Joint Pain Forum – News you can use!
Patient Choice and Treatment Alternatives for Arthritis
20-Jul-2007
Patients with osteoarthritis (OA) and rheumatoid arthritis (RA) face
different treatment options and determining which ones to try can be
confusing.
Two new studies published in the July 2007 issue of Arthritis
& Rheumatism examined patients' decisions regarding therapy for RA
and glucosamine for OA and found that most RA patients are reluctant to
change their treatment as long as their condition didn't worsen, and
that there are discrepancies in clinical trial results for glucosamine.
Recent advances in RA treatment include multi-drug therapy with
antirheumatic drugs such as methotrexate, as well as improved tools for
measuring the response to therapy. Although high-dose aggressive
therapy seems to hold promise, patients' decisions often do not follow
this recommendation.
Frederick Wolfe and Kaleb Michaud, of the National Data Bank
for Rheumatic Diseases in Wichita, KS, queried over 6,000 RA patients
about their acceptance and satisfaction with therapy, their willingness
to change and their reasons for not changing.
They found that more than three-quarters were satisfied with
their medications and almost 64 % would not want to change therapy as
long as their condition didn't get worse. Fear of loss of control over
their condition and fear of side effects emerged as major concerns, and
maintaining their current status, as opposed to future improvement,
appeared to be a high priority for patients.
Interestingly, 71 % of those satisfied with their therapy had
moderate or greater arthritis activity according to the Patient
Activity Scale.
"These data indicate that there is an important discrepancy
between declared satisfaction with therapy and measured activity and
functional status, and that clinical activity is not an adequate
explanation for satisfaction with therapy," the authors state.
In another study led by Steven C. Vlad of Boston University
Medical Center in Boston, MA, researchers analyzed 15 double-blind,
randomized, placebo-controlled trials of glucosamine for OA pain that
were reported between 1980 and 2006. Glucosamine is classified as a
dietary supplement in the U.S., is widely available, and appears to be
safe but its efficacy is uncertain, with some trials reporting little
effect and others reporting positive results.
The authors attempted to identify factors that explain these
differing results and found that glucosamine hydrochloride, as opposed
to glucosamine sulfate, has no effect on pain.
Among the 12 glucosamine sulfate trials,
only two were not funded by industry, and like trials of glucosamine
hydrochloride, both showed no effect on pain. Industry involvement
appeared to be the strongest predictor of trial results which suggested
that industry bias accounted for the results of these studies and not
treatment efficacy. Trials using preparations by Rottapharm had an
especially large effect compared with other studies and this may be due
to bias or possibly to unique efficacy of the Rotta formulation.
Allocation concealment, (which attempts to prevent
selection bias) was the only other factor that had a major impact, with
trials that had adequate allocation concealment showing no glucosamine
efficacy. Although trials with industry involvement were more likely to
have positive results, they still had varied outcomes (heterogeneity);
this may be due to differences in formulations or dosages, although
trials using only Rottapharm products also had varying outcomes.
"Among glucosamine sulfate trials, enough heterogeneity
existed such that no definitive conclusion about efficacy is possible,"
the authors state. However, industry bias remains the most likely
explanation for the positive results of some studies whereas others
show no efficacy.
In an accompanying editorial in the same issue,
Jean-Yves Reginster of the WHO Collaborating Center for Public Health
Aspects of Rheumatic Disease in Liège, Belgium, finds the conclusions
of the Vlad report to be "inaccurate and misleading."
The author points out that trials by pharmaceutical
companies are designed to avoid the influence of confounders that could
distort the true effect of the product being tested, and they are of a
high quality since they must adhere to high standards in terms of study
design, analysis and reporting. He also maintains that heterogeneity is
common in meta-analyses of drug trials in OA, and is usually handled by
subgrouping the trials based on common characteristics, which was not
done in the Vlad study.
Regarding the studies that showed no effects, the
author notes that they used unknown formulations of the dietary
supplement glucosamine, whose inconsistency is well recognized. He
notes that an analysis of three pivotal Rottapharm studies (two of
which were performed by Reginster and his colleagues) showed results
that were consistent and as clinically valid as other OA treatments.
"Scientists should be careful when interpreting studies
such as the one by Vlad and colleagues," Reginster concludes, adding
that all forms of conflict by pharmaceutical companies and independent
investigators should be assessed.
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