Efficacy and safety of Dengyinnaotong Capsule in patients with Cognitive impairment caused by cerebral Small Vessel Disease: study protocol of a multicenter, randomized, open-label, controlled trial (De-CSVD trial).

BACKGROUND: Cerebral small vessel disease (CSVD) is a common syndrome in the older population, with a prevalence ranging from 5% in subjects aged 50 years to almost 100% in those aged 90 years and older. It is regarded to be a major cause of vascular cognitive impairment. Existing prevention and treatment approaches have not yet shown ideal clinical outcomes. Dengyinnaotong Capsule has shown great potential for improving cognitive function. This trial (De-CSVD trial) is designed to investigate the efficacy and safety of Dengyinnaotong Capsule on cognitive function in patients with CSVD . METHODS: This multicenter, randomized, open-label, controlled trial is planned to recruit at least 270 patients with mild cognitive impairment related to CSVD in 25 centers in China. Recruitment started on 10 May 2021 and is foreseen to end on 31 December 2022. The final follow-up of participants will be completed by the end of March 2023. Participants will be randomized in a ratio of 1:1 to the experimental group (routine basic treatment plus Dengyinnaotong Capsule) or the control group (routine basic treatment). The primary outcome is the change in the Montreal Cognitive Assessment score from baseline to week 12. Secondary outcomes are changes in Shape Trail Test, Activities of Daily Living, Geriatric Depression Scale, and Dizziness Handicap Inventory score from baseline to week 12, new vascular events, and the changes in serum level of homocysteine, high-sensitivity C-reactive protein, and D-dimer from baseline to week 4 and 12, respectively. The exploratory outcome is the changes in the Tinetti performance-oriented mobility assessment score from baseline to week 12. Safety assessment is performed by monitoring vital signs, general biochemical examinations, 12-lead electrocardiogram examinations, and incidence of cardiovascular and cerebrovascular ischemia or bleeding events. Visits will be performed at week 0 (baseline, pre-randomization), week 4, and week 12 in the treatment period (post-randomization). DISCUSSION: This trial is the first to investigate the efficacy and safety of Dengyinnaotong Capsule on cognitive impairment in patients with CSVD. The findings of this study might provide convincing evidence regarding the efficacy of Dengyinnaotong Capsule in patients with mild cognitive impairment related to CSVD. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100045831. Registered on 25 April 2021.

[Controlled study on treatment of cervical spondylopathy of the nerve root type with acupuncture, moxibustion and massage as main].

OBJECTIVE: To probe into clinical value of comprehensive program of acupuncture, moxibustion and massage as main for treatment of cervical spondylopathy of the nerve root type. METHODS: Five centers, single blind, randomized controlled method were used, 660 cases were divided into a treatment group of 317 cases and a control group of 311 cases. They were treated respectively with comprehensive program of acupuncture, moxibustion and massage as main, and comprehensive program of physical therapy as main. Establish syndrome detection scale and multiply dimensional effect assessment indexes, and evaluate the therapeutic effects and safety. RESULTS: The cured rate, the cured-markedly effective rate were 42.9%, 64.4% in the treatment group, respectively, better than 16.7%, 36.3% in the control group (P<0.01); after treatment of 2 weeks, clinical symptoms improved in the both groups, but the treatment group was better than the control group in the improvement degrees of neck-shoulder-limb pain, neck rigidity, abnormality of cervical anteflexion, etc. (P<0.01 or P<0.05); the treatment group was shorter than the control group in the time of producing the effect and therapeutic course (P<0.01). CONCLUSION: Comprehensive program of acupuncture, moxibustion and massage as main is safe and effective for treatment of cervical spondylopathy, with a better therapeutic effect compared with the comprehensive program of physical therapy.

[Controlled observation on electroacupuncture combined with cake-separated moxibustion for treatment of tennis elbow].

OBJECTIVE: To explore an effective method for treatment of tennis elbow. METHODS: One hundred and twenty-eight cases were randomly divided into a treatment group and a control group, 64 cases in each group. The treatment group were treated by electroacupuncture at Hegu (LI 4) and Taichong (LR 3), combined with cake-seperated moxibustion at Ashi points and Shousanli (LI 10) in the affected elbow, and the control group by routine block treatment of 1 mL lidocane and 25 mg prednisone. RESULTS: The cured rate and the effective rate were 40.6% and 93.7% in the treatment group, and 25.0% and 78.1% in the control group, respectively, with a significant difference between the two groups (P < 0.05). CONCLUSION: Electroacupuncture combined with cake-separated moxibustion is an effective method for tennis elbow.

[Clinical observation on moving cupping therapy combined with moxibustion for treatment of senile habitual constipation].

OBJECTIVE: To explore an effective method for treatment of senile habitual constipation. METHODS: Sixty-four cases were randomly divided into a treatment group treated with moving cupping at Hechelu plus Shenque (CV 8) Bazhenxue moxibustion, and a control group with oral administration of Tab phenolphthaleinum, 32 cases in each group. Improvement of constipation in the patients were observed and compared. RESULTS: The short-term (14 days) clinical cured-markedly effective rate was 84.4% in the treatment group, which was significantly better than 59.4% of the control group (P < 0.05), and there was a significant difference between the two groups in the long-term (2 months) therapeutic effect (P < 0. 01). CONCLUSION: Moving cupping at the Hechelu combined with Shenque (CV 8) Bazhenxue moxibustion is an effective method for senile habitual constipation.