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Dana129

Supposed “breakthrough” for episodic sufferers, take a look at the article below

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I think that I will stick to the D3 Regimen. It is also directed to CGRP as well and has been proven to help many patients become pain free with vitamins only. Over the counter and good for you stuff. No CH beats a 'reduction' in CH any day of the week. And vitamins are cheap. This biologic will not be. Also I have found that if there is a side effect I likely will have it!! So, for me, no Pharma is best.

ATB!

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For episodic cluster headache folks there have been promising results with this class of medication.  Certainly better than GammaCore.  The concern remains long term effects of such an injection and cost.  This costs roughly 1200.00 a month and no one is sure if you need to take it year round , in anticipation of a cycle or at the onset.    neurologists  dont know either but most are suggesting using it year round.  If you have access, are willing to deal with unknown consequences and other things don't work it is worth a try.  My concern is invariably when a new class of drug is released all sorts of unanticipated effects start to appear within a few years and enthusiasm tapers.  In the end it needs to be an individual choice.  Remember that MM have a long track record of safety when used properly.  Few others things can claim the same.  Then again MM are illegal, can be misused, hard to find unless you self provide and difficult to standardize the dose.  D3 is another consideration with favorable experience worth considering.

 

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Hey Spiny and Pebbles,

Thanks for the plug with kind words about the D3 Regimen efficacy.   After reading the article on galcanezumab-gnlm (Emgality) results when treating episodic CHers... all I can say is bless my long gray whiskers, the author of this article and the folks at Lilly who paid for this RCT must have been thinking pure thoughts.

Here's my analysis of the results.  BTW, I've read the results from all the anti-CGRP monoclonal antibody RCTs for episodic migraine and episodic cluster headache...   The published results of these RCTs tend to sugar coat the absolute efficacy of these mAbs with clever wording and relatively new measures of effectiveness like "Patient Global Impression of Improvement scale."  In short, the results of these RCTs are at best fair with respect to prophylactic effect (headache prevention)... but not great... as a rating of great would be a complete cessation of headache symptoms...

To get the absolute efficacy of a cluster or migraine prophylactic intervention in an RCT you subtract the mean measure of improvement from the Placebo Control Group from the mean measure of improvement from Test Group taking in this case taking Emgality.  In this RCT, the primary measurable endpoint was the reduction in CH frequency as indicated in the following quotes from the article/RCT... 

"In this study there were 106 participants with episodic cluster headache who had an average of 17.5 cluster headache attacks per week at baseline."

Note: There's no discussion of how these 106 episodic CHers were divided between the Placebo Control arm and the Treatment arm...  

The article when on to say "Across weeks 1 to 3 of the 2-month study period, the group treated with 300-mg galcanezumab reported a statistically significant difference in the reduction of weekly cluster headache attacks compared to placebo (-8.7 reduction for galcanezumab vs. -5.2 reduction for placebo; P = .036).  

Note: There's no mention of efficacy at the end of the 2-month study period...

If you do the math, the placebo control arm of this RCT experienced decrease in average weekly CH from 17.5/week down to 12.3 CH/week (17.5 CH/week minus 5.2 CH/week).  That also works out to 5.2/17.6 = 0.297 or a 29.7% reduction in CH weekly frequency Doing the same math on the treatment arm, Episodic CHers receiving 300-mg galcanezumab had a reduction in average weekly CH from 17.5 CH/week down to an average of 8.8 CH/week... and that works out to 8.7/17.5 = 0.497 or a 49.7% reduction in average CH/week.

Now lets look at the absolute efficacy by subtracting 29.7% for the placebo control arm from 49.7% for the Emgality treatment arm and to get an absolute average reduction in weekly CH of 20%.  By the way you get the same 20% by subtracting 5.2 from 8.7 you get 3.5 and dividing by 17.5.

A better measure of efficacy is the number needed to treat (NNT) to achieve the stated improvement... in this case 3.5 fewer (20%) CH/week in one CHer.  To get the NNT we divide 1 by the % improvement or 1/0.20 and we get 5.  That means neurologists need to treat 5 episodic CHers to get on CHer to respond to this regimen... for an estimated $550 per treatment plus the neurology consult and labor of administering the Emgality injection and the bill per treatment comes to ~$750... assuming three months per treatment for an episodic CH cycle...

Now let's look at the efficacy of the anti-inflammatory regimen.   Data from the online survey of 293 CHers taking this regimen since the survey started in Jan of 2011.  This data indicates 80% of CHers who start this regimen experience an average  80% reduction in the frequency of their CH in the first 30 days and 50% of the CHers who start this regimen experience a complete and lasting cessation of of CH symptoms in the first 30 days  These are combined figures for both episodic and chronic CHers...

There was no placebo control arm in this study, but we can use figures provided by a study run by a team of neurologists expert in treating CHers.  They found the highest reported placebo response in CH of 14% to 43%.  The lowest value was reported
using the strict endpoint; cessation of headache attacks.  Using these figures to come up with the absolute efficacy we subtract 43% from 80% for a 37% reduction in CH frequency for 80% of CHers, we multiply 0.37 times the 0.8  we get 0.296.  Dividing that into 1 we get 3.37 so round up to the next whole person for an NNT of 4 CHer taking this regimen to get one of them to have a favorable response.

Using the same math to get the absolute efficacy for a complete cessation of CH we subtract 14% from 50% for 36% or 0.36 and dividing that into one to get the NNT we get 2.77. Rounding up to the next whole CHer we have an NNT of 3 CHers treated with the anti-inflammatory regimen to get one CH to experience a CH pain free response.  Using the same 3-month treatment period as the Emgality RCT, at 55 cents a day, the cost of this regimen for 3 months is $49.50.

Accordingly comparing efficacy of Emgality with an NNT of 5 for a 20% reduction in average weekly CH frequency for a cost $750 with the anti-inflammatory regimen at an NNT of 4 for one CHer to experience an 37% reduction in CH in average weekly frequency at a cost of $49.50 and an NNT of 3 to get one CHer a pain free response for $49.50... I think the nod goes to the anti-inflammatory regimen based on bang for the buck...

BTW this doesn't count the Emgality adverse side effects... Vitamin D3 has essentially none...

Take care,

V/R, Batch

 

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Batch,

Spot on!!  Their breakthrough is really no breakthrough if it only has a positive efficacy for 2 out of 10 people.  I'd be curious how it works long term.  I'd bet massage has about the same efficacy.. ha ha..  I'll give them this though, at least someone is doing something...  I'm sure their results will swing quite wildly with a larger test group.  If they did a 50/50 split (I didn't read the details) of the control from test subjects then out of 53 people they only had approx 10 that responded to the treatment positively.  That's not going to provide very accurate results.  

J

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I'm happy to see that there's people out there trying to find something to help cluster headache people.. Not sure it will help or not but its one step more in our direction..

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It can't pass the blood brain barrier. Here in Germany it costs around 600€ and nobody can afford that. However, some people had tested it and got smaller reliefs.

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Hey Milelli,

You're spot on!

There's a good reason why the mAb RCTs can't achieve better efficacy in preventing CH and MH.  When you consider the site of action are neurons within the brain that express calcitonin gene-related peptide (CGRP) and other nasty peptides that trigger CH and MH.  The mechanism of action espoused by Big Pharma is neutralization of CGRP.  Accordingly, the first step in this process is getting the anti-CGRP mAb into the brain.  That's a very real problem Big Pharma has yet to solve.  

The maximum opening size through the tightly packed endothelial cells forming the blood brain barrier (BBB) in arteries, capillaries and microvasculature is a molecular mass of 400 Da (Daltons).  The anti-CGRP mAbs have a molecular mass of 150 kDa (150,000 Da)... 375 times larger than openings through the BBB.  If the mAbs cannot pass through the BBB to enter neurons throughout the brain, neutralizing CGRP within these neurons is a non-starter.  My guess is the reduction in migraine days made possible with mAbs is due to reducing serum CGRP.

For reference, vitamin D3 has a molecular mass of 385 Da so passes readily through the BBB and into neurons where it's hydroxylated by enzymes to 1,25(OH)2D3, the genetically active vitamin D3 metabolite.  The 1,25(OH)2D3 molecule in turn, attaches to Vitamin D Receptors (VDR) at the genetic layer initiating the genetic expression that down-regulates CGRP expression... and in the process, prevents our CH and MH.  Better living through chemistry...  and molecular biology...  That's my SWAG... and I'll stick with it until a better mechanism of action is found.

Regarding the comment that there's people out there trying to find something to help cluster headache people...  There are and there have been some great RCTs with real ground-breaking findings in the last few years...  I just wouldn't count Big Parma among them.  Their motivation is not to help migraineurs or CHers...  Their motivation is profit. 

See the following link for details on a number of studies and RCTs helping CHers and Migraineurs: 

https://vitamindwiki.com/Cluster+headaches+substantially+reduced+by+10%2C000+IU+of+Vitamin+D+in+80+percent+of+people+

Two recent RCTs come to mind.  The first was an RCT using 4000 IU/day vitamin D3 as a migraine prophylaxis.  The results indicated 4000 IU/day vitamin D3 reduced the frequency of migraine headache just as effectively as the anti-CGRP mAbs, but at a fraction of the cost and with no adverse side effects.  The second study assessed the effects of an Atkins-ketogenic diet in reducing CH frequency.

See the following link titled: Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial:

https://www.frontiersin.org/articles/10.3389/fneur.2018.00064/full

Take care,

V/R, Batch

 

 

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4 hours ago, Batch said:

 

See the following link titled: Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial:

https://www.frontiersin.org/articles/10.3389/fneur.2018.00064/full

Take care,

V/R, Batch

 

 

Hey Batch is this diet good for episodic people?

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Hey Dana,

 The answer is Yuppers!  This diet works great to prevent all kinds of migraine and cluster headache...  It also gets rid of jiggles in places that shouldn't jiggle and turns people into hard body good lookers.  It works great on my 74 year old frame...  I lost so much around my middle I had to switch to braces to keep my drawers up.  My wife isn't complaining either...

Take care and please keep us posted.

V/R, Batch

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Hey Batch, I totally agree! It's a pity but the big pharma industry is only concerned about profit. There are other promising candidates like Bol-148 which seems to have almost no side effects. The CGRP antibody was developed to treat migraine, since much more people are suffering from this which in turn provides more profit. If it is happen to give relief also to CH, why not?

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To be fair survey data, which is basically self reporting, can not be compared to a RCT.  There are many differences: no control group, no establishment of diagnosis, no validated assessment measures, no way to control for compliance.  Survey data can provide guidance, create a framework for future study and stimulates discussion but it is not the same as a placebo controlled study where the participant are vetted and monitored.  This does not dismiss the intervention as ineffective but it is invalid to equate the two processes.  

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On 3/16/2019 at 8:53 PM, Batch said:

Hey Dana,

 The answer is Yuppers!  This diet works great to prevent all kinds of migraine and cluster headache...  It also gets rid of jiggles in places that shouldn't jiggle and turns people into hard body good lookers.  It works great on my 74 year old frame...  I lost so much around my middle I had to switch to braces to keep my drawers up.  My wife isn't complaining either...

Take care and please keep us posted.

V/R, Batch

Hi Batch,

Another member gave me your user name as a reference for D3 vitamin supplement. Any special type?  I have just been taking the D3 from the grocery store a few at a time. Trying to get as close to 10,000 IU a day as possible staggered throughout the day. This combined with verapamil, topamax, melatonin, and Sumatriptan injections has this cycle under control. Not sure which preventatives are actually doing the trick, (maybe all of them) or maybe my cycle has come to an end and I just think I’ve found something that works... wouldn’t be the first time. Thank you for any info you can give me regarding D3 vitamin supplements type/brand...

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EggMan, you need to do the whole D3 regimen.  Read this: http://www.vitamindwiki.com/tiki-download_wiki_attachment.php?attId=7708

You don't have oxygen???  You really should.  The more you use triptans, the more it makes your attacks worse and is likely to extend your cycle, not to mention just being bad for you.  At least, consider splitting your injections if you aren't already: https://clusterbusters.org/forums/topic/2446-extending-imitrex/  Verap and Topamax aren't great for you, either. If you do the D3 regimen right, you will probably be able to stop taking them. 

Edited by CHfather

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Hey Eggman,

What CHfather said...  I'll add the vitamin D3 conutrients/cofactors are very important for a favorable response to this regimen.  You may have an initial favorable response to the vitamin D3 by itself, but without the supplemental 400 mg/day magnesium and the rest of the conutrients, the vitamin D3 will deplete what little magnesium you had in your system and this will create a calcium-magnesium imbalance with too much calcium and not enough magnesium. 

This condition can easily result in muscle cramps.  It happens because our muscles require calcium to contract and magnesium to relax.  With too little magnesium our muscles can't relax properly... This is annoying when it results in hand, leg or foot cramps... However, when it happens to your heart... it will get your attention big time with a fluttering sensation...

Regarding the best brand of vitamin D3, I switched to Bio-Tech D3-50 last June.  This water soluble 50,000 IU capsule of vitamin D3 appears to be faster acting and more potent at the same dose in terms of elevating serum 25(OH)D than the liquid softgel vitamin D3 formulations.

I1fb9Dm.jpg

I order it from amazon.com or iherb.com depending on which has the best sale price.  At one capsule every five days, the Bio-Tech D3-50 is also the least expensive form of vitamin D3 you can buy at a little over 4 cents a day.  The liquid softgel vitamin D3 formulation with run you 12 cents a day for 10,000 IU of vitamin D3.  You can order the Super K with Advanced K2 Complex at the same time. 

Most CHers benefit with a faster response when they start this regimen with the 12-Day accelerated vitamin D3 loading schedule taking the Bio-Tech D3-50 at one (1) 50,000 IU capsule a day for 12 days then drop back to one (1) of these D3-50 capsules every 5 days for an average dose of 10,000 IU/day vitamin D3.

Once you've been on this regimen for at least 30 days, be sure to see your PCP/GP or neurologist for lab tests of your serum 25(OH)D, calcium and PTH.  When you have the results of these lab tests in hand, please find the time to take the online survey of CHers taking this regimen to prevent their CH.   To start this survey, click on the following link:
http://www.esurveyspro.com/Survey.aspx?id=fb8a2415-629f-4ebc-907c-c5ce971022f6

Take care and please keep us posted.

V/R, Batch

Edited by Batch

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1 hour ago, Batch said:

Hey Eggman,

What CHfather said...  I'll add the vitamin D3 conutrients/cofactors are very important for a favorable response to this regimen.  You may have an initial favorable response to the vitamin D3 by itself, but without the supplemental 400 mg/day magnesium and the rest of the conutrients, the vitamin D3 will deplete what little magnesium you had in your system and this will create a calcium-magnesium imbalance with too much calcium and not enough magnesium. 

This condition can easily result in muscle cramps.  It happens because our muscles require calcium to contract and magnesium to relax.  With too little magnesium our muscles can't relax properly... This is annoying when it results in hand, leg or foot cramps... However, when it happens to your heart... it will get your attention big time with a fluttering sensation...

Regarding the best brand of vitamin D3, I switched to Bio-Tech D3-50 last June.  This water soluble 50,000 IU capsule of vitamin D3 appears to be faster acting and more potent at the same dose in terms of elevating serum 25(OH)D than the liquid softgel vitamin D3 formulations.

I1fb9Dm.jpg

I order it from amazon.com or iherb.com depending on which has the best sale price.  At one capsule every five days, the Bio-Tech D3-50 is also the least expensive form of vitamin D3 you can buy at a little over 4 cents a day.  The liquid softgel vitamin D3 formulation with run you 12 cents a day for 10,000 IU of vitamin D3.  You can order the Super K with Advanced K2 Complex at the same time. 

Most CHers benefit with a faster response when they start this regimen with the 12-Day accelerated vitamin D3 loading schedule taking the Bio-Tech D3-50 at one (1) 50,000 IU capsule a day for 12 days then drop back to one (1) of these D3-50 capsules every 5 days for an average dose of 10,000 IU/day vitamin D3.

Once you've been on this regimen for at least 30 days, be sure to see your PCP/GP or neurologist for lab tests of your serum 25(OH)D, calcium and PTH.  When you have the results of these lab tests in hand, please find the time to take the online survey of CHers taking this regimen to prevent their CH.   To start this survey, click on the following link:
http://www.esurveyspro.com/Survey.aspx?id=fb8a2415-629f-4ebc-907c-c5ce971022f6

Take care and please keep us posted.

V/R, Batch

 

2 hours ago, CHfather said:

EggMan, you need to do the whole D3 regimen.  Read this: http://www.vitamindwiki.com/tiki-download_wiki_attachment.php?attId=7708

You don't have oxygen???  You really should.  The more you use triptans, the more it makes your attacks worse and is likely to extend your cycle, not to mention just being bad for you.  At least, consider splitting your injections if you aren't already: https://clusterbusters.org/forums/topic/2446-extending-imitrex/  Verap and Topamax aren't great for you, either. If you do the D3 regimen right, you will probably be able to stop taking them. 

Thanks. I do split my sumatriptan. That has helped a lot. Just spoke to my doctor (GP) about oxygen. He said he would prescribe it if it’s something I want to try.  He said it can be a “headache” getting everything cleared through insurance... I’d like to look into purchasing the equipment myself. Looks like 15-25 LPM with a large bottle is the way to go. I live in a very rural area without oxygen service. How would I go about getting the equipment?  Buy it myself or get a prescription and that would allow me to buy it?  (My doctor appointment was focused on higher dose verapamil that seemed to work and a nerve block that only worked for a few days... wish I’d been prepared for more oxygen questions for my next cycle).

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Eggman I posted some stuff about using welding o2. It could help if you have trouble getting it through you're insurance. If you want you can private message me and I can offer some help. Welding o2 is all I use

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You can't get medical O2 without a prescription.  But as the Boatman said to the Eggman, welding O2 is an alternative that many use, and no prescriptions are required to set up a welding-O2-based system.  Info here: https://clusterbusters.org/forums/topic/5627-notes-about-welding-o2/.  I know many people who use welding O2, and who prefer to use it for many reasons.  But I would at least follow up on your doctor's offer and see where it leads, unless you are certain that in fact there are no oxygen suppliers to service you.

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