Low dose niacin versus placebo in the treatment of Parkinson’s Disease: A Randomized Controlled Trial

Abstract BackgroundParkinson’s Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation versus placebo on motor symptoms in Parkinson’s disease subjects.MethodsA randomized, placebo-controlled, double-blind, single-center clinical trial in Parkinson’s disease patients was performed in Augusta, GA, between September 2016 to September 2019. Randomized participants were 47 PD patients who received either low-dose niacin (N = 21 ) or placebo (N = 26) for the first six months (mean age 68.4 SD, 8.7; mean duration of disease 5.8 SD 4.9; H&Y scores between 0.5 to 4; 64% subjects were Veterans). The Veterans Affairs Pharmacy generated the randomized sequence. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue.Results39 subjects were analyzed with low-dose niacin (N = 18) and placebo (N = 21) for the completion of the first six months (randomized, double-blind), and 31 subjects were analyzed for the completion of the next six months (open-label) with low-dose niacin (N = 14) and placebo (N = 17). Niacin treatment was not tolerated by two subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 0.05 [95% CI, -2.4 to 2.32], and niacin was 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 4.58 [95% CI, -0.85 to 8.30] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down).ConclusionLow-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD.Trial registrationClinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

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Low Dose Niacin Versus Placebo Treatment for Parkinson's Disease: A Randomized Controlled Trial

10.21203/rs.3.rs-660606/v1 ◽

2021 ◽

Author(s):

Chandramohan Wakade ◽

Raymond Chong ◽

Marissa Seamon ◽

Sharad Purohit ◽

Bababihari Giri ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Low Dose ◽

Rating Scale ◽

Controlled Trial ◽

Secondary Outcome ◽

Double Blind Study ◽

Double Blind ◽

One Year ◽

Time Point

Abstract Background Parkinson's Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation on motor symptoms in Parkinson's disease subjects. Methods Forty-Seven PD patients were randomly assigned to receive low-dose niacin or placebo in a randomized, double-blind study for the first six months. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson's Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Results Niacin treatment was tolerated well by 45 subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 1.5 [95% CI, -0.73 to 3.73], and niacin was − 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 2.66 [95% CI, -0.95 to 6.24] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down). Conclusion Low-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD. Trial registration: Clinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

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Low-Dose Niacin Supplementation Improves Motor Function in US Veterans with Parkinson’s Disease: A Single-Center, Randomized, Placebo-Controlled Trial

Biomedicines ◽

10.3390/biomedicines9121881 ◽

2021 ◽

Vol 9 (12) ◽

pp. 1881

Author(s):

Chandramohan Wakade ◽

Raymond Chong ◽

Marissa Seamon ◽

Sharad Purohit ◽

Banabihari Giri ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Motor Function ◽

Low Dose ◽

Rating Scale ◽

Controlled Trial ◽

Randomized Study ◽

Secondary Outcome ◽

Open Label ◽

Double Blind

A six-month double-blind, placebo-controlled randomized study was conducted to ascertain whether low-dose daily niacin supplementation would improve motor symptoms in Parkinson’s disease (PD) patients. A total of 47 PD patients were assigned to receive low-dose niacin or a placebo. At the end of the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, after six months, and after one year of treatment. The primary outcome measure was the Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Niacin treatment was well-tolerated by forty-five subjects. The mean [95% CI] change in UPDRS III scores at six months of placebo was −0.05 [95% CI, −2.4 to 2.32], and niacin was −1.06 [95% CI, −3.68 to 1.57]. From six to twelve months when both groups received open-label niacin supplementation, the average UPDRS III scores significantly decreased for the placebo group by 4.58 [95% CI, −0.85 to 8.30] and the niacin group by 4.63 [95% CI, 1.42 to 7.83] points. Low-dose niacin supplementation is a well-tolerated adjunct therapy and may improve motor function in PD when taken over a longer period.

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The Add-On Effect of Lactobacillus plantarum PS128 in Patients With Parkinson's Disease: A Pilot Study

Frontiers in Nutrition ◽

10.3389/fnut.2021.650053 ◽

2021 ◽

Vol 8 ◽

Author(s):

Chin-Song Lu ◽

Hsiu-Chen Chang ◽

Yi-Hsin Weng ◽

Chiung-Chu Chen ◽

Yi-Shan Kuo ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Lactobacillus Plantarum ◽

Outcome Measures ◽

Rating Scale ◽

Controlled Trial ◽

Secondary Outcome ◽

Motor Deficits ◽

Motor Symptoms ◽

Non Motor Symptoms

Background:Lactobacillus plantarum PS128 (PS128) is a specific probiotic, known as a psychobiotic, which has been demonstrated to alleviate motor deficits and inhibit neurodegenerative processes in Parkinson's disease (PD)-model mice. We hypothesize that it may also be beneficial to patients with PD based on the possible mechanism via the microbiome-gut-brain axis.Methods: This is an open-label, single-arm, baseline-controlled trial. The eligible participants were scheduled to take 60 billion colony-forming units of PS128 once per night for 12 weeks. Clinical assessments were conducted using the Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr scale, and change in patient “ON-OFF” diary recording as primary outcome measures. The non-motor symptoms questionnaire, Beck depression inventory-II, patient assessment of constipation symptom, 39-item Parkinson's Disease Questionnaire (PDQ-39), and Patient Global Impression of Change (PGI-C) were assessed as secondary outcome measures.Results: Twenty-five eligible patients (32% women) completed the study. The mean age was 61.84 ± 5.74 years (range, 52–72), mean disease duration was 10.12 ± 2.3 years (range, 5–14), and levodopa equivalent daily dosage was 1063.4 ± 209.5 mg/daily (range, 675–1,560). All patients remained on the same dosage of anti-parkinsonian and other drugs throughout the study. After 12 weeks of PS128 supplementation, the UPDRS motor scores improved significantly in both the OFF and ON states (p = 0.004 and p = 0.007, respectively). In addition, PS128 intervention significantly improved the duration of the ON period and OFF period as well as PDQ-39 values. However, no obvious effect of PS128 on non-motor symptoms of patients with PD was observed. Notably, the PGI-C scores improved in 17 patients (68%). PS128 intervention was also found to significantly reduce plasma myeloperoxidase and urine creatinine levels.Conclusion: The present study demonstrated that PS128 supplementation for 12 weeks with constant anti-parkinsonian medication improved the UPDRS motor score and quality of life of PD patients. We suggest that PS128 could serve as a therapeutic adjuvant for the treatment of PD. In the future, placebo-controlled studies are needed to further support the efficacy of PS128 supplementation.Clinical Trial Registration:https://clinicaltrials.gov/, identifier: NCT04389762.

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A Randomized Controlled Trial of Chinese Medicine on Nonmotor Symptoms in Parkinson’s Disease

Parkinson s Disease ◽

10.1155/2017/1902708 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Ka-Kit Chua ◽

Adrian Wong ◽

Kam-Wa Chan ◽

Yin-Kei Lau ◽

Zhao-Xiang Bian ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Chinese Medicine ◽

Rating Scale ◽

Controlled Trial ◽

Nonmotor Symptoms ◽

Double Blind ◽

Term Administration ◽

Post Hoc ◽

Chinese Medicine Theory

Nonmotor symptoms (NMS) of Parkinson’s disease (PD) have devastating impacts on both patients and their caregivers. Jiawei-Liujunzi Tang (JLT) has been used to treat some NMS of PD based on the Chinese medicine theory since Qing dynasty. Here we report a double-blind, randomized, placebo-controlled, add-on clinical trial aiming at evaluating the efficacy and safety of the JLT in treating NMS in PD patients. We randomly assigned 111 patients with idiopathic PD to receive either JLT or placebo for 32 weeks. Outcome measures were baseline to week 32 changes in Movement Disorder Society-Sponsored Revision of Unified PD Rating Scale (MDS-UPDRS) Parts I–IV and in NMS assessment scale for PD (NMSS). We observed improvements in the NMSS total score (p=0.019), mood/cognition (p=0.005), and reduction in hallucinations (p=0.024). In addition, post hoc analysis showed a significant reduction in constipation (p<0.001). However, there was no evidence of improvement in MDS-UPDRS Part I total score (p=0.216) at week 32. Adverse events (AEs) were mild and comparable between the two groups. In conclusion, long-term administration of JLT is well tolerated and shows significant benefits in improving NMS including mood, cognition, and constipation.

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Treatment of Levodopa-induced dyskinesia with Vitamin D: A Randomized, double-blind, placebo-controlled trial

Neurology International ◽

10.4081/ni.2018.7737 ◽

2018 ◽

Vol 10 (3) ◽

Cited By ~ 2

Author(s):

Amir Hassan Habibi ◽

Arezo Anamoradi ◽

Gholam Ali Shahidi ◽

Saeed Razmeh ◽

Elham Alizadeh ◽

...

Keyword(s):

Parkinson’S Disease ◽

Vitamin D ◽

Parkinson's Disease ◽

Parkinson Disease ◽

Rating Scale ◽

Involuntary Movement ◽

Controlled Trial ◽

The Body ◽

Double Blind ◽

Double Blind Clinical Trial

Dyskinesia refers to any involuntary movement, such as chorea, dystonia, ballism that affect any part of the body. Levodopa-induced dyskinesia is a neurological disorder that afflicts many patients with Parkinson disease usually 5 years after the onset of levodopa therapy and can cause severe disability. The pathophysiology of this dyskinesia is complex and not fully understood. However, the association between vitamin D and Parkinson disease is interesting. The present study was conducted to evaluate the effect of vitamin D on levodopa induced dyskinesia in patients with Parkinson’s disease .In this Double blind clinical trial, 120 patients with PD divided into two groups randomly, vitamin D and placebo group. A dose of 1000 IU/d was selected, Demographic information is registered. In the first visit, three variables have been measured which were the duration, severity of dyskinesia and unified Parkinson’s disease rating scale (UPDRS). These variables were measured again after 3 months and the data was analyzed using SPSS 22. There are no differences between two groups after 3 months. This study revealed, vitamin D has no effects on improvement of levodopa induced dyskinesia.

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Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson’s disease: a randomized controlled pilot study

Clinical Rehabilitation ◽

10.1177/0269215514536060 ◽

2014 ◽

Vol 28 (12) ◽

pp. 1210-1217 ◽

Cited By ~ 44

Author(s):

Daniele Volpe ◽

Maria Giulia Giantin ◽

Roberto Maestri ◽

Giuseppe Frazzitta

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Outcome Measures ◽

Rating Scale ◽

Controlled Trial ◽

Berg Balance Scale ◽

Secondary Outcome ◽

Balance Confidence ◽

Balance Scale ◽

Confidence Scale

Objective: Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson’s disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy. Design: A randomized single-blind controlled trial. Setting: Outpatients. Subjects: Thirty-four patients with Parkinson’s disease in Hoehn-Yahr stage 2.5–3. Intervention: Group 1 hydrotherapy treatment, group 2 land-based rehabilitation treatment. The two groups underwent the same rehabilitation period (60 minutes of treatment, five days a week for two months). Main measures: The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes, using a stabilometric platform. Secondary outcome measures were Unified Parkinson’s Disease Rating Scale II and III, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence Scale, Falls Efficacy Scale, Falls diary and Parkinson’s Disease Questionnaire-39. Results: Hydrotherapy treatment proved to be feasible and safe. Patients in both groups had a significant improvement in all outcome variables. There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes (mean SD change: 45.4 SD64.9 vs. 6.9 SD45.3, p = 0.05), Berg Balance Scale (51.2 SD3.1 vs. 6.0 SD3.1, p = 0.005), Activities-specific Balance Confidence Scale (16.8 SD10.6 vs. 4.1 SD5.4, p = 0.0001), Falls Efficacy Scale (−5.9 SD4.8 vs. −1.9 SD1.4, p = 0.003), Parkinson’s Disease Quetionnaire-39 (−18.4 SD12.9 vs. −8.0 SD7.0, p = 0.006) and falls diary (−2.4 SD2.2 vs. −0.4 SD0.5, p = 0.001). Conclusion: Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease.

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Cholinesterase inhibitor to prevent falls in Parkinson’s disease (CHIEF-PD) trial: a phase 3 randomised, double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease

BMC Neurology ◽

10.1186/s12883-021-02430-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

S. Neumann ◽

J. Taylor ◽

A. Bamford ◽

C. Metcalfe ◽

D. M. Gaunt ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Cholinesterase Inhibitor ◽

Controlled Trial ◽

Secondary Outcome ◽

Fall Rate ◽

Idiopathic Parkinson’S Disease ◽

Double Blind ◽

Link Type ◽

Idiopathic Parkinson's Disease

Abstract Background Falls are a common complication of Parkinson’s disease. There is a need for new therapeutic options to target this debilitating aspect of the disease. Cholinergic deficit has been shown to contribute to both gait and cognitive dysfunction seen in the condition. Potential benefits of using cholinesterase inhibitors were shown during a single centre phase 2 trial. The aim of this trial is to evaluate the effectiveness of a cholinesterase inhibitor on fall rate in people with idiopathic Parkinson’s disease. Methods This is a multi-centre, double-blind, randomised placebo-controlled trial in 600 people with idiopathic Parkinson’s disease (Hoehn and Yahr stages 1 to 4) with a history of a fall in the past year. Participants will be randomised to two groups, receiving either transdermal rivastigmine or identical placebo for 12 months. The primary outcome is the fall rate over 12 months follow-up. Secondary outcome measures, collected at baseline and 12 months either face-to-face or via remote video/telephone assessments, include gait and balance measures, neuropsychiatric indices, Parkinson’s motor and non-motor symptoms, quality of life and cost-effectiveness. Discussion This trial will establish whether cholinesterase inhibitor therapy is effective in preventing falls in Parkinson’s disease. If cost-effective, it will alter current management guidelines by offering a new therapeutic option in this high-risk population. Trial registration REC reference: 19/SW/0043. EudraCT: 2018–003219-23. ISCRTN: 41639809 (registered 16/04/2019). ClinicalTrials.gov Identifier: NCT04226248 Protocol at time of publication Version 7.0, 20th January 2021.

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A Double-Blind Study of Symmetrel (Amantadine Hydrochloride) in Parkinson's Disease

Journal of International Medical Research ◽

10.1177/030006057400200206 ◽

1974 ◽

Vol 2 (2) ◽

pp. 137-141 ◽

Cited By ~ 1

Author(s):

R T G Merry ◽

A W Galbraith

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Daily Living ◽

Rating Scale ◽

Controlled Trial ◽

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

Double Blind Placebo

A double-blind, placebo-controlled trial of Symmetrel for five months in Parkinson's Disease was performed. Using a daily living ability rating scale, a significant improvement amongst the less severely affected patients and a highly significant improvement of the severely affected patients receiving the drug was observed. The improvement of both groups was maintained for the duration of the study.

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