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Quantity and quality of complementary and alternative medicine recommendations in clinical practice guidelines for type 2 diabetes mellitus: A systematic review
Complementary and alternative medicine (CAM) use is prevalent among patients with type 2 diabetes mellitus (T2DM)
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An assessment of CAM recommendations in T2DM practice guidelines is absent
•
CAM recommendations were present in one quarter of all eligible guidelines
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The quality of CAM recommendations varied within and across guidelines
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A gap exists as the majority of guidelines do not provide CAM recommendations
Abstract
Aims
Approximately 70% of Americans with diabetes have used complementary and alternative medicine (CAM) in the past year. Healthcare providers often receive minimal training on these therapies and subsequently rely on clinical practice guidelines (CPGs) to supplement their knowledge about the safe and effective use of CAM for the treatment/management of type 2 diabetes mellitus (T2DM). The purpose of this systematic review is to determine the quantity and assess the quality of CAM recommendations in CPGs for the treatment and/or management of T2DM.
Data synthesis
MEDLINE, EMBASE, and CINAHL were systematically searched from 2009 to 2020, in addition to the Guidelines International Network and the National Center for Complementary and Integrative Health websites. CPGs containing treatment and/or management recommendations for T2DM were eligible; those with CAM recommendations were quality-assessed with the AGREE II instrument twice, once for the overall CPG and once for the CAM sections. Twenty-seven CPGs were deemed eligible, of which 7 made CAM recommendations. Mean scaled domain percentages were (overall, CAM): scope and purpose (89.7%, 79.8%), clarity of presentation (85.7%, 48.4%), stakeholder involvement (67.9%, 28.2%), applicability (54.8%, 20.2%), rigour of development (49.7%, 35.7%), and editorial independence (44.1%, 44.1%).
Conclusions
Quality varied within and across CPGs; domain scores across CAM sections generally scored lower than the overall CPG. Given that CAM therapies for T2DM are only represented in one-quarter of eligible CPGs and are of lower quality, a knowledge gap exists for healthcare providers who seek evidence-based information on this topic in order to effectively counsel inquiring patients.
]. This type develops in adulthood and arises when the pancreas produces insulin adequately but the body is unable to transport glucose into the cells for fuel [
]. The study of diabetes is important since high blood sugar can result in kidney disease, retinopathy that may cause blindness, diabetic peripheral neuropathy from nerve damage, and increased risk of foot ulcers, among other complications [
]. Type 2 diabetes mellitus (T2DM) can be managed through medications, such as alpha-glucosidase inhibitors, biguanides, SGLT2 inhibitors, and insulin, as well as through controlled diet and exercise [
]. The use of complementary and alternative medicine (CAM) therapies is also prevalent among T2DM patients. A national survey revealed that 72.8% of Americans with diabetes used CAM in the past year [
]. CAM encompasses a wide variety of therapies that are not a part of conventional medicine. Specifically, “complementary medicine” refers to a non-mainstream practice used together with conventional medicine, while “alternative medicine” refers to those used in place of conventional medicine [
Making sense of “alternative”, “complementary”, “unconventional” and “integrative” medicine: exploring the terms and meanings through a textual analysis.
Examples of common CAM therapies used for T2DM include dietary and herbal supplements (DHS), yoga, traditional Chinese medicine (TCM), and manual therapies [
Effects of chromium supplementation on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.
]. Individuals with diabetes also seek manual therapies including chiropractic, physiotherapy, shiatsu, and massage therapy to help with musculoskeletal issues [
]. Despite the high prevalence of CAM use among T2DM patients, many healthcare providers still report being unfamiliar with and uncomfortable counselling patients about these therapies [
Physicians' attitudes toward complementary and alternative medicine and their knowledge of specific therapies: 8-Year follow-up at an academic medical center.
]. Healthcare providers rely on clinical practice guidelines (CPGs) to provide evidence-based recommendations for the diagnosis, treatment, and management of diseases [
]; CPGs are of specific value in situations where healthcare providers lack knowledge on topics, such as CAM therapies. To date, no study has determined the quantity nor assessed the quality of CAM recommendations found across CPGs for the treatment and/or management of T2DM, thus this is the present study's objective.
Methods
Approach
A systematic review was undertaken to identify CPGs for the treatment and/or management of T2DM using standard methods [
]. A protocol was registered with PROSPERO, registration number CRD42019132306. Eligible CPGs containing CAM recommendations were assessed by two assessors (KDV and KG) with the widely-used and validated Appraisal of Guidelines for Research & Evaluation (AGREE II) Instrument [
]. The AGREE II instrument consists of 23 items grouped by six domains: scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability, and editorial independence [
]. These CPGs were assessed twice using AGREE II; first to assess the quality of all recommendations overall, and second to assess the quality of only CAM recommendations.
Eligibility criteria
Eligibility criteria for CPGs were based on the Population, Intervention, Comparison and Outcome (PICO) framework. Eligible populations were adults aged 19 years and older and diagnosed with T2DM. For interventions, CPGs were deemed eligible if they provided recommendations for the treatment and/or management of T2DM. We then reviewed each eligible CPG to identify whether any recommendations for CAM therapies were provided. For the purpose of this review, we defined what constituted a CAM therapy based on Cochrane Complementary Medicine's operational definition [
]. Only eligible CPGs containing CAM recommendations were assessed using the AGREE II instrument, and comparisons were made between the quality of overall and CAM recommendations across the six domains. Outcomes included all AGREE II scores which reflect CPG content and format. The following eligibility criteria were also applied to define eligible CPGs: published in 2009 or later; written in the English language; and either publicly available or orderable through our library system. Publications in the form of consensus statements, protocols, abstracts, conference proceedings, letters, or editorials; based on primary studies that evaluated T2DM management or treatment; or focused on T2DM curriculum, education, training, research, professional certification, or performance, were all ineligible. CPGs designed for highly-specialized populations, such as individuals with T2DM in the context of other comorbidities were also deemed ineligible, as this review sought to capture general T2DM CPG recommendations. Finally, patient versions of CPGs and consensus-based CPGs were excluded, as they are not designed to be assessed by AGREE II. If multiple versions of the same CPG were found in the search results, the most updated version was assessed, and all previous versions were excluded.
Searching and screening
MEDLINE, EMBASE, and CINAHL were searched on August 15, 2020, from 2009 to August 14, 2020, inclusive. The search strategy included indexed headings and keywords that reflect terms commonly used in the literature to refer to diabetes. A sample search strategy is provided in Supplementary File 1. We also searched the Guidelines International Network, a repository of CPGs [
], using keyword searches based on the eligibility criteria including “diabetes”. Next, we searched the National Center for Complementary and Integrative Health website which contained a list of CAM CPGs [
]. KDV and KG screened titles and abstracts from all sources and screened full-text items to confirm eligibility. JYN reviewed the screened titles, abstracts, and full-text items to standardize screening, and met with KDV and KG to discuss and resolve any discrepancies that arose.
Data extraction and analysis
The following data were extracted from each CPG and summarized: date of publication, country of the CPG, type of organization that published the CPG (i.e., academic institutions, government agencies, disease-specific foundations, or professional associations or societies), and what CAM therapies were mentioned and/or recommended in the CPG. We determined that a CPG made “mention” of CAM when there was no recommendation provided associated with the given therapy in question. In contrast, we defined a “recommendation” of CAM to represent an evidence-informed suggestion or proposal made by the CPG panel regarding the best course of action surrounding the given therapy in question. CAM funding sources and whether any CAM providers were part of the CPG panel were collected from CPGs containing CAM recommendations. Most data were available in the CPG, however, the website of each developer was also visited and reviewed for any additional details not captured in the main CPG document.
Guideline quality assessment
Prior to quality assessing eligible CPGs containing CAM recommendations [
], all three authors participated in a pilot test whereby we independently assessed three CPGs using the AGREE II instrument; we then met to discuss and standardize scoring. Then, KDV and KG independently assessed all eligible CPGs containing CAM recommendations twice (i.e., once for the overall CPG and once for the CAM sections) for 23 items across six domains using a seven-point Likert scale from strongly disagree (1) to strongly agree (7) that the item is met, rated the overall quality of each CPG (1–7), and recommended for or against the use of each CPG. CAM sections were evaluated using modified AGREE II questions provided in Supplementary File 2. All three authors met to discuss and resolve any discrepancies. Average appraisal scores, average overall assessments, and scaled domain percentages for each CPG were calculated for comparison. Average appraisal scores for each CPG were calculated by taking the average of the ratings for the 23 AGREE II items, followed by taking the average of this value for both appraisers. Average overall assessments were calculated as the average of both appraisers' “overall guideline assessment” scores for each CPG. Scaled domain percentages were generated by adding both appraisers' ratings of items within each domain, and scaling by maximum and minimum possible domain scores before converting into a percentage.
Combined searches retrieved 2875 items, of which 2609 were unique; a total of 2530 items were eliminated by title/abstract screening, leaving 79 items for full-text review. Of those, 52 were not eligible for the following reasons: CPG summary (n = 10), not published in English (n = 7), review of CPGs (n = 6), position statement (n = 5), duplicate/part of the same CPG (n = 4), highly-specialized target populations (n = 4), CPG not focused on treatment/management (n = 3), editorial (n = 3), CPGs not focused on T2DM (n = 2), irretrievable (n = 2), newer/updated version of CPG available (n = 2), consensus-based CPG (n = 1), patient version of CPG (n = 1), systematic review (n = 1), and withdrawn CPG (n = 1). This resulted in a total of 27 eligible CPGs [
Evidence-informed guidelines for treating frail older adults with type 2 diabetes: from the diabetes care program of Nova Scotia (DCPNS) and the Palliative and Therapeutic Harmonization (PATH) program.
American association of clinical endocrinologists and American college of endocrinology – clinical practice guidelines for developing A diabetes mellitus comprehensive care plan – 2015.
Clinical guidelines committee of the American college of physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American college of physicians.
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
Eligible CPGs were published from 2009 to 2020, with first authors originating from the United States (n = 7), Canada (n = 2), Malaysia (n = 2), the United Kingdom (n = 2), Australia (n = 1), Belgium (n = 1), China (n = 1), Colombia (n = 1), Germany (n = 1), India (n = 1), Japan (n = 1), Pakistan (n = 1), Poland (n = 1), Qatar (n = 1), South Korea (n = 1), Sweden (n = 1), and Uganda (n = 1). Additionally, one CPG originated from both Brazil and Portugal. CPGs were funded and/or developed by professional associations or societies (n = 26), and an international agency (n = 1). Eleven CPGs made mention of CAM. These CAMs included DHSs (n = 8), special diets (n = 5), yoga (n = 3), TCM (n = 2), acupuncture (n = 2), manual therapies (n = 2), aromatherapy (n = 1), Ayurveda (n = 1), meditation (n = 1), naturopathy (n = 1), pranayama (n = 1), psychological intervention (n = 1), relaxation techniques (n = 1), Siddha (n = 1), tai chi (n = 1), and unani (n = 1). Recommendations relating to CAM were made in seven CPGs and included DHSs (n = 5), special diets (n = 3), psychological intervention (n = 1), and yoga (n = 1). CAM funding sources were not identified in any of the CPGs. One CPG included two CAM providers including a chiropractor and dietician as part of the CPG panel [
], while the others did not. We provide a summary of CAM recommendations made across eligible CPGs for the benefit of clinicians and researchers, in Fig. 2.
Evidence-informed guidelines for treating frail older adults with type 2 diabetes: from the diabetes care program of Nova Scotia (DCPNS) and the Palliative and Therapeutic Harmonization (PATH) program.
American association of clinical endocrinologists and American college of endocrinology – clinical practice guidelines for developing A diabetes mellitus comprehensive care plan – 2015.
Malaysian Endocrine and Metabolic Society, Ministry of Health Malaysia, Academy of Medicine Malaysia, Diabetes Malaysia, Family Medicine Specialists Association of Malaysia
Identification, diagnosis, and management of type 2 diabetes
Clinical guidelines committee of the American college of physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American college of physicians.
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
Sociedade Brasileira de Diabetes (SBD), Sociedade Brasileira de Endocrinologia e Matabologia (SBEM), Sociedade Portuguesa de Diabetologia (SPD), Sociedade Portuguesa de Endocrinologia, Diabetes e Metabolismo (SPEDM)
Management of hyperglycemia in type 2 diabetes mellitus
Of the 11 eligible CPGs making mention of CAM, four did not provide any CAM recommendations. One of these CPGs briefly mentioned the Mediterranean diet and complementary medicine in general [
]. The authors provided a short sentence about why the Mediterranean diet is beneficial, in addition to one small section about the use of complementary medicine, some examples of complementary medicine, and that CAM use should be assessed in patients. Another CPG included tai chi and yoga in a list of activities that may be appropriate for older adults [
]. The third CPG briefly discussed the benefits and disadvantages of a number of special diets and nutritional supplements, such as the Mediterranean diet, the Dietary Approaches to Stop Hypertension (DASH) diet, vegan & vegetarian diets, multivitamin supplements, and herbal supplements or spices [
]. The fourth CPG included three short paragraphs outlining TCM and its beneficial effects using an example from an experimental study, while also briefly stating that nutritional supplements may be useful [
Average appraisal scores and average overall assessments: overall guideline (Table 2)
The average appraisal scores for the 7 CPGs that included CAM recommendations ranged from 3.6 to 5.8 on the seven-point Likert scale; 6 CPGs exceeded an average appraisal score of 4.0. Average overall assessments for the 7 CPGs ranged from 3.5 to 6.5; with 4 exceeding an overall score of 5.0.
Table 2Average appraisal scores and average overall assessments of each guideline.
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
Average appraisal scores and average overall assessments: CAM sections (Table 2)
The average appraisal scores for the 7 CPGs ranged from 2.6 to 4.7 on the seven-point Likert scale; two CPGs exceeded an average appraisal score of 4.0. Average overall assessments for the 7 CPGs ranged from 3.0 to 5.5, with 2 CPGs exceeding a score of 5.0.
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
None of the CPGs were recommended by both appraisers. One CPG was recommended by one appraiser and recommended with modifications by the other appraiser [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
With regards to scaled domain percentages of the overall CPGs, scope and purpose scores ranged from 97.2% to 83.3%, stakeholder involvement scores ranged from 88.9% to 47.2%, rigour of development scores ranged from 80.2% to 28.1%, clarity-of-presentation scores ranged from 97.2% to 69.4%, applicability scores ranged from 77.1% to 27.1%, and editorial independence scores ranged from 75.0% to 0.0%. For the CAM sections, scope and purpose scores ranged from 94.4% to 69.4%, stakeholder involvement scores ranged from 63.9% to 8.3%, rigour of development scores ranged from 57.3% to 19.8%, clarity-of-presentation scores ranged from 80.6% to 11.1%, applicability scores ranged from 47.9% to 2.1%, and editorial independence scores ranged from 70.8% to 0.0%.
Table 4Scaled domain percentages for appraisers of each guideline.
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
The overall objectives were well-defined in all CPGs. Scores for the CAM sections of the CPGs for the objectives were the same as the overall CPGs. The health questions were also well-presented typically including the intervention or action, the outcome, and the population. The health questions were easy to identify in most CPGs [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The population to whom the CPG was meant to apply was also well-stated. All CPGs referred to the target population as being diabetic and sometimes also those at risk of developing diabetes, and in most instances, the target population was only referring to adults. Although severity and comorbidities were not explicitly stated, they were identifiable throughout the CPGs. Three CPGs mentioned that they were designed for populations in certain countries [
]. None of the CPGs gave specific ages and there was no mention of gender. Considering that the population is the same for the whole CPG, scores of the CAM sections were the same as the rest of the CPG.
Stakeholder involvement
All CPGs included the names of the development group. Most CPGs also included the discipline, institution, and location of the development group members, while one did not [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. Two CPGs included patient representatives in the CPG development group, but did not include the methods for including them or how their perspectives were taken into consideration [
]. For those CPGs that did seek target population preferences, the CAM sections of the CPGs scored similar or slightly lower since it was assumed the preferences were sought for the whole CPG, however, there was no discussion of specific views or preferences of CAM users. Target users were clearly defined by three CPGs as “all healthcare workers involved” [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The scores for the CAM section were also the same for this category. The strengths and limitations of the body of evidence that were collected were described in most CPGs [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The scores for the CAM section were similar for this section. Most CPGs had little to no information on the methods of formulating the recommendations [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The scores for the CAM section were the same for this category. All CPGs considered some health benefits, side effects, and/or risks to some extent when formulating their recommendations. Sometimes they were not very easily identifiable [
]. The CAM sections of the CPGs received a lower score since they generally had less detailed benefits and harms and sometimes only covered one or the other. One CPG, however, did not include this information for its CAM section [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. All CPGs provided an explicit link between their recommendations and the supporting evidence, with links to the references and/or with evidence in the accompanying paragraphs. How the evidence was used to form the recommendations was not always clear. The CAM sections received similar scores. One CPG only had a link to references but no accompanying paragraph for the CAM sections [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. Most CPGs stated that they were externally reviewed by experts prior to publication, but did not include some of the following information: outcomes of the review, purpose of the review, or methods employed for the external review [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. None of the CPGs that were externally reviewed mentioned that there were CAM experts as a part of the reviewers. Most CPGs stated that the CPG will be updated. One provided a timeframe and methods [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. These scores were the same for the overall CPGs and CAM sections.
Clarity of presentation
Generally, the CPGs offered specific and unambiguous recommendations, however, in all CPGs, some recommendations lacked one or more of the following details: identification of the purpose, relevant population, or caveats. The scores for the CAM sections were slightly lower than the rest of the CPG for most CPGs. All CPGs scored highly in presenting different options for the management of the condition or health issue, thus contributing to this high scaled domain percentage. With respect to the CAM section scores, three CPGs had provided information about more CAM therapies [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The CAM sections of the CPGs scored similarly to the rest of the CPG, except for four CPGs in which the CAM recommendations were not separated or easily identifiable [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
There was limited discussion about facilitators and barriers in the CPGs, some of which had specific implementation sections, otherwise spread out through the CPG. One CPG had more discussion on dissemination and implementation strategies [
]. All CPGs included advice and/or tools to support the implementation of the recommendations. Four CPGs contained little discussion on resource implications [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The CAM sections scored low as there was less or no discussion of facilitators/barriers to implementation, tools, resource implications, or auditing criteria specific to CAM recommendations [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. Two CPGs stated competing interests were present but were missing some of the following: methods, how the competing interests influenced the CPG, or a list of the competing interests that were found [
2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD).
]. The scores of the CAM sections for this domain were the same as the overall CPG.
Discussion
The purpose of the present review was to identify the quantity and assess the quality of CAM recommendations in CPGs for the treatment and/or management of T2DM. This study identified seven CPGs published between 2010 and 2020 that made CAM therapy recommendations. Quality varied greatly across CPGs overall and by domain, as assessed by the AGREE II instrument. In assessing the overall CPGs, all CPGs scored 3.0 or higher for both the average appraisal score and the average overall assessment. In assessing the CAM section of each CPG, all CPGs scored over 2.0 for both the average appraisal score and the average overall assessment (1 = strongly disagree; 7 = strongly agree that criteria are met).
To our knowledge, this is the first study to explore the nature of CAM therapy recommendations in CPGs for the treatment and/or management of T2DM. With respect to comparative literature, a number of reviews have assessed the quality of diabetes CPGs. One study assessed seven T2DM CPGs and found similar scores, whereby the scope and purpose and clarity of presentation domains received the highest scores, while the rigour of development and applicability domains received the lowest scores [
Quality assessment of recent evidence-based clinical practice guidelines for management of type 2 diabetes mellitus in adults using the AGREE II instrument.
]. Another study also assessed seven T2DM CPGs and reported similar findings with respect to the clarity of presentation and scope and purpose domains receiving the highest scores, and the rigour of development and editorial independence domains receiving the lowest scores [
Identifying the quantity and assessing the quality of clinical practice guidelines for the treatment and management of type 2 diabetes: a systematic review.
]. Yet another study evaluated 21 paediatric T2DM CPGs and found that the clarity of presentation domain scored the highest and the rigour of development and editorial independence domains scored the lowest [
]. Lastly, one study that assessed the quality of 13 gestational diabetes CPGs found that the scope and purpose and clarity of presentation domains had the highest scores, while the rigour of development, stakeholder involvement, and editorial independence domains received the lowest scores [
]. Collectively, the order of AGREE II domain scores reported by each of these aforementioned studies is similar to our study's findings. With respect to the overall quality of CPGs, some of these studies reported most CPGs to have high quality [
Quality assessment of recent evidence-based clinical practice guidelines for management of type 2 diabetes mellitus in adults using the AGREE II instrument.
], indicating that variability in quality across CPGs is not uncommon.
A number of studies have also identified the quantity and assessed the quality of CAM recommendations found in CPGs across a wide-range of other common diseases/conditions. Reviews assessing CAM recommendations in low back pain and depression CPGs both found that the majority of CPGs had CAM recommendations, and their quality was the same or lower than those of the overall CPG [
]. Another study found that only one-third of multiple sclerosis CPGs provided CAM recommendations, and that they scored lower than the overall CPG recommendations [
]. Yet another review assessed CAM recommendations in rheumatoid arthritis and osteoarthritis CPGs, and found that half of the CPGs contained CAM recommendations, which scored lower than overall recommendations across all domains except for clarity of presentation [
Rheumatoid arthritis and osteoarthritis clinical practice guidelines provide few complementary and alternative medicine therapy recommendations: a systematic review.
]. Across other conditions, CAM recommendations were virtually absent; for example, across hypertension CPGs, only a single CPG provided CAM recommendations [
]. Apart from hypertension CPGs, the present review found that proportionately fewer T2DM CPGs provided CAM recommendations in comparison to CPGs of the aforementioned diseases/conditions. Our findings are comparable to these aforementioned studies, with respect to the fact that our CAM section AGREE II scores were also generally the same or lower than overall CPG scores across most if not all of the instrument's domains.
Given that only one-quarter of CPGs for the treatment and/or management of T2DM provide CAM recommendations, a knowledge gap exists for healthcare providers who seek evidence-based resources to support informed and shared decision-making with their patients who inquire about these therapies. A number of reasons can explain why a lack of high-quality CAM-specific recommendations exist across this subset of CPGs as a number of barriers exist with regards to conducting CAM research. Although the body of literature on CAM and T2DM continues to grow, there is still insufficient information surrounding the effectiveness, efficacy, and safety of many CAM therapies, making it difficult to access rigorous and reliable evidence [
]. Some of the barriers to CAM research that have been identified include a lack of the following: access to funding, education/skills in research, CAM journals in mainstream databases, and existing high-quality research/researchers in CAM [
]. Others have identified skepticism and a lack of familiarity with CAM as barriers to healthcare professionals' ability to effectively counsel patients about CAM therapies [
Physicians' attitudes toward complementary and alternative medicine and their knowledge of specific therapies: 8-Year follow-up at an academic medical center.
]. This landscape is changing, however, and more recently published studies have found that an increased number of healthcare practitioners and trainees seek knowledge and education about CAM [
]. Further research that focusses on translating CAM research knowledge into recommendations that can be incorporated into T2DM CPGs is warranted. Additionally, improving the applicability and implementation of CAM research can increase CAM representation in CPGs. Knowledge of the present review's findings is of value for those who will develop/update future T2DM CPGs; in addition to the AGREE II instrument, numerous resources exist to provide developers with guidance on how to incorporate high-quality CAM recommendations into CPGs [
The present review was informed by a comprehensive, systematic search of the literature and adhered to PRISMA guidelines. Eligible CPGs containing CAM recommendations were assessed using the AGREE II instrument, which is widely-regarded as the gold standard for appraising CPGs, as it has been found to be both reliable and valid [
]. The interpretation of these findings may be limited by the fact that CPGs were independently assessed by two appraisers, as opposed to four as recommended by the AGREE II instrument instruction manual. To mitigate this and standardize scoring, all three authors participated in an initial pilot test designed to appraise separate CPGs and standardize the application of the instrument before assessing CPGs included in this study. Although we used Cochrane Complementary Medicine's operational definition to determine whether a given therapy was categorized as CAM [
], we acknowledge that consensus surrounding a list of all therapies that make up this category is lacking among healthcare researchers and practitioners alike. For example, certain diets such as the Mediterranean Diet, as well as certain mind-body therapies, such as cognitive behavioural therapy, may or may not be considered CAM. Lastly, another limitation includes our inclusion of only English-language CPGs; as CAMs originate from different regions of the world, the present review may not have captured CPGs published in non-English-speaking countries with traditional medical systems, notably those in Asia, the Middle East, and Africa.
Conclusions
This present review identified CAM therapy recommendations across seven CPGs for the treatment and/or management of T2DM. Appraisal of these CPGs with the AGREE II instrument revealed that quality varied within and across CPGs with the CAM sections of the CPG scoring lower or the same in comparison to the overall CPG. Given that CAM therapies for T2DM are only represented in one-quarter of CPGs and are of lower quality, this may leave healthcare providers underprepared to discuss the benefits or risks of CAM therapies with patients. The findings of this review justify the need for further research on translating CAM research knowledge into recommendations that can be incorporated into T2DM CPGs, and are therefore, of value to those who will update/develop this subset of CPGs in the future. The presence of recommendations across T2DM CPGs for commonly used CAM therapies can, in turn, better support informed discussion and shared decision-making between physicians and inquiring patients.
Ethics approval and consent to participate
This study involved a systematic review of peer-reviewed literature only; it did not require ethics approval or consent to participate.
Consent for publication
All authors consent to this manuscript's publication.
Availability of data and materials
All relevant data are included in this manuscript.
Funding
This study was unfunded.
Authors' contributions
JYN: designed and conceptualized the study, collected and analysed data, co-drafted the manuscript, and gave final approval of the version to be published.
KDV: assisted with the collection and analysis of data, co-drafted the manuscript, and gave final approval of the version to be published.
KG: assisted with the collection and analysis of data, revised the manuscript critically, and gave final approval of the version to be published.
Declaration of competing interest
The authors declare that they have no competing interests.
Acknowledgements
JYN was awarded a Research Scholarship and an Entrance Scholarship from the Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences at McMaster University.
Appendix A. Supplementary data
The following are the Supplementary data to this article:
Making sense of “alternative”, “complementary”, “unconventional” and “integrative” medicine: exploring the terms and meanings through a textual analysis.
Effects of chromium supplementation on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.
Physicians' attitudes toward complementary and alternative medicine and their knowledge of specific therapies: 8-Year follow-up at an academic medical center.
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Quality assessment of recent evidence-based clinical practice guidelines for management of type 2 diabetes mellitus in adults using the AGREE II instrument.
Identifying the quantity and assessing the quality of clinical practice guidelines for the treatment and management of type 2 diabetes: a systematic review.
Rheumatoid arthritis and osteoarthritis clinical practice guidelines provide few complementary and alternative medicine therapy recommendations: a systematic review.