Impact of humic acids on the colonic microbiome in healthy volunteers

AIMTo test the effects of humic acids on innate microbial communities of the colon.METHODSWe followed the effects of oral supplementation with humic acids (Activomin®) on concentrations and composition of colonic microbiome in 14 healthy volunteers for 45 d. 3 × 800 mg Activomin® were taken orally for 10 d followed by 3 × 400 mg for 35 d. Colonic microbiota were investigated using multicolor fluorescence in situ hybridization (FISH) of Carnoy fixated and paraffin embedded stool cylinders. Two stool samples were collected a week prior to therapy and one stool sample on days 10, 31 and 45. Forty-one FISH probes representing different bacterial groups were used.RESULTSThe sum concentration of colonic microbiota increased from 20% at day 10 to 30% by day 31 and remained stable until day 45 (32%) of humic acid supplementation (P < 0.001). The increase in the concentrations in each person was due to growth of preexisting groups. The individual microbial profile of the patients remained unchanged. Similarly, the bacterial diversity remained stable. Concentrations of 24 of the 35 substantial groups increased from 20% to 96%. Two bacterial groups detected with Bac303 (Bacteroides) and Myc657 (mycolic acid-containing Actinomycetes) FISH probes decreased (P > 0.05). The others remained unaffected. Bacterial groups with initially marginal concentrations (< 0.1 × 109/mL) demonstrated no response to humic acids. The concentrations of pioneer groups of Bifidobacteriaceae, Enterobacteriaceae and Clostridium difficile increased but the observed differences were statistically not significant.CONCLUSIONHumic acids have a profound effect on healthy colonic microbiome and may be potentially interesting substances for the development of drugs that control the innate colonic microbiome.

Impact of endoscopy-based research on quality of life in healthy volunteers

AIM:To study the impact of an endoscopy-based long-term study on the quality of life in healthy volunteers(HV).METHODS:Ten HV were included into a long-term prospective endoscopy-based placebo-controlled trial with 15 endoscopic examinations per person in 5 different drug phases.Participants completed short form-36(SF-36) and visual analog scale-based questionnaires(VAS) for different abdominal symptoms at days 0,7 and 14 of each drug phase.Analyses wereperformed according to short-and long-term changes and compared to the control group.RESULTS:All HV completed the study with duration of more than 6 mo.Initial quality of life score was comparable to a general population.Analyses of the SF-36 questionnaires showed no significant changes in physical,mental and total scores,either in a short-term perspective due to different medications,or to potentially endoscopic procedure-associated long-term cumulative changes.Analogous to SF-36,VAS revealed no significant changes in total scores for pathological abdominal symptoms and remained unchanged over the time course and when compared to the control population.CONCLUSION:This study demonstrates that quality of life in HV is not significantly affected by a longterm endoscopy-based study with multiple endoscopic procedures.

Effect of a Combination of Berberine and Monacolin on CYP Enzymes： An Oral Cocktail Interaction Study in Healthy Volunteers

Objectives： This study was aimed at investigating the potential of the herbal exctracts, berberine and monacolin, administered in combination at the recommended dose, to generate clinically relevant inhibition of the CYP （cytochromes P450） enzyme system after a single oral administration in human healthy volunteers. Methods： Twelve healthy male volunteers received a five-probe drug cocktail alone （reference） or with the combination of berberine and monacolin （test）, in a randomized, open label, crossover fashion. Plasma concentrations of cocktail components, caffeine （CYP1A2）, metoprolol （CYP2D6）, omeprazole （CYP2C 19）, midazolam （CYP3A4）, warfarin （CYP2C9）, and plasma concentrations of berberine, monacolin and its metabolite were measured by LC-MS/MS. Pharmacokinetic parameters were determined by non-compartmental analysis. Lack of inhibition was assumed if the 90% CI （confidence interval） for estimated ratio test/reference was included in the acceptance limits 0.70-1.43 for phenotyping metrics AUClast and Cmax. Key findings： All test/reference ratios were close to unity and CIs （confidence intervals） were within the acceptance limits, except for the upper value of omeprazole Cmax. Given the high intraindividual variability, this finding was considered clinically irrelevant. Conclusions： Clinically relevant inhibition of the activities of the CYP isoenzymes investigated can be excluded when berberine and monacolin are administered in combination at the recommended dose.

Role of fNIRS technology in observing the effect of needling Hegu(LI 4) on the functions of prefrontal cortex in healthy volunteers

Objective： To observe the effect of needling Hegu （LI 4） on functions of the prefrontal cortex using the functional near infrared spectroscopy （fNIRS）. Methods： A total of 12 healthy volunteers were randomly assigned to an acupuncture group （n=6） and a control group （n=6）. The control group received no intervention. The acupuncture group received needling Hegu （LI 4） on the right side. The real-time concentration changes of oxygenated hemoglobin （HbO2）, deoxygenated hemoglobin （d-Hb） and total hemoglobin （t-Hb） in the prefrontal cortex were recorded using the fNIRS, allowing for effect analysis of needling Hegu （LI 4） on the functions of the prefrontal cortex. Results： Compared with the control group, the HbO2 and t-Hb concentrations were increased in the acupuncture group and there were between-group statistical significances （bothP〈0.05）. There was no between-group statistical significance in d-Hb concentration （P〉0.05）. Conclusion： Needling Hegu （LI 4） can extensively activate the prefrontal cortex and therefore has significant effect on the functions of the brain＆#39;s prefrontal cortex.

Multi-frequency magnetic resonance elastography of the pancreas:measurement reproducibility and variance among healthy volunteers

Background Patients with chronic pancreatitis often have irreversible pancreatic insufficiency before a clinical diagnosis.Pancreatic cancer is a fatal malignant tumor in the advanced stages.Patients having high risk of pancreatic diseases must be screened early to obtain better outcomes using new imaging modalities.Therefore,this study aimed to investigate the reproducibility of tomoelastography measurements for assessing pancreatic stiffness and fluidity and the variance among healthy volunteers.Methods Forty-seven healthy volunteers were prospectively enrolled and underwent two tomoelastography examinations at a mean interval of 7 days.Two radiologists blindly and independently measured the pancreatic stiffness and fluidity at the first examination to determine the reproducibility between readers.One radiologist measured the adjacent pancreatic slice at the first examination to determine the reproducibility among slices and measured the pancreas at the second examination to determine short-termrepeatability.The stiffness and fluidity of the pancreatic head,body,and tail were compared to determine anatomical differences.The pancreatic stiffness and fluidity were compared based on sex,age,and body mass index(BMI).Results Bland–Altman analyses(all P>0.05)and intraclass correlation coefficients(all>0.9)indicated near perfect reproducibility among readers,slices,and examinations at short intervals.Neither stiffness(P=0.477)nor fluidity(P=0.368)differed among the pancreatic anatomical regions.The mean pancreatic stiffness was 1.45±0.09 m/s;the mean pancreatic fluidity was 0.83±0.06 rad.Stiffness and fluidity did not differ by sex,age,or BMI.Conclusion Tomoelastography is a promising and reproducible tool for assessing pancreatic stiffness and fluidity in healthy volunteers.

Effect of food on the Oral Bioavailability of Berberine and Monacolin Administered in Combination in Healthy Male Volunteers

Objectives： To investigate the effect of food on the bioavailability of a combination of monacolin and berberine in healthy volunteers. Methods： Eighteen male volunteers received a single recommended oral dose of the combination under fasted conditions （reference） and fed conditions （high fat meal; test）, in a randomized, open label, crossover fashion. Plasma concentrations of berberine, monacolin and its metabolite were measured by LC-MS/MS. Pharmacokinetic parameters were determined by non-compartmental analysis. No effect of food was assumed if the 90% CIs （confidence intervals） for estimated ratio test/reference was included in the acceptance limits 0.80-1.25 for phenotyping metrics AUCt and Cmax- Key findings： For berberine, the Cmax and AUCt test/reference ratios were 2.97 and 2.69, respectively, and relevant 90% CIs （2.25-3.91 and 2.15-3.36, respectively） were above the acceptance limit. For lovastatin hydroxy acid, the active metabolite of monacolin, the test/reference ratios were 1.18 （Cmax） and 0.98 （ALJCt）. The 90% CIs fell entirely within the acceptance limit for AUCt, （0.85-1.13）, whereas the upper bound of the 90% CIs for Cmax （1.01-1.37） was just above the predefined interval. Conclusions： Food intake significantly increases berberine bioavailability and does not significantly affect monacolin bioavailability when these two extracts are administered in combination.

Pharmacokinetics of metadoxine for injection after repeated doses in healthy volunteers

Alcohol-induced liver disease is one of the main .epidemic problems nowadays. Metadoxine is apyridoxine-pyrrolidone carboxylate with significant scavenging property. Metadoxine is able to accelerate the elimination of alcohol from the blood and tissues, help restore the functional structure of the liver and relieve neuro-psychological disorders associated with alcohol intoxication.The purpose of the study was to assay the pharmacokinetics of domestic metadoxine after repeated doses.

Pharmacokinetics and bioequivalence of ranitidine and bismuth derived from two compound preparations

AIM： To evaluate the bioequivalence of ranitidine and bismuth derived from two compound preparations. METHODS： The bioavailability was measured in 20 healthy male Chinese volunteers following a single oral dose （equivalent to 200 mg of ranitidine and 220 mg of bismuth） of the test or reference products in the fasting state. Then blood samples were collected for 24 h. Plasma concentrations of ranitidine and bismuth were analyzed by high-performance liquid chromatography and inductively coupled plasma-mass spectrometry （ICPMS）, respectively. The non-compartmental method was used for pharmacokinetic analysis. Log-transformed Cmax, AUC（0-t） and AUC（0-∞） were tested for bioequivalence using ANOVA and Schuirmann two-one sided t-test. Tmax was analyzed by Wilcoxon＇s test. RESULTS： Various pharmacokinetic parameters of ranitidine derived from the two compound preparations, including Cmax, AUC（0-t）, AUC（0-∞）, Tmax and T1/2, were nearly consistent with previous observations. These parameters derived from test and reference drug were as follows： Cmax（0.67 ± 0.21 vs 0.68 ± 0.22 mg/L）, AUC（0-t）（3.1 ± 0.6 vs 3.0 ± 0.7 mg/L per hour）, AUC（0-∞）（3.3 ± 0.6 vs 3.2 ± 0.8 mg/L per hour）, Tmax （2.3 ± 0.9 VS 2.1 ± 0.9 h） and T1/2 （2.8 ± 0.3 vs 3.1 ± 0.4 h）. In addition, double-peak absorption profiles of ranitidine were found in some Chinese volunteers. For bismuth, those parameters derived from test and reference drug were as follows： Cmax （11.80 ± 7.36 vs 11.40 ± 6.55 μg/L）, AUC（0-t） （46.65 ± 16.97 vs 47.03 ± 21.49 μg/L per hour）, Tmax （0.50 ± 0.20 vs 0.50 ± 0.20 h） and T1/2 （10.2 ± 2.3 vs 13.0 ± 6.9 h）. Ninety percent of confidence intervals for the test/reference ratio of Cmax, AUC（0-t） and AUC（0-∞） derived from both ranitidine and bismuth were found within the bioequivalence acceptable range of 80%-125%. No significant difference was found in Tmax derived from both ranitidine and bismuth. CONCLUSION： The two compound preparations are bioequivalent and may be prescribed interchangeably.

Nature and mechanism of immune boosting by Ayurvedic medicine: A systematic review of randomized controlled trials

BACKGROUND Many Ayurvedic preparations are claimed to have immune-boosting properties,as suggested in various published randomized clinical trials(RCTs)AIM To compile evidence on the nature and mechanism of immune system enhancement by Ayurvedic preparations in healthy and sick individuals.METHODS After prospectively registering study protocol with PROSPERO,we searched PubMed,DOAJ,Google Scholar,three dedicated Ayurveda research portals,two specialty Ayurveda journals,and reference lists for relevant records published until February 6,2021 using appropriate search strategies.Baseline features and data pertaining to the nature and mechanism of immune system function were extracted from all eligible records.Methodological quality was assessed using the Cochrane RoB-2 tool.RESULTS Of 12554 articles screened,19 studies reporting 20 RCTs(17 parallel group design,three crossover design)with 1661 unique patients were included;11/19 studies had Indian first authors.Healthy population was included in nine studies,of which one study included pregnant women and two included pediatric population;remaining studies included patients with different health conditions,including one study with coronavirus disease 2019 patients.A total of 21 Ayurvedic interventions were studied,out of which five were composite mixtures.The predominant route of administration was oral;dose and frequency of administration of the intervention varied across the studies.The results reported with five RCTs exploring five Ayurvedic interventions were incomplete,ambiguous,or confusing.Of the remaining 16 interventions,indirect evidence of immune enhancement was reported with four interventions,while lack of the same was reported with two interventions.Enhancement of T helper cells and natural killer cells was reported with three and four interventions,respectively,while the pooled results did not clearly point toward enhancement of other components of the immune system,including cytotoxic T cells,B lymphocytes,immunoglobulins,cytokines,complement components,leucocyte counts,and other components.Nine of the 20 RCTs had a high risk of bias,and the remaining 11 RCTs had some concerns according to RoB-2.CONCLUSION Various Ayurvedic preparations appear to enhance the immune system,particularly via enhancements in natural killer cells and T helper cells.

Use of the Multispecies Probiotic Winclove 500/BactoSan pro FOS Leads to Less Gastrointestinal Complaints in Adults—An Observational In Vivo Pilot Study

The potential benefit of probiotics on the gut microbiota and on various gastrointestinal disorders is well documented. It has become clear that these probiotic effects are strain-specific, underlying the necessity for a well-founded strain selection for research and clinical practice. Whether probiotics also have a positive effect on parameters of gastrointestinal function in a healthy population is less investigated. The objective of this in vivo observational study was to investigate the effect of a 6-week intervention with a multispecies probiotic product on gut health and quality of life (QoL) in a population of otherwise healthy adults and to evaluate the feasibility of conducting a controlled trial on probiotic effects in this population. A total of 40 participants from 3 different health centres were included in the study. After a 1-week inclusion phase, participants were supplemented for a 6-week period with Winclove 500/BactoSan pro FOS. During the run-in phase and each week during the observational period, gastrointestinal functional parameters were documented by an adapted version of the Eypasch questionnaire. Data on QoL was collected at baseline and at the end of the intervention period. The total gastrointestinal (GI) symptom score was reduced from 10 (4 - 21) at baseline to 6 (0 - 15) (p < 0.05) after 6 weeks intervention. More specifically, after the probiotic intervention the percentage of participants which were fully resolved of a particular symptom significantly increased to 27.5% (p < 0.02) for gastrointestinal pain, to 25% (p < 0.03) for epigastric fullness/bloating and to 20% (p < 0.02) for flatulence, compared to baseline. The treatment was well-tolerated. This observational study provides important information on the ability to investigate potential effects of a probiotic product in otherwise healthy adults. The promising results Winclove 500/BactoSan pro FOS showed on gut health and QoL in this target group should be further investigated in a randomized, placebo-controlled study.

Pharmacokinetic study of single and multiple oral dose administration of antofloxacin hydrochloride in healthy male volunteers

Background A new fluroquinolone antibacterial agent,antofloxacin hydrochloride,developed in China,is an 8-NH2 derivant of levofloxacin.The purpose of the study was to evaluate the pharmacokinetic characteristics of single and multiple oral doses of antofloxacin hydrochloride in Chinese healthy male volunteers.Methods An open-label,non-randomized,single and multiple dose clinical trial was conducted.In single dose study,12 subjects took 200 mg antofloxacin hydrochloride.In multiple dose study,12 subjects took antofloxacin hydrochloride 400 mg once on day 1 and 200 mg once daily from day 2 to day 7.HPLC was used to assay the serum and urinary concentrations of antofloxacin.Results In single dose study,the maximum concentration of drug in serum （Cmax）,the time to reach Cmax （Tmax）,and the area under the serum concentration-time curve （AUC （O-∞）） of antofloxacin were （1.89±0.65） mg/L,（1.29±0.26） hours,39.1%.In multiple dose study,blood concentration of antofloxiacin achieved stable state on day 2 after dosing.The minimum concentration drug in serum （Cmin）,AUCss,mean concentration of drug in serum （Cav）,and degree offluctuation （DF） were （0.73±0.18） mg/L, （47.59±7.85） mg·h^-1·L^-1, （1.98±0.33） mg/L, and 1.74±0.60, respectively. On day 7 after dosing, Tmax ,Cmax and AUC （0-∞） was （1.14±0.50） hours, （2.52±0.38） mg/L, and （48.77±8.44） mg·h^-1·L^-1, respectively. Accumulating elimination rate of antofloxaxin from urine within 120 hours after the last dosing was 60.06%.Conclusions The regimen of 400 mg loading dose given on the first treatment day and then 200 mg dose once daily results in satisfactory serum drug concentration.

Effect of An-pressing manipulation on the serum levels of T-AOC and CK-MM in volunteers with delayed onset muscle soreness in biceps brachii

Objective：To observe the effect of An-pressing manipulation on biceps brachii with delayed onset muscle soreness （DOMS） in healthy male volunteers.Methods：A total of 30 male college student volunteers were randomly divided into a blank group,a model group and a treatment group,10 cases in each group.Subjects in the blank group did not receive any intervention;subjects in the model group received active weight-bearing eccentric exercise on the non-favored side of the upper limb to establish the models,while not receiving any treatment;subjects in the treatment group received both the same modeling and An-pressing manipulation treatment.The subjective rating of perceived exertion （RPE）,subjective soreness sensation threshold and soreness grade were evaluated before modeling,immediately after modeling,and 24,48,72,96 and 120 h after modeling.Serum total antioxidant capacity （T-AOC） was measured before modeling,immediately after modeling,and 24,48 and 72 h after modeling.Serum creatine kinase MM isoenzyme （CK-MM） was measured before modeling and 24,48 and 72 h after modeling.Results：At 24,48,72 and 120 h after treatment,the soreness grades of the treatment group were lower than those of the model group （all P〈0.05）.The RPE scores of the treatment group were lower than those of the model group （all P〈0.05） immediately after modeling,at 24,48,72,96 and 120 h after modeling.The subjective soreness sensation threshold of the treatment group was higher than that of the model group immediately after modeling,at 24,48,72 and 96 h after modeling （all P〈0.05）.Immediately after modeling,T-AOC value in the treatment group was higher than that in the model group and blank group （both P〈0.05）.CK-MM of the treatment group was lower than that of the model group at 48 h and 72 h after modeling （P〈0.05）.Conclusion：An-pressing manipulation shows a certain therapeutic effect on biceps brachii with DOMS by strengthening the body＇s antioxidant and anti-damage abilities,which can effectively reduce the pain and accelerate the recovery from fatigue damage.

Influence of different-distance mild moxibustion at Zusanli(ST 36) on functional brain imaging in healthy population

Objective： To explore the beneficial regulatory effect of mild moxibustion from different distances at Zusanli（ST 36） of healthy population on the functions of temperature-related brain regions. Methods： In 20 recruited healthy subjects, the change of the temperature-related brain regions induced by mild moxibustion from different distances at Zusanli（ST 36） was observed by functional magnetic resonance imaging（fM RI）. Results： In comparison of the values in amplitude of low-frequency fluctuation（fA LFF） during and before moxibustion, it has been found that in moxibustion of 2 cm distance, fA LFF value increased in the brain regions of the left anterior cingulated cortex and lateral surrounding cerebral regions, and fA LFF value decreased in the cerebral regions of the peripheral cortex of the calcarine fissure; in moxibustion of 3 cm distance, fA LFF value increased in the brain regions of the right and medial side and paracingulated gyrus, and fA LFF value decreased in the cerebral zone of the left middle temporal gyrus; in moxibustion of 4 cm distance, fA LFF value increased in the brain regions of the right and medial and paracingulated gyrus; and in moxibustion of 5 cm distance, fA LFF value increased in the brain regions of the left hippocampus. In comparison of the value of regional homogeneity（ReH o）, it has been found that in moxibustion of 2 cm distance, ReH o value increased in the cerebral zone of the posterior lobe of the right cerebellum, and ReH o value decreased in the cerebral zone of the right occipital lobe; in moxibustion of 3 cm distance, ReH o value increased in the brain regions of the left cerebellar posterior lobe and left frontal lobe, and ReH o value decreased in the cerebral zone of the right inferior temporal gyrus; in moxibustion of 4 cm distance, ReH o value increased in the brain regions of the right superior frontal gyrus and ReH o value decreased in the brain regions of the right parietal lobe and angular gyrus; in moxibustion of 5 cm distance, ReH o value increased in the cerebral zone of the right frontal lobe and ReH o value decreased in the cerebral zone of the right brainstem. Conclusion： In moxibustion of 3 cm distance, the changes in the brain regions basically conform to the transmission route of body trunk temperature.

Investigating the effects of moxibustion on serum metabolism in healthy human body based on the ~1 H NMR metabolomics technology

Objective： To investigate the effects of moxibustion on the serum metabolism in healthy human body based on the 1H nuclear magnetic resonance （1H NMR） metabolomics technology, and to find the differences in metabolites, as well as to elucidate the effects of moxibustion on healthy human body from the viewpoint of global metabolism. Methods： Sixty subjects of healthy young men from the enrolled students were randomly divided into a moxibustion group and a control group using random number table, with 30 cases in each group. Subjects in the moxibustion group accepted mild moxibustion on the right Zusanli （ST 36）, once a day, 15 min for each time, and continuous treatment for 10 d; those in the control group did not receive any intervention. There were 28 cases in the moxibustion group and 23 cases in the control group after interventions. On the 2st day, 5th day and lOth day of the intervention, serum samples were collected from subjects of the two groups, and metabolic spectra were obtained by the 1H NMR technology. Results： Before and after the intervention, serum 1H NMR of the moxibustion group was significantly different, while the difference was insignificant in the control group. Metabolite changes in the moxibustion group were mainly in low density lipoprotein （LDL）/very low density lipoprotein （VLDL）, valine, isoleucine, leucine, lactic acid, glutamine, citric acid, polyunsaturated fatty acids, creatine, glycine, glycerol, glucose, tyrosine, histidine, formic acid, alanine, lysine, acetic acid, and glutamic acid. Conclusion： Moxibustion can cause changes of serum metabolic patterns in healthy human by influencing the concentrations of branched-chain amino acids, polyunsaturated fatty acids, and other metabolites to strengthen body＇s metabolisms of amino acids and fatty acid.

Effect of electroacupuncture at the Pericardium Meridian on the heart function of volunteers with acute hypoxia

Objective： To study the effect of electroacupuncture （EA） at the Pericardium Meridian on the heart function of volunteers with acute hypoxia, and to provide scientific evidence for the acupoints selection along the affected meridian in acupuncture-moxibustion therapy. Methods： Based on a self-control design, eighteen healthy volunteers were recruited in the study. Points from the Pericardium Meridian [Neiguan （PC 6）, Ximen （PC 4）, Quze （PC 3） and Tianquan （PC 2）], non-Pericardium Meridian point [Shousanli （LI 10）], non-meridian and non-acupoint points [1.0-1.5 cm lateral to Neiguan （PC 6） and Ximen （PC 4）, respectively on both sides], and a blank control （only inhaling low-oxygen gas without EA stimulation] were selected to observe, once every week, 10 sessions in total, and only 1 acupoint was observed once. The volunteers inhaled low-oxygen gas mixture （10.8% 02 and 89.2% N2] for 30 min to imitate acute hypoxia. EA was conducted when the gas mixture was inhaled for 10 min and then lasted for 20 min; meanwhile, hemodynamic indexes such as cardiac output （CO）, cardiac index （Cl）, systemic vascular resistance （SVR）, systemic vascular resistance index （SVRI], left cardiac work （LCW], left cardiac work index （LCWl） and heart rate （HR） were recorded on a hemodynamic monitor. Results： EA at the acupoints of Pericardium Meridian significantly down-regulated the increased CO/CI, LCW/LCWl, and HR （P〈0.05）, and significantly up-regulated the decreased SVR/SVRI in hypoxia （P〈0.05）; EA at other meridian acupoints or at non-meridian and non-acupoint points didn＇t produce such effects. Conclusion： EA at the Pericardium Meridian can obviously improve the cardiac hyper-activation caused by acute hypoxia in healthy volunteers.

Experimental study on the influence of pressing force and time on thermal effect of An-pressing manipulation

Objective:To observe the influence of pressing force and time on the thermal effect of An-pressing manipulation.Methods:Eight healthy volunteers were recruited to receive An-pressing manipulation at Xinshu (BL 15) on the right side.The pressing force and time were both divided into five levels:the force described as extremely mild,mild,moderate,strong and extremely strong and time given by 2.5 min,5.0 min,7.5 min,10.0 min and 15.0 min.The real-time change in local acupoint temperature as well as the change during 1.0-15.0 min after the manipulation were observed.Results:Compared with the baseline data,the real-time changes in the temperature after An-pressing Xinshu (BL 15) on the right side with different levels of force (from mild to strong) were respectively (1.88t0.64) ℃,(2.05±0.68) ℃,(2.25±0.59) ℃,(2.35±0.61) ℃ and (2.32±0.69) ℃;the changes in 15.0 min after the manipulation were respectively (-0.11±0.11) ℃,(0.03±0.14) ℃,(0.59±0.58) ℃,(1.38±0.70) ℃ and (2.09±0.98) ℃.The real-time temperature changes after the manipulation for different durations (from short to long) were respectively (1.94±0.37) ℃,(2.33±0.29) ℃,(2.49±0.31) ℃,(2.51±0.39) ℃ and (2.41±0.55) ℃;the changes in 15.0 min after the manipulation were respectively (0.53±0.49) ℃,(0.33±0.30) ℃,(0.52±0.33) ℃,(0.55±0.38) ℃ and (0.76±0.36) ℃.Conclusion:The thermal effect presented an increasing tendency with the extension of pressing time,and the temperature reached the top at 7.5 min;the thermal effect showed an increasing tendency with the rise of pressing force,and the temperature reached the top upon a moderate level of force.The pressing time can produce a greater influence on the real-time temperature than the pressing force;the pressing force can produce a greater influence on maintaining the temperature than the pressing time.

Orthogonal test on local temperature influenced by different parameters and manipulation types of An-pressing Xinshu (BL 15)

Objective:To explore the optimal thermal effect parameter combination of An-pressing manipulation based on the pressing force, time and frequency, and to compare the thermal effect differences between the rhythmic and the continuous An-pressing manipulations. Methods:Three levels of light, moderate and heavy pressing forces were determined according to the An-pressing forces of the clinical tuina physicians;the pressing time and frequency parameters were determined according to the literatures about An-pressing manipulation. The volunteers were stimulated by the homemade An-pressing manipulation stimulator on the right Xinshu (BL 15), and then the three-factor and three-level orthogonal tests were carried out according to the test sequence specified by the L9(34) orthogonal table, and the temperature before and after pressing was recorded by an infrared thermal imaging system to screen the best parameters for the thermal effect of the An-pressing manipulation, thus to determine the optimal pressing parameters. The optimal parameters were then used for both continuous and rhythmic An-pressing manipulations to stimulate the bilateral Xinshu (BL 15). The temperature changes after pressing and the duration of the thermal effect (temperature difference ≤0.5℃ on both sides) were recorded by the infrared thermal imaging system, to explore the differences in the thermal effects of different An-pressing manipulations. Results:Among the three factors of pressing force, time and frequency, the influences of different pressing forces on temperature were significantly different (F=32.843,P=0.030), and the influence of 2.5 kg pressing force was the most significant;the effects of different pressing time on temperature were significantly different (F=54.102,P=0.018), and the pressing time of 7.5 min was the most significant;the influences of different pressing frequencies on temperature were not statistically significant (F=2.181,P=0.314), though the influence of 10 times/min pressing frequency was the largest. The influences on temperature difference of the rhythmic and the continuous An-pressing manipulations were significantly different (P=0.031 on the left side andP=0.045 on the right side), but there was no statistical difference in the duration of the thermal effect (P=0.690). Conclusion:The An-pressing manipulation parameters that significantly affect the temperature difference are pressing force and time. The optimal combination of thermal effect parameters is pressing force of 2.5 kg, time of 7.5 min, and frequency of 10 times/min. The local thermal effect of the rhythmic An-pressing manipulation is significantly greater than of the continuous An-pressing manipulation.

Clinical observation on the correlation between moxibustion sensation and distance of moxa stick

Objective： To explore the correlation between moxibustion sensation and distance of moxa stick and provide reference for clinical practice.Methods： A total of 16 healthy volunteers aged 18-35 years old in college were recruited and given mild moxibustion at Shousanli（LI 10）, Zusanli（ST 36）, Shenshu（BL 23） and Tianshu（ST 25） with moxa stick, and the occurrence and frequency of moxibustion sensation were recorded at distances of 5 cm, 4 cm, 3 cm and 2 cm. Mild moxibustion scale was used to count the score.Results： Warm was the main moxibustion sensation, burning pain and soreness decreased with the rise of distance; for the same acupoint, score of mild moxibustion scale increased with the decrease of distance; score ranged between 5.5 and 6.5at distance 3 cm, which was the most comfortable distance for volunteers.Conclusion： The distance of 3 cm is the most comfortable distance in mild moxibustion.

Mechanism study of the transmission of moxibustion heat in human acupoint tissues

Objective: To discuss the topical action characteristics of the biological transmission of moxibustion heat via temperature collection and numerical modeling. Methods: Temperature of moxibustion was measured at multiple points at a distance of 3 cm to obtain the moxibustion temperature field nephograms by the high-accuracy temperature measure array. Finite element analysis was used to imitate the three-dimensional dynamic distribution of temperature in acupoint tissues. Results: Through numerical analysis, the one-dimensional, two-dimensional and three-dimensional distributions of temperature in human acupoint tissues at 5 min of moxibustion were established. The result showed that moxibustion heat mainly tran smitted from the surface of the tissue to the internal, and the in flue nee of moxibusti on heat decreased with the depth of the tissue. The analysis of the nephograms of acupoint tissue temperature at 5,10, 15 and 20 min of moxibustion showed that with the in crease of the moxibusti on time, the temperature in acupoint tissues consta ntly rose, and the transmission depth of moxibustion heat also further expanded inside acupoint. Conclusion: By establishing the three-dimensional dynamic model of heat transmission inside acupoint tissues with the biological parameters of human tissues and the temperature values obtained, this study used finite element analysis software ANSYS 14.0 and discovered the rules in the transmission of heat in body tissues during moxibustion, and the features in moxibustion heat transmission (from the proximal to the distant) and heat penetration (from the surface to the intern al). This study provides theoretical and experime ntal support for the application of moxibusti on in clinical practice.

Study of the thermal pain threshold latency of acupoints based on Fei Teng Ba Fa

Objective： By applying moxibustion to the eight confluent points in different periods of time, to observe the changes in thermal pain threshold latency of acupoints based on Fei Teng Ba Fa. Methods： A total of 468 healthy college student volunteers received moxibustion at the eight confluent points in three different periods of time, i.e. Chen （7：00-9：00）, Wu （11：00-13：00） and Xu （19：00-21：00）. The thermal pain threshold latency was adopted to measure the changes in pain threshold of the eight confluent points under different conditions （different periods of time, different genders, different acupoints and different states of the acupoints） based on Fei Teng Ba Fa. Results： Finally, thirty subjects dropped out and 438 subjects were included. The comparison of thermal pain threshold latencies of the eight confluent points in the same opening or closing state based on Fei Teng Ba Fa： latencies of the closing points and adjunct points were significantly different in different periods of time （P〈0.05）, the latencies of the males were significantly longer than those of the females （P〈0.05）; there was no significant difference in the latency between the left and right sides （P〉0.05）; in the female group, there was a significant difference in the latency between the lower-limb points and the upper-limb points （P〈0.05）. The comparison of thermal point threshold latencies of the eight confluent points in different opening or closing state： in the period of Wu （11：00-13：00）, the latencies of the opening points were significantly longer than those of the closing points and adjunct points （P〈0.05）; for men, their opening and closing points had significantly longer thermal pain threshold latencies than their adjunct points （P〈0.05）; despite the gender, the latencies of the upper limb opening and closing points were significantly longer than the latency of the adjunct points （P〈0.05）; in the female group, the latencies of the lower-limb opening points were significantly shorter than those of the lower-limb closing and adjunct points （P〈0.05）. Conclusion： Based on Fei Teng Ba Fa, the pain thresholds of the eight confluent points vary in different periods of time, gender, acupoint location and opening/closing state, which can be taken as the evidence of making time-based acu puncture-moxibustion prescriptions.