| 1 BackgroundThis study is derived from the National Key Basic Research Program of China(973 program)Study on Mechanism of Moxibustion based on Clinical efficacy "(2015CB554506),which was designed to evaluate the difference of clinical efficacy of moxibustion of different origins and different storage periods and summarize quality variation rules as well as combustion characteristics,to find out factors that play an important role in the clinical efficacy and finally a quality evaluation system based on the clinical efficacy can be established.This study is the second phase of the 973 program(comparison of clinical efficacy of Moxibustion of different storage periods for Treating Knee Osteoarthritis).The prevalence of knee osteoarthritis(knee OA)is high,which can reach 85%among elderly people over 65 years old in China and disability rate is as high as 53%.In 2007,the expert consensus of the International Association for osteoarthritis research(OARSI)recommended the combination of non drug therapy and drug therapy as the best the treatment for KOA.At present,studies have shown that moxibustion hanve a good effect in reducing knee’s pain and improve knee joint function.According to traditional Chinese medicine theory,the effect of moxibustion is related to the origin,storage period and processing of moxa."Compendium of Materia Medica" and Modern researches suggested that the longer the storage period of moxibustion is,the better,the better is the curative effect of moxibustion.However,few researches study the difference Moxiburstion of different storage periods.At present,there is no clear research evidence that can indicate whether different storage periods will affect the clinical efficacy of moxibustion..Based on the previous research of moxibustion of different storage period by domestic and foreign researchers,we believe that the clinical efficacy of moxibustion of different storage periods may be different.Therefore,we designed this study aims at observating and comparing the clinical efficacy and the combustion characteristics of moxibustion of different storage periods(1-year of storage period,Qichun,Hubei VS 3-year of storage period,Qichun,Hubei)for the treatment of knee osteoarthrosis.2 Objective(1)To assess the clinical efficacy of moxibustion of different storage periods for Treating Knee Osteoarthritis(2)Through the comparison and analysis of the combustion characteristics,explaining the possible material basis for the difference in the efficacy of moxibustion of different storage periods3 MethodsThis study was divided into two parts:study on difference in clinical efficacy Moxibustion of different storage periods for Treating Knee Osteoarthritis and study on difference of combustion characteristics of Moxiburstion of different storage periods3.1 Study on difference in clinical efficacy Moxiburstion of different storage periods for Treating Knee Osteoarthritis3.1.1 MethodsThis study recruited 176 eligible participants from the acupuncture and combustion Hospital of China Academy of Chinese Medicine Sciences,Shanghai Research Institute of acupuncture and meridian,Beijing First Hospital of Integrated Chinese and Weatem Medicine,DuShanZi people’s Hospital from March 2018 to March 2019.All participants signed informed consent before enrollment.Eligible participants were randomly divided into moxa group 1 and moxa group 2 according to the ratio of 1:1 using the central random system of the Institute of Traditional Chinese Medicine and Basic Medical Sciences of China Academy of Chinese Medical Sciences,with 88 cases in each group.In moxa group 1 and moxa group 2,moxibustion therapy was performed with 1-year of storage period moxibustion and 3-year of storage period moxibustion respectively.After the patient is lying on his back,and the skin on the affected knee was routinely sterilized,,the doctor used a custom moxibustion rack to clamp the moxa sticks and adjusted to the appropriate height to align the three acupoints.the burning end of the moxa stick is located about 2cm above the acupuncture point.Light the moxa stick,adjust the moxa stick burning height appropriately according to the patien’s feeling,and take the patient’s tolerance as the degree.At the same time,during the treatment process,clear the moxa stick every 5 min.Both groups took moxibustion on three standard acupoints(EX-LE2,EX-LE 4 and ST 35)of the affected knee.The duration of treatment is about 20 minutes.The treatment frequency was once every other day and 3 times a week for a total of 2 weeks.Outcome measures included Baseline information,VAS score of knee pain,,WOMAC pain item scores,WOMAC stiffness item scores,WOMAC function item scores,and overall patient assessment scores.The main outcome measures were the change of VAS score of knee pain and the change of WOMAC pain item score after 2 weeks of treatment compared with baseline.The time of evaluation was at the time of enrollment,2 weeks after treatment and 4 weeks follow up.3.1.2 Results3.1.2.1 Baseline dataThere was no statistically significant difference between the moxa group 1and the moxa group 2 in terms of gender,age,course of disease,WOMAC pain item scores,VAS scores of knee pain,WOMAC stiffness item scores,WOMAC function item scores,and overall patient assessment scores(P>0.05).The two groups are comparable in baseline.3.1.2.2 The primary outcome measures3.1.2.2.1 WOMAC pain item scoresIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the WOMAC pain item scores of moxa group 1 and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment and 6 weeks after treatment,there was no statistically significant difference in WOMAC pain item scores between moxa group land moxa group 2(P>0.05).3.1.2.2.2 VAS scores of knee painIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the VAS scores of knee pain of moxa group 1 and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment and 6 weeks after treatment,there was no statistically significant diffrence in VAS scores of knee pain between moxa group 1 and moxa group 2(P>0.05).3.1.2.3 The secondary outcome measures3.1.2.3.1 WOMAC stiffness item scoresIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the WOMAC stiffness item scores of moxa group 1 and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment,,there was no statistically significant difference in WOMAC stiffness item scores between moxa group 1 and moxa group 2(P>0.05).At 6 weeks after treatment,there was a statistically significant difference in the WOMAC stiffness item scores between moxa group 1 and moxa group 2(p<0.05).3.1.2.3.2 WOMAC function item scoresIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the WOMAC function item scores of moxa group 1and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment and 6 weeks after treatment,there was no statistically significant difference in WOMAC function item scores between moxa group 1 and moxa group 2(P>0.05).3.1.2.3.3 Total scores of WOMACIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the total scores of WOMAC of moxa group 1 and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment and 6 weeks after treatment,there was no statistically significant difference in total scores of WOMAC between moxa group 1 and moxa group 2(P>0.05).3.1.2.3.4 Overall patient assessment scoresIntra-group comparison:At 2 weeks after treatment and 6 weeks after treatment,the overall patient assessment scores of moxa group 1 and moxa group 2 was statistically significant compared to baseline(P<0.01).Comparison between groups:At 2 weeks after treatment and 6 weeks after treatment,there was no statistically significant difference in overall patient assessment scores between moxa group 1 and moxa group 2(P>0.05).3.1.2.4 Comparison of temperature and duration of heat sensationThere was no significant difference between the two groups in the time when the temperature of EX-LE2 acupoint reached 41℃,the time that the patient could not tolerate,the temperature that the patient could not tolerate,and the duration of heat sensation after the first moxibustion(p>0.05).3.1.2.5 Participant’s blind testParticipant identified the storage periods of moxibustion in moxa group 1 and moxa group 2.There was no significant difference between the two groups(P>0.05).3.2 study on difference of combustion characteristics of Moxiburstion of different storage periods3.2.1 MethodsThe 1-year of storage period moxibustion and 3-year of storage period moxibustion were provided by professor Guo Shuangxi,and the production of moxa sticks was processed by Nanyang Han Medicine Company.According to the physical characteristics of moxa’s biomass and the characteristics of routine clinical use,select air as the carrier gas,and refer to the experimental conditions of similar biomass pyrolysis process,program the temperature scan,and set the experimental temperature range of 28-900°The carrier gas is air,the heating rate is 10℃/min,the air flow rate is 100 mL/min,and the empty Al2O3 crucible is used as a control.The sample dosage is about 7.5 mg.Sample determination n≥2.3.2.2 ResultsThe J value of 3-year of storage period moxibustions is 9053 J/g,and the J value of 1-year of storage period moxibustion is 12019.3.The W values of the oxidation section and carbonization section are 1-year of storage period moxibustion(15.96,11.96)and 3-year of storage period moxibustion(21.93,32.50);The Rv value of the 3-year of storage period moxibustion is 1.181331%/min,which is higher than the 1.600%/min of the 1-year of storage period moxibustion;the burning index S of 3-year of storage period moxibustion(13.7720)is higher than the one year(9.2132);the Ti index for3-year of storage period moxibustion is 275,which is higher than 258 for 1-year of storage period moxibustion4 Conclusion(1)Moxibustion of different storage periods(1 year vs 3 years)can effectively alleviate the symptoms of patients with moderate to severe knee osteoarthritis.However,there is no significant difference in the clinical efficacy in relieving pain and stiffness and improving knee osteoarthritis function;(2)There are differences in the combustion characteristics of moxbustion of different storage periods(1 year vs.3 years),but these differences may not be enough to make a difference in clinical efficacy. |
