ABSTRACT
The coordination and collaboration of many links are required to achieve the successful development of a high-quality clinical randomized controlled trial, in which, the compliance of the researchers affects the ultimate results and quality of the study since it is responsible for the safety and benefits of subjects in the trials and study quality. Focusing on the researchers' compliance, it is believed that the improvements in the researchers' compliance are very significant in the implementation of study scheme. At present, commonly, the researchers are of the low compliance, manifest as failure to obey the study scheme (such as inclusive criteria, enrollment sequence), failure to obey the rules of operation and data collection, failure to store the original documents but to modify the data, failure to report timely adverse events, etc. In view of clinical research monitors, the reasons on the low compliance are analyzed and the solutions are proposed.
ABSTRACT
<p><b>OBJECTIVE</b>To observe the clinical efficacy differences between electroacupuncture (EA) and regular treatment for severe acute pancreatitis accompanied with paralytic ileus.</p><p><b>METHODS</b>This was a prospective pragmatic randomized controlled trial. A total of 140 cases of severe acute pancreatitis accompanied with paralytic ileus were randomly assigned into an EA group and a regular treatment group, 70 cases in each one. The patients in the regular treatment group were treated with regular treatment, including intensive care, gastrointestinal decompression, fasting, blood capacity supplement, acid suppression treatment, internal environment maintenance, infection prevention, inhibition of pancreatic exocrine secretion, etc. Based on the regular treatment, patients in the EA group were treated with EA at Zusanli (ST 36) and Zhigou (TE 6), 30 min for each treatment, once a day for totally 5 days. The VAS-based abdominal distension severity scale and abdominal pain severity scale were compared before and during treatment in the two groups, moreover, the number of patients who transferred to surgery or ICU was compared.</p><p><b>RESULTS</b>(1) After the 1st EA, the abdominal pain and distension severity scales were both improved in the EA group, which were superior to those of the regular treatment group (all<0.05); afterwards, the abdominal distension and pain severity scales of each day in the EA group were all significantly superior to those of the regular treatment group (all<0.05). (2) The number of patients who transferred to surgery or ICU was not significantly different between the two groups (>0.05).</p><p><b>CONCLUSIONS</b>EA at Zusanli (ST 36) and Zhigou (TE 6) can significantly reduce the abdominal distension and pain severity scales in patients of severe acute pancreatitis accompanied with paralytic ileus, indicating positive clinical significance; in addition, EA is safe and can be recommended to the treatment of severe acute pancreatitis in combination with treatment plan of integrated Chinese and western medicine.</p>
ABSTRACT
<p><b>OBJECTIVE</b>To verify the clinical efficacy of acupuncture and moxibustion on depressive states of stroke patients' spouses.</p><p><b>METHODS</b>Forty-four subjects who were stroke patients' spouses and according with inclusive criteria with mild or moderate depressive states were randomly divided into an acupuncture-moxibustion group and a blank control group, 22 cases in each group. In the acupuncture-moxibustion group, acupuncture was applied at Baihui (GV 20), Shenting (GV 24), Sishencong (EX-HN 1), Hegu (LI 4), Zusanli (ST 36) and Taichong (LR 3), and suspended moxibustion was used at Shenque (CV 8), Guanyuan (CV 4) and Zhongwan (CV 12). The treatment was given twice a week for continuous 8 weeks. In the blank control group, neither acupuncture nor moxibustion treatment was given, and the patients were only treated with health and psychological guidance. Before treatment and after 8-week treatment, scores of self-rating depression scale (SDS) and numbers of insomnia severity grade were observed.</p><p><b>RESULTS</b>In the two groups, the scores of SDS were both reduced than those before treatment (both P<0.05), and the decrease in the acupuncture-moxibustion group was more obvious (P<0.05). After treatment, the number of insomnia severity grade in the acupuncture-moxibustion group was improved than that before treatment (P<0.001), and the improvement was evidently superior to that in the blank control group (P<0.05). The numbers of insomnia severity grade of the blank control group before and after treatment had no statistic significance (P>0.05).</p><p><b>CONCLUSION</b>The acupuncture and moxibustion intervention plan has clinical treatment significance on the improvement of mild and moderate depressive states for the stroke patients' primary caregivers who are the patients' spouses.</p>