Application of clinical value assessment of treatment protocols in guideline development: taking the WFAS Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine as an example. / 治疗方案临床价值评估在指南制定中的应用.

To enhance the clinical applicability of guidelines and provide more effective guidance for clinical practice, a clinical value assessment was conducted during the development of the World Federation of Acupuncture-Moxibustion Societies (WFAS) Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine, which involved the evaluation of 59 acupuncture and moxibustion treatment protocols from randomized controlled trials (RCTs). This article introduced the methodology, content and results of the clinical value assessment of RCT-based acupuncture and moxibustion treatment protocols, which involved the integration of historical and contemporary medical evidence and expert consensus. It served as a methodological reference for the future development of acupuncture and moxibustion clinical practice guidelines.

Effectiveness of Acupuncture for Prophylactic Treatment of Migraine: A Systematic Review and Bayesian Network Meta-Analysis.

It is aimed to evaluate the effectiveness and provide evidence-based medical support for acupuncture as a prophylactic treatment for migraines. Randomized controlled trials (RCTs) from inception to April 2022 are included in 14 databases. Pairwise meta-analysis is conducted using STATA software V14.0, while Windows Bayesian Inference Using Gibbs Sampling (WinBUGS V.1.4.3) is applied to generate Bayesian Network Meta-analysis (NMA) using Markov chain Monte Carlo algorithm. Forty RCTs are included, with 4405 participants. The effectiveness of six acupuncture techniques, three types of prophylactic drugs, and psychotherapy are compared and ranked. Acupuncture outperformed prophylactic drugs in terms of diminishing visual analog scale (VAS) score, migraine attack frequency, and days during the treatment and at the 12-week follow-up. At the 12-week follow-up, the effectiveness of various interventions is ranked as follows: manual acupuncture (MA) > electroacupuncture (EA) > calcium antagonists (CA) in reducing VAS score; MA > EA > CA in reducing migraine attack frequency; MA > EA > ß-receptor blocker and CA in reducing headache attack days. Acupuncture is a promising treatment for migraine prevention. The best option of acupuncture for improving various migraine outcomes has changed over time. However, the quality of included trials and NMA inconsistency limited the credibility of the conclusion.

[Developing process and term analysis of WFAS standard: General Requirements for the Risk Control in the Safe Use of Acupuncture].

In order to promote the application of WFAS standard, General Requirements for the Risk Control in the Safe Use of Acupuncture and the safe practice of acupuncture technology worldwide, the paper introduces the developing process and main contents of this standard, explains the developing purpose, scope, ideas, methods and basis, and analyzes the definition of the relevant terms. Through strictly complied with the development procedure of standard, the terms related to acupuncture risk in this standard are defined. The connotations of 5 special terms are clarified, i.e. "acupuncture risks" "adverse events of acupuncture" "adverse reactions of acupuncture" "acupuncture accidents" and "acupuncture negligence". The range, rank, control flow and source of risk, as well as the control measures are determined. The standard extracts the underlying common problems and basic requirement of the safe practice of acupuncture so as to lay a framework for the development of the relevant technical standards of acupuncture.

[Study on key outcome indexes in treatment of migraine with acupuncture and moxibustion].

OBJECTIVE: To identify the key outcome indexes in treatment of migraine with acupuncture and moxibustion. METHODS: Using literature research, questionnaire survey and consensus conference, the key outcome indexes in treatment of migraine with acupuncture and moxibustion were screened and prioritized. RESULTS: The critical outcome indexes for the treatment in attack stage of migraine included 6 effectiveness outcome indexes (headache intensity, headache duration, headache relieve time, effectiveness and level of headache relief within 2 h, headache-related quality of life, level of headache relief within 24 h) and 1 safety outcome index (incidence of serious adverse reactions). The critical outcome indexes for prophylactic treatment included 6 effectiveness outcome indexes (headache day, headache frequency, headache intensity, effective rate, headache-related quality of life, health-related quality of life) and 1 safety outcome index (incidence of serious adverse reactions). CONCLUSION: In terms of the attack stage treatment and prophylactic treatment with acupuncture and moxibustion, the outcome indexes are different, among which, those can directly reflect the conditions of migraine should be optioned in priority. To assess the effectiveness of attack stage, the headache intensity is preferred, using the visual analogue scale (VAS) score, and the preferred time is 2 hours after treatment. Regarding the effectiveness of prophylactic treatment, the headache day, headache frequency and headache intensity should be firstly considered in the assessment, in which, the preferred time for assessment is 12 weeks into treatment, while, the best time for follow-up should be 12 weeks after treatment completion. When the quality of life is considered, the migraine-specific quality of life questionnaire (MSQ) is the top option. For either the attack stage treatment or the prophylactic treatment, the high attention should be laid on the outcome indexes for safety and medical economics evaluation.

[WU Zhong-chao's clinical experience of "dredging stagnation and collaterals" acupuncture for migraine].

Professor WU Zhong-chao's clinical experience of "dredging stagnation and collaterals" acupuncture for migraine is summarized. Professor WU proposes that occiput-nape dysfunction, meridians-tendons dysfunction and stagnation of collaterals due to obstruction of excess-evil could lead to migraine. As such, migraine is treated by comprehensive treatment of adjusting occiput-nape functional zone, relaxing meridians-tendons and blood-letting combined with fire acupuncture.

Efficacy Analysis of the Reinforcing and Circulation-Promoting Protocol of Acupuncture and Moxibustion in Treatment of Twenty-Four Patients with Refractory Chronic Low Back Pain.

Objectives: The purpose of this study was to observe the clinical efficacy of the reinforcing and circulation-promoting protocol of acupuncture and moxibustion in treatment of refractory chronic low back pain, analyze therapeutic principles to obtain treatment efficacy, and develop new therapeutic principles to treat chronic low back pain. Methods: Twenty-four patients from the registry of patients suffering from refractory chronic low back pain were invited to our self-controlled case series, which was conducted in "real-world" settings. We implemented the reinforcing and circulation-promoting protocol of acupuncture and moxibustion to treat these patients and used the Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI) as the observation indices. Results: All 24 patients completed the treatment of acupuncture and moxibustion. The VAS of low back pain was 6.83 ± 2.18 before treatment and 2.13 ± 1.45 after treatment. The difference before and after treatment was significant (P < 0.001). The ODI was 28.21 ± 13.06 before treatment and 16.63 ± 7.20 after treatment. Their difference before and after treatment was significant (P < 0.001). Conclusion: The reinforcing and circulation-promoting protocol of acupuncture and moxibustion is effective in treating refractory chronic low back pain mainly because low back pain can be significantly relieved and motor function can be promoted. This trial was registered with AMCTR-OOO-17000045 (3 December 2016).

[Problems in randomized controlled trial on acupuncture and moxibustion for migraine in the development of international standard of Guideline for Clinical Practice of Acupuncture and Moxibustion: Migraine].

Regarding the development of international standard of Guideline for Clinical Practice of Acupuncture and Moxibustion: Migraine, the existing problems of the design and methodology of randomized controlled trial (RCT) on acupuncture and moxibustion for migraine were summarized in views of participant, intervention, control, outcome and study design. Four directions need to be further explored, (1) research of adolescent migraine, special subtype of migraine and migraine in a special population; (2) research of the immediate analgesic effect of acupuncture and moxibuation at the attack stage of migraine and the therapeutic effect of migraine at each stage; (3) research on safety and health economics; (4) clinical trial registration of acupuncture and moxibustion. In study, the target population should be further determined and specialized, the diagnosis criteria of western medicine and traditional Chinese medicine be generalized and concentrated, the staging and type division of disease be accurate, the intervention procedure be integrated, the control design be rationalized, the outcomes be validated, and the description of randomization and blinding be clarified.

Investigation and Analysis of the Key Objectives of WFAS "Technical Specifications of Acupuncture and Moxibustion: General Rules for the Drafting".

OBJECTIVE: To determine the key objectives of WFAS "Technical Specifications of Acupuncture and Moxibustion: General Rules for the Drafting" (hereinafter referred to as General Rules). METHODS: From the medical institutions, colleges, and scientific research organizations at major levels in China and overseas, leading researchers and experts in the field of acupuncture-moxibustion standardization, as well as some experienced foreign specialists in acupuncture-moxibustion, were selected as the respondents. The questionnaire was prepared by using the website of Questionnaire Star, and 60 links of the questionnaire were sent out through e-mail. Excel was used to set up the database and conduct statistical analysis. RESULTS: Fifty-one valid questionnaires were collected with effective recovery rate of 85%, involving 9 countries (China, South Korea, Italy, Spain, Sweden, Norway, Netherlands, United States, and Canada) from 3 continents. Most experts agreed with us on the target people, structural elements, and text structure proposed in General Rules and held that the General Rules should emphasize the safety and international applicability and should stipulate in details the common problems (contraindications, indications, taboo crowd, target people, therapeutic effects) of various techniques and the specific contents of technical operation (manipulating techniques, selection of patient's body position and treated areas, disinfection and environmental requirements, selection of acupuncture-moxibustion instruments, cautions, needle retention time, treatment frequency, precise location of the acupoints, treatment course) in order to enhance the practicality and operability. CONCLUSION: The key objectives of General Rules mainly include target people, structural elements, text structure, safety requirements, common technical problems of acupuncture-moxibustion, and specific details of technical manipulations.

[Analysis of the results of international demand survey on Guideline for Clinical Practice of Acupuncture-Moxibustion: Migraine].

The survey is conducted prior to the development of international standard, Guideline for Clinical Practice of Acupuncture-Moxibustion: Migraine (Guideline) to determine the international demand. The survey includes 5 aspects, i.e. the application status of acupuncture and moxibustion abroad and the demand for the development of international standards, the priority of diseases developed by international standards, the necessity of the transformation of international standards from domestic standards, the key clinical problems to be solved by international standards, and the correlation between professional level and demand intention. The survey results show that the international demand of the Guideline is definite. Regarding the application range of acupuncture-moxibustion and the key clinical questions, the special consideration should be taken to the differences in the demands of the practitioners from different countries during the development of standard.

[Effect of acupuncture on the cognitive function of migraine patients with depression/anxiety disorder].

OBJECTIVE: To observe the effect of five-element acupuncture on the cognitive function repair of migraine patients with depression/anxiety disorder. METHODS: The migraine patients with depression/anxiety disorder (19 cases, 5 cases dropped off) were taken as the observation group, and received five-element acupuncture twice a week for 8 weeks. Healthy subjects (19 cases) were selected by demographic data matching as the control group. The cognitive function was evaluated with the event related potential (ERP) technique, and the latency and amplitude of visual evoked potential P300 were adopted as the observation indexes. The headache days (every 4 weeks), headache intensity [visual analogue scale(VAS) score], and headache impact test-6 (HIT-6) score, Hamilton depression scale (HAMD) score and Hamilton anxiety scale (HAMA) score were used as the observation indexes for curative effect. RESULTS: Before the treatment, latency of target stimulus at Fz [ (417.5±34.3) ms] in the observation group was extended compared with the healthy subjects of the control group [(388.6±42.1) ms, P<0.05]. In the observation group, the latency of each point target stimulus [Fz: (376.1±36.2) ms, F3: (374.8±37.6) ms, F4: (372.0±37.6) ms] after treatment were shorter than those [Fz: (417.5±34.3) ms, F3: (417.4±33.8) ms, F4: (416.0±36.6) ms] before treatment (P<0.05). Before and after treatment, there was no significant difference in the amplitude of each point between the observation group and the control group (P>0.05). In the observation group, the headache days was shorter than that before treatment (P<0.01), and the VAS score, HIT-6 score, HAMD score and HAMA score were all lower than before treatment (P<0.01). CONCLUSION: There are some cognitive impairments in migraine patients with depression/anxiety disorder. Five-element acupuncture not only relieves headache, anxiety and depression effectively, but also improves the activation level of the frontal lobe. It significantly repairs the impaired cognitive function.

[Analysis on development necessity and key points for Technical Specification of Acupuncture- Moxibustion: General Rules of Drafting of international industry organization standard].

This paper analyzes the development necessity of a series of international technical specification of acupuncture-moxibustion from three aspects, the development status of global Technical Specification of Acupuncture-Moxibustion, providing technical support for acupuncture-moxibustion legislation and assisting standardized acupuncture-moxibustion research. The necessity of giving priority to the development of WFAS's Technical Specification of Acupuncture-Moxibustion: General Rules of Drafting (General Rules for short) in the series of standards is discussed from filling the field gap and following the international practice. The key points should be paid attention to in the development process of General Rules are summarized，such as improving practicality based on international perspective, enhancing authority by following international rules, improving international applicability by forming a professional team and ensuring high quality and objective neutrality of the General Rules.

[Analysis on international demand investigation for technical specification of acupuncture- moxibustionthe and its general rules of drafting].

The electronic questionnaire was adopted to survey the international demand on Technical Specification of Acupuncture-Moxibustion: General Rules of Drafting (General Rules for short) to explore the potential problems during the application and provide the evidence for the development of international standard of General Rules. A total of 102 valid questionnaires were collected from 18 countries and regions. The priority of the demand for international standard on the technical specification of acupuncture-moxibustion is filiform needle, moxibustion, electroacupuncture, cupping, auricular acupuncture, scalp acupuncture and scraping. One hundred experts (98.04%) at home and abroad believe the necessity of the international standard development of General Rules. The awareness rate of the existing national standard of General Rules is 71.57% and the foreign experts think that its expression may be "unclear" and the domestic experts think it may be "lack of practicability". The domestic experts hope to highlight the commonness in the scope of the international standard of General Rules and the foreign experts hope to retain more individuality. Regarding the specific questions during the technique manipulations of acupuncture-moxibustion, there are the big differences in "relevant terminology" "preoperative preparation" and "adverse reaction and contraindications" at home and abroad. In order to improve the international compatibility and applicability, it is necessary to give full consideration to the needs of different countries in the development of international standard of General Rules and balance as far as possible between refining "common problems" and satisfying "individual needs".

[Professor WU Zhong-chao's clinical experiences of "syndrome differentiation and Chinese herbal plaster application" based on meridian and zangfu theories].

Focusing on the limits of the plaster application of Chinese herbal medicine in clinical practice, i.e. limit in the region exerted, inadequate meridian effect, more attention to the exterior rather than the interior and limit in the application of zangfu differentiation, professor WU Zhong-chao proposes his clinical experiences in the plaster application of Chinese herbal medicine based on meridian and zangfu differentiation, including: The Chinese herbal plaster application alone meridian course guided by meridian differentiation. Multidimensional plaster application on the base of the meridian differentiation of muscle region. Split-field plaster application by taking collateral differentiation as principle. Selective plaster application in association with disease differentiation. Specific plaster application rooted on zangfu differentiation.

Callus growth kinetics and accumulation of secondary metabolites of Bletilla striata Rchb.f. using a callus suspension culture.

Bletilla striata is an endangered traditional Chinese medicinal plant with multiple uses and a slow regeneration rate of its germplasm resources. To evaluate the callus growth kinetics and accumulation of secondary metabolites (SMs), a callus suspension culture was proven to be a valuable approach for acquiring high yields of medicinal compounds. An effective callus suspension culture for obtaining B. striata callus growth and its SMs was achieved with the in vitro induction of calluses from B. striata seeds. The callus growth kinetics and accumulation of SMs were analyzed using a mathematical model. The resulting callus growth kinetic model revealed that the growth curves of B. striata suspension-cultured calluses were sigmoidal, indicating changes in the growth of the suspension-cultured calluses. Improved Murashige and Skoog callus growth medium was the most favorable medium for B. striata callus formation, with the highest callus growth occurring during the stationary phase of the cultivation period. Callus growth acceleration started after 7 days and thereafter gradually decreased until day 24 of the cultivation period and reached its highest at day 36 period in both the dry weight and fresh weight analyses. The coelonin concentration peaked during the exponential growth stage and decreased afterward during the stationary stage of the callus suspension culture. The maximum content of coelonin (approximately 0.3323 mg/g callus dry weight) was observed on the 18th day of the cultivation cycle, while dactylorhin A and militarine reached the highest concentrations at day 24, and p-hydroxybenzyl alcohol at day 39. This investigation also laid a foundation for a multimathematical model to better describe the accumulation variation of SMs. The production of SMs showed great specificity during callus growth and development. This research provided a well-organized way to increase the accumulation and production of SMs during the scaled-up biosynthesis of calluses in B. striata callus suspension cultures.

[Transformation of the domestic standard (Guideline for Clinical Practice of Acupuncture-Moxibustion: Migraine) to international standard: in the perspective of the differences in clinical questions].

Through analyzing the differences in the clinical questions of Guideline for Clinical Practice of Acupuncture- Moxibustion: Migraine (Guideline) between the domestic standard and international standard (under development), the specific issues are determined in the transformation from domestic standard to international one. Taking acupuncture practitioners as investigation object, by means of the survey, the basic information and clinical questions were investigated. The survey results show that the following aspects should be supplemented in terms of the international requirements during the development of this international Guideline: suitable patient population, applicable types of disease, the optimal intervention time of acupuncture for migraine, common methods in treatment as well as the other involved health problems. Moreover, it needs to update the key clinical questions, recommended regimens for the newly supplemented types of disease, as well as the more specified assessment on therapeutic effect. The ultimate solution of these questions relies on the quality of clinical evidence.

[Moxa-stick moxibustion activates mast cells of small intestine tissue in rats].

OBJECTIVE: To explore the effect of moxa-stick moxibustion and joss-stick moxibustion at "Guanyuan" (CV4) on the activity of mast cells in the small intestine tissue in rats. METHODS: Twelve male SD rats were randomly divided into control, joss-stick moxibustion and moxa-stick moxibustion groups (n=4 rats in each group). Joss-stick or moxa-stick moxibustion was applied to CV4 for 10 min. After moxibustion, the skin temperature of the CV4 region was measured immediately with a thermometer. The mast cells and nerve fibers in the small intestine tissue were displayed by immunofluorescence histochemistry. RESULTS: Compared with the control group, the skin temperature of the CV4 region in both the joss-stick and the moxa-stick groups were significantly increased (P<0.05), while the skin temperature of the moxa-stick group was significantly higher than that in the joss-stick group (P<0.05). There were a large number of tryptase-positive mast cells in the small intestine of rats, some of which were co-expressed with lysosomal-associated membrane protein 1, displaying an activated state. The average numbers of mast cells in the control, joss-stick and moxa-stick groups were 9.2±3.6, 10.8±5.3 and 17.1±6.3, respectively, being significantly higher in the moxa-stick group than in the control and joss-stick groups (P<0.05). In addition, calcitonin gene-related peptide(CGRP) and neuropeptide Y(NPY) positive nerve fibers were found around the mast cells in the small intestinal tissues. CONCLUSION: Moxa-stick moxibustion gives rise a higher temperature at CV4 to activate mast cells surrounded by CGRP and NPY positive nerve fibers in the small intestine tissue in rats, suggesting an involvement of the sensory and sympathetic nervous system in the activation of intestinal mast cells possibly by way of somatic sympathetic reflex.

[Clinical study of fire acupuncture with centro-square needles for knee osteoarthritis].

OBJECTIVE: To compare the efficacy difference between fire acupuncture with centro-square needles (FACSN) and filiform needling (FN) for knee osteoarthritis (KOA). METHODS: Seventy-two patients were randomly assigned into an FACSN group and an FN group, 36 cases in each one. Ashi points, Xuehai (SP 10), Liangqiu (ST 34), Neixiyan (EX-LE 4), Dubi (ST 35), Zusanli (ST 36), Yanglingquan (GB 34) and Yinlingquan (SP 9) were selected in the two groups. The FACSN group was treated with FACSN, and three acupoints were selected for each treatment; the FN group was treated with FN, and all the acupoints were selected for each treatment. The cupping treatment was given after acupuncture in the two groups. The treatment was given once every other day, without treatment on Sundays. The treatment was given three times a week, 6 times as one course; totally 2 courses were provided. The visual analogue scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were observed in the two groups before treatment, two weeks, four weeks into treatment and at one-month follow-up visit. In addition, the comprehensive efficacy was compared between the two groups. RESULTS: Compared before treatment, the score of VAS and the total score of WOMAC were improved in the two groups at each time point after treatment (all P<0.01); the scores of VAS at each time point after treatment in FACSN group were lower than those in the FN group (all P<0.05); four weeks into treatment and at one-month follow-up visit, the total score of WOMAC in the FACSN group was lower than that in the FN group (both P<0.05). Two weeks into treatment, the total effective rate was 88.9% (32/36) in the FACSN group, which was higher than 61.1% (22/36) in the FN group (P<0.01); four weeks into treatment and at one-month follow-up visit, the cured and remarkable effective rates were 66.7% (24/36) and 83.3% (30/36) in the FACSN group, which were higher than 41.7% (15/36) and 44.4% (16/36) in the FN group (P<0.05, P<0.01), respectively. CONCLUSIONS: Fire acupuncture with centro-square needles has relatively high cured and remarkable effective rate for KOA, with rapid onset; as for pain relief, the efficacy is superior to filiform needling.

[Explanation of Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion: Adult Bronchial Asthma].

The development and compilation of Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion: Adult Bronchial Asthma are introduced from three aspects, named the guideline methodology, the guideline structure and the guideline content. Based on the acupuncture-moxibustion practice and clinical research, the evidence-based medicine method is adopted. During the development and compilation of the guideline, the characteristics and advantages of acupuncture and moxibustion are specially considered in the treatment of this disease; the latest optimum evidences at home and abroad, experts' experience and patients' value are closely integrated with each other. Additionally, the worldwide accepted assessments of evidence quality and the recommendation (GRADE system) are combined with the clinical evidences of the ancient and modern famous acupuncture-moxibustion experts, and the clinical research evidences are with the experts' consensus to the large extent. The purpose of the guideline is to provide the maximal guidance to the clinical physicians.

[Professor WU Zhongchao's experience in the treatment of bi syndrome with fire needling therapy at lower he-sea points].

Bi syndrome is classified into five categories. Based on the syndrome differentiation of meridians and collaterals and zangfu theories, Professor WU Zhongchao proposed the fire needling therapy at the lower he-sea points for five types of bi syndromes. Professor WU stresses on the flexible application of fire needling therapy for bi syndrome at the lower he-sea points and innovated the unique five techniques of fire needling therapy, named lifting and threating needle of small amplitude at the lower he-sea points, the stimulation along the relevant meri-dians before fire needling, detecting the sensitive sites by gentle pressing the relevant lower he-sea points, combining the movement of affected upper limb or joint during fire needling, or combining with contralateral needling technique, and controlling the depth of fire needling based on the duration of sickness and depth of affected site. He pointed out that Shangjuxu (ST 37) is for skin bi syndrome, Zusanli (ST 36) for muscle bi syndrome, Yanglingquan (GB 34) for tendon bi syndrome, Weizhong (BL 40) for bone bi syndrome and Xiajuxu (ST 39) for vessel bi syndrome.

[Interpretation of Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion:Migraine of the version 2014].

Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion:Migraine (Guideline) was updated in 2014 on the basis of the version 2011. In Guideline of the updated version, the evidence quality grade and GRADE were adopted for the evidence evaluation and recommendation grading in methodology, and the clinical feasibility was stressed. In text, the recognition of modern medicine was updated, the sta-ging treatment of acupuncture and moxibustion was emphasized, the inclusive articles were expanded and the important indexes of efficacy evaluation were increased and highlighted. The paper aims to provide the instruction for the application of Guideline of the version 2014.