Table 1.
Study characteristics.
| Author & year | Study type | Sample size (N) | Age (mean [SD]) | Gender | PD duration (mean years) | Treatments | Dose | Outcomes | Efficacy findings | Safety findings | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Male (N) | Female (N) | ||||||||||
| An Alternative Medicine Treatment for Parkinson's Disease: Results of a Multicenter Clinical Trial. HP-200 in Parkinson's disease study group, 1995 [30] | Clinical trial | 60 | 59 (9) | 46 | 14 | 4.1 | HP-200 containing 33.33 mg levodopa per gram | - LD naïve group patients averaged 5 ± 2 sachets/day - Carbidopa/levodopa-treated patients averaged 7 ± 3 sachets/day 1 sachet = 1.5 g M. pruriens |
Efficacy Safety |
Improvement in voluntary motor response, quality-of-life-related symptoms, disability symptoms. Any observed dyskinesia. | There was no observed dyskinesia in either levodopa (LD)-naïve patients or those previously treated with LD/carbidopa (LD/CD) after M. pruriens administration; however, nausea, vomiting, and insomnia were noted in both groups |
|
| |||||||||||
| Katzenschlager et al. 2004 [31] | Randomized clinical trial | 9 | 62.2 | 4 | 5 | 12.4 | Levodopa/carbidopa, 15 or 30 g M. pruriens | 15 g M. pruriens (≈500 mg levodopa) 30 g M. pruriens (≈1000 mg levodopa) Compared with 200 mg levodopa/50 mg carbidopa (standard LD/CD) |
Efficacy Pharmacokinetics |
Improvement in voluntary motor response but similar for involuntary motor response, “full on stage” with prolonged duration and reduced time to reach, increase in AUC & Cmax, reduced Tmax but similar Tk, some AEs observed | One patient withdrew due to brief vomiting after consuming 30 g of M. pruriens. Among the patients who completed the trial, two experienced nausea following 30 g of M. pruriens treatment, and one reported dizziness after taking 15 g of M. pruriens |
| Cilia et al. 2017 [32] | Randomized clinical trial | 18 | 61.8 (9.10) | 13 | 5 | 9.8 | Levodopa, M. pruriens, dopamine agonists, iMAO-B, iCOMT, amantadine, anticholinergics | Low-dose (M. pruriens-Ld): 12.5 mg/kg of levodopa from M. pruriens High-dose (M. pruriens-Hd): 17.5 mg/kg of levodopa from M. pruriens |
Efficacy Safety |
Improvement in voluntary motor response, involuntary motor response, and quality-of-life-related symptoms; reduction in therapy-related complications; no improved disability; AEs observed | Adverse events were compared across multiple treatments, with excessive daytime somnolence occurring significantly more often in the M. pruriens group compared to LD plus dopa-decarboxylase inhibitors (LD + DDCIs) |
|
| |||||||||||
| Cilia et al. 2018 [33] | Randomized clinical trial | 14 | 61.1(10) | 11 | 3 | 9.4 | LD, M. pruriens | The mean levodopa dose from M. pruriens was 4144.7 mg/day, consistent with the 5.7% calculation | Efficacy Safety |
Improvement of voluntary motor response in ITT and PP populations, improvement in quality-of-life-related symptoms, improvement in nonmotor response in PP population but not in ITT, similar score for disability scale, reduced time of on phase with troublesome, some AEs observed | There were reported symptoms such as revulsion, nausea, excessive daytime somnolence, dizziness, worsening of PD symptoms, psychiatric effects, and other prolonged events in patients continuing M. pruriens treatment; some patients discontinued the trial due to dizziness or other adverse effects |
|
| |||||||||||
| Sakata et al. 2024 [34] | Randomized clinical trial | 7 | 66.1 (7.2) | 2 | 5 | 11.2 | LD/CD, M. pruriens | Each patient received a single dose of 100/10 mg LD/CD tablets, and 11 g of M. pruriens reagent contained 442.2 mg of levodopa | Efficacy | Improvement in voluntary motor response but similar score for involuntary motor response, “full on stage” with prolonged duration and reduced time to reach increase in AUC and C max, reduced Tmax | |
Note: N = number, LD = levodopa, LD/CD = levodopa/carbidopa, M. pruriens = Mucuna pruriens, HP-200 = an extract from Mucuna pruriens containing L-dopa, AUC = area under the plasma concentration curve, Cmax = the peak plasma levodopa concentration, Tmax = time to peak, Tk = apparent elimination half-time, ITT = intention-to-treat population, PP = per-protocol population, IMAO-B: monoamine oxidase-B inhibitors, iCOMT = catechol-O-methyltransferase inhibitor, LD + DDCI = levodopa with dopa-decarboxylase inhibitor.
Abbreviations: AEs = adverse events, PD = Parkinson's disease, SD = standard deviation.