Background and purpose: Vascular and tension-type headache is most commonly encountered, and SI17 therapy has been tested to treat headache with good results. The efficacy of SI17 therapy for vascular and tension-... Background and purpose: Vascular and tension-type headache is most commonly encountered, and SI17 therapy has been tested to treat headache with good results. The efficacy of SI17 therapy for vascular and tension-type headache was compared and the effect of SI17 therapy on pancreatic polypeptide (PP) was studied. Materials and methods: 29 cases of vascular headache (20 cases in acute attack during the trial) and 27 cases of tension-type headache (19 cases in acute attack) were enrolled in the study. Plasma PP level before and 4th day after treatment was measured by radioimmunoassay. Results: SI17 therapy is better for the treatment of vascular headache. Vascular headache with higher PP level and tension-type headache with normal PP level had good therapeutic results. Conclusion: The clinical efficacy is better for vascular headache with the increase of vagus tension and for tension-type headache with normal vagus tension. 展开更多
We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(R...We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.展开更多
Objective： To investigate the masseter inhibitory tension-type headache （TTH）. Methods： MIR was studied in 21 sex matched to the study cohort. Median age of patients was reflex （MIR） and its eventual changes in ...Objective： To investigate the masseter inhibitory tension-type headache （TTH）. Methods： MIR was studied in 21 sex matched to the study cohort. Median age of patients was reflex （MIR） and its eventual changes in patients with episodic patients with episodic TTH and 30 healthy subjects, with age and 17.0 years （ranged 16-49 years）, median duration of disease 12 months （1-5 years）, and median frequency of headache 7.5 d per month. Results： The second period of suppression （$2） of MIR was reduced in intensity and duration in 10% of controls and 66.7% （confidence interval （CI） 45.3%-85%; P〈0.05） of patients with episodic TTH （X2=74.9; P〈0.001）. In 3 （14.3%） of patients with episodic TTH, S2 was completely absent. No significant correlation between the duration of disease and headache frequency was found. Conclusion： Our results confirm the link between episodic TTH and reduction or absence of S2. Teenage patients with episodic TTH may exhibit marked pathological changes in S2 in contrast to older individuals.展开更多
Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)e...Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)evaluating the effect and safety of MSN treatment.All articles published up to November 15,2018 were retrieved.A meta-analysis was conducted for the included studies,and the risk of bias was assessed.Primary outcomes were visual analogue scale(VAS)or numeric rating scale(NRS)score.Secondary outcomes were clinical effective rates including total effective rate(TER),markedly effective rate(MER),and totally cured rate(TCR)determined by improvement in clinical symptoms or VAS scores,the frequency of adverse events(AEs)that occurred during the study,and participant quality of life(QOL).Results:Seven RCTs involving 724 participants were included.MSN treatment showed significantly higher MER and TCR[relative risk(RR)1.27,95%confidence interval(Cl)1.01 to 1.61;RR 1.31,95%Cl 1.09 to 1.57,respectively],but not TER(RR 1.03,95%Cl 0.96 to 1.10)compared to acupuncture.MSN treatment plus conventional treatment showed significant lower VAS and higher TER,MER,and TCR(mean difference-3.54,95%Cl-3.80 to-3.28;RR 1.14,95%Cl 1.06 to 1.23;RR 2.31,95%Cl 1.50 to 3.58;RR 3.01,95%Cl 2.25 to 4.02,respectively)compared to conventional treatment.Conclusions:According to current evidence,MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH.However,since the number and the sample size of studies included were both small and the methodological quality was poor,the findings of this review should be interpreted with great caution,and our confidence in the results is low.A high quality RCT using objective outcomes should be performed on this topic.展开更多
Objective:To observe the clinical efficacy of acupuncture plus auricular point sticking for tension-type headache(TTH).Methods:A total of 90 TTH patients were divided into an acupuncture group,an auricular point stick...Objective:To observe the clinical efficacy of acupuncture plus auricular point sticking for tension-type headache(TTH).Methods:A total of 90 TTH patients were divided into an acupuncture group,an auricular point sticking group and an observation group by random number table method,with 30 cases in each group.Patients in the observation group received acupuncture plus auricular point sticking for treatment,while those in the acupuncture group only received acupuncture and those in the auricular point sticking group only received auricular point sticking for treatment.The headache attack frequency and the scores of visual analog scale(VAS),self-rating anxiety scale(SAS)and self-rating depression scale(SDS)were observed before treatment,after treatment and 3 months after treatment.The clinical efficacy was evaluated at the follow-up of 3 months after treatment.Results:At follow-up,there were significant differences in clinical efficacy among the three groups(P<0.01 or P<0.05),and the clinical efficacy ranking from high to low was the observation group,the acupuncture group and the auricular point sticking group.After treatment and at follow-up,the VAS score,headache attack frequency,SAS and SDS scores in the three groups were significantly lower than those before treatment(all P<0.01).The above four results in the observation group were lower than those in the acupuncture group and the auricular point sticking group at the same time point(all P<0.01);VAS score in the acupuncture group was lower than that in the auricular point sticking group(both P<0.05).At follow-up,the headache frequency in the acupuncture group was lower than that in the auricular point sticking group(P<0.05).Conclusion:Either using acupuncture and auricular point sticking together or separately can reduce the headache degree of TTH patients,reduce the number of headache attacks,and relieve anxiety and depression.The efficacy of acupuncture plus auricular point sticking is most significant.展开更多
Objective: To explore the demographic and disease-related factors associated with acupuncture response in patients with chronic tension-type headache(CTTH). Methods: Using data from the randomized clinical trial(218 c...Objective: To explore the demographic and disease-related factors associated with acupuncture response in patients with chronic tension-type headache(CTTH). Methods: Using data from the randomized clinical trial(218 cases) consisting of 4 weeks of baseline assessment, 8 weeks of treatment, and 24 weeks of follow-up, participants were regrouped into responders(at least a 50% reduction in monthly headache days at week 16 compared with baseline) and non-responders. Twenty-three demographic and disease-related factors associated with acupuncture response in 183 participants were analyzed by multivariable logistic regression. Results: One hundred and nineteen(65.0%) participants were classified as responders. Four factors were significantly independently associated with acupuncture response, including treatment assignment, headache intensity at baseline, and 2 domains [general health(GH) and social functioning(SF)] from the 36-Item Short Form Health Survey quality of life questionnaire. Treatment assignment was associated with nonresponse: participants receiving true acupuncture were 3-time more likely to achieve a CTTH response than those receiving superficial acupuncture [odds ratio(OR) 0.322, 95% confidence interval(CI) 0.162 to 0.625, P=0.001]. Compared with patients with mild-intensity headache, patients with moderate-intensity headache were twice as likely to respond to acupuncture(OR 2.001, 95% CI 1.020 to 4.011, P=0.046). The likelihood of non-response increased by 4.5% with each unit increase in the GH grade(OR 0.955, 95% CI 0.917 to 0.993, P=0.024) while decreased by 3.8% with each unit increase in the SF grade(OR 1.038, 95% CI 1.009 to 1.069, P=0.011). Conclusions: Greater headache intensity, lower GH score, and higher SF score were associated with better acupuncture responses in CTTH patients. These 3 factors require independent validation as predictors of acupuncture effectiveness in CTTH.展开更多
Tension-type headache（TTH） is the most prevalent type of primary headache. Many studies have shown that the pathogenesis of primary headache is associated with fine structural or functional changes. However, these s...Tension-type headache（TTH） is the most prevalent type of primary headache. Many studies have shown that the pathogenesis of primary headache is associated with fine structural or functional changes. However, these studies were mainly based on migraine. The present study aimed to investigate whether TTH patients show functional disturbances compared with healthy subjects. We used restingstate functional magnetic resonance imaging（f MRI） and regional homogeneity（Re Ho） analysis to identify changes in the local synchronization of spontaneous activity in patients with TTH. Ten patients with TTH and 10 age-, gender-, and education-matched healthy controls participated in the study. After demographic and clinical characteristics were acquired, a 3.0-T MRI system was used to obtain restingstate f MRIs. Compared with healthy controls, the TTH group exhibited significantly lower Re Ho values in the bilateral caudate nucleus, the precuneus, the putamen, the left middle frontal gyrus, and the superior frontal gyrus. There was no correlation between mean Re Ho values in TTH patients and duration of TTH, number of attacks, duration of daily attacks, Visual Analogue Scale score, or Headache Impact Test-6 score. These results suggest that TTHpatients exhibit reduced synchronization of neuronal activity in multiple regions involved in the integration and processing of pain signals.展开更多
OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemi...OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemic stroke,hemorrhagic stroke,vascular cognitive impairment,tension-type headache before September 22,2020 on the platform of Chinese Clinical Trial Registry(Chi CTR),and Clinical Trials.gov were searched.Two researchers independently selected the literature and extracted data.RESULTS:A total of 180 interventional clinical trials were included for analysis.Out of 180 trials,127 were from Chi CTR and 53 from Clinical Trials.gov.The countries primary sponsoring the included trials were China(176,97.8%),and the common categories of primary sponsors were hospital(131,72.8%).Among the study design,the largest proportion of allocation was randomized(172,95.6%),interventional model assignment was parallel(163,90.6%),masking was double blind 49(27.2%),and the sample size was≤400(144,80.0%).The trials were most carried out at a single center(102,56.7%).Among the included studies,112(62.2%)registered on Chi CTR attached the ethical approval documents.In terms of trial stages,50(27.7%)studies were in phaseⅣ.The mostly used intervention was Chinese herbal medicines(99,55%),acupuncture(68,37.8%)was the second.By searching the registration number on China National Knowledge Infrastructure Database and Pub Med,38(21.1%)registered trials were published,including 25 protocol studies and 14 research results with one(NCT02275949)published both the protocol and the results.CONCLUSIONS:Irregular and inadequate reporting,untimely update and publication,insufficient information on traditional medicine unique characteristics,and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases.More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.展开更多
文摘 Background and purpose: Vascular and tension-type headache is most commonly encountered, and SI17 therapy has been tested to treat headache with good results. The efficacy of SI17 therapy for vascular and tension-type headache was compared and the effect of SI17 therapy on pancreatic polypeptide (PP) was studied. Materials and methods: 29 cases of vascular headache (20 cases in acute attack during the trial) and 27 cases of tension-type headache (19 cases in acute attack) were enrolled in the study. Plasma PP level before and 4th day after treatment was measured by radioimmunoassay. Results: SI17 therapy is better for the treatment of vascular headache. Vascular headache with higher PP level and tension-type headache with normal PP level had good therapeutic results. Conclusion: The clinical efficacy is better for vascular headache with the increase of vagus tension and for tension-type headache with normal vagus tension.
基金the National Key Research and Development Program of China:Research on“the Pattern Dominating Disease”of Postmarket Evaluation on Two Classic Chinese Herbal Formulas based on Basket Design(No.2018YFC1707407)。
文摘We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.
文摘Objective： To investigate the masseter inhibitory tension-type headache （TTH）. Methods： MIR was studied in 21 sex matched to the study cohort. Median age of patients was reflex （MIR） and its eventual changes in patients with episodic patients with episodic TTH and 30 healthy subjects, with age and 17.0 years （ranged 16-49 years）, median duration of disease 12 months （1-5 years）, and median frequency of headache 7.5 d per month. Results： The second period of suppression （$2） of MIR was reduced in intensity and duration in 10% of controls and 66.7% （confidence interval （CI） 45.3%-85%; P〈0.05） of patients with episodic TTH （X2=74.9; P〈0.001）. In 3 （14.3%） of patients with episodic TTH, S2 was completely absent. No significant correlation between the duration of disease and headache frequency was found. Conclusion： Our results confirm the link between episodic TTH and reduction or absence of S2. Teenage patients with episodic TTH may exhibit marked pathological changes in S2 in contrast to older individuals.
基金Chung-Yeon Central Institute(Research Program 2020)。
文摘Objective:To investigate the clinical efficacy and safety of miniscalpel-needle(MSN)treatment for tension-type headache(TTH).Method:Seven medical databases were searched to identify randomized controlled trials(RCTs)evaluating the effect and safety of MSN treatment.All articles published up to November 15,2018 were retrieved.A meta-analysis was conducted for the included studies,and the risk of bias was assessed.Primary outcomes were visual analogue scale(VAS)or numeric rating scale(NRS)score.Secondary outcomes were clinical effective rates including total effective rate(TER),markedly effective rate(MER),and totally cured rate(TCR)determined by improvement in clinical symptoms or VAS scores,the frequency of adverse events(AEs)that occurred during the study,and participant quality of life(QOL).Results:Seven RCTs involving 724 participants were included.MSN treatment showed significantly higher MER and TCR[relative risk(RR)1.27,95%confidence interval(Cl)1.01 to 1.61;RR 1.31,95%Cl 1.09 to 1.57,respectively],but not TER(RR 1.03,95%Cl 0.96 to 1.10)compared to acupuncture.MSN treatment plus conventional treatment showed significant lower VAS and higher TER,MER,and TCR(mean difference-3.54,95%Cl-3.80 to-3.28;RR 1.14,95%Cl 1.06 to 1.23;RR 2.31,95%Cl 1.50 to 3.58;RR 3.01,95%Cl 2.25 to 4.02,respectively)compared to conventional treatment.Conclusions:According to current evidence,MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH.However,since the number and the sample size of studies included were both small and the methodological quality was poor,the findings of this review should be interpreted with great caution,and our confidence in the results is low.A high quality RCT using objective outcomes should be performed on this topic.
文摘Objective:To observe the clinical efficacy of acupuncture plus auricular point sticking for tension-type headache(TTH).Methods:A total of 90 TTH patients were divided into an acupuncture group,an auricular point sticking group and an observation group by random number table method,with 30 cases in each group.Patients in the observation group received acupuncture plus auricular point sticking for treatment,while those in the acupuncture group only received acupuncture and those in the auricular point sticking group only received auricular point sticking for treatment.The headache attack frequency and the scores of visual analog scale(VAS),self-rating anxiety scale(SAS)and self-rating depression scale(SDS)were observed before treatment,after treatment and 3 months after treatment.The clinical efficacy was evaluated at the follow-up of 3 months after treatment.Results:At follow-up,there were significant differences in clinical efficacy among the three groups(P<0.01 or P<0.05),and the clinical efficacy ranking from high to low was the observation group,the acupuncture group and the auricular point sticking group.After treatment and at follow-up,the VAS score,headache attack frequency,SAS and SDS scores in the three groups were significantly lower than those before treatment(all P<0.01).The above four results in the observation group were lower than those in the acupuncture group and the auricular point sticking group at the same time point(all P<0.01);VAS score in the acupuncture group was lower than that in the auricular point sticking group(both P<0.05).At follow-up,the headache frequency in the acupuncture group was lower than that in the auricular point sticking group(P<0.05).Conclusion:Either using acupuncture and auricular point sticking together or separately can reduce the headache degree of TTH patients,reduce the number of headache attacks,and relieve anxiety and depression.The efficacy of acupuncture plus auricular point sticking is most significant.
基金Supported by the International Cooperation Program of Science and Technology Department of Sichuan Province,China(No.2016HH0007)。
文摘Objective: To explore the demographic and disease-related factors associated with acupuncture response in patients with chronic tension-type headache(CTTH). Methods: Using data from the randomized clinical trial(218 cases) consisting of 4 weeks of baseline assessment, 8 weeks of treatment, and 24 weeks of follow-up, participants were regrouped into responders(at least a 50% reduction in monthly headache days at week 16 compared with baseline) and non-responders. Twenty-three demographic and disease-related factors associated with acupuncture response in 183 participants were analyzed by multivariable logistic regression. Results: One hundred and nineteen(65.0%) participants were classified as responders. Four factors were significantly independently associated with acupuncture response, including treatment assignment, headache intensity at baseline, and 2 domains [general health(GH) and social functioning(SF)] from the 36-Item Short Form Health Survey quality of life questionnaire. Treatment assignment was associated with nonresponse: participants receiving true acupuncture were 3-time more likely to achieve a CTTH response than those receiving superficial acupuncture [odds ratio(OR) 0.322, 95% confidence interval(CI) 0.162 to 0.625, P=0.001]. Compared with patients with mild-intensity headache, patients with moderate-intensity headache were twice as likely to respond to acupuncture(OR 2.001, 95% CI 1.020 to 4.011, P=0.046). The likelihood of non-response increased by 4.5% with each unit increase in the GH grade(OR 0.955, 95% CI 0.917 to 0.993, P=0.024) while decreased by 3.8% with each unit increase in the SF grade(OR 1.038, 95% CI 1.009 to 1.069, P=0.011). Conclusions: Greater headache intensity, lower GH score, and higher SF score were associated with better acupuncture responses in CTTH patients. These 3 factors require independent validation as predictors of acupuncture effectiveness in CTTH.
基金supported by the National Natural Science Foundation of China (81071140)
文摘Tension-type headache（TTH） is the most prevalent type of primary headache. Many studies have shown that the pathogenesis of primary headache is associated with fine structural or functional changes. However, these studies were mainly based on migraine. The present study aimed to investigate whether TTH patients show functional disturbances compared with healthy subjects. We used restingstate functional magnetic resonance imaging（f MRI） and regional homogeneity（Re Ho） analysis to identify changes in the local synchronization of spontaneous activity in patients with TTH. Ten patients with TTH and 10 age-, gender-, and education-matched healthy controls participated in the study. After demographic and clinical characteristics were acquired, a 3.0-T MRI system was used to obtain restingstate f MRIs. Compared with healthy controls, the TTH group exhibited significantly lower Re Ho values in the bilateral caudate nucleus, the precuneus, the putamen, the left middle frontal gyrus, and the superior frontal gyrus. There was no correlation between mean Re Ho values in TTH patients and duration of TTH, number of attacks, duration of daily attacks, Visual Analogue Scale score, or Headache Impact Test-6 score. These results suggest that TTHpatients exhibit reduced synchronization of neuronal activity in multiple regions involved in the integration and processing of pain signals.
基金Supported by NATCM TCM Inheritance and Innovation Hundred-Thousand-Ten Thousand“Talents Project Qi Huang Scholar)-National TCM Leading Personnel Support Program(NATCM Personnel and Education Department[2018]No.12)”Research on optimizing construction of evidence-based ability of traditional Chinese medicine encephalopathy(No.ZZ13-024-3),Special fund for basic scientific research business expenses of central public welfare scientific research institutes。
文摘OBJECTIVE:To analyze the current status of clinical trial registration of Traditional Chinese Medicine(TCM)for the treatment of neurological diseases.METHODS:Interventional clinical trials of TCM treatment for ischemic stroke,hemorrhagic stroke,vascular cognitive impairment,tension-type headache before September 22,2020 on the platform of Chinese Clinical Trial Registry(Chi CTR),and Clinical Trials.gov were searched.Two researchers independently selected the literature and extracted data.RESULTS:A total of 180 interventional clinical trials were included for analysis.Out of 180 trials,127 were from Chi CTR and 53 from Clinical Trials.gov.The countries primary sponsoring the included trials were China(176,97.8%),and the common categories of primary sponsors were hospital(131,72.8%).Among the study design,the largest proportion of allocation was randomized(172,95.6%),interventional model assignment was parallel(163,90.6%),masking was double blind 49(27.2%),and the sample size was≤400(144,80.0%).The trials were most carried out at a single center(102,56.7%).Among the included studies,112(62.2%)registered on Chi CTR attached the ethical approval documents.In terms of trial stages,50(27.7%)studies were in phaseⅣ.The mostly used intervention was Chinese herbal medicines(99,55%),acupuncture(68,37.8%)was the second.By searching the registration number on China National Knowledge Infrastructure Database and Pub Med,38(21.1%)registered trials were published,including 25 protocol studies and 14 research results with one(NCT02275949)published both the protocol and the results.CONCLUSIONS:Irregular and inadequate reporting,untimely update and publication,insufficient information on traditional medicine unique characteristics,and lack of international collaborations are the problems existing in the interventional clinical registration trials of traditional medicine treatment on neurological diseases.More efforts need to be made from the above aspects to standardize and improve the registration of traditional medicine trials.
