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Old 06-09-2010, 08:12 PM #11
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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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Old 06-10-2010, 06:17 AM #12
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Default Over time--

--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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Old 06-10-2010, 08:40 AM #13
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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:
...Nevertheless, some critics have questioned whether orphan drug legislation was the real cause of this increase (claiming that many of the new drugs were for disorders that were already being researched anyway, and would have had drugs developed regardless of the legislation), and whether the ODA has really stimulated the production of truly non-profitable drugs; the act also received some criticism for allowing some pharmaceutical companies to make a large profit off of drugs that have a small market but still sell for a high price.[2]

Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on pharmacokinetics and pharmacodynamics, dosing, stability, safety and efficacy. However, some statistical burdens are lessened in an effort to maintain development momentum. For example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease in question.

Since the market for any drug with such a limited application scope would, by definition, be small and thus largely unprofitable, government intervention is often required to motivate a manufacturer to address the need for an orphan drug. Critics of free market enterprise often cite this as a failure of free market economic systems. Free market advocates often respond that without government-mandated minimum safety and efficacy requirements, drug development costs would be considerably lower.

The intervention by government on behalf of orphan drug development can take a variety of forms:

* Tax incentives.
* Enhanced patent protection and marketing rights.
* Clinical research financial subsidization.
* Creating a government-run enterprise to engage in research and development (see Crown corporation).
I think this partially explains the high price of these patches.
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Old 06-10-2010, 10:37 AM #14
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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:
Results of a 12-week a multicentre trial published in which 402 patients with PHN of ≥6 month duration were treated with one 60-min application of NGX-4010 (8% capsaicin) or a low-concentration capsaicin control patch (0.04% capsaicin).

The average baseline numeric pain rating scale (NPRS) score was 3-9. The mean changes in NPRS score from baseline to weeks 2-8 (primary endpoint) were −29.6% vs. −19.9% respectively (difference −9.7% [95%CI −15.47 to −3.95] p=0.001).

42% vs. 32% of patients had a ≥30% reduction in mean NPRS score (odds ratio 1.56 [1.03 to 2.37] p=0.03). Erythema and pain at application site were common but short-lasting...

Adverse Events: erythema was reported in 94% of the treatment group (n=205) versus 65% of the control group (n=197). Pain at the site of application was reported in 56% versus 22% of patients, respectively.
This basically means that the inexpensive low dose 0.04% patch available OTC - think of the Salonpas 0.025% Hot patch, as a readily available substitute - had 3/4 of the efficacy of the expensive Qutanza that need to be applied in a controlled environment by prescription...

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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Old 06-10-2010, 10:55 AM #15
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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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Old 06-10-2010, 12:18 PM #16
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There is a substantial difference in strength between 8% and 0.04%: it's a 200 to 1 ratio...

Between 8% and the 0.025% Salonpas patches, the ratio is even greater at 320 to 1...

I just covered one foot - top and bottom - with the 0.025% Capsaicin Hot Salonpas patch and the other one with the Salonpas Gel patch, a much more substantial looking patch made with 0.025% Capsaicin and 1.25% Menthol: I plan to keep them on for 8 hours, baring any painful reaction...

Having recently used 0.075% Zostrix cream for as long, it should be fine: however, the area is now covered, which tends to amplify the effects...

Quote:
Originally Posted by mrsD View Post
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.

Last edited by Seagem; 06-10-2010 at 02:41 PM.
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Old 06-10-2010, 04:44 PM #17
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Preliminary report:

Well, the first 4 hours of the experiment have gone by without any hitch:

- The all Capsaicin 0.025% Hot Salonpas patch is thin enough to fit inside a shoe and one patch cut in two will cover most of one foot, top and bottom for about $1.00, if bought in packs of 10. There is no burning but a mild stinging sensation that is relieved by not wearing socks when at home...

- The 0.025% Capsaicin, 1.25% Menthol Salonpas Gel patch is much thicker and 2 will be required to cover a foot top and bottom, which may no longer fit comfortably inside certain shoes: cost $4.81 for a set of 6, or $1.60 per foot. They are much more comfortable to wear and there is no stinging at all...

So far, the winner appears to be the combination Capsaicin/Menthol (CM) patch, as there is no stinging and no Peripheral Neuropathy pain noticeable at present. The foot with patches on top and bottom with socks on will still fit inside some Crox...

Starting tomorrow, I plan to wear one (CM) patch on top of the foot one day alternating with one patch on the bottom the next day - for 8 hours (12 noon to 8:00 pm) for one whole week to assess the remaining Neuropathic pain at the end of the period: cost ~80 cents per foot per day, which should hopefully be affordable for most...

Alternatively, one should be able to wear the patch in bed for 8 hours, so that it won't interfere with the wearing of shoes during day time...



Quote:
Originally Posted by Seagem View Post
There is a substantial difference in strength between 8% and 0.04%: it's a 200 to 1 ratio...

Between 8% and the 0.025% Salonpas patches, the ratio is even greater at 320 to 1...

I just covered one foot - top and bottom - with the 0.025% Capsaicin Hot Salonpas patch and the other one with the Salonpas Gel patch, a much more substantial looking patch made with 0.025% Capsaicin and 1.25% Menthol: I plan to keep them on for 8 hours, baring any painful reaction...

Having recently used 0.075% Zostrix cream for as long, it should be fine: however, the area is now covered, which tends to amplify the effects...
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Old 06-10-2010, 09:47 PM #18
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End of 8 hour period Report:

Actually, the patches remained on for about 9 hours, as I went for a snooze at 7:00 pm and woke 2 hours later when I dutifully removed both set of patches...

- No redness whatsoever on either foot and no side effect. The left foot where the all Capsaicin patch was located is a bit more sensitive and felt less numb, while the right foot is its usual numb self at superficial skin level...

- The pain, usually in the 6/7 range is barely noticeable, perhaps in the 1/2 range to put a number on it...

- I am not taking any other pain management medicine orally or otherwise, except for anti-inflammatory herbs, such as Curamin (high absorption Cucurmin) Bromelain, Boswellia, Turmeric and Astaxanthin...

So far, so good...

Instead of continuing the experiment as planned, wearing one Capsaicin/Menthol patch for 8 consecutive hours on top of the foot one day alternating with one patch on the bottom the next day, starting at 12 noon tomorrow, I now intend to wait for the pain to return to at least a level 5 before using the Capsicum/Menthol patches again and proceeding with the rest of the experiment...

In conclusion, the 0.025% Capsaicin/1.25% Menthol patch has proven best, as contrary to the whole Capsaicin patch, there is no stinging while wearing it and it's more comfortable.

Although both patches have substantially lowered the pain at a similarly low level, because the CM patch is thicker and more substantial in bulk, it may be best worn at night when it won't interfere with wearing shoes...

Quote:
Originally Posted by Seagem View Post
Preliminary report:

Well, the first 4 hours of the experiment have gone by without any hitch:

- The all Capsaicin 0.025% Hot Salonpas patch is thin enough to fit inside a shoe and one patch cut in two will cover most of one foot, top and bottom for about $1.00, if bought in packs of 10. There is no burning but a mild stinging sensation that is relieved by not wearing socks when at home...

- The 0.025% Capsaicin, 1.25% Menthol Salonpas Gel patch is much thicker and 2 will be required to cover a foot top and bottom, which may no longer fit comfortably inside certain shoes: cost $4.81 for a set of 6, or $1.60 per foot. They are much more comfortable to wear and there is no stinging at all...

So far, the winner appears to be the combination Capsaicin/Menthol (CM) patch, as there is no stinging and no Peripheral Neuropathy pain noticeable at present. The foot with patches on top and bottom with socks on will still fit inside some Crox...

Starting tomorrow, I plan to wear one (CM) patch on top of the foot one day alternating with one patch on the bottom the next day - for 8 hours (12 noon to 8:00 pm) for one whole week to assess the remaining Neuropathic pain at the end of the period: cost ~80 cents per foot per day, which should hopefully be affordable for most...

Alternatively, one should be able to wear the patch in bed for 8 hours, so that it won't interfere with the wearing of shoes during day time...

Last edited by Seagem; 06-11-2010 at 08:57 AM.
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Old 06-11-2010, 09:16 AM #19
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I wonder if you have tried high % menthol alone?

I use Biofreeze for burning pain... 3.5% It also has Ilex in it which is an antioxidant. It always works for me.

The mechanism for menthol is this:

There are two temperature type nerves, one that relays heat and one cold. The cold sensors have neurological priority in reporting pain. (I guess this is a survival mechanism).
So when the cold sensors are stimulated by menthol, the heat ones never get registered by the brain as long as the menthol is there working.

So it is no surprise that the mixed patch is working better.

Menthol is often added to compounded dermatological creams too, for patients with chronic itching problems. But that dose is much lower in range, more like .25%.

We have had several discussions on the subject of Menthol. You might do a search here to find them.
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Old 06-11-2010, 11:45 AM #20
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That was exactly my thinking as well, since the Menthol in the Salonpas patches clearly removes the sting without diminishing the effects of the Capsaicin...

Likewise, Qutenza specifies the use of Lindocaine first to lessen the burning sensation before applying the high Capsaicin concentration...

Those who complain about the burning of the Capsaicin, which is the main problem encountered, might well benefit by applying some menthol based cream first...

The one problem with the patch, I am finding out now, is that the areas not covered yesterday are now causing pain and it's really hard to cover the entire foot with patches...

I'll continue experimenting with both patches and Capsaicin cream, as another poster with PN has reported here some good results with Zostrix over a 10 years period...

Quote:
Originally Posted by mrsD View Post
I wonder if you have tried high % menthol alone?

I use Biofreeze for burning pain... 3.5% It also has Ilex in it which is an antioxidant. It always works for me.

The mechanism for menthol is this:

There are two temperature type nerves, one that relays heat and one cold. The cold sensors have neurological priority in reporting pain. (I guess this is a survival mechanism).
So when the cold sensors are stimulated by menthol, the heat ones never get registered by the brain as long as the menthol is there working.

So it is no surprise that the mixed patch is working better.

Menthol is often added to compounded dermatological creams too, for patients with chronic itching problems. But that dose is much lower in range, more like .25%.

We have had several discussions on the subject of Menthol. You might do a search here to find them.
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