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06-09-2010, 01:35 PM | #1 | |||
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Wisest Elder Ever
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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 Quote:
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.
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06-09-2010, 02:11 PM | #2 | ||
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Junior Member
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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:
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06-09-2010, 08:12 PM | #3 | |||
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Senior Member
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so keep using the capsaicin and see how it works out long term for you if it is helping you now. let us know how it goes.
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06-10-2010, 06:17 AM | #4 | ||
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Magnate
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--most of us have learned to look critically at studies/papers that come out trumpeting "magnificent" results, especially those published int he US, as opposed to those that come from Canada, Europe, or Japan, places in which the influence of big pharma on what gets published and what doesn't isn't as pervasive.
Still, many of us would like to have new drugs that show promise for the relief of neuropathic (and other) pain. Substances based on capsaicin are certainly worth investigating, and it is likely they will have positive effects for at least some people, though these may be variable based on dose, formulation, and particular genetic background. In that sense, they'll be very much like other drugs used for neuropathic pain--anti-epileptics, anitdepressants, and even opiates and synthetic equivalents (such as Tramadol) work well for some and not others. In all probability, individual differences in genetic make-up, substance metabolism, and pain mechanism explain the highly variable results associated with these trials, though many of these are still too complex to disentangle. The problem comes when studies that show equivocal results on symptoms, or other effects not intended, are either suppressed or relegated to less widely disseminated media channels. |
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"Thanks for this!" says: | mrsD (06-10-2010) |
06-10-2010, 08:40 AM | #5 | |||
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Wisest Elder Ever
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Qutenza was passed by the FDA under the Orphan Drug Act:
http://www.checkorphan.org/grid/news...etic-neuralgia What this means: http://en.wikipedia.org/wiki/Orphan_drug Quote:
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All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei ************************************ . Weezie looking at petunias 8.25.2017 **************************** These forums are for mutual support and information sharing only. The forums are not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Always consult your doctor before trying anything you read here.
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06-10-2010, 10:37 AM | #6 | ||
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Junior Member
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Qutenza could have a substantial market, based on the percentage of population affected by Peripheral Neuropathy, bearing in mind that the European approval is much wider in scope than that of the FDA, as it applies to PN in general...
It is estimated that about 8% of the UK population suffer from neuropathic pain. HIV-associated polyneuropathy affects 29% to 62% of patients with HIV and AIDS. Of course, a lot will depend on pricing, insurance coverage and modalities of application... However, I am far more interested in what the clinical trials have shown: the efficacy of cheap, low dose Capsaicin patches, even though they were used for a short time interval, when they're far better suited for repeated applications of longer duration, which should have a beneficial effect on overall efficacy... Clinical Study: http://www.ukmi.nhs.uk/applications/...newDrugID=4080 Quote:
BUT, when the low dose patch is used as designed, that is for repetitive applications of much longer duration, I feel that it will likely not only outperform Qutenza, but will also have fewer side effects... http://www.amazon.com/SALONPAS-Hot-C.../dp/B000BRPZPM I'll soon know, as DHL just called to inform me of the delivery of a bunch of Salonpas patches that I can't wait to try out... Last edited by Seagem; 06-10-2010 at 11:04 AM. |
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06-10-2010, 10:55 AM | #7 | |||
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Wisest Elder Ever
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The control patch difference with the 8% patch is not that terribly much different.
The Orphan status of the product allows for less restrictions by the FDA and typically an easier approval. Only time will tell. Maybe someone else will come out with a different % and different application directions, which would be OTC and just as effective. We'll have to wait and see. Let us know how it goes with the Salonpas with Capsaicin. Sometimes the regular one will make the skin red for a while, so if you get that side effect you won't know if it is the Capsaicin or the stickem from the patch.
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All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei ************************************ . Weezie looking at petunias 8.25.2017 **************************** These forums are for mutual support and information sharing only. The forums are not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Always consult your doctor before trying anything you read here.
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