Evaluation of a granulated formula for the nerve root type and vertebral artery type of cervical spondylosis: a multicenter, single-blind, randomized, controlled, phase Ⅲ clinical trial.

OBJECTIVE: To evaluate the effectiveness and safety of cervical spondylosis formula granules in reducing the symptoms of patients with the nerve root type and the vertebral artery type of cervical spondylosis.

METHODS: This was a multicenter, single-blind, randomized, controlled trial. From April 2002 to November 2003, 499 patients were randomly assigned to either the treatment or the control group. The treatment group was orally administered granules prepared with a formula for cervical spondylosis, while the control group was given Jingfukang granules. The treatment course was 1 month for both groups.

RESULTS: In patients with the nerve root type of cervical spondylosis, the total effect rate in the treatment group (87.21% ) was significantly higher than that in the control group (80.70%, P < 0.01). After the treatment period in both groups, the treatment group had a significantly greater rate of resolution of pain, numbness of the upper limbs, muscle strength of the upper limbs, and fatigue than the control group (all P < 0.05). In patients with the vertebral artery type of cervical spondylosis, the total effect rate in the treatment group (82.07%) was similar to that in the control group (71.21% , P > 0.05). After the treatment period in both groups, the treatment group had a significantly greater rate of resolution of weakness of the waist and knees than the control group (P < 0.05).

CONCLUSION: The cervical spondylosis formula granules significantly improve numbness, muscle strength, and fatigue, and reduce pain in patients with the nerve root type of cervical spondylosis, and improve the weakness of the waist and knees in patients with the vertebral artery type of cervical spondylosis.