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Testing Ausanil, Capsaicin Nasal Spray for Migraine & Headache

Capsaicin (an active component of chili peppers) as a treatment for migraine, severe headaches or pain flits in and out of the news. For migraine, the preferred form is a nasal spray. Ausanil, a nasal spray of capsaicin and ginger, is the latest entry into the marketplace.

The company sent me a free sample bottle and, after I tested it once, I interviewed company founder Dr. Anjan Chatterjee. Dr. Chatterjee is a neurologist by training who has worked in drug development for the last 10 years. He also has migraine and is unable to take many medications, but has found relief with Ausanil, which he’s been using for three years.

How Ausanil is Said to Work

Capsaicin nasal spray is thought to work for headache and migraine by desensitizing the trigeminal nerve (which it accesses through the nose) and reduces CGRP, thus reducing swelling and inflammation. CGRP, as we’re learning, is thought to play a pivotal role in migraine.

The Research

Capsaicin is known to be effective for pain relief, but there’s not resounding evidence – or even very many studies – that show its efficacy for any headache disorder. Civamide, a lab-created version of capsaicin, was promising in a few small studies, but drug development was halted early. I don’t know if that’s because it wasn’t very effective, didn’t have a high enough profit potential, patients hated the sting or if it was due to some other reason.

A study presented at the American Academy of Neurology last week tested intranasal capsaicin (presumably Ausanil, since Dr. Chatterjee was one of the researchers and his company is mentioned in the PR materials) in 18 patients with a variety of headache disorders that cause severe pain (including migraine, cluster headache and tension-type headache). Thirteen participants reported complete pain relief, four had some relief and one had no relief. Relief lasted between 30 minutes and several hours. (According to those criteria, the 30 minutes of pain relief the first time I tried Ausanil would be considered a positive response, even though the pain came back even worse than before I used it.)

My Experience

I wanted to test Ausanil as any consumer would, so I tried it before I talked to Dr. Chatterjee. I read the package instructions, looked at the website and watched the YouTube video on using Ausanil correctly. That’s more thorough than I usually am. I was about to spray chili pepper up my nose and didn’t want it to hurt more than necessary.

Use 1: I sprayed Ausanil in both nostrils. It burned. A lot. The stinging hurt intensely for about 15 minutes and was gone after 30. The initial pain relief was also gone after 30 minutes… and the migraine came back worse than before I used the spray.

Use 2: After talking with Dr. Chatterjee, I gave the spray another try. This time, I only sprayed it in the left nostril since the migraine was concentrated above my left eye. The stinging wasn’t as intense, likely because it was only one nostril, but it still hurt. The spray didn’t provide any pain relief this time, not even through the distraction of the stinging. It didn’t make the migraine worse, though it seemed to render ineffective the triptan I took 15 minutes beforehand.

Two tests were enough (in fact, Dr. Chatterjee usually says that if it doesn’t work, a person shouldn’t bother trying it again). Considering the potential pain of a migraine, the stinging isn’t a big deal. I would gladly trade 30 minutes of burning in my nose to stop a migraine attack. Except that it didn’t work for me.

In our call, Dr. Chatterjee said that only a few people, all of whom have chronic migraine, have told the company that the spray made the migraine worse. Most users either have a response or they don’t.

What You Need to Know

  • Ausanil will sting and burn when you spray it in your nose. There’s no way around that side effect. Participants in Dr. Chatterjee’s recent study said the burn lasted 2-10 minutes. He told me that the sting lessens over time and that he barely feels it anymore.
  • Watch the YouTube video on the correct use of Ausanil.
  • Don’t inhale.
  • Spray it only in the nostril on the side that the migraine is on. If you have pain on both sides, you can spray it in both nostrils, but it will burn more.
  • Have Kleenex nearby. You may sneeze, your nose may run or your eyes might water. Use a separate tissue for your eyes and your nose so you don’t get any residual capsaicin in your eyes.
  • Check Ausanil’s website to learn more about the product and how it works. You can also watch testimonials from patients for whom it has been effective.

Bottom Line

I recommend giving Ausanil a try if your headaches or migraines are severe. Yes, it burns, but the burn lasts way less time than the headache or migraine would. Other than that, there are no documented side effects. The research doesn’t strongly support the use of intranasal capsaicin for headache disorders, but there’s enough there that it’s worth a try, especially if you’re not getting relief elsewhere.

To Buy

  • Ausanil is currently $28.95 (with free shipping) for an 8 ml bottle on Amazon. It’s strength is listed as 3x capsaicin and 3x ginger.
  • Sinol Headache, a competing product, is $11.27 (including shipping) for a 15 ml bottle. It’s strength is listed as 4x capsaicin. It doesn’t contain ginger, which Ausanil does.

(I feel like a jerk telling you about a competing product after Dr. Chatterjee and his PR team were so kind and helpful. But, as a patient who has spent a lot of money on products that don’t work for me, I feel obligated to tell you about the less expensive option. The two products aren’t identical; you may find one works better than the other.)

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Diamine Oxidase (DAO) is Why I’m Doing Better

The Amazing Feat of a Normal Life prompted a lot of questions about why I’m feeling so much better. It’s still the digestive enzyme, diamine oxidase (DAO), that I started in January. (To learn more, read The Post I Never Thought I’d Get to Write and follow the links at the end for more details. If you want to try DAO yourself, you can get it through Amazon. Even though it’s called Histamine Block, it isn’t an antihistamine and doesn’t block histamine.)

I continue to follow a restricted diet, though that’s more about wanting to reintroduce foods slowly and methodically rather than any particular food being a problem. As long as I take DAO, I’m doing great with nearly every food I try (even dairy and wheat). I’ve even tried a few high-histamine foods (with a little extra DAO) and have done fine.

The other dietary change is that I’m eating most foods on a rotating schedule, leaving two or three days between each time I eat a particular food. I began this when I developed an intolerance to coconut after eating it multiple times a day for months without a problem. This has been a very effective way to vary my diet.

It’s a slow process, but I’m getting almost complete nutrition from the foods I eat (I’m still a little low on calcium). I eat mostly vegetables, though I have salmon a couple times a week and am currently testing eggs and milk.

That’s it. I’m past the three-month placebo window and continue to feel better than I ever thought possible. I know DAO is an unconventional migraine treatment. I know the science behind it is weak. I also know it’s working better for me than anything else I’ve ever tried.

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Opioids Under-Prescribed Due to Addiction Fears?

Fear of Addiction Means Chronic Pain Goes Untreated, according to an NPR story that aired last weekend. While there’s definitely some truth to the headline, it obscures the nuances of physicians’ reluctance to prescribe opioids (a.k.a narcotics) for chronic pain in general and headache disorders specifically (particularly migraine).

Opioids were originally prescribed for short-term pain, like from surgery or an injury, or for use in end-of-life care. Chronic pain is a serious medical issue that is both under-treated and has limited treatment options, so it’s understandable that opioid painkillers filled that void, especially because opioids are the only source of relief for many people with chronic pain. Unfortunately, they began to be prescribed for long-term use before there were a lot of studies on their long-term effects. Now that research is catching up, this use is being questioned.

Beyond addiction, other potential problems for using opioids for chronic pain include opioid-induced hyperalgesia, tolerance and the systemic effects of long-term use. Opioid-induced hyperalgesia, when opioid use increases a person’s sensitivity to pain, is one concern. Tolerance — which requires taking increasingly higher doses of the medication for it to still be effective — is another. The repercussions of regular (and often increasingly higher) doses of opioids could have on the body’s systems should also be considered.

Headache disorders have additional issues. Rebound headache (medication overuse headache) is the most widely addressed concern. In addition, the American Migraine Prevalence and Prevention study found that using opioids more than eight times a month can cause episodic migraine to transform into chronic. (Diana Lee recently reported that there may be a difference between short-acting opioids and long-acting ones and that long-acting opioids may be OK for long-term pain management for people with chronic migraine.) Headache specialists also believe opioids impair the efficacy of preventive medications.

On top of all that, opioids aren’t even particularly effective for any type of head pain. In the video I shared last week, headache specialist Mark Green explained why:

“Part of the reason for that is there are fundamental differences in the chemistry of head pain compared to visceral pain. In the receptors subserving head pain, we really don’t have a lot of opioid receptors, so the upside for the use of opioids is rather low. That’s why we use, for example triptans and ergots. Those serotonin receptors are very well represented on those receptors that subserve headache.”

What do I get from all this?

  • Boiling down concerns about opioid use to a fear of patients becoming addicted is an oversimplification.
  • There are a lot of unknowns about opioid use for chronic pain. As more research is published, the less they seem like a good long-term solution.
  • Head pain is different than bodily pain and migraine may different still.
  • Chronic migraine isn’t a chronic pain disorder, nor are chronic cluster headaches. I don’t know where tension-type headache falls on the continuum, but I’m inclined to believe it’s more on the side of other types of headache disorders.
  • Using opioids can significantly alter treatment for an underlying headache disorder.
  • Mostly, I’m left with a lot of questions (and so are researchers and physicians).

I’m not anti-opioid, but want anyone who takes them for headache disorders to know the facts and to be very, very careful. Ideally, your headache specialist would be the prescriber, but fewer and fewer are willing to prescribe opioids (not out of fear of addiction or the DEA, but because of the ramifications for treating the condition you’re using opioids for in the first place). If your headache specialist won’t prescribe them, still be honest with them about how often you use them and at what dose — without that information, your specialist can’t treat your headache disorder properly.

Note: I’ve used words like “potentially” and “can” a lot in this post because not everyone’s the same. It’s important to be aware of the risks, but also to remember that not everyone will have all the same issues.

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Candesartan Trial (and Overlooking the Obvious)

Candesartan (Atacand), a medication for high blood pressure, has recently shown to be quite effective for migraine prevention. After writing about it for Migraine.com (Candesartan: Effective Preventive, Low Weight Gain Risk) and having the week of more severe than usual migraine pain, I finally decided to fill the prescription my headache specialist wrote for me in January.

It’s the reason I’ve been so quiet the last few weeks.

My blood pressure is normally on the low end of the healthy range. That’s great for cardiovascular health, but limits migraine prevention options. While my headache specialist won’t prescribe beta blockers because of this, candesartan works in a different way than beta blockers do, so he didn’t think it would lower my blood pressure too much.

Over two weeks of taking 4 mg candesartan each morning, I was increasingly fatigued and brain fog made writing nearly impossible. It felt a lot like I had a migraine all the time, but the pain wasn’t any worse than usual. When checking my blood pressure finally occurred to me, it was bordering on too low. Not dangerously low, but considerably lower than I was used to. Whether that was the issue or I was feeling typical side effects of the drug, I decided to stop taking candesartan*. A week later, I feel almost back to normal (my new normal, that is).

I’m very careful to monitor my symptoms when I take a new drug or try a different food, but I so often miss changes that seem like they should have been obvious. It’s funny how the mind goes with what it knows rather than making new connections. My symptoms were migraine-like, so I dug around for triggers because that’s what I always do. It took a week of significant, escalating fatigue before I considered that the drug could be the culprit, even though I thought I was vigilant in watching for adverse effects.

Candesartan wasn’t for me, but I do recommend trying it if you’re looking for a new preventive and aren’t at risk for your blood pressure dropping too low. The research is quite strong (as far as migraine preventives go) and the side effect profile is pretty minimal.

*Stopping blood pressure meds abruptly could cause a stroke. If you’re considering discontinuing yours, please talk to your doctor about the safest way to do so.

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Promising Migraine Preventive Drugs Target CGRP

Positive findings from two phase II clinical trials of promising migraine preventive medications were announced today (here’s the full press release). If these drugs make it to market, they’ll be the first developed specifically for migraine prevention.

These drugs are the first to test monoclonal antibodies for migraine prevention and both target the protein calcitonin gene-related peptide (CGRP). If those words are gibberish to you, here’s a brief introduction to CGRP and its role in migraine from James at Headache and Migraine News. (I intend to write an explanation at some point, but don’t currently have the mental ability.)

The first study included 163 people who had five to 14 days of migraine attacks each month. They either received a single IV dose of the drug, called ALD403, or a placebo*. After 24 weeks, those who received the drug had an average of 5.6 fewer migraine days a month (a 66% reduction) than before receiving the dose and 16% were migraine-free after 12 weeks. Those who received the placebo had 4.6 fewer days per month (a 52% decrease) and none were migraine-free. Side effects were the same for both groups.

The second study included 217 people who had migraine from four to 14 days per month. For 12 weeks, participants received biweekly injections of the drug, LY2951742, or a placebo. After 12 weeks, those who received the drug had an average of 4.2 fewer migraine days a month (a 63% decrease), while those who received the placebo had 3 fewer migraine days a month (a 42% reduction). Participants who received the drug were more likely to have side effects than those who received the placebo. These side effects included pain at the injection site, upper respiratory tract infections and abdominal pain. Still, the drug was considered overall to be safe and well-tolerated.

Those are definitely good early results. More, larger studies are needed to confirm the findings.

Even more than the results, I’m struck by the positive, hopeful comments from two researchers involved in the studies, both highly regarded in the field:

“These results may potentially represent a new era in preventive therapy for migraine.” –Peter Goadsby, MD, PhD, UC San Francisco

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning.” –David Dodick, MD, Mayo Clinic Arizona

While not effusive, these comments echo the optimistic, hopeful attitude I’ve heard countless headache specialists use when talking about CGRP drugs. I, too, am quite hopeful for these drugs.

*The placebo effect is way oversimplified as the power of positive thinking. The process is far more intricate that “you think it will work, so it does.” It’s another topic I’m planning a post on, but I don’t know when I’ll get to it. If you’re curious to learn more, Jerome Groopman’s book The Anatomy of Hope describes it well, and Placebo Effect Stronger Than We Thought? is a good article.