A Multi-center, Double-blind, Randomized and Comparative Clinical Study for the Safety and Analgesic Effect after four-week-treatment with Neurotropin(R) in Patients with Low Back Pain: Compared to Aceclofenac / 대한척추외과학회지

ABSTRACT

STUDY DESIGN: A Multicenter double-blind randomized clinical study comparing Neurotropin and Aceclofenac. OBJECTIVE: To evaluate the analgesic effect, efficacy and safety of Neurotropin in patients with low back pain. SUMMARY OF LITERATURE REVIEW Non steroidal anti inflammatory analgesics are used as the main medical treatment in patients with low back pain. However, complications, such as gastrointestinal or cardiovascular problems, have been well documented. Neurotropin acts to recover the analgesic state arising from a decrease in pain threshold and has a completely different mechanism to that of existing anti-inflammatory and narcotic analgesics, with its action of restoring the immune system having been confirmed. MATERIALS & METHOD: 376 patients with back pain were randomly divided into two groups; one group was administered Neurotropin and the other Aceclofenac. The overall improvement after 4 weeks was used as the first efficacy variable, and with the second efficacy variable the improvements in spontaneous pain, tenderness, motion pain, radiating pain, severity, pain intensity, and the overall severity and Oswestry Disability Indices were used as the evaluation criteria. To evaluate safety, the abnormal clinical response and alternations on physical examination and the clinical laboratory values were used. RESULTS: A total of 358 patients received the experimental and comparison drugs, of which 351 were evaluated for safety. The overall improvement after 4 weeks, severity of symptoms, overall severity, and the pain intensity and Oswestry Disability Indices were decreased in both groups, but the differences between the two groups were not statistically significant. The overall decrease in the severity was greater in the Aceclofenac group, but both groups had statistically meaningful decreases after the administration of the drugs. i.e. Adverse drug reactions were less in the Neurotropin group, but these showed no significant statistical difference. CONCLUSIONS: Neurotropin and Aceclofenac are equally effective in patients with low back pain, but in terms of safety from a clinical view point Neurotropin is more reliable.