Friday, 27 May 2011

Amitriptyline

(...Treatments 5)

It's pretty depressing to discover that one of the most commonly prescribed drugs to help with neuropathic problems, is probably not much better than a placebo but that's the way it looks. That said, if you look up the issue on the internet, most links refer to the same research, which only goes to show how few trials have been done. If you narrow that down to trials concerning, Amitriptyline + neuropathy + HIV, you're counting on the fingers of one hand. My only question is why? If the incidence of neuropathy is growing at the rate it is suggested amongst HIV patients, why isn't more research done into the efficacy of probably the most commonly issued drug? ...and manufacturing drug companies, why aren't the negative findings of the research here below being challenged? ...and don't get me started on the side effects!
If there's a will, there's a way people!


First, general information from http://www.aidsmap.com and then information from the research itself (if you're going cross-eyed from all the technical info, skip to the conclusions at the end):

Amitriptyline hydrochloride is an antidepressant drug. It is available as a generic (non-branded) product.
Low-dose amitriptyline can also be used to treat the pain caused by neuropathy (nerve damage), including neuropathy due to diabetes and herpes. Around two thirds of patients who try this treatment have at least moderate pain relief, although a fifth find the drug’s side-effects unacceptable.

It is less certain whether low-dose amitriptyline is effective in alleviating neuropathy due to HIV or HIV treatment. In one placebo-controlled study of 250 patients with peripheral neuropathy caused by HIV, amitriptyline with or without acupuncture did not bring about a significant improvement in pain symptoms after 14 weeks of treatment. Similarly, a ten-week trial of 145 patients failed to show a benefit of amitriptyline over placebo.

The main side-effects seen with amitriptyline treatment include sedation, perturbations of the heart rhythm, drowsiness, dry mouth, blurred vision, constipation, urinary retention and sweating.

Amitriptyline levels may be increased in patients taking protease inhibitors, with the possible exception of nelfinavir (Viracept). This may increase the risk of amitriptyline-related side-effects and may require the use of a reduced dose of amitriptyline.

References

1.Saarto T et al. Antidepressants for neuropathic pain (review). Cochrane Database Syst Rev 3: CD005454, 2005
2.Shlay JC et al. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomised controlled trial. JAMA 280: 1590-1595, 1990
3.Kieburtz K et al. A randomized trial of amitryptiline and mexiletine for painful neuropathy in HIV infection. Neurology 51: 1682-1688, 1998

http://www.aidsmap.com/Amitriptyline-hydrochloride/page/1731424/



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Acupuncture and Amitriptyline for Pain Due to HIV-Related Peripheral Neuropathy

A Randomized Controlled Trial

Judith C. Shlay, MD;
Kathryn Chaloner, PhD;
Mitchell B. Max, MD;
Bob Flaws, Dipl, Ac;
Patricia Reichelderfer, PhD;
Deborah Wentworth, MPH;
Shauna Hillman, MS;
Barbara Brizz, BSN, MHSEd;
David L. Cohn, MD;
for the Terry Beirn Community Programs for Clinical Research on AIDS


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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