A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome.

[Dolphin]

Free full text: http://www.ijcem.com/files/ijcem0010510.pdf

A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome.

Int J Clin Exp Med. 2015 Jul 15;8(7):11064-11074.

Kaiser JD1.
Author information

Abstract

Stimulant drugs and various micronutrient interventions have previously been studied in chronic fatigue syndrome (CFS) but they have never been studied in combination.

This proof of concept investigation seeks to examine the clinical effects and safety profile of KPAX002 (a combination of methylphenidate hydrochloride and mitochondrial support nutrients) in patients with CFS.

Fifteen patients diagnosed with CFS by 1994 Fukuda criteria were recruited and treated with KPAX002 to explore a potential synergistic effect of this combination.

Fatigue and concentration disturbance symptoms were measured at baseline, 4 weeks, and 12 weeks using two clinically validated tools: Checklist Individual Strength (CIS) and Visual Analog Scale (VAS).

The primary outcome objective was a decrease in the total CIS score of ≥25% in at least 50% of the subjects.

The mean total CIS score decreased by 36.4 points (34%) at 12 weeks (P<0.0001), corresponding to a ≥25% decrease in 87% of the participants.

Treatment with KPAX002 was well tolerated and significantly improved fatigue and concentration disturbance symptoms in greater than 50% of patients with CFS.

These results were statistically significant.

This combination treatment is worthy of additional investigation.

KEYWORDS:
Chronic fatigue syndrome; antioxidants; methylphenidate; micronutrients; mitochondria

PMID:

26379906

[PubMed - as supplied by publisher]

 

[Dolphin]

I've read this paper. The results look promising on their own.

However, a thread on the (so far unpublished) placebo-controlled trial is here: http://forums.phoenixrising.me/inde...henidate-ritalin-trial-results-are-out.37363/ and the results from that don't look so good.

 

[Denise]

I am confused by this quote:
"The majority of enrolled subjects also described moderate to severe post-exertional malaise as part of their symptoms profile."
I can't tell if all subjects had PEM but only some had moderate to severe PEM
or
if not subjects had PEM.

I am also unclear if functional status referred to here:
"...this investigation did not formally measure the treatment’s effect on the subject’s functional status."
is cognitive function or physical or both.

 

[jimells]

concentration disturbance symptoms were measured

Is this an objective measure? I haven't seen it mentioned in other studies.

 

[Dolphin]

Is this an objective measure? I haven't seen it mentioned in other studies.

No, self-report questionnaire.

 

[MikeJackmin]

This stuff is basically just a stimulant, isn't it?

 

[Dolphin]

This stuff is basically just a stimulant, isn't it?

This also includes various supplements. See Table 2.