Objective:To assess efficacy of Chinese medicine(CM)on insomnia considering characteristics of treatment based on syndrome differentiation.Methods:A total of 116 participants aged 18 to 65 years with moderate and seve...Objective:To assess efficacy of Chinese medicine(CM)on insomnia considering characteristics of treatment based on syndrome differentiation.Methods:A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo(n=20)or the CM group(n=96)for a 4-week treatment and a 4-week follow-up.Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation.The primary outcome was change in total sleep time(TST)from baseline.Secondary endpoints included sleep onset latency(SOL),wake time after sleep onset(WASO),sleep efficiency,Pittsburgh Sleep Quality Index(PSQI)and CM symptoms.Results:The CM group had an average 0.6 h more(95%confidence interval(CI):0.3–0.9,P<0.001)TST and 34.1%(10.3%–58.0%,P=0.005)more patients beyond 0.5 h TST increment than that of the placebo group.PSQI was changed–3.3(–3.8 to–2.7)in the CM group,a–2.0(–3.2 to–0.8,P<0.001)difference from the placebo group.The CM symptom score in the CM group decreased–2.0(–3.3 to–0.7,P=0.003)more than the placebo group.SOL and WASO changes were not significantly different between groups.The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes.Prescriptions for these clinicians displayed relative stability,while the herbs varied.All adverse events were mild and were not related to study treatment.Conclusions:CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia.It is effective and safe for primary insomnia.In future studies,the long-term efficacy validation and the exploratory of eutherapeutic clinicians'fixed herb formulas should be addressed.(Registration No.NCT01613183).展开更多
Background: Low back pain(LBP) is a prevalent and debilitating condition that poses a significant burden on healthcare systems. Acupuncture has been proposed as a promising intervention for LBP, but the evidence suppo...Background: Low back pain(LBP) is a prevalent and debilitating condition that poses a significant burden on healthcare systems. Acupuncture has been proposed as a promising intervention for LBP, but the evidence supporting its specific effect is insufficient, and the use of sham acupuncture as a control in clinical trials presents challenges due to variations in sham acupuncture techniques and the magnitude of the placebo effect.Objective: To investigate the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and to assess whether different types of sham acupuncture are associated with different responses. Methods: Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials(RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences(SMDs, Hedges’ g) were applied to estimate the effect size. Results: A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD –1.43, 95% confidence interval(CI) –1.95 to –0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status(SMD –0.49, 95% CI –0.70 to –0.29, I2=73%),but not in quality of life(SMD 0.34, 95% CI –0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.Conclusions: Sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.(PROSPERO registration No. CRD42022304416)展开更多
基金Supported by the National Natural Science Foundation of China(No.81973713 and No.81303149)。
文摘Objective:To assess efficacy of Chinese medicine(CM)on insomnia considering characteristics of treatment based on syndrome differentiation.Methods:A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo(n=20)or the CM group(n=96)for a 4-week treatment and a 4-week follow-up.Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation.The primary outcome was change in total sleep time(TST)from baseline.Secondary endpoints included sleep onset latency(SOL),wake time after sleep onset(WASO),sleep efficiency,Pittsburgh Sleep Quality Index(PSQI)and CM symptoms.Results:The CM group had an average 0.6 h more(95%confidence interval(CI):0.3–0.9,P<0.001)TST and 34.1%(10.3%–58.0%,P=0.005)more patients beyond 0.5 h TST increment than that of the placebo group.PSQI was changed–3.3(–3.8 to–2.7)in the CM group,a–2.0(–3.2 to–0.8,P<0.001)difference from the placebo group.The CM symptom score in the CM group decreased–2.0(–3.3 to–0.7,P=0.003)more than the placebo group.SOL and WASO changes were not significantly different between groups.The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes.Prescriptions for these clinicians displayed relative stability,while the herbs varied.All adverse events were mild and were not related to study treatment.Conclusions:CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia.It is effective and safe for primary insomnia.In future studies,the long-term efficacy validation and the exploratory of eutherapeutic clinicians'fixed herb formulas should be addressed.(Registration No.NCT01613183).
基金the National Natural Science Foundation of China(No.82174234)the National Science Fund for Distinguished Young Scholars(No.81825024)。
文摘Background: Low back pain(LBP) is a prevalent and debilitating condition that poses a significant burden on healthcare systems. Acupuncture has been proposed as a promising intervention for LBP, but the evidence supporting its specific effect is insufficient, and the use of sham acupuncture as a control in clinical trials presents challenges due to variations in sham acupuncture techniques and the magnitude of the placebo effect.Objective: To investigate the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and to assess whether different types of sham acupuncture are associated with different responses. Methods: Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials(RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences(SMDs, Hedges’ g) were applied to estimate the effect size. Results: A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD –1.43, 95% confidence interval(CI) –1.95 to –0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status(SMD –0.49, 95% CI –0.70 to –0.29, I2=73%),but not in quality of life(SMD 0.34, 95% CI –0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.Conclusions: Sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.(PROSPERO registration No. CRD42022304416)
