A Clinical Study Of Hand-yangming Meridian Penetrating Acupuncture In The Treatment Of Hashimoto's Disease: A Randomized Controlled Trial

BackgroundHashimoto disease,often known as Hashimoto thyroiditis(HT),is the main cause of hypothyroidism,and the incidence rate is increasing year by year.With the etiology and pathogenesis unclear,currently,effective treatment is still lacking.The clinical symptoms of HT patients are related to the state of thyroid function and immune disorders;even HT patients with normal thyroid function can still suffer from clinical symptoms that affect the quality of life.Acupuncture and Moxibustion enjoys a long history and rich experience in the treatment of thyroid diseases.Earlier clinical study has suggested that acupuncture is potentially effective in the treatment of HT,however,it is still necessary to explore more reasonable therapeutic schemes and conduct higher-quality clinical research to evaluate the clinical value of acupuncture in the treatment of HT.Purpose1.Using a Scoping Review approach,we systematically evaluate the clinical research status of acupuncture and moxibustion for HT,regarding the research design and reporting quality,so as to explore the value and direction of future clinical research or systematic review.2.Based on ancient literature and related textbooks of acupuncture,we summarize the regularity of acupuncture and moxibustion for the treatment of thyroid diseases and moxibustion,so as to provide more sufficient literature basis and rationality for acupuncture treatment plan for HT.3.Using a randomized controlled trial(RCT)design,we perform a preliminary evaluation of clinical efficacy and feasibility of the hand-yangming meridian penetration needling for the treatment of HT,through thyroid antibody test,thyroid function test,quality of life scale,anxiety and depression scale;We compare the thermal imaging difference of the neck and upper limbs of HT patients with healthy subjects by infrared thermal imaging examination.MethodsStudy 1:Current status and prospects of controlled clinical studies on acupuncture and moxibustion in the treatment of Hashimoto disease:A scoping reviewBased on the PRISMA-ScR report regulation released in 2018,using the scoping review approach,we systematically searched 4 Chinese databases((China Knowledge Network(CNKI),Wanfang,Weipu,China Biomedical Database(SinoMed)),and 3 English databases(PubMed,Embase,and Cochrane Library).The time range was from database establishment to April 6,2021.Systematic reviews and clinical controlled studies of acupuncture and moxibustion treatment for HT,including RCT and non-randomized control trial(NRCT)were included.We described the basic characteristics of the included literature,and evaluated the report quality of the related research types using PRISMA statement,CONSORT 2010 statement and STRICTA statement,TREND list.Study 2:A study on acupoint selection for Yingbing disease in ancient medical books and modern acupuncture textbooksWe determined the search scope of ancient books from the pre-Qin to Qing dynasty with reference to "Chinese Acupuncture and Moxibustion Collection Second Volume-Existing Medical Books of Acupuncture and Moxibustion","Chinese Medical Dictionary(5th edition)"and comprehensive medical books containing acupuncture and moxibustion.A combination of electronic retrieval and manual retrieval was used to retrieve records of acupuncture and moxibustion in the treatment of Yingbing disease in ancient books.The combining of frequency analysis and descriptive analysis is used to analyze the regularity of selecting acupoints in the treatment of Yingbing disease by ancient physicians.We manually searched 21 textbooks of"Acupoints","Acupoints and Meridians" and "Acupuncture and Moxibustion Therapeutics"published by China Traditional Chinese Medicine Press,People's Medical Publishing House,and Shanghai Science and Technology Press.The frequency analysis and association rule analysis were used to summarize the main acupoints for Yingbing disease in acupuncture and moxibustion textbooks.Study 3:Hand Yangming meridian penetration acupuncture therapy in the treatment of Hashimoto disease:a randomized controlled trialAdopting a practical,parallel,randomized,blank-controlled,pilot trial,60 patients with HT hypothyroidism or hypothyroidism were recruited,and randomly divided into experiment group and control group with 1:1 ratio.Subjects in both groups took Levothyroxine Sodium Tablets(Euthyrox)to control their thyroid function at a normal level.The experiment group received 16 weeks of Hand Yangming meridian penetration acupuncture therapy,and then entered a 16-week follow-up observation period;the control group completed 16-week observation period,and then entered acupuncture compensation treatment.The plan of Hand Yangming meridian penetration needling includes bilateral Sanjian(LI3)penetrating Hegu(LI4),Quchi(LI11)penetrating Binao(LI14),Binao(LI14)penetrating Jianyu(LI15),oblique needling Jianyu(LI15),straight needling Zusanli(ST36),and straight needling Renying(ST9),using filiform needling.The main outcome measure for effectiveness was the comparison of thyroid antibody changes from the baseline level to the 16th week between two groups.The secondary outcome measures for effectiveness include thyroid antibodies at each time point,thyroid function,SF-36 health measurement scale(SF-36),the concise version of the Quality of Life Scale for Patients with Thyroid Diseases(ThyPRO-39),and the Hospital Anxiety and Depression Scale(HADS)between groups and within groups.In addition,we recruited the patients who is willing for the infrared thermal imaging examination,and 15 healthy subjects as controls,before the start of acupuncture treatment to explore the thermal imaging characteristics of the neck and upper limbs of patients with HT.ResultsStudy 1:Current status and prospects of controlled clinical studies on acupuncture and moxibustion in the treatment of Hashimoto disease:A scoping reviewA total of 267 relevant literatures were retrieved,and 23 articles that met the criteria for inclusion and exclusion were included,including 2 systematic reviews,19 RCTs,and 3 NRCTs,including one of the systematic reviews and RCT from the same graduate dissertation.The 23 articles involved 19 original studies.The report qualities of the 2 systematic reviews were relatively high,and the unreported items were program registration information.The report quality of RCT and NRCT were relatively low,and the unreported items mainly focused on auxiliary intervention measures,random methods,sample size,statistical methods and results of auxiliary analysis;the discussion parts rarely involved extrapolation and comparative analysis of similar studies;the rationality of the treatment plan lacked sufficient literature support.The most frequently used outcome measures were thyroid antibody(22%),thyroid function(20%),TCM symptom score(15%),effective rate(13%),and thyroid volume(7%).Study 2:A study on acupoint selection for Yingbing disease in ancient medical books and modern acupuncture textbooksA total of 99 ancient acupuncture and moxibustion medical books were retrieved,of which 75 were electronically retrieved using the "Chinese Medical Dictionary" and 24 were manually retrieved.A total of 164 records related to acupuncture and moxibustion treatment for Yingbing disease were observed.In terms of the frequency of acupoints use,more types and higher frequencies were observed in acupoints located on the neck and upper limbs(11 acupoints each),and the total frequency of acupoints use was 73 and 68,respectively.Through sorting out the acupuncture points used in the treatment of Yingbing disease in different historical periods,26 acupoints for the treatment of Yingbing disease were summarized.In "Acupoints" and"Acupoints and Meridians",the main acupoints for Yingbing disease were mainly distributed on the neck,upper limbs,head and back;the core acupoints of the Yingbing disease prescriptions in " Acupuncture and Moxibustion Therapeutics" were Ashi acupoints,Tiantu(RN22),Danzhong(RN1 7),and Zusanli(ST36),Fenglong(ST40),Hegu(LI4).Study 3:Hand Yangming meridian penetration acupuncture therapy in the treatment of Hashimoto disease:a randomized controlled trial3.1 Thyroid antibodiesAt week 16,the level of thyroid peroxidase antibody(TPOab)in the experiment group changed from baseline by-3.40(-49.35,7.39)IU/mL,the control group changed by 0.00(-9.77,16.53)IU/mL,and difference between groups was statistically insignificant(P=0.116);thyroglobulin antibody(TGab)in the experiment group changed from baseline by-33.30(157.30,4.80)IU/mL,the control group changed 2.79(-9.00,74.60)IU/mL,and difference between groups was statistically significant(P=0.009).3.2 Thyroid functionDuring the study period,the thyroid function of the two groups of subjects remained stable,and there was no statistical difference between and within the group(P>0.05).3.3 Thyroid-Specific Patient Reported Outcome 39(ThyPRO-39)The total Thy PRO score of the experiment group was only 3.737 points lower than that of the control group at 16 weeks[95%confidence interval:1.546 to 5.928,P=0.001].At 16 weeks after treatment,the total ThyPRO score of the test group had returned to the pre-treatment level(P=0.062).In terms of subscale scores,the hypothyroidism score(P=0.002),goiter score(P=0.011),and composite quality of life score(P=0.006)of the experiment group improved better than the control group at the 16th week.3.4 The MOS Item Short From Health Survey(SF-36)The total score of SF-36 in the experiment group increased by 5.753[95%confidence interval:1.703 to 9.804,P=0.004]compared with the control group at the 16th week,but dropped to the pre-treatment level at 8 weeks after the treatment(P=0.134).In terms of scores in various fields,acupuncture treatment has significantly improved energy(P=0.035),mental health(P=0.027),and physiological functions(P=0.008).3.5 Hospital Anxiety And Depression Scale(HADS)Before treatment,the overall anxiety and depression scores of the subjects in this study were 5.22±3.54 and 6.98±2.84,respectively.After treatment,there was no statistical difference in the comparison of the HADS scale between groups(P>0.05).3.6 Infrared thermal imaging inspectionThe highest temperature,lowest temperature,mean temperature and heterogeneity of neck in HT patients were higher than those of healthy people(P highest temperature<0.001,P lowest temperature=0.008,P mean temperature=0.001,P heterogeneity=0.002);There was a difference in the proportion of the high temperature area on the front of the upper arms on both sides in HT patients than in healthy people(P right<0.001,P left=0.001).3.7 Safety evaluationAdverse events of acupuncture were mainly manifested as subcutaneous bruises of the upper limbs.There were no adverse events related to the use of L-T4 drugs in the two groups of subjects,and there were no serious adverse events.Conclusion1.The scoping review study shows that it is not necessary to make more detailed systematic reviews.It is more in line with the current clinical and scientific research needs to explore more reasonable treatment plans and carry out higher-quality clinical research.2.The main characteristics of acupoints selected by ancient acupuncture and moxibustion doctors to treat Yingbing disease were the preference of acupoints near the neck and on the anterolateral arm.The acupoints for Yingbing disease in modern "Acupoints" and "Acupoints and Meridians" are similar to the ancient literatures,and "Acupuncture and Moxibustion Therapeutics" further emphasizes the selection of acupoints in the remote parts in Yingbing disease prescriptions,like Zusanli(ST36),Fenglong(ST40),and Hegu(LI4)based on Traditional Chinese Medicine theory.3.Clinical studies have shown that the treatment of Hashimoto disease by Hand Yangming meridian penetration acupuncture for 16 weeks can reduce the level of TGab and improve the quality of life and some clinical symptoms.The Hand Yangming Meridian acupoints on the arm may have a specific effect on the treatment of thyroid diseases.