Endpoint
Expanded Disability Status Scale (EDSS)
CAT:outcome/edssreported in score (0-10)3 findings from 3 compounds
What moved it
How to read these marks3 findings · 3 compounds · 1 null · by evidence strength
| Compound | Direction | Findings | Strongest evidence |
|---|---|---|---|
| biotin | down | 1 | Evidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers. |
| calciol | down | 1 | Evidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers. |
| sodium(1+) | no effect | 1 | Evidence strength: limited. Human evidence with several recorded weaknesses, or a design that tops out at limited. |
Reported to move it
2 findings
calciol — decreases
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.Finding“Average progression of the EDSS score was significantly lower in the cholecalciferol group (−0.06 ± 0.78) compared with the placebo group (0.32 ± 0.87, 95% CI −0.614 to −0.043; p = 0.03).”
Quoted verbatim from Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).. - Study
- RCT
- Duration
- 22 months
- Dose
- 100,000 IU oral solution every other week (equivalent to 7,143 IU/day) for 96 weeks
- Population
- Completers' population only (patients who finished the 96-week trial, 45 per arm) with relapsing-remitting MS, low serum 25OHD, all on interferon beta-1a background in both arms; not the intention-to-treat population
Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).2019PMID:31454777An author is affiliated with a producerPermalink
biotin — decreases
ModerateEvidence strength: moderate. Human evidence with one recorded weakness, or capped at moderate by its design or by unread numbers.Finding“At month 12, the mean (±standard deviation (SD)) EDSS decreased from baseline in the MD1003 arm (−0.03 ± 0.50) but increased at the expected rate in the placebo arm (+0.13 ± 0.33, p = 0.01; Figure 3).”
Quoted verbatim from MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study.. - Study
- RCT
- Participants
- 154
- Duration
- 12 months
- Dose
- 100 mg biotin orally three times daily (300 mg/day)
- Population
- Adults aged 18-75 with primary or secondary progressive multiple sclerosis, baseline EDSS 4.5-7 and disease worsening in the previous 2 years; month 12 of the double-blind phase; all patients on stable concomitant therapy allowed
MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study.2016PMID:27589059Industry fundedPermalink
Measured, no effect detected
1 finding
sodium(1+) — no detected effect on
LimitedEvidence strength: limited. Human evidence with several recorded weaknesses, or a design that tops out at limited.FindingNull result“Average 24-hour urine sodium levels were not associated with conversion to clinically definite MS over the 5-year follow-up (hazard ratio [HR] = 0.91, 95% confidence interval [CI] = 0.67-1.24 per 1g increase in estimated daily sodium intake), nor were they associated with clinical or MRI outcomes (new active lesions after 6 months: HR = 1.05, 95% CI = 0.97-1.13; relative change in T2 lesion volume: -0.11, 95% CI = -0.25 to 0.04; change in EDSS: -0.01, 95% CI = -0.09 to 0.08; relapse rate: HR = 0.78, 95% CI = 0.56-1.07).”
Quoted verbatim from Sodium intake and multiple sclerosis activity and progression in BENEFIT.. - Study
- cohort
- Population
- 465 patients with a clinically isolated syndrome in the BENEFIT trial; exposure is estimated 24-hour urine sodium (Tanaka equations) from repeated spot urines, per 1 g increase, not an assigned dose
Sodium intake and multiple sclerosis activity and progression in BENEFIT.2017PMID:28556498Permalink
How it is measured
Expanded Disability Status Scale, rated by a neurologist from the standard neurological examination and functional system scores, from 0 to 10 in half-point steps.
Measured, not recorded
- Subject
- expanded disability status scale (edss)
- Measurements
- 1 measurement
- Recorded as a finding
- No
Show what was measured
Expanded Disability Status Scale (EDSS)
no effect, n = 10
No significant changes in brain atrophy, EDSS, MSFC, or cognitive measures occurred
PMID:26298797 · one of two readings recorded this
Sources cited
3 papers
- Subject
- expanded disability status scale (edss)
- Findings
- 3
- Papers
- 3
Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).record2019PMID:314547771 finding
Sodium intake and multiple sclerosis activity and progression in BENEFIT.record2017PMID:285564981 finding
MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study.record2016PMID:275890591 finding