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Randomized Controlled Trial
. 2010 May 20:10:22.
doi: 10.1186/1472-6882-10-22.

The effect of Neuragen PN on neuropathic pain: A randomized, double blind, placebo controlled clinical trial

Li Li  1
Affiliations
Randomized Controlled Trial

The effect of Neuragen PN on neuropathic pain: A randomized, double blind, placebo controlled clinical trial

Li Li. BMC Complement Altern Med. .

Abstract

Background: A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN" for the treatment of neuropathic pain.

Methods: Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale.

Results: There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed.

Conclusions: This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief.

Trial registration: ISRCTN registered: ISRCTN13226601.

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Figures

Figure 1
Figure 1
Trial outline.
Figure 2
Figure 2
Average pain reduction effects of Neuragen PN® and the placebo, represented by the Visual Analog Scale (VAS), are graphed with a time (pre/post) axis. The VAS ranged from 0-10. The vertical whiskers on each data point represent the standard error about that point. Pre/post pain level was measured 30 minutes before/after treatment applications. There was no significant difference in pain levels before the treatment applications. There was an overall pain reduction for both treatments from pre to post application. Further, Neuragen PN® had significantly greater pain reduction effects than the placebo (p < .05)
Figure 3
Figure 3
Average pain reduction effects of Neuragen PN® and the placebo, represented by the Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates maximal or severe pain. The vertical whiskers on each data point represent the standard error about that point. Pre pain level was measured 30 minutes (hour 0) before treatment application and post pain was measured 30 minutes (hour 1) after treatment application and every hour thereafter (hour 2 - 9), up to 8 hours. There was a pain reduction (p < .05) for both treatments up to hour 9. Neuragen PN® led to more pain reduction than the pacebo during the first 4 hours after treatment application
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References

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