Clinical Drug Experience Knowledgebase

Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

Cervical radiculopathy is a distinct consideration in the evaluation of any patients who have neck pain and may be defined simply as an abnormality of a nerve root, which originates in the cervical spine. The initial approach to the management of cervical spondylopathy radiculopathy is nearly the same that the nonspecific neck or back pain can be found in most of patients. Conservative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), narcotics, muscle relaxants, physical therapy and transcutaneous electrical nerve stimulation (TENS). The main objectives of conservative treatments are to relieve pain, improve function and improve health-related quality of life.However, these treatments for cervical radiculopathy are limited by their modest effectiveness. Surgical treatment for cervical disc disease is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. In terms of pharmacotherapy, there generally is no randomized, placebo-controlled trial available comparing the standard nonsurgical treatments. Therefore, care plans should be designed principally based on accumulated experience, the services available locally, and the respective preferences of patients. Treatment plans are developed to alleviate pain, improve function, and prevent recurrences.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the adverse effects of medications and surgery.In the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by some pathogenic factors, such as "Feng"(wind), "Han"(cold), "Shi"(dampness), invading the neck, induces cervical degenerative disc diseases which are the cause of cervical radiculopathy. According to the four traditional methods of diagnosis - observation, listening, interrogation, and pulse-taking, on patients, TCM doctors can analyze the certain pathogenic factors which cause neck pain. And then they will prescribe herbal formulae based on the effect and the main indications of Chinese medicine. Natural substances, including herbal medicines, have being used to promote healing and alleviate neck pain in western countries. Previous studies have demonstrated that some active substances in herbal medicine can promote Qi flow and blood circulation to alleviate pain.

A number of studies on the effects of the Chinese herbal medicine on cervical radiculopathy have been proposed, but useful empirical research is insufficiency. For chronic neck pain with or without radicular symptoms, there is low quality evidence that herbal is more effective than placebo for pain relief, which is measured at the end of the treatment. However, the size of the studies was small and the effect was measured in the short-term. Further research is very likely to change both the effect size and our confidence in the results. There is a need for trials with adequate numbers of participants that address long-term efficacy or effectiveness of herbal medicine compared to placebo.

Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, Calculus Bovis Artifactus. Using a well-designed clinical trial, we will survey the effectiveness of concurrent use of this remedy in relieving neck pain. Therefore, the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, on neck pain in cervical spondylotic radiculopathy in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Qishe Pill as an intervention to alleviate neck pain caused by cervical radiculopathy.