Cervical radiculopathy is a significant public health problem worldwide, accounting for 60% to 70% of all cases of cervical spondylopathy; it is generally believed that most symptoms can be cured or relieved by non-surgical treatment . The chief symptom of cervical radiculopathy is neck pain, which usually originates from a variety of non-specific musculoskeletal causes, including direct trauma, progressive structural changes with or without associated systemic disease (e.g., rheumatoid arthritis), degenerative conditions, and chronic stress or strain injury [12, 13]. A Canadian-based cohort reported that, although cervical spondylopathic radiculopathy is less common among the annual incidence of neck pain (14.6%), a systematic approach to its evaluation when encountered is no less important . Therefore, those considerations are unique to cervical radiculopathy in the assessment of patients who have neck pain and the treatment of neck pain relief.
Analgesic and nutritive nerve medicine have considerable effects on neck pain. Analgesics, such as aspirin, seem to be relatively secure, but it is reported that gastrointestinal reactions often appear . Mecobalamin, a neuropathy drug, can relieve neck pain by means of stimulating the inhibition of nerve degeneration and improving the excitability of nerve fibers . However, it seems to be too late to cure oncenerve degeneration occurs.
Qishe Pill provides specific benefits for “Qi and Blood”, terms in TCM, which can profit and activate blood circulation. Using the model animal pathology comprehensive validation, other effects have been found that indicate involvement in inhibition of disc inflammation factors and delayed disc cell apoptosis . According to modern research and preparation standards, Qishe Pill was developed to improve the various symptoms of cervical radiculopathy, especially for neck pain.
Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. Based upon the theory of TCM prescription, there is a leading, coordinating, auxiliary, and guiding effect in the remedy components. In Qishe Pill, Radix Astragali and Szechuan Lovage Rhizome have leading effects, Musconehas a coordinating effect, Radix Stephaniae Tetrandrae and Ovientvinehave auxiliary effects, and Calculus Bovis Artifactushas guiding effects. Each component of Qishe Pill is thought to be beneficial to neck pain patients. The ability of AS-IV, which can be found in Radix Astragali to inhibit the NF-qB pathway, might be one underlying mechanism contributing to its anti-inflammatory potential in vivo. The Szechuan Lovage Rhizome extract has been found to have the ability to inhibit platelet surface activity and platelet aggregation . The Radix Stephaniae Tetrandrae exerts anti-inflammatory effects by interfering with ROS production and Ca2+ influx through G protein modulation to prevent Mac-1 up-regulation in neutrophil activation . Ovientvineis used in TCM to treat pain, arthritis, etc., and its extract could inhibit synthesis and release of local PGE . Calculus Bovis Artifactus could decrease the malondialdehydecontent in inflammatory exudates induced by carrageen an in rats . Pretreatment with muscone inhibited the IL-1beta-induced phosphorylation of extracellular signal-regulated kinases 1/2 and c-Jun N-terminal kinase in a dose-dependent manner, and the expression of prostaglandin E2, 6-keto-prostaglandin F1alpha, IL-1beta, and tumor necrosis factor alpha, and recovered the structural distortion of the degenerative disc. Musconeis a promising agent in the treatment of intervertebral disc degeneration through its anti-inflammatory effects . Qishe Pill prevents intervertebral disc degeneration induced by upright posture .
Outcome measures assessing patients with neck pain are used widely in research and in clinical settings to establish baselines, to evaluate the effect of an intervention, and to motivate patients to evaluate their treatment. Generally, the VAS measurements have been found to be both valid and reliable. In many studies, the VAS has been shown to be the easiest to use and is considered to provide the most reliable measurements of pain intensity; it is therefore used as the criterion standard against new rating methods . Similarly, the NDI, a neck-specific questionnaire, has been cited in the literature as the criterion standard for many other questionnaires and is the most valid of the tools reported [24–27]. Furthermore, the NDI discriminates between those who improved or deteriorated and, as expected, does not detect change in score in those who remained stable . Therefore, for the self-effectiveness assessment, we selected the VAS for self-assessment of pain and NDI for self-assessment of function.
We intend to conduct this well designed RCT to investigate both the efficacy and safety of Qishe Pill in patients with neck pain, and consider that conscientiously performed studies and positive outcomes can benefit patients with neck pain. If this study demonstrates the efficacy and safety of Qishe Pill in significant strides, it will contribute to a useful clinical therapy for relieving neck pain in cervical radiculopathy.