{"title":"白藜芦醇和药物护理对 2 型糖尿病及其神经病理性并发症的影响:随机安慰剂对照临床试验","authors":"Gulabakh Sabir M. Amin, Bushra Hassan Marouf, Hiwa Shafiq Namiq, Jamal Mahmood Salih","doi":"10.1155/2024/7739710","DOIUrl":null,"url":null,"abstract":"<p><i>Background</i>. Management of diabetic neuropathy (DN) is a challenging issue. Therefore, integration of pharmaceutical care provided by the clinical pharmacists with pharmacotherapy may provide multifaceted approach to target the management of hyperglycemia and diabetic neuropathic complication. This study aimed to evaluate the effects of resveratrol (Resv) and/or pharmaceutical care (PC) on glycemic control and amelioration of diabetes-associated neuropathic complications. <i>Patients and Methods</i>. A four-arm randomized placebo-controlled clinical trial assigned 120 patients from the Diabetes and Endocrinology Center in Sulaymaniyah City, Iraq. The patients were divided into four groups. The Resv group (<i>n</i> = 30) received 500 mg Resv capsules once daily. The Placebo group (<i>n</i> = 30) received placebo capsules. Resv + PC (<i>n</i> = 30) received Resv 500 mg capsules with PC. Placebo + PC (<i>n</i> = 30) received placebo capsule plus PC. The duration of the intervention was 90 days. Drug therapy problems (DTPs) have been utilized as an important domain in PC. Clinical signs, symptoms, and neuropathic abnormalities were assessed using the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4) questions, and nerve conduction studies (NCSs) of the lower-limb sensory and motor nerves. <i>Results</i>. 97 patients from all the groups completed the study. At baseline, 84% of the Resv, 87% of the Placebo, and 92% of each of Resv + PC and Placebo + PC groups, respectively, had at least one DTP. The provision of PC resulted in a dramatic reduction in the number of DTP. Resveratrol with PC significantly ameliorated hyperglycemic status, neuropathic signs, and symptoms, as evidenced by a decrease in MNSI and DN4 scores and improvement in electroneurographic parameters. <i>Conclusion</i>. These findings support the integration of the PC concept into a pharmacotherapy intervention; they also encourage supplementation of Resv with conventional diabetes therapy to emphasize on the importance of this herbal medicine with the provision of PC in the management of diabetes and its neuropathic complications. This trial is registered with NCT05172947.</p>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of Resveratrol and Pharmaceutical Care on Type 2 Diabetes Mellitus and Its Neuropathic Complication: A Randomized Placebo Controlled Clinical Trial\",\"authors\":\"Gulabakh Sabir M. Amin, Bushra Hassan Marouf, Hiwa Shafiq Namiq, Jamal Mahmood Salih\",\"doi\":\"10.1155/2024/7739710\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><i>Background</i>. Management of diabetic neuropathy (DN) is a challenging issue. Therefore, integration of pharmaceutical care provided by the clinical pharmacists with pharmacotherapy may provide multifaceted approach to target the management of hyperglycemia and diabetic neuropathic complication. This study aimed to evaluate the effects of resveratrol (Resv) and/or pharmaceutical care (PC) on glycemic control and amelioration of diabetes-associated neuropathic complications. <i>Patients and Methods</i>. A four-arm randomized placebo-controlled clinical trial assigned 120 patients from the Diabetes and Endocrinology Center in Sulaymaniyah City, Iraq. The patients were divided into four groups. The Resv group (<i>n</i> = 30) received 500 mg Resv capsules once daily. The Placebo group (<i>n</i> = 30) received placebo capsules. Resv + PC (<i>n</i> = 30) received Resv 500 mg capsules with PC. Placebo + PC (<i>n</i> = 30) received placebo capsule plus PC. The duration of the intervention was 90 days. Drug therapy problems (DTPs) have been utilized as an important domain in PC. Clinical signs, symptoms, and neuropathic abnormalities were assessed using the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4) questions, and nerve conduction studies (NCSs) of the lower-limb sensory and motor nerves. <i>Results</i>. 97 patients from all the groups completed the study. At baseline, 84% of the Resv, 87% of the Placebo, and 92% of each of Resv + PC and Placebo + PC groups, respectively, had at least one DTP. The provision of PC resulted in a dramatic reduction in the number of DTP. Resveratrol with PC significantly ameliorated hyperglycemic status, neuropathic signs, and symptoms, as evidenced by a decrease in MNSI and DN4 scores and improvement in electroneurographic parameters. <i>Conclusion</i>. These findings support the integration of the PC concept into a pharmacotherapy intervention; they also encourage supplementation of Resv with conventional diabetes therapy to emphasize on the importance of this herbal medicine with the provision of PC in the management of diabetes and its neuropathic complications. 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引用次数: 0
摘要
背景。糖尿病神经病变(DN)的管理是一个具有挑战性的问题。因此,临床药剂师提供的药物护理与药物治疗相结合,可提供多方面的方法,有针对性地管理高血糖和糖尿病神经病变并发症。本研究旨在评估白藜芦醇(Resv)和/或药物护理(PC)对血糖控制和改善糖尿病相关神经病理并发症的影响。患者和方法一项四臂随机安慰剂对照临床试验分配了 120 名来自伊拉克苏莱曼尼亚市糖尿病和内分泌中心的患者。患者被分为四组。Resv组(n = 30)服用500毫克Resv胶囊,每天一次。安慰剂组(n = 30)服用安慰剂胶囊。Resv + PC组(n = 30)服用Resv 500毫克胶囊和PC。安慰剂 + PC 组(30 人)服用安慰剂胶囊和 PC。干预持续时间为 90 天。药物治疗问题(DTP)已被作为 PC 的一个重要领域。使用密歇根神经病变筛查工具 (MNSI)、Douleur Neuropathique 4 (DN4) 问题以及下肢感觉神经和运动神经的神经传导研究 (NCS) 评估临床体征、症状和神经病变异常。结果来自各组的 97 名患者完成了研究。基线时,84% 的 Resv 组、87% 的安慰剂组以及 92% 的 Resv + PC 组和安慰剂 + PC 组分别至少有一次 DTP。PC 可显著减少 DTP 的数量。白藜芦醇加 PC 能明显改善高血糖状态、神经病理性体征和症状,这体现在 MNSI 和 DN4 评分的降低以及电神经图学参数的改善上。结论这些研究结果支持将 PC 概念融入药物治疗干预中;它们还鼓励在常规糖尿病治疗中补充 Resv,以强调这种草药在治疗糖尿病及其神经病理性并发症中提供 PC 的重要性。该试验已在 NCT05172947 上注册。
Impact of Resveratrol and Pharmaceutical Care on Type 2 Diabetes Mellitus and Its Neuropathic Complication: A Randomized Placebo Controlled Clinical Trial
Background. Management of diabetic neuropathy (DN) is a challenging issue. Therefore, integration of pharmaceutical care provided by the clinical pharmacists with pharmacotherapy may provide multifaceted approach to target the management of hyperglycemia and diabetic neuropathic complication. This study aimed to evaluate the effects of resveratrol (Resv) and/or pharmaceutical care (PC) on glycemic control and amelioration of diabetes-associated neuropathic complications. Patients and Methods. A four-arm randomized placebo-controlled clinical trial assigned 120 patients from the Diabetes and Endocrinology Center in Sulaymaniyah City, Iraq. The patients were divided into four groups. The Resv group (n = 30) received 500 mg Resv capsules once daily. The Placebo group (n = 30) received placebo capsules. Resv + PC (n = 30) received Resv 500 mg capsules with PC. Placebo + PC (n = 30) received placebo capsule plus PC. The duration of the intervention was 90 days. Drug therapy problems (DTPs) have been utilized as an important domain in PC. Clinical signs, symptoms, and neuropathic abnormalities were assessed using the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4) questions, and nerve conduction studies (NCSs) of the lower-limb sensory and motor nerves. Results. 97 patients from all the groups completed the study. At baseline, 84% of the Resv, 87% of the Placebo, and 92% of each of Resv + PC and Placebo + PC groups, respectively, had at least one DTP. The provision of PC resulted in a dramatic reduction in the number of DTP. Resveratrol with PC significantly ameliorated hyperglycemic status, neuropathic signs, and symptoms, as evidenced by a decrease in MNSI and DN4 scores and improvement in electroneurographic parameters. Conclusion. These findings support the integration of the PC concept into a pharmacotherapy intervention; they also encourage supplementation of Resv with conventional diabetes therapy to emphasize on the importance of this herbal medicine with the provision of PC in the management of diabetes and its neuropathic complications. This trial is registered with NCT05172947.
期刊介绍:
The Journal of Clinical Pharmacy and Therapeutics provides a forum for clinicians, pharmacists and pharmacologists to explore and report on issues of common interest. Reports and commentaries on current issues in medical and pharmaceutical practice are encouraged. Papers on evidence-based clinical practice and multidisciplinary collaborative work are particularly welcome. Regular sections in the journal include: editorials, commentaries, reviews (including systematic overviews and meta-analyses), original research and reports, and book reviews. Its scope embraces all aspects of clinical drug development and therapeutics, including:
Rational therapeutics
Evidence-based practice
Safety, cost-effectiveness and clinical efficacy of drugs
Drug interactions
Clinical impact of drug formulations
Pharmacogenetics
Personalised, stratified and translational medicine
Clinical pharmacokinetics.