An analytical review of 24 controlled clinical trials for fibromyalgia (FM) syndrome

We performed a combined manual and computer search of the FMS
literature to identify controlled clinical trials in FMS from
1980 to June 1994 inclusive. Our specific objectives were: 1)
to determine which outcome measures have been used in clinical
trials for FMS, and the methods utilized to measure these
outcomes; 2) to identify which outcome measures were most and
least sensitive in distinguishing between treatment groups,
and 3) to identify weakness in trial design. Our analysis of
24 clinical trials demonstrates the large diversity of outcome
measures and measurement instruments that have been used to
detect differences between treatment and placebo in the
management of FMS. Whereas certain outcomes, such as
self-reported pain and sleep quality, were frequently
measured, other clinically important outcomes, such as
functional and psychological status, were infrequently
included in data collection. Finally, we identified several
significant potential sources of bias, including potential
flaws in subject selection and group allocation, inadequate
randomization, incomplete blinding, errors in outcome
measurement, and inappropriate analysis of data.

White KP, Harth M

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