Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson's disease: study protocol of a multicenter, open-label, randomized active-controlled trial / 中西医结合学报

<p><b>BACKGROUND</b>Parkinson's disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine (TCM) has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill (XFDCP), a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease.</p><p><b>METHODS AND DESIGN</b>This is a multicenter, randomized controlled trial. In total, 320 patients with early- (n = 160) and middle-stage PD (n = 160) will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group (n = 80) will be given XFDCP, and the control group (n = 80) will be given Madopar. Of the 160 patients with middle-stage PD, the trial group (n = 80) will be given XFDCP combined with Madopar and Piribedil, and the control group (n = 80) will be given Madopar and Piribedil. The Unified Parkinson's Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar's dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period.</p><p><b>DISCUSSION</b>It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages.</p><p><b>TRIAL REGISTRATION</b>This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.</p>

Efficacy and safety of piribedil in early combination with L-dopa in the treatment of Parkinson's disease: a 6-month open study.

BACKGROUND: Piribedil is a non-ergot D2/D3 dopamine agonist with antagonistic effect on alpha2-adrenoceptors and lack of agonist properties at 5-HT2A/2C receptors. Previous studies indicated its efficacy in monotherapy as well as in combinatio' s disease in L-dopa-treated parkinsonian patients. PATIENTS AND METHOD: A 6-month, open-labeled, multicenter study was conducted in Thai Parkinsonian patients who were insufficiently controlled by L-dopa (< or = 600 mg/day). Piribedil 50 mg in retard form was titrated upward to 150 mg/day (50 mg tid) by the 5th week and up to 6 months as an add-on treatment. L-dopa daily dose was kept stable until the 3rd month and could be adjusted afterwards. The main efficacy parameter was the change in UPDRS part III score versus baseline over Full Analysis Set, score variation, and percentage of responders defined by at least 30% decrease from baseline of total UPDRS part III score. The secondary efficacy criteria were changes in L-dopa dose between the third month and the end of the study, UPDRS part II score variation, Hoehn and Yahr stage variation and Schwab and England Activities of Daily Living Scale variation. The acceptability of piribedil was assessed by physical examination, weight, blood pressure and heart rate as well as the reported adverse events. RESULTS: Twenty-nine patients (55.2% male) with the mean age of 64.0 +/- 7.2 years and mean duration of disease of 18.3 +/- 8.2 months were recruited The mean UPDRS part III score at baseline was 19.8 +/- 11.4. After 6-month treatment with piribedil, mean UPDRS part III score significantly decreased to 6.6 +/- 4.7 (p < 0.0001) with mean score variation of 13.3 +/- 10.3. Twenty-seven patients (93.1%) were responders. Mean UPDRS part II score was significantly decreased from 7.2 +/- 5.4 at baseline to 2.7 +/- 2.1 at the end of 6 months (p < 0.0001). Hoehn and Yahr stage and Schwab and England Activities of Daily Living Scale were also significantly improved Reported adverse events were mainly gastrointestinal symptoms. Blood pressure and heart rate were not significantly changed during the study period. Peak dose dyskinesia was reported only in one patient. Two patients (6.9%) were withdrawn because of adverse events. CONCLUSION: Piribedil was effective on motor symptoms during a 6-month treatment in early parkinsonian patients insufficiently controlled by L-dopa and it was well tolerated.

Treatment of memory impairment, vertigo and tinnitus in the elderly with piribedil in an Indian general practice setting.

Age-related dopamine decline leads to memory impairment, vertigo or tinnitus leading to a reduced quality of life in the elderly. This study demonstrates the efficacy and acceptability of piribedil, a dopamine agonist, in improving these conditions. Of the 515 patients included in the study, there was complete resolution of memory impairment, vertigo and tinnitus in 103 patients (20%), improvement in 374 cases (72.6%), with 38 cases (7.4%) showing no change after one month's treatment with piribedil. The treatment was well accepted with a low frequency of side-effects and full compliance with daily medication.

evidence-based review of dopamine receptor agonists in the treatment of Parkinson's disease

Apomorphine and certain ergot alkaloids [bromocriptine, lisuride and pergolide] have been available for several decades; for the last few years, they were joined by newer dopamine agonists [cabergoline, pramipexole and ropinirole] most of them are non-ergolines. Each of these dopamine agonists has its own pharmacological characteristics and occupies a place in the pharmacotherapy of Parkinsons disease. In this evidence-based review, emphasis is put on the clinical efficacy of dopamine agonists in early and advanced Parkinsons disease, and where possible comparative evidence regarding their efficacy and safety is provided. In addition, their clinical pharmacokinetics, adverse effect profiles and most relevant interactions will be summarized

Efficacy and tolerance of Trivastal retard 50 in combination with levodopa in the treatment Parkinson

30 patients with Parkinson’s, ages of more than 45 years treated by levodopa but clinical symptoms were unstable. Trivastal slowed the demand of increase of dose of levodopa when combining with levodopa. The adequate dose of trivastal was 1 tablet/day within 15 days, then increased to 2 tablets/day. The drug usually had an effect in 45th day, mainly on the improvement of tremble and speaking difficulty.

Efectos cardiovasculares, renales y hormonales del piribedil en pacientes hipertensos / Cardiovascular renal and hormonals effects of the piribedil in hypertensive patients

La dopamina y sus derivados, los agonistas dopaminérgicos, han sido estudiados en pacientes con insuficiencia cardíaca, insuficiencia renal crónica y shock cardiogénico. Su utilidad en estas patologías se ha explicado por su accion agonista sobre los receptores adrenérgicos y dopaminérgicos. Recientemente fue introducido un agonista dopaminérgico, Piribedil (Trivastal), en el tratamiento de la insuficiencia circulatoria cerebral y del Síndrome de Raynaud. En este estudio se señalan sus efectos cardiovasculares, renales y sobre el Sistema Renina-Angiotensiva en pacientes hipertensos. El piribedil se empleó en dosis de 50 a 100 mg diarios durante un período de 8 semanas, como parte de un diseño experimental placebo comparativo-cruzado en 9 pacientes con hipertensión esencial. Se midió: 1.- Presión arterial (PA) y frecuencia cardíaca (FC), antes y durante el ejercicio submáximo en una cincha sin fin. 2.- Fracción de eyección (FE) y fracción de acortamiento (FA) por ecocardiograma. 3.- Depuración de urea (UCI) y de creatinina (CrCl). 4.- Actividad de renina plasmática por radioinmunoensayo. 5.- Aldosterona por radioinmunoensayo en fase sólida. El PIRIBEDIL redujo la presión arterial con un discreto aumento de la frecuencia cardíaca, acompañado de un modesto incremento no significativo de la actividad de renina plasmática y de aldosterona, y un incremento importante de la función renal. Concluimos que la activación del RD (D-1) es una respuesta vasodilatadora y antihipertensiva, con activación refleja del sistema simpático

Hiperprolactinemia: possivel emprego do piribedil (ET-495) no diagnóstico diferencial em relaçäo a prolactinas / Hyperprolactinemia: possible use of piribedyl (ET-495) in the differential diagnosis related to prolactins

O diagnóstico sindrômico das hiperprolactinemias em si näo traz tantas dificuldades. A principal dificuldade consiste em discriminar as de origem tumoral e as de origem funcional em indivíduos com sela túrcica radiologicamente normal após ter afastado nestes, o uso de drogas que aumentam a secreçäo de PRL. Atualmente, várias substâncias vem sendo utilizadas nestes tipos de pacientes no sentido de detectar indiretamente um possível microadenoma através da sua atuaçäo farmacodinâmica sobre as células prolactínicas da hipófise. O piribedil (ET 495), um potente agente dopaminérgico foi testado em 30 indivíduos divididos em três grupos: normal, hiperprolactinemia puerperal e hiperprolactinemia tumoral. Foi entäo evidenciado queda de PRL superior a 50% em relaçäo aos valores iniciais em dois primeiros grupos. Já em grupo tumoral este índice foi inferior a 50%, além de observar um comportamento irregular de prolactinemia durante o teste. Sugere o autor que a substância poderia faze parte como um elemento no diagnóstico diferencial das hiperprolactinemias tumora e funcional, mencionando também a possibilidade de utilizaçäo do piribedil no tratamento de algumas hiperprolactinemias sensíveis as substâncias dopaminérgicas tendo em vista a sua prolongada açäo, poucos efeitos colaterais e baixo custo