Objective:To evaluate the efficacy and safety of a Chinese medicine(CM)Modified Qufeng Runmian Powder(加减祛风润面散,MQFRMP)for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis.Methods:In ...Objective:To evaluate the efficacy and safety of a Chinese medicine(CM)Modified Qufeng Runmian Powder(加减祛风润面散,MQFRMP)for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis.Methods:In this multicenter,randomized,double-blind,placebo-controlled clinical trial,220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo,with 110 cases in each group.MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks,respectively.The primary index of efficacy was the effective rate according to the acne severity score(ASS).The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI)score,VISIA scores(spots,pores,brown spots,porphyrins and red areas)and skin assessment(skin p H,sebum amount and hydration)according to a SOFT skin multianalyzer.Results:(1)Follow-up:a total of 204 patients completed the follow-up,with 103 in the treatment group and 101 in the control group.(2)Effective rate:the total effective rate of the treatment group was significantly higher than the control group[83.5%(86/103)vs.31.7%(32/101),P<0.01)]with 95%confidence interval of 39.3%–66.4%.(3)DLQI:DLQI scores were significantly decreased the treatment and control groups(both P<0.01),but the treatment group was more obvious than the placebo group(P<0.01).(4)VISIA scores:the scores of spots,brown spots and red areas in the treatment group decreased compared with baseline(P<0.05).In the control group,the scores of brown spots and pores decreased compared with baseline(P<0.05).The improvement was more obvious in the treatment group than in the control group for all items(P<0.05).(5)Skin assessment:the p H and sebum score in the both groups decreased drastically compared with the baseline(all P<0.01),however,the improvement was more obvious in the treatment group than in the control group(P<0.01).The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P>0.05).(6)Safety:two cases of mild drug allergy were observed in the treatment group.Conclusion:MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No.ChiCTR1900020479).展开更多
OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significan...OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significant deviation from acupuncture. METHODS: We focused on literature from the last ten years (2002-2011) included in PubMed about controlled clinical trials on acupuncture vs sham acupuncture carried out in Germany. The methods applied in sham acupuncture are summarized, and the difference between the acupuncture and sham groups were analyzed. We measured effects based on the following criteria: acupuncture is effective and superior to sham, acupuncture is effective but similar to sham, both of them have uncertainty regarding treatment effect, or no significant effect. Finally, we reviewed the hypotheses of different scholars on sham acupuncture and analyzed their results.RESULTS: Four types of controlled clinical trials including sham acupuncture on non-Traditional Chinese Medicine acupoints, minimal acupuncture on non-acupoints, placebo needle and sham laser acupuncture had varying results in the 57 articles analyzed. Some showed that acupuncture had a better effect than sham, while some suggest acupuncture and sham had similar effects. In all studies using sham acupuncture on non-therapeutic points, sham electrodes, and sham electro-acupuncture, the therapeutic effect was better than sham. Of the trials, 37 demonstrated that acupuncture had a better effect than sham acupuncture. Only nine trials found no significant difference between acupuncture and sham. Two controlled trials for the same condition (neck pain) conducted by two different German research institutes used the same control method, but reached contradictory conclusions. CONCLUSION: We found problems in conclusions based on results of controlled clinical trials of sham acupuncture in Germany. Therefore, there is still not enough evidence to support the statements that "acupuncture and sham acupuncture have no difference in treatment effect" and "acupuncture is just a placebo effect." The control methods of sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research. We suggest that research on the methodology of sham acupuncture should be given priority in the design of acupuncture trials in the future.展开更多
[目的]对应用过渡期护理模式降低我国老年慢性病病人再入院率进行系统评价。[方法]检索万方数据库、中国知网、Web of Science数据库中涉及我国老年慢性病病人采取过渡期护理模式的随机对照试验,检索时限为建库至2016年7月1日,严格按照...[目的]对应用过渡期护理模式降低我国老年慢性病病人再入院率进行系统评价。[方法]检索万方数据库、中国知网、Web of Science数据库中涉及我国老年慢性病病人采取过渡期护理模式的随机对照试验,检索时限为建库至2016年7月1日,严格按照纳入标准筛选文献、提取资料和评价质量。[结果]共纳入9篇文献,其中中文7篇,英文2篇;中等质量文献5篇,低质量文献4篇,共涉及2 442例病人;病人随访主要通过电话随访、家庭访问、门诊随访或其中两项相结合的方式进行,干预持续3个月~6个月时,再入院率降低,且干预效果稳定。[结论]应用过渡期护理模式干预3个月~6个月可降低我国老年慢性病病人的再入院率,但目前我国尚未形成系统的过渡期护理模式。展开更多
文摘Objective:To evaluate the efficacy and safety of a Chinese medicine(CM)Modified Qufeng Runmian Powder(加减祛风润面散,MQFRMP)for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis.Methods:In this multicenter,randomized,double-blind,placebo-controlled clinical trial,220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo,with 110 cases in each group.MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks,respectively.The primary index of efficacy was the effective rate according to the acne severity score(ASS).The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI)score,VISIA scores(spots,pores,brown spots,porphyrins and red areas)and skin assessment(skin p H,sebum amount and hydration)according to a SOFT skin multianalyzer.Results:(1)Follow-up:a total of 204 patients completed the follow-up,with 103 in the treatment group and 101 in the control group.(2)Effective rate:the total effective rate of the treatment group was significantly higher than the control group[83.5%(86/103)vs.31.7%(32/101),P<0.01)]with 95%confidence interval of 39.3%–66.4%.(3)DLQI:DLQI scores were significantly decreased the treatment and control groups(both P<0.01),but the treatment group was more obvious than the placebo group(P<0.01).(4)VISIA scores:the scores of spots,brown spots and red areas in the treatment group decreased compared with baseline(P<0.05).In the control group,the scores of brown spots and pores decreased compared with baseline(P<0.05).The improvement was more obvious in the treatment group than in the control group for all items(P<0.05).(5)Skin assessment:the p H and sebum score in the both groups decreased drastically compared with the baseline(all P<0.01),however,the improvement was more obvious in the treatment group than in the control group(P<0.01).The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P>0.05).(6)Safety:two cases of mild drug allergy were observed in the treatment group.Conclusion:MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No.ChiCTR1900020479).
基金Supported by the Program of China Academy of Chinese Medical Sciences for Young Researchers in Medical Science(No.ZZ040305)
文摘OBJECTIVE: To examine German controlled clinical trials on the therapeutic effects of acupuncture vs sham acupuncture, and to find whether there are problems with the conclusion that sham acupuncture has no significant deviation from acupuncture. METHODS: We focused on literature from the last ten years (2002-2011) included in PubMed about controlled clinical trials on acupuncture vs sham acupuncture carried out in Germany. The methods applied in sham acupuncture are summarized, and the difference between the acupuncture and sham groups were analyzed. We measured effects based on the following criteria: acupuncture is effective and superior to sham, acupuncture is effective but similar to sham, both of them have uncertainty regarding treatment effect, or no significant effect. Finally, we reviewed the hypotheses of different scholars on sham acupuncture and analyzed their results.RESULTS: Four types of controlled clinical trials including sham acupuncture on non-Traditional Chinese Medicine acupoints, minimal acupuncture on non-acupoints, placebo needle and sham laser acupuncture had varying results in the 57 articles analyzed. Some showed that acupuncture had a better effect than sham, while some suggest acupuncture and sham had similar effects. In all studies using sham acupuncture on non-therapeutic points, sham electrodes, and sham electro-acupuncture, the therapeutic effect was better than sham. Of the trials, 37 demonstrated that acupuncture had a better effect than sham acupuncture. Only nine trials found no significant difference between acupuncture and sham. Two controlled trials for the same condition (neck pain) conducted by two different German research institutes used the same control method, but reached contradictory conclusions. CONCLUSION: We found problems in conclusions based on results of controlled clinical trials of sham acupuncture in Germany. Therefore, there is still not enough evidence to support the statements that "acupuncture and sham acupuncture have no difference in treatment effect" and "acupuncture is just a placebo effect." The control methods of sham acupuncture used in Germany may not be standardized and may not be suitable for acupuncture clinical trial research. We suggest that research on the methodology of sham acupuncture should be given priority in the design of acupuncture trials in the future.
文摘[目的]对应用过渡期护理模式降低我国老年慢性病病人再入院率进行系统评价。[方法]检索万方数据库、中国知网、Web of Science数据库中涉及我国老年慢性病病人采取过渡期护理模式的随机对照试验,检索时限为建库至2016年7月1日,严格按照纳入标准筛选文献、提取资料和评价质量。[结果]共纳入9篇文献,其中中文7篇,英文2篇;中等质量文献5篇,低质量文献4篇,共涉及2 442例病人;病人随访主要通过电话随访、家庭访问、门诊随访或其中两项相结合的方式进行,干预持续3个月~6个月时,再入院率降低,且干预效果稳定。[结论]应用过渡期护理模式干预3个月~6个月可降低我国老年慢性病病人的再入院率,但目前我国尚未形成系统的过渡期护理模式。
