The Synergy Trial: Ritalin and Micronutrients

[Bob]

Fwiw, I've been experimenting with taking caffeine pills almost everyday since Feb 3rd and they're helping my energy level.

We've had a forum poll about caffeine usage.
It had mixed results.
A few of us 'usually' find caffeine helpful, but others find it unhelpful and some find it dangerous:
http://forums.phoenixrising.me/inde...ll-safe-or-unsafe-helpful-or-unhelpful.23753/

 

[heapsreal]

im addicted to my pepsi max which contains a 1/3 of the caffeine of a normal cup of coffee. Been told its bad for me etc etc and said its whats causing my sleep issues, so i gave up for 3-4 months and all i got was greatly increased fatigue. If my sleep is bad i may cut it back to no pepsi after 5pm. Probably with caffeine i guess is tolerance but then thats like most stimulants. I think went it hits u have to realise its time to take a long break from caffeine maybe??

 

[xchocoholic]

Caffeine pills work different and much better for me than cofee, tea or chocolate.

The tablets, chewable Leader brand (gf), don't make me jittery like coffee, tea and chocolate do.

I'm using 1/4-1/3 of a tablet in the morning. It seems I feel best if I take it after breakfast but before 11ish.

I chew it up and thoroughly saturate every part of the inside of my mouth with it. Sublingual and on top of my tongue didn't work as well.

I've only taken an afternoon dose once or twice. It worked great as a pick me up but interferred with my sleep. The morning dose doesn't interfere with sleeping.


The most annoying symptom of my PEM in recent years was excessive daytime drowsiness. This stopped that. I still have some muscle weakness and incoordination but I'm hoping increased activity level will resolve this. Or kill me, lol. Jk. I'm taking breaks but still exercising daily. I couldn't do that pre caffeine.

Fun fun ... tc ... x

 

[xchocoholic]

Looking back, I was using caffeine or food to keep me going pre cfs. I was working full time and I had a 2 year old so I wasn't getting a lot of sleep. But I can't remember avoiding caffeine anytime in my life.

MAYBE? My body needs this now. Maybe pwcs need it? Or a different spark?

There certainly are a lot of people dependent on caffeine nowadays.

Tc .. x

 

[Ember]

Stanford University and K-PAX Pharmaceuticals Studying New Treatment for CFS
Tue, 03/04/2014 - 9:29am

“The results of this trial will be presented at the International Chronic Fatigue Syndrome Biennial Conference (IACFS/ME) to be held at the Parc 55 Hotel in San Francisco this month (March 20-23).”

 

[alex3619]

Not long to wait till the results, less than three weeks.

 

[xchocoholic]

I had to stop this due to insomnia, headaches and pre seizure feelings.

No surprise since I wouldn't have been eligible to participate anyways.

I'm back to listening to my body and resting more. I'll still use caffeine pills from time to time if I need a boost. Just not daily.

Tc .. x

 

[catly]

Stanford University and K-PAX Pharmaceuticals Studying New Treatment for CFS
Tue, 03/04/2014 - 9:29am

“The results of this trial will be presented at the International Chronic Fatigue Syndrome Biennial Conference (IACFS/ME) to be held at the Parc 55 Hotel in San Francisco this month (March 20-23).”

I'm guessing the results that are being presented are for the original study of 15 patients??? I think the full trial just started in November 2013 and is slated to go until Sept. 2014.

 

[Bob]

Personally, I'd avoid Ritalin with a barge-poll. I know it's being given at very low sub-clinical doses in this study, but it's application misunderstands the nature of ME. And it also sends out the wrong signal about ME to clinicians. But perhaps it could help patients with chronic fatigue who don't experience post-exertional exacerbation.

Having said that, I reckon I should be open-minded about the outcomes.

 

[Snow Leopard]

Does the study have ritalin-only and 'micronutrient' only arms?

If not, then forgive me for being cynical, but I am worried about the intention of this. The reason I say this because Ritalin has already been studied and shown to lead to improvements in some areas in placebo-controlled trials in CFS patients.

But most patients probably won't want to take Ritalin, so they'll end up just taking the 'micronutrients' and we have no evidence of the efficacy of the 'micronutrients' on their own. And guess who makes the 'micronutrient' supplement?

 

[Wally]

A blog written back in 2010 discusses K-PAX and Dr. Kaiser - http://www.reportingonhealth.org/blogs/hyping-supplement-hiv. Here is an article about the company from Febuary of this year - http://www.news-medical.net/news/20...-effective-treatment-for-chronic-fatigue.aspx

I did not find much other information about this company or doctor except I remember Rich Von Kronenberg mentioning that Dr. Kaiser was looking for CFS patients to be in a trial he was conducting. See, http://www.mecfsforums.com/index.php/topic,11589.msg132827.html#msg13282.

Here is where Drs. Montoya, Levine, Bateman and Klimas are mentioned as being involved in this study. "Montoya, Klimas, Bateman and Sue Levine in NYC.- Confirmed." See, Reply #11 to this thread (http://forums.phoenixrising.me/index.php?threads/the-synergy-trial-ritalin-and-micronutrients.25726/).

Dr. Montoya and Dr. Klimas have been involved in AIDS research for 20+ years, so I would assume that they saw something in this micronutrient profile that they felt was worth their time in getting involved with this study.

I decided not to participate in this study because I was not interested in experimenting with Ritalin. It will be interesting to see what they have found from their preliminary results. I also wonder if methylfolate is included in the K-PAX formula that they are using?

 

[Bob]

I also wonder if methylfolate is included in the K-PAX formula that they are using?

There is a list of ingredients here (see bottom of page):
http://thesynergytrial.org/study-treatment/

 

[xchocoholic]

Thanks for the link to Dr Lipson of whitecoatunderground. I enjoyed reading several of his blogs. He appears to be very down to earth.

Fwiw, I probably couldn't tolerate the supplement because multis make me feel toxic. I'm not sure how common this is for pwcs/pwmes.

Also, I've tried most of the nutrients listed and when they worked for me I had to experiment with each nutrient to find the right dose. For ex. I need 50 mg of zinc daily to make a dent in my allergies.

I would think we're all going to require different dosages of each nutrient. And even that will vary once our bodies get what they need.

Tc ... x

 

[deirdre]

If I understand correctly, some where between 95-99% of the treatment they are using in this research trial is all micronutrient based. One of the goals of this treatment, if FDA approved, is to have found a way to get mitochondial immune support vitamins covered by all health insurance coverages. Wouldn't that be nice as the majority of people with CFS simply can not afford high quality vitamin, antioxidant and amino acid formulas.

This treatment would be one of the first FDA approved hybrid medications. If only there were more approved treatments which were founded upon the vitamins which have been shown to be beneficial...

 

[deirdre]

The OTC version of the micronutrient formula looks like nothing special compared to what PWME take routinely, so the main benefit of this product (if there is one) appears to be in the Ritalin.

Stanford University and K-PAX Pharmaceuticals Studying New Treatment for CFS
Tue, 03/04/2014 - 9:29am

“The results of this trial will be presented at the International Chronic Fatigue Syndrome Biennial Conference (IACFS/ME) to be held at the Parc 55 Hotel in San Francisco this month (March 20-23).”

The results of the Phase 1 study will be presented at the conference. The Phase 2 Synergy trial is currently enrolling patients and preliminary results should be coming near the end of 2014.

 

[Snow Leopard]

http://www.clinicaltrials.gov/ct2/show/NCT01966276?recr=Open&cond=chronic+fatigue+syndrome&rank=3

I find it really disappointing that the nutrient supplement is not being tested alone in its own arm of the trial.

It means that we won't know whether the results are due to Ritalin or the nutrient profile or the combination due to poor trial design.

 

[Bob]

@Snow Leopard, perhaps this article answers your question?:

Mill Valley company develops treatment for mysterious chronic fatigue syndrome
By Richard Halstead
Marin Independent Journal
March 22 2014
http://www.marinij.com/marinnews/ci...develops-treatment-mysterious-chronic-fatigue

Used alone neither methylphenidate nor the K-PAX supplements have proven effective as a treatment for CFS, Kaiser said, but the combination of the two seem to produce a synergistic result.

@Firestormm, posted the article on a new thread:
http://forums.phoenixrising.me/index.php?threads/k-pax-ritan-and-montoya-treatment-for-cfs.29130/

 

[Snow Leopard]

@Bob that is not actually true though, as methylphenidate has been shown to have effectiveness (in blinded studies) in CFS as well as related condtions such as post-cancer fatigue.

It is an issue because when it comes to actual treatment, many patients and physicians may be reluctant to take or prescribe methylphenidate, and it is heavily restricted in some countries (Australia). The end result is that many patients may end up taking just the nutrient supplement, with unknown effectiveness.

 

[catly]

I recieved an email today regarding a webinar to be hosted by K-PAX regarding the synergy trial. The webinar is Wed 5/21/14 from 1-2 pm PDT.

This is from their website http://www.kpaxpharmaceuticals.com/the-synergy-trial/

Please join Dr. Jon Kaiser in a free webinar entitled, “The Synergy Trial – Pursuing an FDA-Approvable Treatment for CFS” occurring on Wednesday, May 21st at 1pm PDT. Register now by clicking https://attendee.gotowebinar.com/register/1627842716332231938

 

[Carola]

At the suggestion of my physician, I've started a 3-month trial of the supplement, which is K-Pax Immune Support. In the past, I'd tried dosing myself with most of the individual ingredients but was only guessing at the proper dosages and after a while gave that effort up. So I'm glad to have a formula that has proven effective, albeit not in CFS specifically. My physician did not want me to enroll in the study because of my poor tolerance of stimulants. I am slowly working up to the 8 tablet/day dose, so can't report on any response yet. I can say that it's expensive.