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Research Article
Mohammad Taghi Joghataei
Iran University of Medical Sciences
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease
characterized by the terminal degenerative disease of the motor units. This clinical trial was aimed to investigate the modulatory effect of bumetanide on physiological symptoms of ALS patients.
Methods: This was a double-blind, placebo-controlled trial in which ALS patients were randomized 1:1 to receive bumetanide (2 mg daily) or matching placebo group for up to 4 months. Motor Unit Number Index (MUNIX), motor unit size index (MUSIX), and ALS Functional Rating Scale, revised (ALSFRS-R) was assessed before and after treatment as following bumetanide treatment.
Results: 18 patients were allocated to bumetanide and 18 to the placebo group. In final analysis, 16 patients in bumetanide and 15 patients in the placebo group completed the trial. Patients in the placebo group showed a significant decrease in MUNIX value for all examined muscles after treatment, while MUNIX value for trapezius in bumetanide group increased significantly (p˂0.05). MUZIX value for tibialis anterior and trapezius (p˂0.05) improved significantly after bumetanide administration, whereas trapezius (p˂0.05) and abductor pollicis brevis (p˂0.01) in the placebo group showed a significantly decreased value. ALSFRS-R score decreased significantly in the placebo group after treatment (p˂0.001), but ALSFRS-R in bumetanide group improved significantly (p˂0.05). Three adverse effects (polyuria, vertigo, orthostatic hypotension) in bumetanide group were judged to be related to bumetanide.
Conclusion: Bumetanide treatment might be effective in modulation of ALS symptoms possibly due to the hyperpolarization of GABA actions and mitigation of cortical hyperexcitability.
Keywords
ALS, Bumetanide, MUNIX, ALSFRS-R
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CURRENT STATUS: Under Review
Version 1
Posted 11 Mar, 2021
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Review #1 received
Received 06 Apr, 2021
Reviewer #1 agreed
On 22 Mar, 2021
Reviewer #2 agreed
On 22 Mar, 2021
Reviewer #6 agreed
On 22 Mar, 2021
Reviewer #7 agreed
On 22 Mar, 2021
Reviewer #5 agreed
On 22 Mar, 2021
Reviewers invited
Invitations sent on 19 Mar, 2021
Editor assigned
On 19 Mar, 2021
Editor invited
On 10 Mar, 2021
Submission checks complete
On 10 Mar, 2021
First submitted
On 22 Feb, 2021
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This preprint is under consideration at Scientific Reports. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Mohammad Taghi Joghataei
Iran University of Medical Sciences
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 11 Mar, 2021
No community comments so far
Review #1 received
Received 06 Apr, 2021
Reviewer #1 agreed
On 22 Mar, 2021
Reviewer #2 agreed
On 22 Mar, 2021
Reviewer #6 agreed
On 22 Mar, 2021
Reviewer #7 agreed
On 22 Mar, 2021
Reviewer #5 agreed
On 22 Mar, 2021
Reviewers invited
Invitations sent on 19 Mar, 2021
Editor assigned
On 19 Mar, 2021
Editor invited
On 10 Mar, 2021
Submission checks complete
On 10 Mar, 2021
First submitted
On 22 Feb, 2021
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease
characterized by the terminal degenerative disease of the motor units. This clinical trial was aimed to investigate the modulatory effect of bumetanide on physiological symptoms of ALS patients.
Methods: This was a double-blind, placebo-controlled trial in which ALS patients were randomized 1:1 to receive bumetanide (2 mg daily) or matching placebo group for up to 4 months. Motor Unit Number Index (MUNIX), motor unit size index (MUSIX), and ALS Functional Rating Scale, revised (ALSFRS-R) was assessed before and after treatment as following bumetanide treatment.
Results: 18 patients were allocated to bumetanide and 18 to the placebo group. In final analysis, 16 patients in bumetanide and 15 patients in the placebo group completed the trial. Patients in the placebo group showed a significant decrease in MUNIX value for all examined muscles after treatment, while MUNIX value for trapezius in bumetanide group increased significantly (p˂0.05). MUZIX value for tibialis anterior and trapezius (p˂0.05) improved significantly after bumetanide administration, whereas trapezius (p˂0.05) and abductor pollicis brevis (p˂0.01) in the placebo group showed a significantly decreased value. ALSFRS-R score decreased significantly in the placebo group after treatment (p˂0.001), but ALSFRS-R in bumetanide group improved significantly (p˂0.05). Three adverse effects (polyuria, vertigo, orthostatic hypotension) in bumetanide group were judged to be related to bumetanide.
Conclusion: Bumetanide treatment might be effective in modulation of ALS symptoms possibly due to the hyperpolarization of GABA actions and mitigation of cortical hyperexcitability.
Figure 1
Figure 2
Figure 3
Figure 4
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