Efficacy and Safety of Pulse Magnetic Therapy System in Insomnia Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: This study's objective is to assess the efficacy and safety of Pulsed Magnetic Therapy System (PMTS) in improving insomnia disorder. METHODS: Participants with insomnia disorder were randomly assigned to receive either PMTS or sham treatment for four weeks (n= 153; PMTS: 76, sham: 77). Primary outcomes are the Insomnia Severity Index (ISI) scores at week 0 (baseline), 1, 2, 3, 4 (treatment), and 5 (follow-up). Secondary outcomes are the Pittsburgh Sleep Quality Index at baseline and week 4, and weekly sleep diary-derived values for sleep latency, sleep efficiency, real sleep time, waking after sleep onset, and sleep duration. RESULTS: The ISI scores of the PMTS group and the sham group were 7.13±0.50, 11.07±0.51 at week 4, respectively. There was a significant group×time interaction for ISI (F3.214, 485.271=24.25, p<0.001, ηp 2=0.138). Only the PMTS group experienced continuous improvement throughout the study; in contrast, the sham group only experienced a modest improvement after the first week of therapy. At the end of the treatment and one week after it, the response of the PMTS group were 69.7% (95% confidence interval [CI]: 58.6%-79.0%), 75.0% (95% CI: 64.1%-83.4%), respectively, which were higher than the response of the sham group (p<0.001). For each of the secondary outcomes, similar group×time interactions were discovered. The effects of the treatment persisted for at least a week. CONCLUSION: PMTS is safe and effective in improving insomnia disorders.

[Effect of electroacupuncture at "Ciliao"(BL 32) on c-fos expression in the sacral segment of spinal cord in rats with detrusor hyperreflexia].

OBJECTIVE: To observe the effect of electroacupuncture (EA) at "Ciliao" (BL 32) on detrusor hyperreflexia and c-fos expression in the sacral segment of spinal cord in rats with spinal cord injury (SCI). METHODS: Thirty-seven adult female Sprague-Dawley rats were randomized into normal control (n=5), SCI model (n=16) and EA (n=16) groups. EA (20 Hz, 3 mA) was applied to bilateral BL 32 for 2 hours, once daily for 14 days. Intravesical pressure was detected by using a pressure transducer and a bioelectric amplifier. The expression of c-fos gene was detected by immunohistochemistry. RESULTS: In comparison with normal control group, the maximum intravesical pressure (MIVP) raised significantly in model group (P < 0.05), and the compliance of the bladder decreased remarkably (P < 0.05). While compared with model group, MIVP decreased significantly in SCI rats of EA group after EA intervention (P < 0.05), and the vesical compliance increased obviously (P < 0.05). In comparison with normal control group, the mean optical density (OD) value of c-fos immuno-reaction (IR) positive products increased significantly in the sacral cord after SCI in model group (P < 0.05), while compared with model group, the mean OD value of c-fos IR positive products in EA group declined evidently but still being higher than that of normal control group (P < 0.05), displaying a downregulation of c-fos expression after EA. CONCLUSION: Electroacupuncture at "Ciliao" (BL 32) can inhibit the overactivity of bladder in SCI rats and reduce the c-fos expression in the sacral cord, suggesting that the declined C-fibers' activity after EA may be one of its mechanism underlying improving detrusor hyperreflexia in spinal cord injury.

[Literature quality evaluation criteria for Clinical Practice Guideline of Evidence-based Acupuncture and Moxibustion].

In Clinical Practice Guideline of Evidence-based Acupuncture and Moxibustion, following principles and methods of evidence-based medicine, in combination with characteristics of acupuncture and moxibustion science, primary literature quality assessment criteria and corresponding scale were stipulated and were repeatedly seeked advice from experts and proved, finally, forming the assessment criteria: (1) Evaluation criteria of literature quality for RCT; (2) Evaluation criteria of literature quality for non-randomly controlled trials; (3) Evaluation criteria of literature quality for cases-study trials.

[Evaluation of literature quality of acupuncture for treatment of herpes zoster and approach to the laws of treatment].

OBJECTIVE: To assess the quality of literature of clinical studies on acupuncture in treatment of herpes zoster. METHODS: The literatures between 1994-2006 were searched by means of electronic retrieval. Type and methodology, general condition, diagnosis of diseases and enrolled and excluded criteria, assessment of sample content, treatment condition, criteria for assessment of therapeutic effects, following-up, etc. in clinical studies are evaluated according to principles and methods of clinical epidemiology and evidence-based medicine. RESULTS: Of the 399 literatures enrolled, only 8 were authentic randomized controlled trials (RCTs), 20 quasi-randomized controlled trials, 66 non-randomized concurrent controlled trials and 277 narrative studies, 70 had clear diagnostic criteria, 16 mentioned enrolled or excluded criteria, 287 had clear criteria for therapeutic effects, 107 reported follow-up, 2 had the description of health economical index, 9 reported adverse reaction. CONCLUSION: At present, correct randomization, concealment, blinding and placebo-control, and the RCTs with generally accepted criteria for assessment of diagnosis and therapeutic effects, safety evaluation and rational design of follow-up are needed. It is indicated by preliminary study of the literatures that blood-letting puncture and cupping at Ashi points are main methods for treatment of herpes zoster.