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Clinical Trial
. 2000 Jun;49(6):574-9.
doi: 10.1046/j.1365-2125.2000.00200.x.

Topical application of doxepin hydrochloride, capsaicin and a combination of both produces analgesia in chronic human neuropathic pain: a randomized, double-blind, placebo-controlled study

G McCleane  1
Affiliations
Clinical Trial

Topical application of doxepin hydrochloride, capsaicin and a combination of both produces analgesia in chronic human neuropathic pain: a randomized, double-blind, placebo-controlled study

G McCleane. Br J Clin Pharmacol. 2000 Jun.

Abstract

Aims: To assess the analgesic efficacy of topical administration of 3.3% doxepin hydrochloride, 0.025% capsaicin and a combination of 3. 3% doxepin and 0.025% capsaicin in human chronic neuropathic pain.

Methods: A randomized, double-blind, placebo-controlled study of 200 consenting adult patients. Patients applied placebo, doxepin, capsaicin or doxepin/capsaicin cream daily for 4 weeks. Patients recorded on a daily basis overall pain, shooting, burning, paraesthesia and numbness using a 0-10 visual analogue scale during the week prior to cream application (baseline levels) and for the 4 week study period. Side-effects and desire to continue treatment were also recorded.

Results: Overall pain was significantly reduced by doxepin, capsaicin and doxepin/capsaicin to a similar extent. The analgesia with doxepin/capsaicin was of more rapid onset. Capsaicin significantly reduced sensitivity and shooting pain. Burning pain was increased by doxepin and by capsaicin and to a lesser extent by doxepin/capsaicin. Side-effects were minor. One patient requested to continue placebo cream, 17 doxepin cream, 13 capsaicin and 9 the combination of doxepin and capsaicin.

Conclusions: Topical application of 3.3% doxepin, 0.025% capsaicin and 3.3% doxepin/0. 025% capsaicin produces analgesia of similar magnitude. The combination produces more rapid analgesia.

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Figures

Figure 1
Figure 1
Overall pain as measured by a 0 – 10 cm visual analogue scale, 0 = no pain. ▪ placebo, ♦ doxepin,▴ capsaicin, • doxepin/capsaicin.
Figure 2
Figure 2
Numbness as measured by a 0 – 10 cm visual analogue scale, 0 = no numbness. ▪ placebo, ♦ doxepin, ▴ capsaicin, • doxepin/capsaicin.
Figure 3
Figure 3
Parasthesiae as measured by a 0 – 10 cm visual analogue scale, 0 = no pain. ▪ placebo, ♦ doxepin, ▴ capsaicin, • doxepin/capsaicin.
Figure 4
Figure 4
Burning pain as measured by a 0 – 10 cm visual analogue scale, 0 = no pain.▪ placebo, ♦ doxepin, ▴ capsaicin, • doxepin/capsaicin.
Figure 5
Figure 5
Sensitivity as measured by a 0 – 10 cm visual analogue scale, 0 = no pain.▪ placebo, ♦ doxepin, ▴ capsaicin, • doxepin/capsaicin.
Figure 6
Figure 6
Shooting pain as measured by a 0 – 10 cm visual analogue scale, 0 = no pain.▪ placebo, ♦ doxepin, ▴ capsaicin, • doxepin/capsaicin.
See this image and copyright information in PMC

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