Objective: To determine the effectiveness and safety of Tricardin (Danshenform 250 mg dripping pills capsules) along with physical rehabilitation in diabetic patients with polyneuropathies and to observe the effect of this drug on the quality of life of these patients.
Methodology: This randomized controlled study was conducted on 100 diabetic patients with established polyneuropathies, of which 50 patients were enrolled in interventional group and 50 in control group after randomization. In the control group, usual therapy for diabetes plus physical rehabilitation comprising of foot care education, pain management using TENS (Transcutaneous electrical nerve stimulation), nerve gliding exercises for lower limbs, balance and proprioception training was provided. In the experimental group, in addition to above protocol, Tricardin Capsule (250mg Danshenform Dripping Pills) three times daily for eight weeks was administered. Pre and post treatment quality of life was assessed by a self- structured quality of life questionnaire. Data were analyzed using SPSS version 21.
Results: Out of 100 patients, 7 (7%) were males and 93 (93%) females. The pre-treatment quality of life score was lower in both groups, with 29.54±1.85 in control group and 34.82±4.78 in experimental group. After the treatment, improvement was observed only slightly in control group (69.08± 4.91), whereas a significant improvement was found in the quality of life score in the interventional group (134.2 ±9.74) (p=0.01).
Conclusion: Quality of life significantly improved in the diabetic neuropathy patients who were given Tricardin (Danshenform 200 mg) along with the current therapy and physical rehabilitation. Thus, Tricardin was found to be a safe and effective treatment option for the management of diabetic polyneuropathies.
Key words: Diabetes, diabetic neuropathy, physical rehabilitation, Tricardin (Danshenform)
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