Acupuncture and Amitriptyline for Pain Due to HIV-Related Peripheral Neuropathy<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>

Abstract

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.

Effect of Acupuncture Administered in a Group Setting on Pain and Subjective Peripheral Neuropathy in Persons with Human Immunodeficiency Virus Disease

“…The results indicated a small decline in pain scores at 6 and 14 weeks for both groups, with no significant difference between real and sham acupuncture. The results from the present study are markedly different from Shlay et al's (1998) findings in that we observed significant reductions in pain levels after 5 weeks of acupuncture. The greater decrease for pain scores in the present study could be due to the specificity of the acupuncture treatment for particular symptoms reported by the participants.…”

“…A relatively large clinical trial (Shlay et al, 1998) examined the effects of a standardized regimen of acupuncture on pain related to peripheral neuropathy in HIV-infected subjects compared to a sham control group. The results indicated a small decline in pain scores at 6 and 14 weeks for both groups, with no significant difference between real and sham acupuncture.…”

“…While only a few studies have examined the effect of acupuncture on HIV-associated pain, the results are inconsistent (Greene et al, 1999;Patel et al, 1989;Shlay et al, 1998). However, the different findings might well result from varying methods among the studies.…”

Pharmacological treatment of painful HIV-associated sensory neuropathy

“…While there is no evidence that amitriptyline is more effective than placebo for painful HIV-SN, [11][12][13] its proven efficacy in other types of neuropathic pain [22] prompted an expert panel to recommend it as a first-line option for HIV-SN pain in SA. [7] These patients were therefore receiving a recommended treatment, albeit at a relatively low dose (25 -50 mg/d).…”

“…[4] Several national and international agencies [5][6][7][8][9][10] have recommended the tricyclic antidepressant amitriptyline for HIV-SN pain, despite evidence that this is no better than placebo. [11,13] Despite the high prevalence [1,2] and considerable impact of HIV-SN, and the lack of proven effective analgesics, few data exist describing the frequency, type and dosage of pain medication patients are receiving. We are aware of only one retrospective case review, with low-quality case ascertainment criteria, that attempted to describe the treatment of HIV-SN pain in a clinical setting.…”