Qishe Pill for Cervical Radiculopathy

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

Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms. Pharmacologic agents treat the underlying condition and provide symptomatic relief. The various classes of medications used to treat radiculopathy include steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and antidepressants. Herbal medicines have been used for centuries in China. In China, many patients with cervical disc disease are increasingly turning to herbal medicines to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical radiculopathy.

Study Overview

• Status: Unknown
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Drug: Qishe Pill; Drug: Qishe Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • Completed
    • No.1 Hospital, Changchun University of TCM
  • Lanzhou, China
    • Completed
    • Gansu Hospital of TCM
  • Shanghai, China, 200032
    • Completed
    • Huadong Hospital
  • Shanghai, China, 200032
    • Completed
    • Longhua Hospital
  • Suzhou, China
    • Recruiting
    • Suzhou Hospital of TCM
    • Contact: Hong Jiang, PhD
    • Contact: Xiang Qin, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinical diagnosis of chronic neck pain since at least 3 months and complaints for a maximum duration of 5 years.
• average pain intensity of the last 7 days more or equal to 25 points measured by a Neck Disability Index.
• intellectual and physical ability to participate in the study.
• informed consent.
• One positive result of Brachial Plexus Traction Test, Cervical compression test or Cervical distraction test

Exclusion Criteria:

• cervical pain related to malignancy
• cervical pain due to an accident
• inflammatory joint disorders
• previous spine surgery
• protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
• actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
• use of pain drugs for other diseases (> 1x/week)
• pregnancy
• severe chronic or acute disease interfering with therapy attendance
• alcohol or substance abuse
• participation in another clinical trial in the last 6 months before study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Qishe	Drug: Qishe Pill; Pill, 3.75 g, twice per day, four weeks
PLACEBO_COMPARATOR: Control; Qishe Placebo	Drug: Qishe Placebo; Pill, 3.75 g, twice per day, four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain severity(measured with a visual analogue scale, VAS)	Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.	changes from baseline at 2 weeks
pain severity(measured with a visual analogue scale, VAS)	Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.	changes from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	a composite of functional status	changes from baseline at 2 weeks
Neck Disability Index（NDI）	a composite of functional status	changes from baseline at 2 weeks
Patient satisfaction degree	To evaluate satisfaction	Changes from baseline at 4 weeks
SF-36	a composite of functional status	changes from baseline at 4 weeks
Neck Disability Index（NDI）	a composite of functional status	changes from baseline at 4 weeks
Neck Disability Index（NDI）	a composite of functional status	changes from baseline at 3 months
Neck Disability Index（NDI）	a composite of functional status	changes from baseline at 6 months
Safety evaluation	Safety evaluation	changes from baseline at 4 weeks
The medicine issue		changes from baseline at 2 weeks
Compliance assessment	To evaluate compliance	changes from baseline at 2 weeks
Compliance assessment	To evaluate compliance	changes from baseline at 4 weeks
Concomitant medication		changes from baseline at 2 weeks
Concomitant medication		changes from baseline at 4 weeks
X-ray(frontal and lateral)		changes from baseline at 4 weeks
Kidney function test		changes from baseline at 4 weeks
Liver function test		changes from baseline at 4 weeks
ECG		changes from baseline at 4 weeks
Occult Blood		changes from baseline at 4 weeks
Excrement routine		changes from baseline at 4 weeks
Urine routine		changes from baseline at 4 weeks
Blood routine		changes from baseline at 4 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Fudan University; Suzhou Hospital of Traditional Chinese Medicine; Changchun University of Chinese Medicine; Lanzhou Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Cui XJ, Sun YL, You SF, Mo W, Lu S, Shi Q, Wang YJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:322. doi: 10.1186/1745-6215-14-322.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ANTICIPATED): February 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (ESTIMATE): January 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: Qishe