Table 2.
Differences in motor and cognitive scores during the randomized trial period (baseline vs. 6MO).
| Clinical | Baseline Values, Mean ±SD | 6-Month Change (Randomized, Placebo-Controlled Trial) | |||
|---|---|---|---|---|---|
| Variable, Units | Placebo Group | Niacin Group | Placebo Group Change | Niacin Group Change | Between Group Difference |
| UPDRS III Scores | 22.4 ± 11.8 | 21.3 ± 15.8 | −0.05 (−2.4–2.32) | −1.06 (−3.68–1.57) | 1.13 (−10.40–12.65) |
| Rigidity | 1.69 ± 2.23 | 1.5 ± 1.92 | 0.14 (−0.14–0.42) | 0.03 (−0.26–0.31) | 0.19 (−1.47–1.85) |
| Resting Tremor | 4.52 ± 2.87 | 3.11 ± 2.82 | 0.05 (−0.54–0.64) | −0.17 (−0.49–0.16) | 1.4 (−0.87–3.7) |
| Bradykinesia | 4.5 ± 4.6 | 4 ± 4.5 | 0.07 (−0.35–0.49) | −0.39 (−1.42–0.65) | 0.5 (−3.15–3.7) |
| Cognitive flexibility | 73.38 ± 57.11 | 79.42 ± 62.46 | −3.04 (−28.04–21.96) | 5.44 (−30.78–41.67) | −6.04 (−54.93–42.85) |
| Grip Strength, PSI | |||||
| First affected hand | 305.09 ± 105.26 | 297.04 ± 125.68 | 5.88 (−14.19–25.94) | −22.56 (−53.54–8.43) | 8.05 (−132.3–148.4) |
| Non (or later) affected hand | 300.43 ± 80.49 | 284.1 ± 123.09 | 3.73 (−35.11–42.56) | −31.67 (−63.74–0.39) | 16.33 (−110–142.7) |
| FSS | 36.65 ± 13.02 | 40.28 ± 11.99 | −0.06 (−2.5–2.37) | 1.78 (−5.5–9.05) | −3.63 (−13.79–6.53) |
| VAFS | 5.4 ± 2.23 | 5.17 ± 2.23 | −0.22 (−0.97–0.53) | −0.44 (−1.74–0.85) | 0.23 (−1.58–2.05) |
| REM sleep, % | 15.19 ± 12.1 | 22.5 ± 13.36 | −6.26 (−11.05–1.47) * | 1.39 (−5.42–8.2) | −7.31 (−17.62–3.0) |
| GDS | 6.2 ± 5.87 | 7.89 ± 7.31 | 0.25 (−0.53–1.03) | 1.17 (−1.75–4.08) | −1.69 (−7.14–3.76) |
| Stroop 3 trial | 8.13 ± 6.64 | 6.18 ± 7.92 | −0.59 (−3.17–1.99) | −2.19 (−5.93–1.54) | 1.96 (−4.16–8.08) |
| Walk and Turn, s | 11.47 ± 3.46 | 10.33 ± 3.16 | 0.44 (−1.08–1.96) | 0.18 (−0.61–0.96) | 1.14 (−1.61–3.88) |
| Valine, mg/dL | 229.33 ± 51.78 | 245.64 ± 33.42 | 1.83 (−27.05–30.72) | −0.71 (−35.17–33.74) | −16.31 (−57.55–24.93) |
| Tyrosine, mg/dL | 73.93 ± 14.77 | 64.93 ± 16.28 | 8.82 (−2.2–19.84) | −0.5 (−10.82–9.82) | 9.01 (−5.75–23.76) |
| Tryptophan, mg/dL | 60.87 ± 11.39 | 53.5 ± 10.81 | 7.48 (−0.39–15.34) | −0.07 (−6.1–5.96) | 7.37 (−3.13–17.86) |
| Serotonin, mg/dL | 89.56 ± 60.5 | 84.21 ± 68.17 | 25.34 (5.79–44.89) * | 1.21 (−17.82–20.25) | 5.35 (−55.03–65.72) |
| Phenylalanine, mg/dL | 74.47 ± 12.59 | 73.07 ± 9.74 | 3.74 (−8.48–15.97) | −1.64 (−8.62–5.33) | 1.40 (−9.23–12.02) |
| Leucine, mg/dL | 136.87 ± 38.75 | 143.07 ± 27.71 | 9.26 (−15.26–33.77) | −4.64 (−28.45–19.16) | −6.21 (−38.02–25.61) |
| Isoleucine, mg/dL | 72.14 ± 24.2 | 73.36 ± 15 | 4.03 (−14.21–22.26) | −4.79 (−19.34–9.77) | −1.21 (−20.89–18.47) |
All of the study personnel and patients were blinded to the group assignment. The treatment group assignment code was disclosed at the completion of the study in April 2020. VAFS: Visual analog severity scale, GDS: Geriatric depression scale, FSS: fatigue severity scale. Values presented are Mean ± SD or Mean (95% CI). * p < 0.05.