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Evaluation of comonly used meds for CH (Read 1466 times)
Bob Johnson
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Evaluation of comonly used meds for CH
Aug 4th, 2010 at 10:37am
 
Neurology. 2010 Aug 3;75(5):463-73.

Acute and preventive pharmacologic treatment of cluster headache.
Francis GJ, Becker WJ, Pringsheim TM.

Department of Clinical Neurosciences, 2888 Shaganappi Trail NW, Calgary, Alberta, T3B 6A8, Canada tmprings@ucalgary.ca.

Abstract
Cluster headache (CH) is a rare and disabling primary headache disorder. CH attacks are unilateral, short, severe headaches associated with ipsilateral autonomic symptoms that occur in a periodic fashion. We provide a systematic review and meta-analysis of existing trials of pharmacotherapy for CH and evidence-based suggestions for acute abortive treatment and preventive therapy for cluster headache. Prospective, double-blind, randomized controlled trials of any pharmacologic agent for the symptomatic relief or prevention of CH were included in this evidence-based review. THE MAIN OUTCOMES CONSIDERED WERE HEADACHE RESPONSE AND PAIN-FREE RESPONSE AT 15 AND 30 MINUTES FOR ACUTE TREATMENT TRIALS, AND THE CESSATION OF CH ATTACKS WITHIN A SPECIFIC TIME PERIOD OR THE NUMBER OF DAYS ON WHICH CH ATTACKS OCCURRED FOR PREVENTIVE TRIALS. Twenty-seven trials were included in the analysis. The American Academy of Neurology quality criteria were used to assess trial quality and to grade advisements. Based on the evidence, for acute treatment of CH, Level A advice can be given for subcutaneous sumatriptan 6 mg, zolmitriptan nasal spray 5 mg and 10 mg, and 100% oxygen 6-12 L/min. Level B advice can be given for sumatriptan nasal spray 20 mg and oral zolmitriptan 5 mg and 10 mg. For the prevention of CH, Level B advice can be given for intranasal civamide 100 mug daily and suboccipital steroid injections, and Level C advice can be given for verapamil 360 mg, lithium 900 mg, and melatonin 10 mg.

PMID: 20679639 [PubMed]
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Bob Johnson
 
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Re: Evaluation of comonly used meds for CH
Reply #1 - Aug 4th, 2010 at 10:53am
 
Why is it we cannot seem to get the medical community to look beyond "100% oxygen 6-12 L/min"?  At 6-12 L/min I'm sucking the bag flat and having to take the mask off because I can't get enough to breathe.  At 15 L/min I gave up because I didn't get enough relief to make it worth the 5-10 minutes difference of going without it.  I wish they would do a real study with high flow oxygen at least15 L/min, but preferably at 25 L/min or greater to where it would do some good.  The difference between 15-20 mins sucking for breath at 15 L/min and 5 mins at 25-30 L/min is vast.

It seems most of these studies keep rehashing what others have already established in prior studies and don't break any new ground.

Test showing relief in 15 mins is showing something of value, but many of us have attacks that end in about 30 mins anyway, so a 30 minute "cessation" is not a great accomplishment.  Much like suffering with a cold for 14 days or taking the medicine and getting over it in only 2 weeks.

Bob, this in not directed at you!  I really appreciate all you do to bring these things to our attention, and I've learned quite a bit from you.  It is the medical community that just keeps rehashing the same stuff over and over to justify monies raised for "research" that don't get into anything new that gets my goat.

Rant over.   Lips Sealed

Jerry
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Bob Johnson
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Re: Evaluation of comonly used meds for CH
Reply #2 - Aug 4th, 2010 at 11:15am
 
Jerry, the issue is how medical research is done and how long is takes for enough separate studies to be done and published.

It may be several years before a number of GOOD studies are published and only quality work is worth compiling, in the kind of summary report we have here, and then, finally publishing the composite study.

In the meanwhile, changes are occuring in how a med, etc. is used and so, in one sense, the final evaluation report is, likely, out of date compared to the actual practice in daily medical practice.

Last year I found a major study reporting the effectiveness of many CH meds. But almost all of the individual studies which were compiled were 3-5 years old. The end result was not worth posting here, in my judgment. But it reflects that GOOD reseach takes a long time: Long time to do good SINGLE research projects; a long time to wait for other quality studies are done; then time to compile and publish the collective evaluations.

This built-in delay is the consequence of practicing good medicine & research and not the failure of the individual doctor/researcher to be on target.

In a current case: the U.S. has just finished gathering data for the census. It will take 2-4 years before all of the data is compiled, analyzed, then published. Just the nature of large, complex projects.
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Bob Johnson
 
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Re: Evaluation of comonly used meds for CH
Reply #3 - Aug 4th, 2010 at 2:53pm
 
Thanks for the reply Bob.  I'll try to be patient.  I really appreciate your posting these reports as they come out, and I realize the complexity of some of the reports and studies.  I also recognize the limited supply of subjects to be studied.  I just feel that sometimes they keep trying to reinvent the wheel and keep duplicating other's work.  I know if it isn't duplicatable it isn't science, but it seems we just keep seeing the same thing.

I know, I'm hard to please. Roll Eyes

Jerry
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"Political correctness is a doctrine, fostered by a delusional, illogical minority, and rabidly promoted by an unscrupulous mainstream media, which holds forth the proposition that it is entirely possible to pick up a piece of dung by the clean end." Texas A&M Student (unknown)
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Re: Evaluation of comonly used meds for CH
Reply #4 - Aug 4th, 2010 at 8:17pm
 
Jerry, we're all hard to please when we are in pain and cannot understand that right here alone we have enough factual evidence that 02 at a higher level than 6 to 12 lpm works and works well.


Thank you Bob for posting this.   I cannot tell you  how much your calm head and information that you post here is appreciated by me and everyone else.


Edit to add:  "Your calm head" comment  was not a pun.  I swear it.
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« Last Edit: Aug 4th, 2010 at 8:18pm by Linda_Howell »  

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Bob Johnson
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Re: Evaluation of comonly used meds for CH
Reply #5 - Aug 4th, 2010 at 9:29pm
 
Jerrry: I neglected to make an important comment about the nature of the scientific method: every time  research duplicates the findings of other research it's a plus--the evidence for the "truth" is stronger. NO scientific type accepts one or two findings, even if exactly the same outcome, as definitive or final.

We have regularly seen cases of a medicine, having gone thru years of research and having been approved for use (all the research was in substantial agreement) being withdrawn from use because some new research outcome has come out of left field (which negates the earlier studies). Science is not easy even if, at its best, it's powerful and a real benefit to us.
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Re: Evaluation of comonly used meds for CH
Reply #6 - Aug 5th, 2010 at 1:02am
 
Bob Johnson wrote on Aug 4th, 2010 at 10:37am:
Neurology. 2010 Aug 3;75(5):463-73.

Acute and preventive pharmacologic treatment of cluster headache.
Francis GJ, Becker WJ, Pringsheim TM.

Based on the evidence, for acute treatment of CH, Level A advice can be given for subcutaneous sumatriptan 6 mg, zolmitriptan nasal spray 5 mg and 10 mg, and 100% oxygen 6-12 L/min. Level B advice can be given for sumatriptan nasal spray 20 mg and oral zolmitriptan 5 mg and 10 mg. For the prevention of CH, Level B advice can be given for intranasal civamide 100 mug daily and suboccipital steroid injections, and Level C advice can be given for verapamil 360 mg, lithium 900 mg, and melatonin 10 mg.

PMID: 20679639 [PubMed]


But really, lets take a moment and look at the bright side - level A evidence for subcutaneous and intranasal tripans!  That's good news!  That may imply that more physicans may be willing to give these forms of the tripans rather than the oral tabs which, for most people with CH, take too long to work.  Also, that O2 is touted as level A (as well it should be) is also good, because perhaps more docs will be more willing to prescibe it for this issue instead of the, rather incomprehensible, reluctance that we see sometimes...

As for 'Level B advice can be given for intranasal civamide 100 mug daily and suboccipital steroid injections, and Level C advice can be given for verapamil 360 mg, lithium 900 mg, and melatonin 10 mg,'  well, I don't really get the intranasal civamide as from I can see from studies, it only has a modest (if that) benefit.  But at least lithium and melatonin are making the list as meds of benefit!

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Listen, and understand. That terminator is out there. It can't be bargained with. It can't be reasoned with. It doesn't feel pity, or remorse, or fear... 'The Terminator' AKA CH
 
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Re: Evaluation of comonly used meds for CH
Reply #7 - Aug 5th, 2010 at 1:09am
 
Here's one of the studies (the easiest to cut/paste) that I found on intranasal civamide - mind you, it's from 2002.  I did also find a summary article from 2009 saying that intranasal civamide wasn't any use in prevention (couldn't copy/paste it), but that's medical research for you...
On the other hand, if you're out of other options, it may be worth trying...


July 9, 2002 — Intranasal civamide, a synthetic isomer of capsaicin, may be modestly effective in preventing episodic cluster headache, according to results of a multicenter, double-blind, randomized trial reported in the June issue of the Archives of Neurology.

"When civamide is applied intranasally to the mucosa, the release of neurotransmitters by the trigeminal plexus centrally to meningeal and dural blood vessels should be decreased," write Joel R. Saper, MD, from the Michigan Headache Pain and Neurological Institute in Ann Arbor, and colleagues. "This would then result in less vasodilation, plasma extravasation, and histamine/serotonin release, with a potential for the amelioration of neurogenic inflammation and cluster headache pain."

This study evaluated 28 subjects at 14 headache/neurology centers in the United States. Over a seven-day treatment period, 18 subjects received 100 ĖL of 0.025% civamide (25 Ėg ; total daily dose, 50 Ėg ) and 10 received 100 ĖL of the vehicle to each nostril via dropper once daily. Observation continued over a 20-day posttreatment period.

Decrease in the number of headaches from baseline to posttreatment during days 1 through 7 was -55.5% in the civamide group and -25.9% in control patients ( P=.03). There was a trend suggesting continued decrease in the number of headaches with civamide during the 20-day follow-up period ( P=.05).

Both groups were similar in cluster headache pain intensity, number of severe headaches, and associated symptoms. The most common adverse events included nasal burning in 14 of 18 civamide-treated subjects and in 1 of 10 vehicle-treated subjects ( P=.001) and lacrimation, seen in nine of 18 civamide-treated subjects and in none of the controls ( P=.01).

"Intranasal civamide solution at a dose of 50 Ėg may be modestly effective in the preventive treatment of episodic cluster headache," the authors write. "There are no medications for the prevention of cluster headaches currently approved by the Food and Drug Administration, and subcutaneous sumatriptan is the only approved medication for abortive therapy of individual cluster headache attacks. Since cluster headaches are among the most severe headaches known and result in significant disability during active cluster periods, any therapy that can reduce their frequency would be valuable."

The authors suggest that the small number of subjects may have contributed to the lack of significance of the secondary efficacy parameters. To decrease the transient nasal burning, rhinorrhea, and lacrimation, they propose several modifications in civamide administration. Future studies will be larger, prospective rather than retrospective, and will have a longer posttreatment period.

"This study offers early support for the possible value of intranasal civamide as a safe and effective preventive treatment for episodic cluster headache," they conclude.

Winston Laboratories Inc., Vernon Hills, Illinois, partially funded this study.

Arch Neurol. 2002;59:990-994
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Listen, and understand. That terminator is out there. It can't be bargained with. It can't be reasoned with. It doesn't feel pity, or remorse, or fear... 'The Terminator' AKA CH
 
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