New to the group

[MRUPE]

Hi all, 

Episodic CH x 18 years. Diagnosed 10 years ago. Provided multiple prescriptions in the past (anti-depressants, convulsants, anxiety, topiramate, hypertensives) without benefit. Similar difficulties of many here: sleep triggers, ER visits, work, friend and family challenges.

First trial of Zomig sub-lingual aborted a headache and then moved to intranasal with good effectiveness. It is my primary triptan.

Several years ago, learned about O2 and found neurologist willing to prescribe. Was shocked at its effectiveness and reduction in use of triptans. 

O2 has been mainstay for last several years with use of triptans at work or when O2 is unavailable. 

Last cluster period of 2018, trialed melatonin toward the end of the cycle. Cycle returned 5 weeks ago (ugh). Have continued using O2, zomig and melatonin before bed.  

Happy to meet a group of folks with similar difficulties and experiences. Hope to learn a thing or two here. 

Currently awaiting completion of psilocybin trials from Yale in hopes of an option to decrease/bust cycles and increase remission times. Fingers crossed.....

[spiny]

Welcome! Are you enrolled in the study?

We have a great group here and they are happy to help.  

ATB!

[jon019]

Hi... welcome...nice summary!

Best

Jonathan

[MRUPE]

Appreciate the welcome everyone. 

I’ve been looking around and saw the vitamin D3   references. The resources were a bit lengthy and not made up of high quality evidence from a research methods perspective. Given the low risk I’m interested to know more. 
 

From what I’ve read it appears to be 10,000IU/daily with an addition of other assorted vitamins/minerals. 
 
am I correct in my interpretation?

[MRUPE]

spiny,

I am not enrolled in the study. I have contacted the authors to learn more. They should be wrapping up the intervention period looking at clinical trials.gov. I figured they’d have some idea of preliminary results at this points. 

[CHfather]

15 minutes ago, MRUPE said:

From what I’ve read it appears to be 10,000IU/daily with an addition of other assorted vitamins/minerals. 
 
am I correct in my interpretation?

Yes, although there can be an initial loading period when the D3 amounts are much higher.  The other assorted vitamins/minerals are important.

 

17 minutes ago, MRUPE said:

The resources were a bit lengthy and not made up of high quality evidence from a research methods perspective.

You are correct. No formal control group, placebo, etc.  The anecdotal evidence from more than a hundred users is, however, extremely compelling, and what research there is is very nicely done.  

1 hour ago, MRUPE said:

Hope to learn a thing or two here. 

Maybe this file might be worth reading in that regard (or maybe not).  https://clusterbusters.org/forums/topic/6213-basic-non-busting-information/

[MRUPE]

1 hour ago, CHfather said:

Yes, although there can be an initial loading period when the D3 amounts are much higher.  The other assorted vitamins/minerals are important.

 

You are correct. No formal control group, placebo, etc.  The anecdotal evidence from more than a hundred users is, however, extremely compelling, and what research there is is very nicely done.  

 

Hi CHfather, 

Without control groups how can someone suggest the other assorted vitamins and minerals are important?  I understand there is research to suggest Vitamin D deficiency in headache conditions (migraine and cluster) but little to draw a causal link, let alone justify supplementing numerous pills? The same can be said for melatonin. Correlation to cluster headaches but little research suggesting supplementing is effective. 

I should probably put it out there; I base my knowledge on the evidence hierarchy in research (see skeptic  ). Unfortunately for me and this condition, that limits me in what I may or may not pursue as treatments. Needless to say, its why I'm paying close attention to the trial out of Yale and the use of psilocybin.  I hate to get my hopes up, but it looks/sounds like the only promising research for this condition.  

[Dallas Denny]

21 minutes ago, MRUPE said:

Hi CHfather, 

Without control groups how can someone suggest the other assorted vitamins and minerals are important?  I understand there is research to suggest Vitamin D deficiency in headache conditions (migraine and cluster) but little to draw a causal link, let alone justify supplementing numerous pills? 

G'evenin MRUPE!

Batch, who came up with the vitamin D3 regimen, is an old Vietnam era Navy fighter pilot, and a fellow clusterhead with a chemistry degree!!  You're correct in that there are no double blind trials, however, Batch has been collecting survey data from the many clusterheads who've had tremendous success with the protocol since he came up with the it almost 10 years ago.....that data shows a efficacy of around 75%!

I couldn't begin to tell you how it works but I've listened to Batch speak at our yearly patient conference and I can tell you that there's a sound reason for each of the co factors and that they all work in correlation with each other.

Dallas Denny 

[CHfather]

1 hour ago, MRUPE said:

The same can be said for melatonin. Correlation to cluster headaches but little research suggesting supplementing is effective. 

Well, I don't know what your high standards would call for regarding melatonin, but here's report of a randomized placebo-controlled study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5012937/: "In a randomized placebo-controlled trial consisting predominantly of episodic cluster headache patients (18/20 with episodic, 2/20 with chronic), melatonin 10 mg orally, when introduced early in a cluster period, i.e. 2nd to 10th day, was superior to placebo at decreasing cluster attack frequency."  Some other references in there as well.  No adverse side effects reported.  Worth trying? Up to you.

Regarding the D3 . . . more or less what Denny said.  Do it; don't do it; up to you.

[jon019]

....hmmmm....that darn anecdotal evidence.....results in insufferable forums like CLUSTERBUSTERS.org....beware...

[Dallas Denny]

Lol @jon019.....yuppers. that damned old anecdotal evidence saved my freakin bacon.....damn proud I didn't have to wait for completion of the Yale psilocybin trials to get on board!!

DD

[jost]

Relatively new here since July and have lurked a lot but posted little. I had my worst CH episode in over a decade from this past June until October to be followed by my first migraines. Still trying to sort out a lot of things including if the migraines are rebound headaches from sumatriptan. I'd like to get away from triptans all together if it's possible. I'm not a skeptic requiring a lot of hard evidence rather I want to feel better.

Ahem...anecdotally:

I've been doing the D3 regimen since late July and I can't prove anything but I have a pretty good sense it played a significant part in ending the vicious CH cycle I was in. At the minimum it sure helped me all around nutritionally and with my moods.

Melatonin has been helpful since my previous vicious cycle in 2007. It was recommended then by a neurologist and every time in the years since I stopped taking it anecdotally the less vicious CH returned.

Likewise with the gabapentin I was prescribed for withdrawal from benzodiazepines which seems to have helped with neuropathy with arthritis and anecdotally CH.

I dallied around and didn't go to a neurologist this last go round for several reasons and in hindsight I view it as a mistake. Anecdotally (that word again) more than a few people in real life have told me oxygen was a godsend for them. My family doctor refused to prescribe it because he's big on sending to specialists and was upset I wouldn't go to a neurologist. He also won't go over the 9 sumatriptan a month drill. The spine doctor I go to for significant osteoarthritis I have from injuries and inherited rheumatoid arthritis also calls himself a pain doctor for Medicare purposes. He is willing to up the sumatriptan and over the 9 a month I can do a GoodRx coupon which is reasonable. I think he also is willing to go to bat for the oxygen.

Speaking of arthritis I'm not so sure that the medications I take for it isn't also possibly at the root of the cycle this past summer along with benzodiazepines withdrawal. I just don't know but I've learned a lot from lurking here and my 2020 is going to be renewed focus on regaining my health. I'm willing to try emagility but I am put off by the cost. Also busting but I would have no idea how to go about obtaining anything. Both of those things leave me feeling pretty helpless on those ideas.

I'm not sure what I'm contributing to this post if anything but if there are any suggestions that might help anecdotal or otherwise I'm open to hearing about them.

 

[MRUPE]

hi CHfather, 

that article and those referenced within are why I trialed melatonin last year and why I’m using this cycle. I’m trying to assess if/how it impacts my cycles. Fingers crossed...
 

I’m not against anecdote as we all need individualized management. I don’t like the idea of adding too many variables to management, hence my questioning of vitamin D3. I may in fact implement if melatonin isn’t showing an effectiveness. Given the numerous favorable reports, I’m interested. 

 

[MRUPE]

Thanks BOF,

you and I sound similar in our thinking. 

May I ask what preventive you use?

[jost]

1 hour ago, Brain on fire said:

...Often people aren't aware meds they are prescribed are used based on anecdotal evidence. I am a minimalist med wise & fully understand not wanting to add buckets of supplements to your daily routine. I like to know what is working for my CH rather than wondering what part of several things I might otherwise throw at it are working.

I'm a minimalist with meds and believe less is more and like to test things out without cluttering it up. My intention wasn't to be critical rather just pointing out that anecdotal may be all we have. That certainly was the case 50 years ago when trying to survive CH when they didn't have a name for it.

As far as non prescribed methods I've never found a doctor who didn't cringe and shrink away from discussing it. They don't even want to acknowledge marijuana much less anything else.

[jost]

I just moved about 40 miles away from my current doctors and am going to change. When I lived in this area before the nurse practitioner I went to was much more open minded. She's narrowed her patients down to a specific category but has another one in  her office I'm going to try who I hear from sister in law is like minded. We'll see about oxygen and other topics. Perhaps I should venture onto the other boards on here.

[Dallas Denny]

Agree with the minimalist approach @MRUPE!

Although I highly recommend the D3 regimen solely bbased on the "anecdotal evidence" that I've witnessed as it was being documented over the years, I don't personally use it.....when I got here 10 years ago I committed to "busting" as a treatment and didn't want to "muddy the water" by adding the D3 and then not knowing for sure which strategy worked!!  When I got here I viewed clusters as a curse but thanks to this place it's become an annoying inconvenience!

DD

[jost]

Do you have your answer now? Is it possible the D3 regimen help or harm it?

[xxx]

Hey MRUPE,

Welcome to Clusterbusters.  You've come to the right place.  We know what you've been going through and the good news is it just doesn't need to be that way.  You've already discovered the wonderful benefits of oxygen therapy.  I only wish more CHers would pressure their neurologists to obtain it.  As you appear to be taking a discerning approach in selecting a CH preventative treatment protocol, you may find the following of interest.

I'm heavily biased to suggest the anti-inflammatory regimen with vitamin D3 and the cofactors as a safe and effective method of controlling/preventing your CH. I'm also biased to suggest psilocybin as another safe and effective method of controlling your CH.  I've seen it work many times when all else failed.

As the guy who developed the anti-inflammatory regimen and started taking it in October of 2010, I consider this method of CH intervention a very safe bet.  I've been essentially CH pain free ever since.   I started providing information outreach on the benefits of this vitamin D3 regimen in December of 2010 and I've been running an online survey of CHers taking this regimen since December of 2011. 

As of 30 December 2018, 290 CHers had completed and submitted their responses to this survey.  The results are impressive to say the least.  In terms of raw efficacy, the 30-day response rate for the entire cohort finds over 80% of CHers starting this regimen experiencing a significant reduction in the frequency of their CH from a mean of 3 CH/day down to a mean of 3 CH/week.  Moreover, 52% of CHers starting this regimen experience a complete cessation of CH symptoms in the first 30 days after starting this regimen. 

It's significant to note that over the 10 years I've been providing information outreach on the benefits of this regimen in preventing CH, that there have been no reports of adverse events requiring medical attention and no cases of hypercalcemia, a.k.a., vitamin D3 intoxication/toxicity.  I've analyzed the results of every RCT and study involving CH and migraines.  None of them including verapamil, have reported or concluded a level of efficacy that comes even close to matching the safety and efficacy of vitamin D3 in preventing CH.

The basic anti-inflammatory regimen supplements illustrated in the following photo haven't changed much since December of 2011 with the exception of vitamin D3.  I began suggesting the Bio-Tech D3-50 50,000 IU water soluble form of vitamin D3 in July of 2018.

I began suggesting the Bio-Tech D3-50 after finding it was faster acting with a higher bioequivalence in elevating serum 25(OH)D3 than the same dose of the oil-based liquid softgel vitamin D3 formulations.  It's also less expensive.

Now for the exciting news regarding the raw efficacy of this regimen in preventing CH.  I took a download of the survey database a week ago on 30 December and have been crunching the numbers ever since.  Surveys submitted during 2019 indicate a 30-Day favorable response rate of over 90% and complete cessation of CH symptoms at greater than 65%.  I'm not going to give the actual raw efficacy figures as I hope to publish these results at some point later this year and I don't want my manuscript rejected for self-plagiarism.  I've already had two of my manuscripts on this study rejected for this reason.

I know the medical evidence purists will say this was not a randomized, blinded and placebo controlled RCT, so lacks strength as medical evidence.  No argument.  However, as a CHer since 1994 and chronic since 2005, I'm not going to pole vault over mouse turds...  To CHers, there's no difference between a CH prevented by an intervention or placebo effect.  In short, I'll take the placebo effect any day to avoid the terrible pain of our disorder.  Moreover, as for the infamous p value reported in RCTs, that over 300 CHers from over 30 countries have enjoyed the same efficacy of this regimen over the last 9 years of this study, this level of efficacy is hardly a coincidence.

We've also made some adjustments to the treatment protocol.  I say "We" as none of this would have been possible without the participation of thousands of CHers here at Clusterbusters and CH.com over the last 10 years.  In a very real sense, this is your regimen and treatment protocol.  Direct feedback from CHers taking this regimen is so valuable.  For example, this feedback indicates the efficacy of this regimen increases with time and higher serum concentrations of 25(OH)D3 due to higher daily maintenance doses of vitamin D3.

These protocol adjustments have been simple, yet effective.  When I first started posting about the efficacy of this regimen in December of 2010, it was one size fits all with 10,000 IU/day vitamin D3 plus the cofactors.  The first adjustment involved starting this regimen with a 2-Week or 4-Week accelerated vitamin D3 loading schedule to elevate serum 25(OH)D3 more rapidly and achieve a favorable response more rapidly.  Over the next two years that loading schedule evolved to a 12-Day loading schedule taking 50,000 IU/day vitamin D3 for 12 days.  It was just as effective and took less time to reach a therapeutic effect.

I attribute the increase in the raw efficacy of this regimen and CH preventative treatment protocol to the switch to the Bio-Tech D3-50 and the 12-Day accelerated vitamin D3 loading schedule.

My analysis of survey data through the end of 2018 indicated the mean 25(OH)D3 serum concentration for Episodic CHers experiencing a favorable response to the anti-inflammatory regimen was 80 ng/mL while the mean 25(OH)D3 serum concentration for Chronic CHers experiencing a favorable response to the anti-inflammatory regimen was 90 ng/mL.  Clearly, one size does not fit all... Accordingly, I've made the following changes to the vitamin D3 dosing strategy regarding the target 25(OH)D3 serum concentration ranges and accelerated vitamin D3 loading dose duration ranges.

Episodic CHer Target:  80 to 100 ng/mL - Load at 50,000 IU/day for 12 - 14 days

Chronic CHer Target:  90 to 120 ng/mL - Load at 50,000 IU/day for 14 - 16 days

Migraineur Target:  100 to 140 ng/mL - Load at 50,000 IU/day for 16 - 18 days

It's important to understand these suggested 25(OH)D3 serum concentration target ranges and loading schedules are starting points for the average CHer.  Many of us (like me) will require a higher 25(OH)D3 serum concentration, a longer period of loading at 50,000 IU/day and a higher maintenance dose to experience and maintain a CH pain free response.  

At the completion of these loading schedules reduce the vitamin D3 intake to an initial maintenance dose of 10,000 IU/day with the oil-based liquid softgel vitamin D3 formulations or if you're taking the suggested Bio-Tech D3-50, you'll need to take one (1) of these 50,000 IU water soluble vitamin D3 capsules a week.  Doing the math, that works out to an average dose of 7,140 IU/day.  Given the higher bioequivalence of the D3-50, this should be sufficient for most CHers.  Changing the dose is a simple matter of adding or subtracting a day or more between doses.

The following chart illustrates the last three years worth of my labs for serum 25(OH)D3, calcium and PTH.  As you'll see, as a chronic CHer, I've maintained my 25(OH)D3 well above 120 ng/mL.  It's been as high as 188 ng/mL to remain CH pain free during a major allergic reaction to mold spores. I've averaged 150 ± 4 ng/mL for the first 7 months of 2019.

If you haven't gotten the message from my labs, don't be afraid to take your serum 25(OH)D3 concentration as high as needed to experience a lasting CH pain free response.  My PCP has no problems with my 25(OH)D3 serum concentration this high as long as my serum calcium remains within its normal reference range (in the green), and it has as you can see in my charts above.  You'll also note that my serum PTH mirrors serum calcium.  This inverse relationship between serum 25(OH)D3 and PTH concentrations indicates normal calcium homeostasis. In short, when serum calcium goes up to a high normal, serum PTH drops to a low normal.  This is a classic indication of calcium homeostasis in action that helps prevent hypercalcemia, a.k.a., vitamin D3 intoxication/toxicity.

Before I go any further, it's essential for CHers to see their PCP/GP or neurologist, whoever has the best visibility of their overall medical history and prescribed medications if any, to discuss this regimen before starting it and to ask for a set of labs for serum 25(OH)D3, calcium and PTH.   It's not uncommon for some physicians to avoid recommending this regimen or even suggest CHers not start it and that's perfectly natural. They're concerned about malpractice suits.  If you feel strongly enough about starting this regimen, have your doctor note any concerns in your medical records, but try to make your doctor part of your team while starting and continuing this regimen. 

You'll need another set of labs for your serum 25(OH)D3, calcium and PTH, 30 days after starting this loading schedule.  Ask your PCP/GP or neurologist to have your lab orders for 25(OH)D3, calcium and PTH sent to the nearest Quest Diagnostics collection center.  

The rationale for doing this is simple.  Quest Diagnostics uses the 25(OH)D Liquid Chromatography Dual Mass Spectroscopy (LC-MS/MS) assay that's good to a maximum  25(OH)D (combined D2 and D3) serum concentration measurement of 512 ng/mL.  The DiaSorin 25(OH)D assay used in most medical clinics can only measure 25(OH)D up to a maximum serum concentration of 117.4 ng/mL.  As you may need a higher 25(OH)D3 serum concentration than 117.4 ng/mL, the LC-MS/MS assay for 25(OH)D3 is the only way to go. Try to get copies of your labs sent to you so you can track your progress.  If you register at MyQuest, it's free, at the following link, https://myquest.questdiagnostics.com/web/home you'll have access to all your lab results as soon as your doctor has acknowleged their receipt.

I'll be posting the above changes to the existing protocol posted on my webpage at vitaminDwiki.com later this month at the following link, ttp://is.gd/clustervitd.  You can download the existing treatment protocol by clicking on the following link. 

http://www.vitamindwiki.com/tiki-download_wiki_attachment.php?attId=7708

. 

It's interesting to note that since I posted this treatment protocol on 21 Jan, 2017, nearly three years ago, readers of my web page at vitaminDwiki have downloaded 43,387 copies of this treatment protocol... Doing the math, that's an average over 45 downloads a day.  I've no idea how many CHers or migraineurs are following this treatment protocol.  That said, if the rule of "one out of ten" applies, > 4000 headache sufferers are following this regimen.

In closing this epistle to vitamin D3, the other great news is it appears there's going to be a gold standard RCT conducted on this regimen as a CH prophylaxis later this year.  When the result of that RCT are published, I'm confident you'll have ample medical evidence to take to your PCP/GP or neurologist.

Take care and please keep us posted should you decide to start this regimen.

V/R, Batch

[xxx]

Nice try...  You'll see the name soon enough when recruiting starts.  Until then, my lips are sealed.  I don't want any goon squads from Big Pharma screwing the pooch.

[MRUPE]

Thanks for the information Batch. I’m happy to hear there is a potential controlled study looking into the D3 regimen. I’ll be paying attention. 
 

As someone that follows evidence and research methods I appreciate your humility when discussing your findings/work.

I also appreciate your comments on the “placebo effect.” The subjective experience that is “pain” is challenging measure objectively. My stance is if we can, we should attempt to control for these effects. Given the amount of non sense and charlatans out there taking advantage of people in pain, we should do our best to be transparent in what we do and don’t know. 
 

Thanks again and I look forward to learning more from everyone here.

 

[xxx]

Hey MRUPE,

Thank you for the kind words.  All humility aside, if the CH beast is jumping ugly making your life miserable, you're missing a very safe and effective CH prophylaxis by not starting the anti-inflammatory regimen.  I'm a 75 year old retired Navy fighter pilot, with a degree in Chemistry, a CHer since 1994, chronic since 2005 and a pragmatist.  If I were faced with a CH intervention offering 80% to 90% efficacy that's proven to be safe and effective over the last 10 years with direct feedback from over 300 CHers from 30 different countries including lab test data, I'd go for it.  But that's just me. 

I'm confident the Gold Standard RCT of this regimen currently in planning as a CH prophylaxis will confirm the results from the present Pre-Post, Open Label Intervention study that's been running for the last 9 years. Waiting for the results of this RCT while the CH beast jumps ugly three or more times a night, even with oxygen therapy for another year makes no sense to me.  It's going to take that long.  At last count, there are 5 doctors taking this regimen to prevent their CH and two of them are neurologists.

This regimen is so safe, I've had my entire family and close friends taking it since 2011.  That includes my daughter and niece who have been on this regimen since 2011.  Between them they've gone through three flawless pregnancies and deliveries.  Their OB's were concerned at first over the 10,000 IU/day vitamin D3 dose.  However, after each of them had two sets of labs for 25(OH)D3, calcium and PTH and the results all came back in the green coupled with the flawless pregnancies, deliveries and super healthy babies, these two OBs are now suggesting the anti-inflammatory regimen to all their expectant and potential mothers in waiting.

At this point I have three grand babies who were bathed in maternal vitamin D3 from conception through breastfeeding.  We're talking babies with Einstein intellect, Olympic class physical development and T-Rex immune systems... they just don't get sick.  They now take vitamin D3 at 50 IU/lb of body weight/day plus a multi-mineral and vitamin chewy.  Fred, a.k.a., Winefred, her photos shown below, is the oldest now at 6.  She was speaking fluent Hochdeutsch at age two, attended pre-kindergarten at age 4 in Heidelberg Germany where only German was spoken.  Little brother Orrin, now 2 is also bi-lingual.

Take care and please keep us posted.

V/R, Batch

Edited January 7, 2020 by Batch