The Quality of Acupuncture Recommendations for Migraine in Global Headache Guidelines: A Systematic Review Using the AGREE II and AGREE-REX Instruments

doi:10.21203/rs.3.rs-3238678/v1

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The Quality of Acupuncture Recommendations for Migraine in Global Headache Guidelines: A Systematic Review Using the AGREE II and AGREE-REX Instruments

https://doi.org/10.21203/rs.3.rs-3238678/v1

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Background and objective: This study aims to identify the quality of acupuncture recommendations for migraine in global headache guidelines.

Methods: Global migraine guidelines published before June 2022 were searched and screened. The AGREE II (Appraisal of Guidelines for Research & Evaluation II) and AGREE-REX (The Appraisal of Guidelines Research & Evaluation Recommendation Excellence) were used to evaluate the reporting quality, methodology quality, and acupuncture recommendations in the included guidelines.

Results: Of the 16 guidelines included, 14 recommended acupuncture treatment for migraine (8 were rated as B by AGREE II, and 6 were rated as C), while 2 recommended against acupuncture treatment (rated as C). One guideline described detailed manipulations (1/14), two described treatment sessions and courses (2/14), and 11 only indicated that acupuncture was effective but without a specific treatment plan mentioned (11/14). The results of the AGREE-REX showed that all 16 guidelines scored relatively high only in the “Evidence” item (mean score: 57.29%), whereas the scores of the other 8 items were low.

Conclusions: Among the current headache guidelines around the world, the number of guidelines recommending acupuncture for migraine treatment is small, the content of recommendations involving acupuncture treatment is limited, and the recommendations for detailed acupuncture treatment programs are insufficient. Within the included guidelines recommending acupuncture for migraine treatment, the report quality, methodology quality, and quality of acupuncture recommendations are low; therefore, it is difficult to meet clinical needs.

Acupuncture

migraine

clinical practice guidelines

recommendation

Epidemiological studies have shown that migraine is a main headache illness that is frequently debilitating and has significant socioeconomic and personal effects¹. Migraine was the second most common cause of young life deaths in the 2019 Global Burden of Disease Study (years lived with disability) ². Global medical groups are taking notice of how serious migraine risks are.

Since 1988, the International Headache Society (IHS) has produced The International Classification of Headache Disorders³, sequentially revised the guidelines^1,4, and subsequently issued various headache clinical trial guidelines^5,6 to provide a uniform paradigm for headache clinical trials. In a report on headache disorders and public health published in 2007, the World Health Organization (WHO) highlighted the significant regional variations in the management of migraine, the vast variety of practitioners engaged in diagnosis and treatment, and the availability of medications. In 2011, the World Health Organization (WHO) published the Atlas of Headache Disorders and Resources in the World⁸, which gathered data on headache illnesses in many nations, increased public awareness of headaches, and enhanced medical treatment and services for headache sufferers. The recommendations and materials produced by these international organizations, however, did not include the migraine treatment plan.

Clinical practice guidelines (CPGs) can assist doctors and patients in choosing the best course of action in a specific clinical context to prevent, diagnose, or treat certain conditions⁹. Numerous CPGs have been made available globally to treat headaches, including migraine. Several migraine therapy recommendations have been released by several national academic groups, including SIGN (Scottish Intercollegiate Guidelines Network) ¹⁰, BASH (British Association for The Study Of Headache) (British Association for The Study Of Headache) ¹¹, NICE (National Institute for Health and Care Excellence) (National Institute for Health and Care Excellence) ¹², AAN (American Academy of Neurology) (American Academy of Neurology) ¹³, EHF (European Headache Federation) (European Headache Federation) ¹⁴, GC (Global Campaign against Headache) (Global Campaign against Headache) ¹⁵, China Association of Moxibustion and Acupuncture ¹⁶, Chinese Medical Association ¹⁸, JHS (Japanese Headache Society ²¹ and others.

A rising number of high-quality clinical studies^22–24 have recently provided evidence that acupuncture is actually an effective therapy for migraines, supporting the thousands of years of usage of the practice in China. Despite the fact that various regulations mention acupuncture suggestions, the quality of those recommendations varies, and there are no internationally acknowledged regulations governing acupuncture treatment regimens. To describe the present state of the worldwide migraine guidelines' recommendations for acupuncture treatment, the specifics of those recommendations' content, and the quality of those recommendations, this study searched global migraine guidelines, which are CPGs developed globally specifically for migraine and CPGs for pain or headache that include a migraine component published by June 2022.

Literature Retrieval

Six literature databases and nine websites were searched from their inception to June 24, 2022. PubMed, Embase, Web of Science (WOS), Chinese National Knowledge Infrastructure (CNKI), WAN FANG Database, and VIP database were the six literature databases mentioned. The National Institute for Health and Care Excellence (NICE, https://www.nice.org.uk/), Guidelines International Network (GIN, https://guidelines.ebmportal.com/), National Guideline Clearinghouse (NGC, https://www.thecommunityguide.org/resources/national-guideline-clearinghouse), Scottish Intercollegiate Guidelines Network (SIGN, https://www.sign.ac.uk/our-guidelines/), European Academy of Neurology (EAN, https://www.ean.org/), and American Academy of Neurology were among the nine websites. https://www.medsci.cn/. There were no linguistic limitations.

The search approach used "headache," "guideline," "suggestion," and "statement" in combination. In Appendix 1, the search strategy's specifics are described.

Literature Selection

The standards for inclusion and removal were specified. The CPGs are covered, and among them, migraine is a target disease, acupuncture is an intervention, and specific recommendations are made for using acupuncture to treat migraine. Whole texts without download access, outdated versions of new recommendations, interpretation/summary/review of the guideline(s), and expert consensus were all removed.

The titles and abstracts of the retrieved papers were independently reviewed by two qualified reviewers. The entire texts of the included articles were then reviewed using the same standards, and any differences were discussed with a third reviewer.

Quality Assessment

Two assessors independently evaluated the relevant recommendations and the accompanying CPG. Each assessor finished the appropriate training sessions before starting, and they also reviewed the AGREE II ²⁵ (Appraisal of Guidelines for Research & Evaluation II) and AGREE-REX²⁶ (The Appraisal of Guidelines Research & Evaluation Recommendation Excellence) user manuals for instructions on how to evaluate each item. After that, a CPG was selected as a pilot, and a conference was scheduled to address any further issues that needed explanation as well as any topics where the assessors' scores varied by more than 20%. Each then independently evaluated the presented instructions, and disagreements were resolved by consensus or by consulting an unbiased expert. The AGREE II²⁵ instrument was used to assess the methodological quality of the included guidelines, and the AGREE-REX²⁶ tool was used to assess the quality of recommendations for acupuncture. These tools may help to improve the quality of guideline recommendations by making them more believable, reliable, and practicable in the clinical setting.

The AGREE II instrument²⁵, which has 6 domains, 23 items, and 2 overall assessments, was used to assess the methodological quality of the guidelines that were included. Scores ranged from 1 (strongly disagree) to 7 for each item (strongly agree). The AGREE-REX²⁶, which consists of 3 domains and 9 items in total, was used to assess the acupuncture recommendations in the guidelines. Each item received a score between 1 and 7, with higher scores indicating better compliance.

Statistical analysis

To represent the data, a mean and standard deviation are utilized. The total number and percentage of guidelines that reported each item were calculated. According to the AGREE II and AGREE-REX user manuals, the final domain scores were calculated by summing the scores of all items inside a domain and scaling the total as a percentage of the greatest attainable score for that domain. The following is the scaled domain rating:

$$\text{s}\text{c}\text{a}\text{l}\text{e}\text{d} \text{d}\text{o}\text{m}\text{a}\text{i}\text{n}=\frac{\text{O}\text{b}\text{t}\text{a}\text{i}\text{n}\text{e}\text{d} \text{s}\text{c}\text{o}\text{r}\text{e}–\text{M}\text{i}\text{n}\text{i}\text{m}\text{u}\text{m} \text{p}\text{o}\text{s}\text{s}\text{i}\text{b}\text{l}\text{e} \text{s}\text{c}\text{o}\text{r}\text{e}}{\text{M}\text{a}\text{x}\text{i}\text{m}\text{u}\text{m} \text{p}\text{o}\text{s}\text{s}\text{i}\text{b}\text{l}\text{e} \text{s}\text{c}\text{o}\text{r}\text{e}–\text{M}\text{i}\text{n}\text{i}\text{m}\text{u}\text{m} \text{p}\text{o}\text{s}\text{s}\text{i}\text{b}\text{l}\text{e} \text{s}\text{c}\text{o}\text{r}\text{e}}\times 100\text{%}$$

The better the domain's quality, the higher the score. According to AGREE II, the overall quality of each guideline was assessed. It was rated "A" when all six domains received scores of at least 60%, "B" when more than three domains had scores of at least 60%, and "C" when fewer than three domains received scores of at least 30%. The classification of domain scores included good (≥ 80%), acceptable (60-79.9%), poor (40-59.9%), and extremely low (< 40%). The intraclass correlation coefficient (ICC)²⁷ (two-way random model), which has the following definitions: 0.20, poor; 0.21–0.40, fair; 0.41–0.60, moderate; 0.61–0.80, good; and 0.81, very good, was used to calculate agreement between reviewers' assessments.

Literature retrieval and guideline selection

After evaluating the titles, abstracts, and full texts of the 5670 records found, 16 guidelines with explicit acupuncture therapy recommendations for migraine were eventually included^{10,12,17,21,28–39} (Fig. 1 shows the flowchart).

Characteristics of the eligible guidelines

The guidelines' 24-year release window runs from 1998 to 2021. Europe (8 guidelines), North America (5 guidelines), and Asia are the involved nations (3 guidelines).

The guidelines are available in Chinese, English, Japanese, and Dutch. The majority of the recommendations are made public by pertinent academic groups in different nations and areas. Table 1 lists the traits of the applicable recommendations.

Table 1

Characteristics of included guidelines
Title	Country	Year	Language	Organization
Guidelines for the Nonpharmacologic Management of Migraine in Clinical Practice²⁸	CA	1998	English	Canadian Headache Society
Migraine in Primary Care Advisors. New guidelines for the management of migraine in primary care²⁹	UK	2002	English	The Migraine in Primary Care Advisors
Evidence-based clinical practice guidelines for interdisciplinary rehabilitation of chronic nonmalignant pain syndrome patients³⁰	US	2005	English	Not reported
Practice guideline for diagnosis and management of migraine headaches in children and adolescents: Part two³¹	US	2008	English	National Association of Pediatric Nurse Practitioners
Diagnosis and management of headache in adults¹⁰	UK	2008	English	Scottish Intercollegiate Guidelines Network
Health Care Guideline: Diagnosis and Treatment of Headache³²	US	2009	English	Institute for Clinical Systems Improvement
Tackling migraines in general practice³³	BE	2010	Dutch	Flemish College of General Practitioners
Italian guidelines for primary headaches: 2012 revised version³⁴	IT	2012	English	Italian Society for the Study of Headaches
Headaches in over 12s diagnosis and management¹²	UK	2012	English	National Institute for Health and Care Excellence
Headaches: Diagnosis and Management of Headaches in Young People and Adults³⁵	UK	2012	English	National Clinical Guideline Centre
Guideline for Clinical Practice of Acupuncture in the Treatment of Migraine¹⁷	CN	2014	Chinese	China Association of Acupuncture-Moxibustion
Guideline for Treatment of Chronic Headache²¹	JP	2016	Japanese	Japanese Headache Society
Medical Treatment Guidelines for Preventive Treatment of Migraine³⁶	CN	2017	Chinese	Taiwan Headache Society
Treatment of migraine attacks and prevention of migraine: Guidelines by the German Migraine and Headache Society and the German Society of Neurology³⁷	DE	2019	English	German Migraine and Headache Society German Society for Neurology Society
Migraine Headache Prophylaxis³⁸	US	2019	English	American Family Physician
Revised guidelines of the French headache society for the diagnosis and management of migraine in adults. Part 3: Non-pharmacological treatment³⁹	FR	2021	English	French Headache Society

Acupuncture recommendations in the included guidelines

Fourteen of the included guidelines^{10,12,17,21,29,32−29} recommended acupuncture, while the other two^30,31 recommended against it. Of the 14 guidelines^{10,12,17,21,29,32–39} that advocate acupuncture, one¹⁷ described in detail acupuncture therapy for migraines, including the manipulation details on filiform needle acupuncture, electroacupuncture, fire needle, scalp acupuncture, and bleeding, and displayed the contraindications and precautions of acupuncture treatment; two^12,35 and eleven^{10,21,28,29,32–34,36−39} guidelines recommended acupuncture sessions; and one³⁵ mentioned the cost-effectiveness of acupuncture. One³⁰ of the two guidelines^30,31 that advise against using acupuncture urged avoiding it, while the other³¹ noted that there are no evidence-based therapeutic recommendations for utilizing acupuncture on children.

In terms of the evidence grading system, 2 guidelines^17,33 applied the GRADE (Grades of Recommendations Assessment, Development and Evaluation) system⁴⁰, 1 guideline²⁸ applied the CTFPHC (Canadian Task Force on the Periodic Health Examination) system⁴¹, 1 guideline¹⁰ applied the SIGN system⁴², and 1 guideline³⁸ applied the SORT (Strength of Recommendations Table) system⁴³ by AAFP (American Academy of Family Physicians). Four guidelines^32,33,36,39 applied a self-defined evidence grading system, and 7 guidelines^{12,21,29–31,35,37} did not report its evidence grading system.

Four guidelines^17,31,34,39 for the intervention stage of migraines discussed acute treatment; of these, 3^17,34,39 suggested acupuncture while 1³¹ did not; and 15^{10,12,17,21,28–38} discussed prophylactic therapy; of these, 13^{10,12,17,21,28,29,32–38} recommended it while 2^30,31 did not. Table 2 lists specific acupuncture recommendations from the guidelines that are included.

Table 2

Acupuncture recommendations in the included guidelines
Guideline	Grading system	Recommended conditions	Stage	Level of evidence	Level of recommendation	Sessions and courses	Others
BE, 2010³³	^aGRADE	Recommend	Prophylactic treatment	C	2	\	\
CN, 2014¹⁷	^aGRADE	Recommend	Acute treatment	Bleeding: D	1	Once a week	Indications and contraindications
				Acupuncture/ electro-acupuncture: B、C、D	1	Each session lasting 30 minutes, scalp acupuncture could be retained to 1 hour. Once every other day, one course contains ten sessions.	Indications and contraindications
				Fire needle: D	2	\	Indications and contraindications
			Prophylactic treatment	Comprehensive acupuncture: B、C、D	1	Each session lasting 30 minutes, scalp acupuncture could be retained to 1 hour. Once every other day, one course contains ten sessions. Cooperate with bleeding: once or twice a week according to the patient's situation.	Indications and contraindications
CA, 1998²⁸	^bCTFPHC	Recommend	Prophylactic treatment	I	B	\	\
UK, 2008¹⁰	^cSIGN	Recommend	Prophylactic treatment	1-、1+、1++	B	\	\
US, 2019³⁸	^dSORT	Recommend	Prophylactic treatment	A	\	\	\
US, 2009³²	^eSelf-defined	Recommend	Prophylactic treatment	A	\	\	Expensive and of variable availability
IT, 2012³⁴	^fSelf-defined	Recommend	Acute treatment	–	IV	\	\
IT, 2012³⁴	^fSelf-defined	Recommend	Prophylactic treatment	A	II	\	\
CN, 2017³⁶	^gSelf-defined	Recommend	Prophylactic treatment	Migraine: B	III	\	\
CN, 2017³⁶	^gSelf-defined	Recommend	Prophylactic treatment	Chronic migraine: C	III	\	\
FR, 2021³⁹	^hSelf-defined	Recommend	Acute treatment	\	Strong	\	\
UK, 2002²⁹	\	Recommend	Prophylactic treatment	\	\	\	The long-term side-effect is not properly understood. The physician can recommend use of these therapies, one at a time if the patient shows interest and wants to try something new.
UK (NICE), 2012¹²	\	Recommend	Prophylactic treatment	\	\	Up to 10 sessions of acupuncture over 5–8 weeks	If both topiramate and propranolol are unsuitable or ineffective, consider acupuncture according to the person’s preference, comorbidities and risk of adverse events.
UK (NCGC), 2012³⁵	\	Recommend	Prophylactic treatment	\	\	Up to 10 sessions of acupuncture over 5–8 weeks	If both topiramate and propranolol are unsuitable or ineffective, consider acupuncture according to the person’s preference, comorbidities and risk of adverse events. When 10 sessions are provided, acupuncture is more cost-effective than no treatment; however above this number (11 sessions onward) acupuncture is not cost-effective.
JP, 2016²¹	\	Recommend	Prophylactic treatment	\	B	\	\
DE, 2019b³⁷	\	Recommend	Prophylactic treatment	\	\	\	Patients who refuse or do not tolerate prevention with drugs
US, 2005³⁰	\	Recommend against	Prophylactic treatment	\	\	\
US, 2008³¹	\	Recommend against	Acute treatment Prophylactic treatment	\	\	\	Children
Notes: a. GRADE, Grades of Recommendations Assessment, Development and Evaluation. 1(Strong), 2(Weak), B(High), C(Low), D(Very low). b. CTFPHE, Canadian Task Force on the Periodic Health Examination. I(Evidence obtained from at least one properly randomized controlled trial), B(There is fair evidence to support the recommendation that the condition is specifically considered in a periodic health examination). c. SIGN, Scottish Intercollegiate Guidelines Network. 1-(Meta-analyses, systematic reviews, or RCTs with a high risk of bias), 1+(Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias), 1++(High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias), B(A body of evidence including studies rated as 2 +, directly applicable to the target population, and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 1 + + or 1 +); d. SORT, Strength of Recommendations Table (AAFP, American Academy of Family Physicians) A: consistent, good-quality patient-oriented evidence; e. A(Randomized, controlled trial) f. A( Two or more clinically controlled, randomized, double-blind studies carried out according to good clinical practice (GCP) versus placebo or versus an active drug for which there is proven evidence of efficacy); II(Drugs whose value of efficacy is statistically of lower significance compared to drugs of group I and with a less significant clinical benefit for patients (clinical effectiveness ++) and no severe adverse events), IV(Drugs of proven efficacy but with frequent and severe adverse events or drugs whose efficacy has not been proven from a clinical or statistical point of view (no difference with respect to placebo). Drugs with unknown clinical patient benefit or statistical significance of efficacy (data unavailable or insufficient)). g. B (There have been several clinical randomized controlled trials to support the recommended items, but the scientific support is lack enough rigorous ), C (A single trial or case series report, no good clinical randomized controlled trials), III(Although the clinical effect is good, there are significant side effects, consider using only under the circumstances of when the aforementioned drugs ineffective or special circumstances). h. Strong (Benefits clearly outweigh risks and burdens for most patients = Can apply to most patients in most circumstances).

Quality evaluation of included guidelines

The methodological quality of the included guidelines (AGREE Ⅱ). The scoring by the two reviewers showed very good consistency (ICC = 0.865, 95% CI = 0.832 ~ 0.891, P < 0.001).

Table 3 provides a summary of the AGREE II's standardized domain scores and the CPGs' overall quality rating. The "clarity" dimension had the highest score (mean score: 72.90%), followed by the "scope and purpose" domain (mean score: 65.06%), indicating "acceptable" quality. Other domains were “very low”. Of the 14 guidelines recommending acupuncture, the AGREE II instrument gave 8 guidelines a “B” and 6 guidelines a “C”. Two guidelines that recommended against acupuncture received a "C" score.

Table 3

Results of the AGREE II-based guidelines evaluation
Guide- line	Recommend- ed conditions	Domain (%)						Final overall assessment score	Domain number of score ≥ 60%	Domain number of score༜30%	Guide- line overall quality
Guide- line	Recommend- ed conditions	D1	D2	D3	D4	D5	D6	Final overall assessment score	Domain number of score ≥ 60%	Domain number of score༜30%	Guide- line overall quality
CA, 1998	√	33.33	33.33	41.67	55.56	0.00	8.33	3.5	0	2	B
UK, 2002	√	55.56	44.44	25.00	50.00	25.00	0.00	5	3	3	C
US, 2005	×	61.11	33.33	29.17	77.78	16.67	8.33	3	2	3	C
US, 2008	×	72.22	22.22	22.92	66.67	16.67	8.33	3	2	4	C
UK, 2008	√	77.78	61.11	62.50	88.89	0.00	0.00	4.5	4	2	B
US, 2009	√	100.00	44.44	14.58	66.67	25.00	83.33	4.5	3	2	B
BE, 2010	√	88.89	33.33	35.42	77.78	8.33	16.67	4	2	2	B
IT, 2012	√	44.44	11.11	27.08	55.56	0.00	25.00	4.5	0	4	C
UK(NICE), 2012	√	66.67	22.22	10.42	72.22	0.00	0.00	5	2	4	C
UK(NCGC), 2012	√	55.56	88.89	93.75	100.00	16.67	58.33	6.5	3	1	B
CN, 2014	√	66.67	72.22	45.83	83.33	20.83	0.00	6.5	3	2	B
JP, 2016	√	44.44	27.78	14.58	38.89	0.00	0.00	3	0	4	C
CN, 2017	√	66.67	0.00	16.67	100.00	12.50	0.00	4.5	2	4	C
DE, 2019	√	38.89	5.56	18.75	83.33	0.00	33.33	4	1	3	C
US, 2019	√	50.00	16.67	35.42	72.22	37.50	0.00	4	1	2	B
FR, 2021	√	88.89	22.22	39.58	61.11	20.83	83.33	4.5	3	2	B
Mean		65.06	33.70	32.81	72.90	13.28	21.06	4.4
Domain overall quality		(+)	(-)	(-)	(+)	(-)	(-)
√: recommend, ×: recommend against, D1: Scope and Purpose, D2: Stakeholder Involvement, D3: Rigor of Development, D4: Clarity of presentation, D5: Applicability, D6: Editorial Independence, (+): acceptable, (-): very low

Two of the six AGREE II domains received median scores of 60% or above across all recommendations. The greatest median standardized scores were found in Domain 4 (Clarity of Presentation), while only 12.5% (n = 2) of the CPGs scored over 60% in Domain 6 (Editorial Independence) (Fig. 2).

The quality of acupuncture recommendations of included guidelines (AGREE-REX). A moderate level of agreement was shown in the two reviewers' assessment (ICC = 0.452, 95% CI = 0.313 ~ 0.573, P0.001).

Figure 3 displays the standardized percentage score for three dimensions of the acupuncture recommendations in the guidelines by AGREE-REX. The greatest score was given to the "Clinical Applicability" area (mean score: 24.31%), while the lowest score was given to the "Values and Preferences" domain (1.82%). The guideline³⁴ released by the IT in 2012 had the greatest mean score (16.67%), while the guideline²¹ issued by the JP in 2016 had the lowest reporting rate (1.85%) in regard to the specific recommendations contained.

The median ratings for the three AGREE-REX domains of the included recommendations were all graded below 30% (Fig. 4).

Migraine has a significant impact on the physical and mental health and quality of life of patients^43–48. An increasing collection of credible research shows that acupuncture can greatly reduce the symptoms of migraines.^22–24, and many headache clinical practice standards include recommendations for the treatment of migraine with or without acupuncture, although the quality of these suggestions varies. This study analyzed the recommendations for acupuncture in global headache guidelines and identified many issues to clarify the current status of acupuncture recommendations for migraine in global headache guidelines and to develop standardized recommendations for acupuncture for migraine in future international guidelines.

There are few recommendations for acupuncture as a migraine therapy. Global awareness of migraine has been progressively growing in recent years, and the creation of excellent clinical standards can aid in directing the clinical treatment of migraine. The findings of this study revealed that while there are numerous guidelines pertaining to headache, only 16 of them—of which 14^{10,12,17,21,28,29,32–39} clearly recommend acupuncture while 2^30,31 advise against it—meet the screening criteria for this study. The fraction of headache guidelines worldwide that prescribe acupuncture for migraine treatment and prevention is low, and the number of such recommendations is rather modest.

Relatively little information is included in the guidelines for acupuncture therapy. The sole nondrug prevention and treatment of migraine was included in the Canadian guideline from 1998²⁸, while the Chinese guideline from 2014¹⁷ was a dedicated guideline for acupuncture. The remaining 14^{10,12,21,29−}39 were thorough prevention and treatment guidelines, with numerous recommendations for drug prevention and treatment programs and specifics on the types and doses of medications, while the suggestions for nondrug therapy methods were mostly restricted to efficacy. Concerning the frequency and length of acupuncture treatments, there are only 2^12,35. In general, the suggestions for acupuncture therapy that are provided in the guidelines are not very extensive. It is challenging to investigate acupuncture as a rigid standard clinical program since doctors must regularly administer treatments and provide corresponding counseling based on the patient's situation.

The accompanying guidelines' methodological quality is not very good. The results of AGREE II demonstrate that the methodological quality of the included guidelines was generally subpar. The "Clarity of presentation" and "Scope and Purpose" domains' overall standard was "acceptable". The "Applicable" domain in particular earned a "very low" score (13.28%), as did other domains. There is a paucity of information on the specific positions, units, and professional details of the members of the guideline development group in the "Stakeholder Involvement" domain. The target population's views and willingness to make decisions were largely ignored during the guideline generation process, and several recommendations lacked specific instructions for users. In the “Rigor of Development” domain, most guidelines did not clearly describe the inclusion and exclusion criteria of evidence and lacked a clear report on the update cycle and steps. Some guidelines lacked relevant, up-to-date information, and the suggestions made by earlier guidelines failed to appropriately direct clinical practice. It is necessary to improve how the rules are applied and promoted. To effectively direct clinical diagnosis and treatment, ensure clinical efficacy, and protect patients, recommendations should not only pay attention to their content and formulation process but also ensure seamless promotion and implementation. Future guideline developers can use the AGREE II²⁵, WHO handbook⁴⁹, GRADE⁴⁰, and other resources to completely enhance the methodological quality of the recommendations.

The acupuncture recommendations in the included guidelines were of poor quality. The quality of the acupuncture recommendations provided in the guidelines was poor, according to the AGREE-REX results. ① The development, implementation, patient acceptance, and policy support of the recommendations may be impacted by the values and preferences of the guidelines. Low marks were given for the included recommendations in this domain. ② The guidelines' description cannot entirely correspond to the "Implementability" domain. It serves as a reminder that the AGREE-REX manual²⁶ must be consulted to encourage the use of the guideline and further enhance the quality of suggestions in the guideline's follow-up development.

The makeup of the panel that developed the guidelines is likely to have an impact on the recommendations for acupuncture. The WHO guideline development handbook⁴⁹ noted that to minimize bias, the guideline development team's members should be experts in a variety of subjects. The majority of the guideline development organizations in our analysis, with the exception of the China-developed guideline from 2014¹⁷, were related headache/migraine/neuropathy societies with a predominance of Western medicine practitioners as members. One of the causes of the poor quality of acupuncture advice may be the dearth of acupuncturist specialists.

It is possible and essential to develop a worldwide standard for acupuncture treatment of migraines. Acupuncture has gained recognition and acceptability in several nations and areas of the world. Acupuncture has increasingly become more well known as a migraine preventative and treatment method. Poor evidence has hindered the study and development of acupuncture guidelines as a result of the inconsistent degree of prior studies on acupuncture treatment for migraines. For instance, the GC's guideline¹⁵ from 2019 indicated that "Acupuncture has several forms and is greatly reliant on the expertise of the therapist. The guideline¹¹ published by BASH in 2019 listed the treatment start dose of acupuncture in the included clinical trial but did not provide clear recommendations for acupuncture. There is limited evidence that acupuncture can be effective in reducing the intensity and frequency of migraine attacks, but large clinical trials have failed to distinguish between real and sham acupuncture. More high-quality clinical evidence supporting the use of acupuncture to treat migraines has recently emerged because of improvements in clinical research techniques in the acupuncture field⁵⁰. It will undoubtedly encourage the inclusion of acupuncture in future migraine treatment recommendations and enable the development of global acupuncture guidelines for treating migraines.

Acupuncture offers special benefits in the prevention and treatment of migraines as one of the most efficient methods available. The effectiveness of acupuncture can be affected by the choice of point selection, stimulation methods, length of needle retention, frequency of treatments, and course of treatments. Except for 3 recommendations^12,17,35, none of the other guidelines^{10,21,28,29,32–34,36−39} in our research use these crucial methodologies. These omissions result in insufficient clinical application of the recommendations, which has an impact on the treatment outcome⁵¹. There are several single-drug and single-operation technical recommendations available at the moment for the prevention and treatment of migraines, but there is only one clinical guide for acupuncture treatment of migraines¹⁷, which was published 9 years ago and cannot adequately answer clinical questions. To better inform clinical decision-making on the acupuncture treatment of migraine, the most recent evidence should be included in the internationally recognized evidence-based guidelines for acupuncture treatment of migraine as soon as feasible. Additionally, before developing recommendations, clinical practice guideline makers should thoroughly examine the demands of the guidelines to better assist acupuncture clinics. The RIGHT⁵² (Reporting Items for practice Guidelines in HealThcare) checklist has an entry created especially for developing guidelines, and the development of guidelines should carefully abide by the RIGHT checklist. Furthermore, while making suggestions for acupuncture for migraine, migraine staging should be taken into account.

Strengths and Limitations

A thorough literature search, the development of stringent inclusion and exclusion criteria, and the use of two assessment methods were all employed in the study to assess the quality of the guidelines and provide specific recommendations for the use of acupuncture for migraine. The findings were largely trustworthy. However, as the AGREE II and AGREE-REX are potentially subjective instruments and other reviewers may interpret the ratings differently, the appraisal should therefore be treated with care.

The number of guidelines recommending acupuncture for migraine treatment is relatively low, the content of recommendations involving acupuncture treatment is relatively constrained, and the recommendations for comprehensive acupuncture treatment programs are insufficient among the current headache guidelines around the world. It is challenging to address clinical demands since the methodology and recommendations for acupuncture in the included guidelines that support it for migraine therapy are of low quality. To offer high-level evidence, better direct clinical decision-making, and advance acupuncture treatment's global acceptance, it is necessary to define an international standard for the treatment of migraines with acupuncture.

AGREE II, Appraisal of Guidelines for Research & Evaluation II; AGREE-REX, The Appraisal of Guidelines Research & Evaluation Recommendation Excellence; YLDs, years lived with disability; HIS, International Headache Society; WHO, World Health Organization; CPGs, Clinical practice guidelines; SIGN, Scottish Intercollegiate Guidelines Network; BASH, British Association for The Study Of Headache; NICE, National Institute for Health and Care Excellence; AAN, American Academy of Neurology; EHF, European Headache Federation; GC, Global Campaign against Headache; JHS, Japanese Headache Society; WOS, Web of Science; CNKI, Chinese National Knowledge Infrastructure; GIN, Guidelines International Network; NGC, National Guideline Clearinghouse; EAN, European Academy of Neurology; ICC, Intraclass correlation coefficient GRADE, Grades of Recommendations Assessment, Development and Evaluation; CTFPHC, Canadian Task Force on the Periodic Health Examination; SORT, Strength of Recommendations Table; AAFP, American Academy of Family Physicians. RIGHT, Reporting Items for practice Guidelines in HealThcare.

Ethics approval and consent to participate

Not applicable

Consent for publication

All authors consent to this manuscript’s publication.

Availability of data and materials

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was supported by the National Key Research and Development Program of China (grant number 2019 YFC1712200, 2019 YFC1712203) and the Independent Project of the Institute of Acupuncture and moxibustion, China Academy of Chinese Medical Sciences (ZZ202219004).

Authors’ contributions

Jingjing Wang conceptualized and designed the study. Shuo Cui and Xiaoyu Wang completed screening and full-text review, and evaluated the retrieved guidelines, drafted the initial manuscript. All authors contributed to drafting the work or revising it critically for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Acknowledgments

We would like to thank the Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medicine Sciences for providing us with a professional literature search.

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013, 33 (9): 629-808.
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020, 396 (10258):1204-1222.
Headache Classification Subcommittee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Headache Classification Committee of the International Headache Society. Cephalalgia. 1988, 8 Suppl 7: 1-96.
Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia 2004, 24 Suppl 1: 9-160.
Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia 2018, 38 (5): 815-832.
Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia 2019, 39(6):687-710.
World Health Organization. Headache disorders and public health: education and management implications. Online Referencing. https://apps.who.int/iris/handle/10665/66516.
World Health Organization‎. Atlas of headache disorders and resources in the world 2011. Online Referencing. https://apps.who.int/iris/handle/10665/44571.
Fervers B, Carretier J, Bataillard A. Clinical practice guidelines. J Visc Surg. 2010, 147 (6):e341-9.
Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of headache in adults (SIGN publication no. 107). Edinburgh: SIGN. 2008.
British Association for The Study of Headache (BASH). National Headache Management System for Adults [M]. UK. 2019.
National Institute for Health and Care Excellence (NICE). Headaches in over 12 s diagnosis and management [S]. UK: London. 2012.
Oskoui M, Pringsheim T, Holler-Managan Y, Potrebic S, Billinghurst L, Gloss D, Hershey AD, Licking N, Sowell M, Victorio MC, Gersz EM, Leininger E, Zanitsch H, Yonker M, Mack K. Practice guideline update summary: Acute treatment of migraine in children and adolescents. Neurology. 2019, 93:1-13.
Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, Martelletti P. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention [published correction appears in J Headache Pain. 2019 May 23; 20(1):58]. J Headache Pain. 2019, 20 (1):6.
Steiner TJ, Jensen R, Katsarava Z, Linde M, MacGregor EA, Osipova V, Paemeleire K, Olesen J, Peters M, Martelletti P. Aids to management of headache disorders in primary care (2nd edition): on behalf of the European Headache Federation and Lifting The Burden: the Global Campaign against Headache. J Headache Pain. 2019, 20 (1):57.
China Academy of Chinese Medical Sciences, China Association of Acupuncture-Moxibustion. Guideline for Clinical Practice of Acupuncture in the Treatment of Migraine [M]. Beijing: China Press of Traditional Chinese Medicine, 2011.
China Association of Acupuncture-Moxibustion. Evidence-based Guidelines of Clinical Practice with Acupuncture and Moxibustion: migraine. Beijing: China Press of Traditional Chinese Medicine, 2014.
Shunwei Li, Yansheng Li, Ruozhuo Liu, et al. Guideline for diagnosis and treatment of migraine. Chinese Journal of Pain Medicine. 2011, 17 (2): 65-86.
Head and Facial Pain Group, Pain Branch, Chinese Medical Association. Specialized Committee on Pain and Sensory Disorders, Neurology Physician Branch, Chinese Medical Doctor Association. Chinese guideline for prevention and treatment of migraine. Chinese Journal of Pain Medicine. 2016, 22 (10): 721-727.
Ren Y, Li H, Wang Y, Chen Y. Report of guidelines for diagnosis and treatment of common internal diseases in Chinese medicine: Headache. J Evid Based Med. 2020, 1–11.
Masahiro Hashizume, Yuzo Nakamura, Jun Miyakoda. Guideline for Treatment of Chronic Headache. Jan J Psychosom Med. 2016, 56 (2): 12.
Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017, 177 (4): 508-515.
Xu S, Yu L, Luo X, Wang M, Chen G, Zhang Q, Liu W, Zhou Z, Song J, Jing H, Huang G, Liang F, Wang H, Wang W. Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicenter, randomized clinical trial. BMJ. 2020, 368: m697.
Naguit N, Laeeq S, Jakkoju R, Reghefaoui T, Zahoor H, Yook JH, Rizwan M, Shahid NUA, Mohammed L. Is Acupuncture Safe and Effective Treatment for Migraine? A Systematic Review of Randomized Controlled Trials. Cureus. 2022, 3;14(1):e20888.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010, 182 (18): E839-842.
AGREE-REX Research Team. The appraisal of guidelines research & evaluation-recommendation excellence （AGREE-REX）. Online Referencing. https://www.agreetrust.org/wp-content/uploads/2019/04/AGREE-REX-2019.pdf. (2019, accessed 10 October 2021).
Qin Shanshan, Nelson Lauren, McLeod Lori, Eremenco Sonya, Coons Stephen Joel. Assessing test-retest reliability of patient-reported outcome measures using intraclass correlation coefficients: recommendations for selecting and documenting the analytical formula. Qual Life Res. 2019, 28(4): 1029-1033.
Pryse-Phillips WE, Dodick DW, Edmeads JG, Gawel MJ, Nelson RF, Purdy RA, Robinson G, Stirling D, Worthington I. Guidelines for the Nonpharmacologic Management of Migraine in Clinical Practice. Canadian Headache Society. CMAJ. 1998, 159 (1): 47-54.
Dowson AJ, Lipscombe S, Sender J, et al. Migraine in Primary Care Advisors. New guidelines for the management of migraine in primary care. Curr Med Res Opin. 2002, 18 (7):414-439.
Sanders SH, Harden RN, Vicente PJ. Evidence-based clinical practice guidelines for interdisciplinary rehabilitation of chronic nonmalignant pain syndrome patients. Pain Pract. 2005, 5 (4): 303-315.
Gunner KB, Smith HD, Ferguson LE. Practice guideline for diagnosis and management of migraine headaches in children and adolescents: Part two. J Pediatr Health Care. 2008, 22 (1): 52–59.
Institute for Clinical Systems Improvement(ICSI). Health Care Guideline: Diagnosis and Treatment of Headache. 2009, 1-76.
Van Leeuwen E, Paemeleire K, Van Royen P, et al. Aanpak van migraine in de huisartsenpraktijk. Huisarts Nu maart. 2010, 39 (2): 37-56.
Sarchielli P, Granella F, Prudenzano MP, Pini LA, Guidetti V, Bono G, Pinessi L, Alessandri M, Antonaci F, Fanciullacci M, Ferrari A, Guazzelli M, Nappi G, Sances G, Sandrini G, Savi L, Tassorelli C, Zanchin G. Italian guidelines for primary headaches: 2012 revised version. J Headache Pain. 2012, 13 (2):31-70.
National Clinical Guideline Centre (UK). Headaches: Diagnosis and Management of Headaches in Young People and Adults. London: Royal College of Physicians (UK). 2012.
Huang T C, Lai T H, Wang SJ, et al. Medical Treatment Guidelines for Preventive Treatment of Migraine[J]. Acta Neurol Taiwan. 2017, 26 (1): 33-35.
Diener HC, Ashina M, Ritter S, Paiva Da Silva Lima G, Rasmussen S, Zielman R, Tfelt-Hansen P. Treatment of migraine attacks and prevention of migraine: Guidelines by the German Migraine and Headache Society and the German Society of Neurology. Clin Transl Neurosci. 2019; 1-40.
Ha H, Gonzalez A. Migraine Headache Prophylaxis. Am Fam Physician. 2019, 99 (1): 17-24.
Demarquay G, Mawet J, Guégan-Massardier E, de Gaalon S, Donnet A, Giraud P, Lantéri-Minet M, Lucas C, Moisset X, Roos C, Valade D, Ducros A. Revised guidelines of the French headache society for the diagnosis and management of migraine in adults. Part 3: Nonpharmacological treatment. Rev Neurol (Paris). 2021, 177 (7):753-759.
Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011, 64 (4): 401-406.
Goldbloom, R, and R N Battista. The periodic health examination: 1. Introduction. CMAJ. 1986, 134 (7): 721-723.
Scottish Intercollegiate Guidelines Network (SIGN). SIGN grading System 1999-2012. Edinburgh: SIGN. Online Referencing. https://www.sign.ac.uk/media/1641/sign_grading_system_1999_2012.pdf. (2012, accessed 10 October 2021).
American Academy of Family Physicians. SORT: Evidence Table of Key Clinical Recommendations. American Academy of Family Physicians. Online Referencing. https://www.aafp.org/dam/AAFP/documents/journals/afp/SORT.pdf. (accessed 10 October 2021).
Jiang Y, Bai P, Chen H, Zhang XY, Tang XY, Chen HQ, Hu YY, Wang XL, Li XY, Li YP, Tian GH. The Effect of Acupuncture on the Quality of Life in Patients With Migraine: A Systematic Review and Meta-Analysis. Front Pharmacol. 2018, 9 :1190.
Linde K, Allais G, Brinkhaus B, Fei Y, Mehring M, Vertosick EA, Vickers A, White AR. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD001218.
Chen YY, Li J, Chen M, Yue L, She TW, Zheng H. Acupuncture versus propranolol in migraine prophylaxis: an indirect treatment comparison meta-analysis. J Neurol. 2020, 267 (1):14-25.
Fan SQ, Jin S, Tang TC, Chen M, Zheng H. Efficacy of acupuncture for migraine prophylaxis: a trial sequential meta-analysis. J Neurol. 2021, 268 (11):4128-4137.
Song Y, Li T, Ma C, Liu H, Liang F, Yang Y. Comparative efficacy of acupuncture-related therapy for migraine: A systematic review and network meta-analysis. Front Neurol. 2022,13:1010410.
WHO (World Health Organization). Handbook for Guideline Development. Online Referencing. http://www.who.int/publications/guidelines/handbook_2nd_ed.pdf?ua=1. (2014, accessed 10 October 2021).
Yinuo Qu, Xin Zhang, Huijuan Yu, et al. Visual Analysis of International Acupuncture Research Theme and Trends in the Past 30 Years. World Chinese Medicine. 2020, 15 (22): 3485-3491+3496.
Guo Y, Zhao H, Wang F, Li SN, Sun YX, Han MJ, Liu BY. Recommendations for acupuncture in clinical practice guidelines of the National Guideline Clearinghouse. Chin J Integr Med. 2017, 23 (11): 864-870.
Chen Y, Yang K, Marušic A, Qaseem A, Meerpohl JJ, Flottorp S, Akl EA, Schünemann HJ, Chan ES, Falck-Ytter Y, Ahmed F, Barber S, Chen C, Zhang M, Xu B, Tian J, Song F, Shang H, Tang K, Wang Q, Norris SL. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med. 2017, 166 (2): 128-132.

No competing interests reported.

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The Quality of Acupuncture Recommendations for Migraine in Global Headache Guidelines: A Systematic Review Using the AGREE II and AGREE-REX Instruments

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Abstract

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Introduction

Methods

Literature Retrieval

Literature Selection

Quality Assessment

Statistical analysis

Results

Literature retrieval and guideline selection

Characteristics of the eligible guidelines

Acupuncture recommendations in the included guidelines

Quality evaluation of included guidelines

Discussion

Strengths and Limitations

Summary

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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