofenac in this study.

Aged↗
PubMed1992

Evaluation of an anamnestic questionnaire as an instrument for investigating potential relationships between orthodontic therapy and temporomandibular disorders.

A group of 100 patients who received orthodontic treatment, between the ages of 16 to 31 years, were asked to complete the TMJ Scale (an anamnestic temporomandibular disorder [TMD] questionnaire) and undertake a simple clinical TMD examination, the Helkimo clinical dysfunction index. The purpose of this study was to compare the TMJ Scale and the Helkimo clinical dysfunction index to validate the use of the TMJ Scale as a potential method with which to examine whether there is any relationship between TMD and orthodontic therapy. Comparisons between TMJ Scale scores from the orthodontically treated group were made with previously reported TMJ Scale data. In addition, comparisons were made between various treatment and malocclusion groups identified within the orthodontically treated sample. On the basis of the TMJ Scale global scale scores for the orthodontically treated group and two normative nontemporomandibular disorder groups described by Levitt, Lundeen, and McKinney, no differences were observed. Similarly, TMJ Scale comparisons between various treatment and malocclusion subgroups showed no statistically significant differences. The results of this study support the use of the TMJ Scale as a valid instrument with which to determine whether there is any relationship between orthodontic therapy and TMD.

Adolescent↗
PubMed1992

Rheumatoid arthritis in twins: a study of aetiopathogenesis based on the Australian Twin Registry.

The 1980 cohort of the Australian Twin Registry contains 3808 pairs of twins, 258 of whom self reported a diagnosis of rheumatoid arthritis (RA) in one or both subjects. Seventy two pairs were lost to follow up by 1990. The remaining 186 pairs received a self administered questionnaire, followed, if necessary, by telephone interviews to them, their general practitioners, and their specialists. Twenty discordant and three concordant pairs of twins were verified as having RA. The prevalence of RA in this sample was 0.40%. There was an 89% false positive rate for the self reported diagnosis of RA. Pairwise concordance percentages for RA were as follows: monozygotic 21% (95% confidence interval (CI) = 6 to 44), dizygotic 0% (95% CI = 0 to 25). It was concluded that: (a) there is a high false positive rate in self reporting RA; (b) the prevalence of RA in Australia may be less than the 0.8-1.0% often quoted; and (c) genetic factors play some part in the aetiopathogenesis of RA but do not account entirely for its determination.

Adolescent↗
PubMed1992

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.

Adult↗
PubMed1992

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.

Adult↗
PubMed1992

Observations and effects of educational consults on allopurinol prescribing.

Allopurinol has been used in the management of hyperuricemic states for several years. Despite its efficacy for these indications, recent concerns have been raised regarding the unnecessary morbidity and mortality occasionally associated with its inappropriate use. In an effort to assess the utilization of allopurinol, a concurrent drug utilization review was undertaken. Fifty patients who were prescribed allopurinol were entered into the study and underwent health record review and patient interview, to determine appropriateness of therapy and the need for educational intervention. A number of inconsistencies with regard to established guidelines were identified. As well, 11 of 50 patients (22%) required intervention because of either lack of indication or excessive dose. Fifty-five percent of the educational interventions, performed by the pharmacist, were accepted as written. The current utilization of allopurinol at our facility differs substantially from guidelines developed for optimal utilization of allopurinol. Further, a pharmacy based intervention program can improve prescribing practices of allopurinol.

Aged↗
PubMed1992

Necrotizing mesenteric vasculitis after longstanding cutaneous polyarteritis nodosa.

We describe a 21-year-old woman with cutaneous polyarteritis nodosa (PAN) who developed necrotizing mesenteric vasculitis 6 years after the onset of skin disease. Repeated investigation during that 6-year interval failed to reveal any evidence of systemic PAN. We were unable to wean the patient from prednisone or completely control her skin disease with topical and systemic therapy, including supersaturated potassium iodide, dapsone, azathioprine, methotrexate or plasmapheresis before the development of the mesenteric vasculitis, which responded to cyclophosphamide and prednisone. Development of visceral vasculitis after long-standing cutaneous PAN has very rarely been reported.

Adult↗
PubMed1992

Double-blind randomized controlled trial of flurbiprofen-SR (ANSAID-SR) and diclofenac sodium-SR (Voltaren-SR) in the treatment of osteoarthritis.

A six week, double-blind, randomized, parallel group, multicentre study was conducted in 85 patients with osteoarthritis of the knee and hip to compare the efficacy, tolerability, and safety of Flurbiprofen-SR 200 mg with Diclofenac Sodium-SR 100 mg. Between group comparisons, based on change scores from baseline, we detected no significant differences between the two drugs with respect to efficacy for the majority of outcome measures. There was no significant difference between the groups in the proportion of patients experiencing at least one adverse medical event or in terminations from treatment. We conclude that Flurbiprofen-SR 200 mg is similar in efficacy, tolerability, and safety to Diclofenac Sodium-SR in this trial.

Adolescent↗
PubMed1992

Double blind randomized controlled trial of sodium meclofenamate (Meclomen) and diclofenac sodium (Voltaren): post validation reapplication of the WOMAC Osteoarthritis Index.

Following several years of development and validation, we applied the WOMAC Osteoarthritis Index as the principal outcome measure in a double blind randomized parallel trial of Meclomen (100 mg po tid) and Voltaren (25 mg po tid). Statistically significant improvements in clinical status were noted in both treatment groups. At the doses studied, between drug differences favoring Meclomen were observed in pain and stiffness, no difference being noted in physical function. No significant between drug difference was noted in tolerability at these same doses. Our study also demonstrated that the relative efficiency of WOMAC was similar to that of the Lequesne and Doyle indices. Finally, we defined the standard deviation necessary to calculate sample size for future studies using the WOMAC index, both for studies based on static scores and those based on change scores.

Adult↗
PubMed1992

Osteoarthritis antirheumatic drug trials. I. Effects of standardization procedures on observer dependent outcome measures.

We designed a study to assess the effects of standardization procedures on reducing interobserver variability for outcome measures given in the current Food and Drug Administration and European League Against Rheumatism guidelines and others selected from the rheumatology literature. Over 2 days, 6 rheumatologists independently examined 6 patients with osteoarthritis (OA) in predetermined order before and after standardizing their examination techniques. An important and beneficial effect of the standardization procedure was observed on the majority of outcome variables. Such reductions in observer variability have the potential to diminish sample size requirements for OA antirheumatic drug studies.

Adult↗
PubMed1992

Osteoarthritis antirheumatic drug trials. II. Tables for calculating sample size for clinical trials.

The calculation of sample size for clinical trials requires knowledge of the standard deviation (SD) of index variables. There are no published lists of SD and it is difficult to locate variance estimates based on relevant populations. In this study we used standardized procedures to determine in 60 patients with osteoarthritis (OA) of the knee the standard deviation of key outcome measures recommended in current Food and Drug Administration and European League Against Rheumatism guidelines for OA clinical trials. These tables will be useful to clinical researchers in selecting outcome measures as well as for calculating sample size requirements for future clinical studies in OA.

Clinical Trials as Topic↗
PubMed1992

Osteoarthritis antirheumatic drug trials. III. Setting the delta for clinical trials--results of a consensus development (Delphi) exercise.

Defining the minimum clinically important difference or delta to be detected in a clinical trial depends on a number of factors including the research hypothesis, patient characteristics, the nature of the intervention and the trial design. In 2 studies, we have developed standardized procedures for conducting outcome measurement based on current Food and Drug Administration and European League Against Rheumatism guidelines for osteoarthritis clinical trials, and determined the standard deviation for these outcome measures. In the final component of this series of studies, we have used a Delphi technique to establish estimates for delta, and calculated the sample size requirements under 2 different conditions of Type I and Type II error probabilities.

Clinical Trials as Topic↗
PubMed1991

A survey of current prescribing practices of antiinflammatory and urate-lowering drugs in gouty arthritis.

OBJECTIVE: to assess the prescribing habits in late 1988 of rheumatologists (NZR) and a random sample of general practitioners (NZGP) managing gout and hyperuricaemia. DESIGN: self administered questionnaires containing two demographic questions and 24 items probing the selection and prescription of antirheumatic drugs in patients with acute gout, chronic tophaceous gout and asymptomatic hyperuricaemia were sent to every rheumatologist and a 10% random sample of general practitioners in active practice. RESULTS: replies were received from 26 of 27 (96%) rheumatologists and 163 of 207 (79%) of general practitioners Rheumatologists were more likely to use indomethacin as the preferred drug for acute gout, and colchicine either alone or as adjunctive therapy for prophylaxis in chronic gout to prevent acute attacks occurring following the introduction of urate lowering agents, although nonsteroidal antiinflammatory drugs (NSAIDs) were more commonly used for this purpose by both groups. Prior to prescribing urate lowering therapy general practitioners were more likely to attempt control of alcohol intake, and rheumatologists more likely to avoid concomitant low dose salicylates. Allopurinol was the preferred hypouricaemic drug, with rheumatologists more likely to prescribe an initial dose of 100 mg daily, and gradually increase the dose according to the serum urate (SeUa). Although a minority of respondents prescribed allopurinol for asymptomatic hyperuricaemia, general practitioners were more likely to do so at a lower level of serum urate. CONCLUSION: there was a high level of adherence to what is considered optimal contemporary practice, with a number of differences in prescribing habits probably reflecting differences in case selection between patients attending rheumatologists and general practitioners. The data indicates a continuing need for education programmes for both specialists and general practitioners.

Acute Disease↗
PubMed1991

Relationship between severity and clinical importance of symptoms in osteoarthritis.

Seventeen 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.

Clinical Trials as Topic↗
PubMed1991

Methods of assessment used in ankylosing spondylitis clinical trials: a review.

Twenty non-steroidal anti-inflammatory drug (NSAID) trials in ankylosing spondylitis (AS) were reviewed to assess the frequency with which statistically significant differences had been detected between active drug and either a placebo or an NSAID-free washout period. Differences in pain severity were almost invariability detected, irrespective of the scale employed. In contrast, significant differences in axial movement were rarely detected in placebo controlled studies, and only about half of the variables detected significant improvement with respect to a washout period. From our data it is difficult to differentiate whether the lack of difference with active therapy was due to inadequate sample size, non-responsive patients, or insensitive outcome measures. However, it is not surprising that between-drug differences are rarely detected in AS clinical trials of NSAIDs given our current inability to differentiate consistently an active treatment from a placebo and an active treatment phase from a washout period.

Analgesics↗
PubMed1991

A preliminary study of magnetic resonance relaxation times (T1 and T2) in inflammatory and degenerative synovial fluids.

Multiple synovial fluid samples from 21 patients were analysed using standard synovial analysis techniques and by nuclear magnetic resonance spectroscopy. Significant negative correlations were noted between both T1 (P less than 0.01) and T2 (P less than 0.0006) relaxation times and synovial fluid total protein. No differences in T1 or T2 relaxation times were noted in synovial fluid between 16 patients with inflammatory forms of arthritis and five patients with degenerative arthritis. In a single rheumatoid arthritis patient with concurrent staphylococcal arthritis, T1 and T2 relaxation times did not vary between the active phase and the recovery phase. The lack of any significant differences in the measured relaxation times as a function of joint condition suggest that in vivo magnetic resonance measurements of T1 or T2 for joint analysis may not reveal information of either a diagnostic or pathophysiological nature.

Analysis of Variance↗
PubMed1991

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 patient's level of pain or stiffness, or both.

Adult↗