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Patient Choice And Treatment Alternatives For Arthritis
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
anitrheumatic 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 percent 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 percent
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.
"The Efficacy of Glucosamine Sulfate in
Osteoarthritis: Financial and Nonfinancial Conflict of Interest,"
Jean-Yves Reginster, Arthritis & Rheumatism, July 2007; (DOI:
"Glucosamine for Pain in Osteoarthritis: Why Do Trial Results Differ""
Steven C. Vlad, Michael P. LaValley, Timothy E. McAlindon, David T.
Felson, Arthritis & Rheumatism, July 2007; (DOI: 10.1002/art.22728).
"Resistance of Rheumatoid Arthritis Patients to Changing Therapy:
Discordance Between Disease Activity and Patients' Treatment Choices,"
Frederick Wolfe and Kaleb Michaud, Arthritis & Rheumatism, July
2007; (DOI: 10.1002/art.22719).
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