Objective:This study is conducted to determine the effects of SOOJI CHIM(Koryo hand acupuncture,KHA)therapy on sleep structures and perimenopause symptoms among insomniacs.Methods:Totally 49 participants who met the i...Objective:This study is conducted to determine the effects of SOOJI CHIM(Koryo hand acupuncture,KHA)therapy on sleep structures and perimenopause symptoms among insomniacs.Methods:Totally 49 participants who met the inclusion criteria were enrolled in a two-arm randomized,placebo controlled,patients-blind trial,with 24 cases allocated to a real-KHA group and 25 cases allocated to a sham-KHA group.Patients in each group received corresponding treatment every other day,three times a week for total eight weeks.Both actigraphy and testing of serum hormones level reflected by biological markers such as follicle-stimulating hormone(FSH),luteinizing hormone(LH)and estradiol(E2)were performed at pre-and post-treatment.Additionally,the scores of Pittsburgh sleep quality index(PSQI)was used for assessing the subjective sleep experience of insomniacs.Meanwhile,adverse effects were monitored and recorded.Results:After eight-week treatment,the global scores of PSQI declined significantly(P<0.05)in the realKHA group but not in the sham-KHA group(P>0.05).According to the outcomes of actigraphy,a striking increase was observed in both sleep efficiency(SE)and total sleep time(TST)in the real-KHA group(both P<0.05)but not in the sham-KHA group(P>0.05).However,no significant changes of sleep awakenings(SA)in both groups was found after treatment(both P>0.05).Meanwhile,FSH and LH in the real-KHA group decreased markedly after intervention(both P<0.05)while those indicators only slightly changed in the sham-KHA group(P>0.05).The fluctuation of E2 levels were not significant in both groups(both P>0.05).No serious adverse event was reported in either real-or sham-KHA group.Conclusion:KHA may be a potential alternative therapy for improving perimenopausal insomnia via down regulating the levels of FSH and LH.展开更多
Assays that measure steroid hormones in patient care, public health, and research need to be both accurate and precise, as these criteria help to ensure comparability across all clinical and research applications. Thi...Assays that measure steroid hormones in patient care, public health, and research need to be both accurate and precise, as these criteria help to ensure comparability across all clinical and research applications. This review addresses major issues relevant to assay variability and describes recent activities by the US Centers for Disease Control and Prevention (CDC) to improve assay performance. Currently, high degrees of accuracy and precision are not always met for testosterone and estradiol measurements; although technologies for steroid hormone measurement have advanced significantly, measurement variability within and across laboratories has not improved accordingly. Differences in calibration and specificity are discussed as sources of variability in measurement accuracy. Ultimately, a combination of factors appears to cause inaccuracy of steroid hormone measurements, with nonuniform assay calibration and lack of specificity being two major contributors to assay variability. Within-assay variability for current assays is generally high, especially at low analyte concentrations. The CDC Hormone Standardization (HoSt) Program is improving clinical assays, as evidenced by a 50% decline in mean absolute bias between mass spectrometry assays and the CDC reference method from 2007 to 2011. This program provides the measurement traceability to CDC reference methods and helps to minimize factors affecting measurement variability.展开更多
基金Supported by Traditional Chinese Medicine Research Foundation Project of Shanghai Municipal Commission of Health and Family Planning:No.ZYKC20161016Special Project for Clinical Research,Shanghai Municipal Health Commission:No.20174Y0009
文摘Objective:This study is conducted to determine the effects of SOOJI CHIM(Koryo hand acupuncture,KHA)therapy on sleep structures and perimenopause symptoms among insomniacs.Methods:Totally 49 participants who met the inclusion criteria were enrolled in a two-arm randomized,placebo controlled,patients-blind trial,with 24 cases allocated to a real-KHA group and 25 cases allocated to a sham-KHA group.Patients in each group received corresponding treatment every other day,three times a week for total eight weeks.Both actigraphy and testing of serum hormones level reflected by biological markers such as follicle-stimulating hormone(FSH),luteinizing hormone(LH)and estradiol(E2)were performed at pre-and post-treatment.Additionally,the scores of Pittsburgh sleep quality index(PSQI)was used for assessing the subjective sleep experience of insomniacs.Meanwhile,adverse effects were monitored and recorded.Results:After eight-week treatment,the global scores of PSQI declined significantly(P<0.05)in the realKHA group but not in the sham-KHA group(P>0.05).According to the outcomes of actigraphy,a striking increase was observed in both sleep efficiency(SE)and total sleep time(TST)in the real-KHA group(both P<0.05)but not in the sham-KHA group(P>0.05).However,no significant changes of sleep awakenings(SA)in both groups was found after treatment(both P>0.05).Meanwhile,FSH and LH in the real-KHA group decreased markedly after intervention(both P<0.05)while those indicators only slightly changed in the sham-KHA group(P>0.05).The fluctuation of E2 levels were not significant in both groups(both P>0.05).No serious adverse event was reported in either real-or sham-KHA group.Conclusion:KHA may be a potential alternative therapy for improving perimenopausal insomnia via down regulating the levels of FSH and LH.
文摘Assays that measure steroid hormones in patient care, public health, and research need to be both accurate and precise, as these criteria help to ensure comparability across all clinical and research applications. This review addresses major issues relevant to assay variability and describes recent activities by the US Centers for Disease Control and Prevention (CDC) to improve assay performance. Currently, high degrees of accuracy and precision are not always met for testosterone and estradiol measurements; although technologies for steroid hormone measurement have advanced significantly, measurement variability within and across laboratories has not improved accordingly. Differences in calibration and specificity are discussed as sources of variability in measurement accuracy. Ultimately, a combination of factors appears to cause inaccuracy of steroid hormone measurements, with nonuniform assay calibration and lack of specificity being two major contributors to assay variability. Within-assay variability for current assays is generally high, especially at low analyte concentrations. The CDC Hormone Standardization (HoSt) Program is improving clinical assays, as evidenced by a 50% decline in mean absolute bias between mass spectrometry assays and the CDC reference method from 2007 to 2011. This program provides the measurement traceability to CDC reference methods and helps to minimize factors affecting measurement variability.