Impact of Resveratrol and Pharmaceutical Care on Type 2 Diabetes Mellitus and Its Neuropathic Complication: A Randomized Placebo Controlled Clinical Trial

Abstract

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.