Exploratory open label, randomised study of acetyl- and propionylcarnitine in CFS, 2004, Vermeulen and Scholte

[ME/CFS Skeptic]

Split from Effect of Galantamine Hydrobromide in Chronic Fatigue Syndrome A Randomized Controlled Trial, 2004, Blacker et al.. The quote in this post refers to the Blacker paper.

This study may be useful when explaining the issues with subjective outcomes in unblinded trials with inadequate controls.

This might also be of interest.

It's the main result of an open-label study by Vermeulen et al. published in 2004. They tested the use of acetylcarnitine (ALC), propionylcarnitine (PLC), or a combination of both (ALC + PLC) in a crossover design. At 24 weeks of treatment 59% in the ALC group, 63% in the PLC group, and 37% in the ALC + PLC group reported to be improved.

Exploratory open label, randomized study of acetyl- and propionylcarnitine in chronic fatigue syndrome - PubMed (nih.gov)

After 24 weeks of therapy, the medication was stopped and all patients returned 2 weeks later for follow-up. As you can see in the table, the % of patients reporting to be improved suddenly dropped to zero.

 

[Andy]

After 24 weeks of therapy, the medication was stopped and all patients returned 2 weeks later for follow-up. As you can see in the table, the % of patients reporting to be improved suddenly dropped to zero.

Two weeks seems a remarkably short time for all particpants who reported that they were improved to suddenly have the insight and accept that they weren't. Were they followed for longer?

 

[Ariel]

Two weeks seems a remarkably short time for all particpants who reported that they were improved to suddenly have the insight and accept that they weren't. Were they followed for longer?

Bizarre study design. If this was the only follow-up, how useful is this data?

 

[Hutan]

After 24 weeks of therapy, the medication was stopped and all patients returned 2 weeks later for follow-up. As you can see in the table, the % of patients reporting to be improved suddenly dropped to zero.

Wouldn't that outcome be consistent with a treatment that had to be taken every day to maintain a positive effect though?

 

[Ariel]

Wouldn't that outcome be consistent with a treatment that had to be taken every day to maintain a positive effect though?

Yes, sorry I may have missed something but I didn't understand this - why was the treatment stopped/withdrawn - were effects hypothesised to be permanent? If so, why? Seems a different question as to whether the treatment works.

 

[Hutan]

Abstract
Objectives: We compared the effects of acetylcarnitine, propionylcarnitine and both compounds on the symptoms of chronic fatigue syndrome (CFS).

Methods: In an open, randomized fashion we compared 2 g/d acetyl-L-carnitine, 2 g/d propionyl-L-carnitine, and its combination in 3 groups of 30 CFS patients during 24 weeks. Effects were rated by clinical global impression of change. Secondary endpoints were the Multidimensional Fatigue Inventory, McGill Pain Questionnaire, and the Stroop attention concentration test. Scores were assessed 8 weeks before treatment; at randomization; after 8, 16, and 24 weeks of treatment; and 2 weeks later.

Results: Clinical global impression of change after treatment showed considerable improvement in 59% of the patients in the acetylcarnitine group and 63% in the propionylcarnitine group, but less in the acetylcarnitine plus propionylcarnitine group (37%). Acetylcarnitine significantly improved mental fatigue (p =.015) and propionylcarnitine improved general fatigue (p =.004). Attention concentration improved in all groups, whereas pain complaints did not decrease in any group. Two weeks after treatment, worsening of fatigue was experienced by 52%, 50%, and 37% in the acetylcarnitine, propionylcarnitine, and combined group, respectively. In the acetylcarnitine group, but not in the other groups, the changes in plasma carnitine levels correlated with clinical improvement.

Conclusions: Acetylcarnitine and propionylcarnitine showed beneficial effect on fatigue and attention concentration. Less improvement was found by the combined treatment. Acetylcarnitine had main effect on mental fatigue and propionylcarnitine on general fatigue.