Anti-Inflammatory Regimen - D3 Survey

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Anti-Inflammatory Regimen Survey

Good people and fellow CH'ers here at ClusterBusters, the anti-inflammatory regimen containing vitamin D3 that I began posting about over a year ago at the following link, continues to prove effective as a CH preventative for many of the CH'ers who have tried it.  To date, the raw data indicates an efficacy of 70% and over 25 members of this site have commented on their experience using it.

http://www.clusterheadaches.com/cgi-bin/yabb2/YaBB.pl?num=1291969416

Rather than rely on a rough tally of responses from CH'ers who have tried this regimen any further, we now need to gather more specific information on efficacy and response times for this regimen as well as essential demographic and epidemiological information.  This information is out there, and if you have used this regimen, you have it...  We just need to harvest it efficiently.  Please take this survey.

We will use the data from this survey to generate a paper intended to gather support and the resources needed for a formal assessment of this regimen in a registered clinical study.

The sooner we get the information on the safety and efficacy of this regimen in front of neurologists and headache specialists, the sooner more CH'ers all over the world will find what many of us have already experienced... the same relief from the terrible pain of our disorder.

I've patterned the questionnaire at the following link after the Cluster Headache Survey that 1134 of us took in December of 2008 and PlayDoh has used his IT wizardry and webmeister skills to place this survey on-line.

This survey will maintain your anonymity and guard your rights under the HIPAA Privacy Rule.  No names, usernames or addresses will be captured.  We will post the compiled results on both ClusterBusters and CH.com when we've collected a sufficient number of responses, then update the results when more come in.

If you are a registered member of either site or a guest and you've tried the anti-inflammatory regimen, please take the time to click on the following link and take this survey.  We need your results either way, good, or other, in order to have an accurate assessment of this regimen's efficacy.

PlayDoh has designed this survey to let you quit at any time before you submit, then access it later where you left off, to finish the survey when time permits.

I've already taken this survey...  It took me less than five minutes... and I was checking all the options before I submitted...

If you've not tried the anti-inflammatory regimen to prevent your CH, I've explained it in detail below.

To start this survey, click on the following link:

http://www.esurveyspro.com/Survey.aspx?id=fb8a2415-629f-4ebc-907c-c5ce971022f6

If you experience problems taking this survey or want to comment about it, respond to this post.  If you want to make a comment about your response to this regimen, please make it to the original post at the following link:

http://www.clusterheadaches.com/cgi-bin/yabb2/YaBB.pl?num=1291969416 or its latest companion thread here at ClusterBusters at: http://www.clusterheadaches.com/cb/cgi-bin/yabb2/YaBB.pl?num=1323279255

Thank You.

V/R, Batch

Basic and Complete Anti-inflammatory Regimen

Treatment Protocol and Dosing Guide

Disclaimer:  The following Anti-Inflammatory Regimen, treatment protocol and dosing guide to prevent cluster headaches are provided for information purposes only.  Discuss them with your primary care physician (PCP) or neurologist whoever is most aware of your overall medical health and other prescribed medications before starting this regimen.

If possible, have your PCP or neurologist schedule a lab test for 25-Hydroxyvitamin D, a.k.a. 25(OH)D before starting this regimen.  This is the serum level metabolite of vitamin D3.  The normal reference range for 25(OH)D in the US is 30-100 ng/mL, (50-200 nmol/L in the EU, UK and elsewhere.)  However, CH'ers presenting with active CH have tested as high as 43 ng/mL.  Moreover, CH'ers who have used this regimen and experienced a significant reduction in the frequency and severity of their CH or gone pain free tested in a range of 60 to 90 ng/mL (150 to 225 nmol/L).

If you think your PCP or neurologist will have questions about this regimen, please feel free to take a printed copy of this post with you to the next appointment or email the link.

Anti-Inflammatory Regimen Supplements

The original or "Basic" anti-inflammatory regimen I've used for over a year consists of the three supplements shown below purchased from Costco for $35 or 20 cents a day for a five-month supply.

The daily dose is two tablets/capsules of each supplement as shown below.

For the CH'ers who don't have access to Costco, I've listed the complete anti-inflammatory regimen below.  Most of these supplements are available at major supermarkets, health food stores, and over the Internet.

Omega 3 Fish Oil - 2000 to 2400 mg/day (EPA 360 mg/day, DHA 240 mg/day)

Vitamin D3 *        - 10,000 IU/day

Calcium **           - 500 mg/day (calcium citrate preferred)

Magnesium           - 400 mg/day (magnesium citrate or magnesium gluconate)

Vitamin K2 ***     - 120 mcg/day

Zinc                     - 10 mg/day

Boron                   -   1 mg/day

Vitamin D3 Dosing Strategy:

Studies have shown that the healthy adult processes 25(OH)D at a rate equivalent to 3,000 to 5,000 I.U. a day.  As the rate at which the body metabolizes vitamin D3 from all sources into 25(OH)D can and will vary, it is entirely possible that 25(OH)D is consumed as fast or faster than it's being metabolized from vitamin D3. 

Under these conditions, the body may be unable to build enough 25(OH)D reserves to reach a therapeutic level sufficient to prevent CH at a vitamin D3 dose of 10,000 IU/day.

Accordingly, if you don't experience a favorable response with a significant reduction in the frequency and severity of your CH or go pain free for at least 24 hours after two full weeks on the basic regimen, you may need to titrate up on the vitamin D3 dose. 

You do this by increasing the daily dose of vitamin D3 by 5,000 I.U. on the 15th day of using this regimen from 10,000 IU/day to a total of 15,000 IU/day. 

Repeat the incremental increase in vitamin D3 dosage by 5,000 I.U. every third day until the total vitamin D3 dose reaches 30,000 IU/day or you have a favorable response whichever occurs first, then remain at that dose.

If you don't experience a favorable response by the time you reach a vitamin D3 dose of 30,000 IU/day, remain at this dose for one month then schedule the lab test for 25(OH)D.  If your 25(OH)D level is in the range of 60 to 90 ng/mL, continue at this dose for another month then repeat the lab test for 25(OH)D.  If your 25(OH)D level is [ch8805] 120 ng/mL and you still have not had a favorable response, reduce the vitamin D3 dose to 10,000 IU/day or discontinue the regimen.

In addition, when the daily dose of vitamin D3 reaches 20,000 I.U., increase the total daily supplemental calcium intake to 1,000 mg/day.  This may help maintain calcium homeostasis.

This regimen can be taken any time of the day, but it's best taken with an 8oz glass of lemonade, limeade, orange juice or any fruit juice high in citric acid sweetened with a little honey.  Honey is a natural source of Boron, which is listed as one of the "cofactors" along with magnesium, vitamin K and zinc. 

The Vitamin D Council indicates these cofactors help in metabolizing vitamin D3 into 25(OH)D and also aid in maintaining calcium homeostasis.  The calcium citrate and citric acid also combine to form a buffer that elevates stomach gastric juices and maintains this elevated pH for up to 7 hours.1 that can help elevate arterial pH, which can aid in stimulating vasoconstriction in and around the trigeminal nerves.  See the following link at the Vitamin D Council for an explanation of the vitamin D cofactors and their natural sources:

http://www.vitamindcouncil.org/about-vitamin-d/vitamin-d-cofactors/

Notes:

(1) Medication Interactions and Contraindications: 

     * Reactions to vitamin D3 are very rare as skin exposed to the UVB in direct sunlight produces vitamin D3 naturally.  However, if you are allergic to sunlight, do not start this regimen without contacting your PCP or neurologist first.  If you experience a reaction to this regimen including and not limited to, an upset stomach for more than a day, swelling in and around the mouth or face, or an obvious allergic reaction, discontinue the entire regimen and contact your family physician. 

   ** If you are presently taking verapamil as a cluster headache preventative or for a heart condition, studies have shown that after repetitive dosing with verapamil, the serum half-life can be in a range from 4.5 to 12 hours.  Other studies indicated calcium supplements interfere with calcium channel blockers like verapamil.  Calcium gluconate is also used to treat reactions to oral verapamil.  Accordingly, in order to minimize a possible interaction with calcium that may limit verapamil effectiveness, separate the verapamil and calcium doses by at least 8 hours.  Discus this regimen with your PCP, neurologist, or cardiologist in order to work out an optimum dosing schedule.

   *** If you are presently using blood-thinning drugs such as Warfarin or Coumadin for cluster headache or for a heart condition, vitamin K is generally contraindicated.  However, studies have found vitamin K2 to be an effective stabilizer in anticoagulant therapy, proving beneficial in situations of over-anticoagulation or when the response to therapy has been variable.  See your PCP, neurologist, and or cardiologist.

(2) Safety: This regimen is generally quite safe and well tolerated with many potential health benefits.  However, some physicians and CH'ers may be concerned about the apparent "high" dose of vitamin D3.  There are several studies that have clinically proven that the skin of a fair skinned adult clad in a bathing suit without sun block and exposed to the sun's UVB at midday, can generate 10,000 I.U. vitamin D3 (cholecalciferol) in as little as 15 minutes.

Researchers at GrassRootsHealth, a public health promotion organization, recently published the results of their D*action Project where 3667 people have been taking vitamin D3 and having their 25(OH)D levels tested every 6 months since 2008.  Participants also fill out questionnaires with each lab test in order to capture the essential demographic and epidemiological information. 

See: http://www.grassrootshealth.net/

439 of these D*action project participants reported taking vitamin D3 at doses up to and including 10,000 IU/day.  43 participants have had two or more consecutive tests for 25(OH)D while dosing on vitamin D3 at 10,000 IU/day.  As you can see in the graph illustrated on the GrassrootsHealth home page shown below and used with their permission, none of the 3667 participants dosing at 10,000 IU/day or less had lab tests for 25(OH)D anywhere near the lower threshold for vitamin D3 intoxication at 200 ng/mL, (500 nmol/L).

A recent study by Garland, Heaney et al titled: Vitamin D Supplement Doses and Serum 25-Hydroxyvitamin D in the Range Associated with Cancer Prevention is based on the GrassRootsHealth D*action Project data and provides further proof that long term use of vitamin D3 at doses as high as 10,000 IU/day are very safe.  This study further concludes that: "Universal intake of up to 40,000 IU vitamin D per day is unlikely to result in vitamin D toxicity."

(3) Efficacy and Response Time:  70 out of the 100 CH'ers (both episodic and chronic), who have tried this regimen over the last year have had a significant reduction in the frequency and severity of their CH and better than 90% of them have gone pain free.  Typical response times to this regimen range from two days to three full weeks with the majority occurring by the end of the second week.

As this regimen has many other health benefits beyond being 70% effective as a cluster headache preventative, it's best to stay on it as long as possible if not for life...  There have been a handful of CH'ers who took over a month to respond to this regimen and several clinical studies have shown it can take upwards of three months to elevate 25(OH)D levels from 20 ng/mL to 60 ng/mL, (50 to 150 nmol/L).  Moreover, chronic CH'ers who stop taking this regimen after an extended period of use greater than six months, may experience a relapse with a resumption of CH in as little as a week.

(4) Comorbidities:  Some comorbid conditions may interfere with the capacity of the anti-inflammatory regimen to prevent CH.  Some of these medical conditions include, but are not limited to: cardiac, thyroid, renal, hepatic, and pancreatic insufficiencies. Sub-clinical allergic reactions and sinusitis are also suspect.  If you have one or more of these conditions, work with your PCP to make sure they are being treated.  This may help make the anti-inflammatory regimen more effective as a CH preventative.

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The survey asks about current medications.  Would you like us to list only only prescription/OTC medications or would you would like us to also list any natural supplements we use on a regular basis?

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Good question.  What we're looking for are any present CH medications Rx or other...  and medications taken for other medical conditions.

This cuts several ways...  It can point out any possible interactions or contraindications that work either way as well as give us an indication of any possible medical conditions that might interfere with this regimen or the body's capacity to metabolize vitamin D3 into 25(OH)D. 

For example, hepatic and renal insufficiencies can easily limit the body's capacity to metabolize vitamin D3 into 25(OH)D and that could limit or restrict a favorable response to the anti-inflammatory regimen.

thanks again for the question.

Take care,

V/R, Batch