Acupuncture and Amitriptyline for Pain Due to HIV-Related Peripheral Neuropathy A Randomized Controlled Trial
1998
Context.—Peripheral neuropathy is common in persons infected with the human immunodeficiency
virus (HIV) but few data on symptomatic treatment are available.Objective.—To evaluate the efficacy of a standardized acupuncture regimen (SAR)
and amitriptyline hydrochloride for the relief of pain due to HIV-related
peripheral neuropathy in HIV-infected patients.Design.—Randomized, placebo-controlled, multicenter clinical trial. Each site
enrolled patients into 1 of the following 3 options: (1) a modified double-blind
2 × 2 factorial design of SAR, amitriptyline, or the combination compared
with placebo, (2) a modified double-blind design of an SAR vs control points,
or (3) a double-blind design of amitriptyline vs placebo.Setting.—Terry Beirn Community Programs for Clinical Research on AIDS (HIV primary
care providers) in 10 US cities.Patients.—Patients with HIV-associated, symptomatic, lower-extremity peripheral
neuropathy. Of 250 patients enrolled, 239 were in the acupuncture comparison
(125 in the factorial option and 114 in the SAR option vs control points option),
and 136 patients were in the amitriptyline comparison (125 in the factorial
option and 11 in amitriptyline option vs placebo option).Interventions.—Standarized acupuncture regimen vs control points, amitriptyline (75
mg/d) vs placebo, or both for 14 weeks.Main Outcome Measure.—Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging
from 0.0 (no pain) to 1.75 (extremely intense), recorded daily.Results.—Patients in all 4 groups showed reduction in mean pain scores at 6 and
14 weeks compared with baseline values. For both the acupuncture and amitriptyline
comparisons, changes in pain score were not significantly different between
the 2 groups. At 6 weeks, the estimated difference in pain reduction for patients
in the SAR group compared with those in the control points group (a negative
value indicates a greater reduction for the "active" treatment) was 0.01 (95%
confidence interval [CI], −0.11 to 0.12; P
=.88) and for patients in the amitriptyline group vs those in the placebo
group was −0.07 (95% CI, −0.22 to 0.08; P=.38).
At 14 weeks, the difference for those in the SAR group compared with those
in the control points group was −0.08 (95% CI, −0.21 to 0.06; P=.26) and for amitriptyline compared with placebo was
0.00 (95% CI, −0.18 to 0.19; P=.99).Conclusions.—In this study, neither acupuncture nor amitriptyline was more effective
than placebo in relieving pain caused by HIV-related peripheral neuropathy.
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