That's just it, we don't know, so we stay the course and see what happens. If I was betting, I'd say I had the placebo. I read a lot on this topic and I've probably only read a single report where one person is pretty sure they had the real thing in the initial 28 day trial. I suspect that if it works, people are less likely to share their experience because that's just human nature, we disappear from forums like this when things are good and are here when they're not.
Sorry that your symptoms got a bit worse during the drug trial @Mark55. That's disappointing but hopefully points to your drug being the placebo. I can confirm that hard physical labor, especially in warm weather, can ignite tinnitus, & for me, vertigo. I did long distance running for years before & after my MD diagnosis, & when my hips gave out, I did long distance walking/hiking. I frequently had terrible flares of tinnitus, ear pressure & intermittent awful vertigo after a long walk/hike. I carried electrolyte infused water w/ me whenever I was out to help me stay hydrated - often a liter or two. My ENT kept telling me to quit the distance stuff, & my hips finally forced that. Since then, my tinnitus, ear pressure & vertigo have been much better controlled.
Not to be a killjoy, but I asked my ENT this week what he knew about the SPI 1005 drug. I mentioned that it purportedly helps the sensor hairs in the inner ear regrow. His only comment was "If it makes the sensory hairs regrow, what else might it cause to grow since drugs can't be so specifically targeted?" He then said it'll likely be 10+ years before we know if it has any really detrimental side effects.
wow, so much for a positive outlook from a health care professional. As if we aren't a depressed enough group to hear something like this. It sounds to me like he didn't know anything about it so he had to make it sound bad.
Isaiah, I am anxious to get going on the real drug in July. One of the people on Facebook Meniere's forum is having great results so far. As far as the electrolytes, what did you use? Currently looking for a lower sodium option. And it's sad that some ENTs are close minded when it comes to trying new things in regards to MD. It's a new trial drug. Of course we don't know what the future outcome is, but I am ok being a test subject. I'm all in for the long haul. If I grow a 3td ear ear as a result, so be it. Haha Have a Blessed day!
To be fair he's not wrong, but he's not right either. He probably should have just said that he doesn't know about it, but he felt the need to say something. We don't know what the future will bring with this or any other drug and I'm fine with that.
There are many people having great results with it, ranging from some to full symptomatic relief including some hearing recovery. In fact, hearing recovery of 10db or more for specific frequencies is one of the primary measures.
Isaiah, I am anxious to get going on the real drug in July. One of the people on Facebook Meniere's forum is having great results so far. As far as the electrolytes, what did you use? Currently looking for a lower sodium option. And it's sad that some ENTs are close minded when it comes to trying new things in regards to MD. It's a new trial drug. Of course we don't know what the future outcome is, but I am ok being a test subject. I'm all in for the long haul. If I grow a 3td ear ear as a result, so be it. Haha Have a Blessed day! Agree with whatever the future brings with this drug. I'm happy that we are close to having a drug. The more I think about the 28 day drug/placebo gig, the less I worry about it. It probably takes 2 or 3 months to get the inner ear hairs rejuvenated. And hey, I/we are a month closer to the real drug.
28 days just isn't a lot of time. I started to noticed a decrease in tinnitus at the 3 week mark but I don't know if it was the drug or just one of my many cycles that I run through. I can tell you that I'm feeling better right now than I have in months. If it was indeed the real drug that did it I'm looking forward to a 6 month or more cycle.
On the opinion of the otolaryngologist, ebselen, like all drugs, have been patented for decades and being tested and investigated in both human and animal models. It's embarrassing for a doctor to say such comments because he should know this. Regarding "hair cell regeneration", I think you are misunderstanding. This drug is a powerful anti-inflammatory and antioxidant that, by acting on the inflammation of the inner ear (which we still do not know the cause of), stops the symptoms, that is, vertigo and dizziness, as well as the progression of hearing loss and tinnitus. What can happen is that by stopping the inflammation, those cells that are damaged but not yet dead can recover and that is why some patients can recover part of their hearing or reduce tinnitus. This is why not all patients improve these symptoms or with the same intensity (some do not, others only 10dB or 30). This is not a cure, it is a patch, nothing more. Think of people with diabetes, insulin doesn't really cure their disease. Cell regeneration therapy failed in early clinical trials, and research is still many years away.
Thank you all for your responses to my post. I agree w/ what my ENT said, but also agree w/ all of you in that I'm not sure he was familiar w/ the drug at all since he looked a bit blank when I mentioned it. He's a really sharp doctor, but as with any doctor, has to speak from his base of experience. I'm on the fence as to whether or not I'd try the drug if it's made available commercially (via Rx) because I have an endolymphatic shunt which disqualified me from the drug trials. Thus, I assume the medication might not work so well for me due to the shunt though I question whether my shunt is doing anything at this point. I've also recently had a rhythm section added to my tinnitus symphony as I now have MEM - Middle Ear Myoclonus - twitching of my stapedius muscle. Intermittently throughout the day, I hear clicking in my inner ear. The fun just never stops!! Honestly, I haven't looked into the mechanism(s) by which SPI 1005 works. From @IvanNew's post, I see it's an anti-inflammatory/antioxidant, but do those 2 features alone allow for regrowth of the sensory hairs or are there other components of the drug that encourage that?
There is nothing about this drug that regrows ear hair cells. What it can do is alleviate some of the conditions that cause hearing loss. For example, the inflammation. In my case, my hearing fluctuates, some days it's distorted some days not. So I know that there are portions of my ear that are capable of working correctly some days while other days their not. Perhaps SPI-1005 will foster conditions that help me function at whatever my new best is. As for not taking it because of the shunt. I'm not a Dr but keep in mind that many things disqualify an individual from the trial, not because there's a conflict between the med and whatever procedure you had, but because they need to have a clear, control group. The shunts are intended to help the condition, if you were on the drug how would they know what's helped? Same thing with steroids. I take them occasionally when my hearing drops, but I can't while part of the trial. All for the same reasons, they wouldn't know what helped if I was on it at the same time as SPI-1005.
Hello, SP1005 is Ebselen, on wikipedia you can get a general idea of what this compound is: Ebselen - Wikipedia I am not a doctor or a scientist, I am simply saying what I have been reading for the last three years about this new drug. In any case, your doubts about what this drug can or cannot do right now cannot be answered by anyone; That is why clinical trials are carried out and there are still no results. What is shown by MRI is that there is inflammation in the inner ear of people with Meniere's. So in theory any drug that reduces inflammation could help with symptoms. This is the reason why doctors try oral or intratympanic corticosteroids before moving on to more aggressive treatments. Please note that this trial may show that the drug is safe and has benefits on symptoms and may not have a 100% proven explanation of why it works. This happens with betahistine, it is not known with certainty what mechanism it has in the ear of a Meniere for whom it works. Most resort to simple explanations for people from the "plain town" saying that it works because it improves blood flow and that helps, etc. But it doesn't work for everyone and in fact there were studies where the results showed hardly any changes, etc. That is the reason why the FDA has not approved it as a Meniere's treatment, in Europe it was approved because some studies "suggest" that it works and all or most of the studies have shown that it is a very safe drug even with long-term use. Therefore, the reasoning was: Look, these people are very screwed up and we don't have a cure for them; Let them at least try this before they put a drill in his skull. The risk is worth it. Patience, luck and health.
@IvanNew & @MrE. Thank you for the clarification about Ebselen. I had read somewhere that it helped restore/regrow the sensory hairs in the inner ear. The fact that it's an anti-inflammatory makes much more sense. I've had a few major surgeries since my Meniere's onset & have taken Rx strength anti-inflammatories w/o any affect on my MD symptoms. I also have a store of Prednisone for those days when my tinnitus becomes thunderous. I'm not even sure the Prednisone helps anymore, BUT being one who likes to leave no stone unturned, I would be willing to try a different type of anti-inflammatory to see if it produced any positive changes. Sure would be great to regain some hearing in my MD ear! Thanks for the explanation about the criteria required for the drug trial group. I should have figured that out myself. Silly me.
2nd visit for SPI-1005 trial in the books! Nothing exciting to report other than audio test in bad ear was much worse than first test. I think I got 2 right in the repeating word part of it. It should be noted that the last 2 weeks I have been in distress in regards to symptoms such as Tinnitus/hypersensitivity/aural fullness and occasional bouts of dizziness. We also have very unstable atmospheric pressure here that started 2 weeks ago and thunderstorms are forecasted every day for the next week. Coincidence? Maybe. Maybe not. I am thankful for the good days! Looking forward to July haha! Y'all have a Blessed evening!
You were likely having a bad day that's all, just as I was having a good day during my visit. I keep thinking about July and how it can be a game changer. At the same time I'm cautiously optimistic because it might not do anything. Either way, I'm blessed to have the opportunity to participate in this trial, that's how I look at it.
Today is my 29th day on the drug. I have not yet seen any improvement in my tinnitus or hearing. (My vertigo is under control with Betahistine). In fact, my tinnitus worsened starting at about 10 days on the drug. I hope this is a coincidence and not as a result of the drug. I will report back in another month or earlier if there is any improvement. I am sticking it out, in for a dime in for a dollar.