Anti-Inflammatory Regimen and SurveyCluster headache is one of the most painful and disabling headache disorders known to man. Recent results from two ongoing surveys of cluster headache sufferers indicate many may suffer needlessly from this terribly painful and disabling disorder due to an easily treated vitamin D3 deficiency.
This post invites cluster headache sufferers (CH'ers) who have tried the anti-inflammatory regimen with vitamin D3 for at least one month, to take part in a survey. It also provides the latest updated version of this regimen and dosing strategy.
If you've started the anti-inflammatory regimen with 10,000 IU/day vitamin D3 or more, and stayed on it for at least a month (some chronic CH'ers have taken six to seven weeks to respond), or you had a favorable or an unfavorable response... PLEASE SEE YOUR DOCTOR IF YOU'VE BEEN ON THIS REGIMEN FOR AT LEAST A MONTH TO HAVE YOUR SERUM CONCENTRATION OF 25(OH)D MEASURED IF POSSIBLE. WHEN YOU HAVE THE RESULTS FROM THIS LAB TEST, PLEASE TAKE THIS SURVEY.
If you've had the lab test for 25(OH)D done before you started this regimen please report the results in the survey as well...Note: You do not need to be a member of CH.com to take this survey.
Good people and fellow CH'ers of Clusterville (guests included), the anti-inflammatory regimen 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, episodic and chronic, who have tried it.
As of January 20, 2013, the compiled raw data indicates an efficacy of 80%. 240 out of the 300 CH'ers who have started this regimen and stayed on it for a month or more have experienced a significant reduction in the frequency and severity of their CH... 78% of the 300 CH'ers experienced a pain free response and 60% of the 300 have remained essentially pain free. Episodic and chronic CH'ers respond to this regimen at roughly the same rate.
Preliminary survey results indicate most of these CH'ers were pain free before the end of the third week with some responding in a little as 12 to 24 hours. The average time to respond is five days.
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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 tried 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 Level I, randomized, double blind, placebo controled clinical study. This is the gold standard for RCTs and the only type of study results that will influence the way neurologists treat this disorder.
The sooner we gather and present information on the safety and efficacy of this regimen to 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 CH.com and ClusterBusters 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:
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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:
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Thank You.
V/R, Batch
Basic and Complete Anti-inflammatory Regimen
Treatment Protocol and Dosing GuideDisclaimer: 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. If not, don't delay, start this regimen then get the lab test.
This lab test measures the serum concentration of 25-Hydroxyvitamin D, also called 25(OH)D, (calcidiol). This is a 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, results from the online survey indicate CH'ers presenting with active CH before starting the anti-inflammatory regimen have tested at an average of 28.7 ng/mL, (71.75 nmol/L), min = 8.4 ng/mL, max = 64.0 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 and then had this test have had an average 25(OH)D serum concentration of 81.4 ng/mL. (203.5 nmol/L), min = 34.0 ng/mL, max = 149.0 ng/mL.
At last count, data harvested from posts here at CH.com as of January 2013, indicate 240 out of the 300 CH'ers who posted about their experience with the anti-inflammatory regimen, experienced a significant reduction in the frequency, severity and duration of their cluster headache for an overall raw efficacy of 80%.
Similarly, data from 115 CH'ers who participated in the online survey of CH'ers using this regimen indicate a raw efficacy of 81%. (equally effective for episodic and chronic CH'ers).
Taken at face value, this data clearly suggest a causal relationship between a vitamin D3 deficiency and cluster headache.
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 SupplementsThe original or "Basic" anti-inflammatory regimen I've used since Oct 2010 consists of the three supplements shown below purchased from Costco here in the US for $35 or 20 cents a day for a five-month supply. I've since added a Centrum Silver tablet a day to pick up the vitamin A (retinol) and vitamin K2.
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The basic daily dose is two tablets/capsules of each supplement as shown below.
* New *...Studies have shown that taking vitamin D3 with the largest meal of the day can increase absorption with resulting serum concentrations of 25(OH)D increased by as much as 50% higher after two to three months than taking it on an empty stomach. Accordingly, take this regimen of supplements with the largest meal of the day for optimum results.Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to
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For the CH'ers who don't have access to Costco or who live outside the US, I've listed the complete anti-inflammatory regimen below. Most of these supplements are available at pharmacies, major supermarkets, health food stores, and over the Internet. Citracal Plus has a similar formulation to the Kirkland brand of calcium citrate.
Omega 3 Fish Oil - 1000 to 1200 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, magnesium glycinate, magnesium malate or magnesium orotate)
Vitamin K2*** - 120 mcg/day (MK-4 and/or MK-7)
Vitamin A **** - 900 mcg (3,000 IU) for men and
- 700 mcg (2,333 IU) for women
Zinc - 10 mg/day
Boron - 1 mg/day
Vitamin D3 Dosing Strategy:Several studies have shown that the healthy adult processes 25(OH)D at a rate equivalent to an intake of 3,000 to 5,000 I.U. vitamin D3 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 and 1,25(OH)
2D
3 are being 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 a week 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 8th day of using this regimen from 10,000 IU/day to a total of 15,000 IU/day. Continue to take the calcium, Omega 3 Fish Oil, and vitamin D3 cofactors at the same dose.
In addition to increasing the daily intake of vitamin D3, add a loading dose of 50,000 IU vitamin D3 one day each week. This will bring your weekly total intake to 155,000 IU vitamin D3.
Continue at this dosing rate for one week. If there is no change in your cluster headache pattern by then, add an additional 5,000 IU/day vitamin D3 and continue the once a week loading dose. This will bring your weekly total vitamin D3 intake to 190,000 IU vtamin D3.
Continue at this dose for another week. If you haven't experience a favorable response by the time, then schedule a lab test for 25(OH)D. If your 25(OH)D level is still below 60 ng/mL, (150 nmol/L), continue at this dose for another month then repeat the lab test for 25(OH)D.
If your 25(OH)D level is in the 60 to 110 ng/mL range and you still have not had a favorable response, reduce the vitamin D3 dose to 10,000 IU/day, see your PCP and ask for a consult with an endocrinologist.
As an alternative, try to see an integrative or Homeopathic physician. They are generally more experienced in testing and treating vitamin and mineral deficient conditions than are neurologists or GPs.
This regimen can be taken any time of the day, but it's best taken with the largest meal of the day. You can also take it 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 A, vitamin K2 and zinc.
The Vitamin D Council indicates these cofactors help in metabolizing vitamin D3 into 25(OH)D and 1,25(OH)
2D
3, (calcitriol), the active hormonal metabolite of vitamin D3. This regimen also aids in maintaining calcium homeostasis. The calcium citrate and citric acid also combine to form a buffer that elevates the pH of stomach gastric juices and maintains this elevated pH for up to 7 hours. An elevated arterial pH 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:
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SafetyThe anti-inflammatory regimen is very safe and well tolerated. There haven't been any reports of CH'ers experiencing adverse reactions requiring attention by a physician.
Notes: (1) Medication Interactions and Contraindications:The best practice to consider before taking any over the counter supplement is to read the label and any available supporting documentation on drug interactions and contraindications. Check the serving size. In many cases, the serving size will be two tablets/soft gel capsules to get the dose shown on the supplement label.
The following are examples of drug reactions and contraindications associated with the supplements used in the anti-inflammatory regimen. There are obviously others so read the supplement labels carefully:
* Reactions to vitamin D3 are very rare as skin exposed to the UVB in direct sunlight produces vitamin D3 naturally. It is generally considered to be one of the safest vitamin supplements you can take. However, if you are allergic to sunlight or you suffer from sarcoidosis, do not start this regimen without contacting your PCP or neurologist first.
If you experience a reaction to this regimen including, but not limited to, an upset stomach and or loose stool 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.
The best course of action if this occurs is to start taking the vitamin D3 and if there's no reaction, add each of the other supplements one at a time, every 3 to 4 days to use the process of elimination to determine what is actually causing the reaction.
** 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, its 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 to 12 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 K2 (the clotting vitamin) 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. There are also several reports and studies that indicate vitamin K2 has the capacity to improve bone mineral density and at the same time reduce arterial calcification. Vitamin K2 has two of the menaquinone analogs, (MK-4 and MK-7). Of the two forms of vitamin K2, (MK-4) appears to be more effective in these two roles. On top of that there are several reports and studies that try to rationalize the use of MK-4 over MK-7 or MK-7 over MK-4...
However, at this point there's no general consensus with clear or conclusive evidence to the advantage of one over the other form of vitamin K2. Be prepared to switch between the two or take them in combination... See your PCP, neurologist, and or cardiologist.
**** Vitamin A is an important part of this regimen as long as it's not taken in excess of the RDA... Taking too much vitamin A can be harmful... A daily serving of carrots, spinach, or squash are a great source of beta carotene, a precursor to vitamin A. A serving a day will meet your RDA... A serving of chicken or beef liver a week will also meet most of your vitamin A (retinol) needs.
The rationale for taking vitamin A is important. It's essential for the second mode of vitamin D3 metabolism from the 25(OH)D in the blood serum into 1,25(OH)
2D
3, (calcitriol) that takes place in all the different types of body cells. These cell types include heart muscle, skeletal muscle, smooth muscle, bone, skin, brain, nerve, and the list goes on.
We're not sure at this point, but this mode of cellular metabolism of vitamin D3 into it's active metabolite may be responsible for the prophylactic effect on cluster headache.
(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 - 15,000 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.
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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).
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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. It 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: 240 out of the 300 CH'ers (both episodic and chronic), who have tried this regimen since Jan 2011 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 less than 24 hours to three full weeks with the majority occurring by the end of the second week. A few have taken longer than a month. The following chart of response times after starting the anti-inflammatory regimen is based on current results from the online survey:
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The typical/average time course response to this regimen in terms of 25(OH)D concentration at given vitamin D3 doses is illustrated in the following chart developed by Dr. Robert Heaney, M.D. I've overlaid his chart with color bands that represent 25(OH)D data and CH response collected from CH'ers here at CH.com.
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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) at a vitamin D3 dose of 10,000 IU/day. Moreover, chronic CH'ers who stop taking this regimen after going pain free for 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, parathyroid, renal, hepatic, and pancreatic insufficiencies. Disorders of the small intestine and sub-clinical allergic reactions including 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.
Finally, as this regimen has many other health benefits beyond being 75% effective as a cluster headache preventative, it's best to stay on it as long as possible if not for life...
The potential health benefits are so compelling, I have my entire family taking this regimen... That includes a scaled down version of this regimen for my newest month old grand niece and her mother.
Take care,
V/R, Batch
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