Eisenberg DM, Post DE, Davis RB, Connelly MT, Legedza
MT, Hrbek AL, Prosser LA, Buring JE, Inui T, Cherkin DC.
Addition of choice of complementary therapies to usual
care for acute low back pain: a randomized controlled trial.
Harvard Medical School, Division for Research
and Education in Complementary and Integrative Medical Therapies, Osher
Institute, 401 Park Dr, Ste 22 A, Boston, MA 02215. David_eisenberg@hms.harvard.edu
CONTEXT: Few studies have evaluated care models
which provide coordinated access to and financial coverage for complementary
and alternative medicine (CAM) therapies.
OBJECTIVE: To investigate the effectiveness
and cost of usual care plus patient choice of acupuncture, chiropractic
or massage therapy ("choice") compared with usual care alone
in patients with acute low back pain.
DESIGN, SETTING, AND PATIENTS: Randomized, controlled
trial (April 2001-July 2004) involving 444 patients with acute low back
pain (<21 days). Patients received usual care at their clinic sites
and CAM therapy at offices of credentialed CAM practitioners.
INTERVENTIONS: Usual care was based on a standard
treatment algorithm. The intervention group was also given a choice
of adjunctive CAM therapy, with up to 10 treatments at no charge over
5 weeks, and up to 5 additional treatments at 50% co-pay.
MAIN OUTCOME MEASURES: Differences in symptoms
(bothersomeness), functional status (Roland score) and satisfaction
between baseline and 5 and 12 weeks, as well as costs of medical care
in the 12 weeks after randomization. RESULTS: There were no clinically
significant adverse events in 1778 CAM treatment sessions. Between baseline
and week 5, those in the choice group had a clinically small but statistically
significant greater reduction in pain severity (-1.0, 95% CI: -1.65,
-0.35, p=0.002), but no significantly different improvement in functional
status (change in Roland score, -1.09, 95% CI: -2.51, -0.33, p=0.15).
By week 12 there were no significant differences for either endpoint.
There was a persistent, significantly greater satisfaction with care
in the choice group. There was a net increase in costs in the choice
group of $244 per patient from baseline to week 12 consisting of a $99
reduction in average cost to the insurer, but an additional cost of
$343 for an average of 6.0 CAM treatments per patient.
CONCLUSION: This study demonstrated the feasibility
of conducting preference-driven trials evaluating efficacy, cost and
satisfaction of adjunctive CAM therapies. For acute low back pain, providing
coordinated access to and payment for CAM therapy as adjuncts to usual
care was associated with a small improvement in symptoms at 5 weeks,
but not in functional status, persistently greater satisfaction, at
an increased total cost.
Back