Treatment with L-Citrulline in patients with post-polio syndrome: A single center, randomized, double blind, placebo-controlled trial.
- 2021-11
- Neuromuscular disorders : NMD 31(11)
- Niveditha Putananickal
- Anna-Lena Orsini
- Simone Schmidt
- Vanya Gocheva
- Daniela Rubino
- Tanja Haas
- Sabine Schädelin
- Xeni Deligianni
- Oliver Bieri
- Dirk Fischer
- Patricia Hafner
- PubMed: 34711479
- DOI: 10.1016/j.nmd.2021.08.011
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- patients with post-polio syndrome (PPS)
- Methods
- Single-centered, randomized, double-blind, placebo-controlled study; 29 patients randomized to 15 g L-Citrulline or placebo
- Blinding
- Double-blind
- Duration
- 24 weeks
This single-centered, randomized, double-blind, placebo-controlled study reports the results of L-Citrulline treatment for 24 weeks in patients with post-polio syndrome (PPS). Twenty-nine patients were randomized and assigned into receiving a treatment of 15 g L-Citrulline or placebo. The primary endpoint was the change of the 6 min walking distance test. Secondary endpoints included motor function measure, quantitative muscle strength, quantitative MRI and self-reported impairment questionnaires. Patients receiving L-Citrulline walked 17.5 longer in the 6 min walking distance test when compared to placebo group, however not statistically significant (95% CI = -14.69; 49.68, p = 0.298). None of the secondary endpoints showed a statistically significant change in the L-Citrulline group when compared to placebo group. The motor function measure showed a change of -0.78 (95% CI= [-3.39; 1.83] p = 0.563). Muscle degeneration of leg muscles assessed with quantitative MRI indicated no significant change (estimate= -0.01, 95% CI =-0.13; 0.11, p = 0.869). L-Citrulline was safe and well tolerated. In conclusion, administration of 15 g L-Citrulline daily for 24 weeks to patients with PPS showed no beneficial treatment effect in timed muscle function.
Research Insights
Patients receiving L-Citrulline walked 17.5 longer in the 6 min walking distance test when compared to placebo group, however not statistically significant (95% CI = -14.69; 49.68, p = 0.298)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 15 g/day
The motor function measure showed a change of -0.78 (95% CI= [-3.39; 1.83] p = 0.563)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 15 g/day
Muscle degeneration of leg muscles assessed with quantitative MRI indicated no significant change (estimate= -0.01, 95% CI =-0.13; 0.11, p = 0.869)
- Effect
- Neutral
- Effect size
- Small
- Dose
- 15 g/day
Adverse Events Reported
L-Citrulline was safe and well tolerated.
- Finding
- Reported