Since there are a number of clinical studies on Capsaicin, we can always quote that, which we like the most, or which better supports our respective arguments...
NGX-4010 [Qutenza], a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension.
OBJECTIVES: To assess the efficacy, tolerability, and safety of NGX-4010, a high-concentration capsaicin dermal patch (capsaicin 640 microg/cm(2), 8%) in patients with postherpetic neuralgia (PHN).
METHODS: Patients were randomized to receive NGX-4010 or control patch in a 4-week, double-blind study. This was followed by an open-label extension phase (up to 48 weeks total) where patients could receive up to three additional treatments no sooner than 12 weeks after initial treatment. The primary efficacy variable was mean change from baseline in mean morning and evening numerical pain rating scale (NPRS) scores.
RESULTS: During days 8-28 after the double-blind treatment, NGX-4010 patients had a mean change in NPRS scores from baseline of -32.7% compared with -4.4% for control patients (P = 0.003). Mean NPRS scores decreased from baseline during week 1 in both treatment groups, remained relatively stable through week 12 in NXG-4010 patients, but returned to near baseline during weeks 2-4 in controls. Mean change in NPRS scores from baseline during weeks 2-12 was -33.8% for NGX-4010 and +4.9% for control recipients. A similar decrease in NPRS scores from baseline was maintained with subsequent NGX-4010 treatments, regardless of the number of treatments received. Transient increases in application site pain were adequately managed with analgesics. No increases in application site reactions or adverse events were observed with repeated treatments. No patients discontinued the study due to an adverse event.
CONCLUSION: NGX-4010 is a promising topical treatment for PHN patients, which appears to be tolerable, generally safe, and effective.
http://www.ncbi.nlm.nih.gov/pubmed/20113411
I guess if the FDA based its decision on your study, Qutenza would NOT have been approved...
Also, note that there was no longer any competition with the low dose Capsaicin patch that had done so well in previous tests...
Quote:
Originally Posted by mrsD
The patch used as placebo was most likely made for the study.
I don't expect it to be available, yet. Often studies are done this way and the patches have to be exactly the same in appearance in order for the study to be properly blinded.
Here is the study abstract:
http://www.ncbi.nlm.nih.gov/pubmed/19821411
So this is what we are discussing. It doesn't work for all. And remains unpredictable.
Let us all know how you do in any case. Remember, this does not change the cause of your pain. It is palliative only. If your pain is being generated in your back and not the feet, then placing patches on the feet may not work consistently. You may have to use them on your back in that case.
Good luck. |