Keywords
Complementary and alternative medicine, Type II diabetes mellitus, Scoping review
This article is included in the Manipal Academy of Higher Education gateway.
This review aims to map the evidence on the effectiveness of Complementary and Alternative Medicine (CAM) for Type 2 Diabetes Mellitus (T2DM) and its associated complications and identify research gaps in key outcomes and CAMs.
Our scoping review was informed by Johanna Briggs Institute guidelines. We searched electronic databases from inception to March 2020 and references of included studies. The experimental and non-randomized studies with intervention and control arm were mapped based on the effectiveness of various CAM (Yoga, Ayurveda, Homeopathy, Siddha, Naturopathy, Unani, and Sowa-rigpa) on outcomes among individuals with prediabetes or metabolic syndrome, and T2DM.
A total of 249 studies were included after screening 3798 citations. Most of the included studies were conducted in India (30.52 %) and Iran (28.51 %). Of the 249 studies, 21 were efficacy, feasibility or pilot interventional studies. Most frequently studied CAM interventions include Ayurveda, and herbal products (58.63 %) followed by Yoga (20.88%). Unani medicines (n = 2 studies), Sowa-Rigpa (n = 1) and Homeopathy (n = 1) were the least studied modalities. With regards to population, 15 studies recruited newly diagnosed T2DM and 59 studies had included T2DM with comorbidity. Sixteen studies included population with mean ages 45-years or younger. Twenty-eight studies included pre-diabetic or metabolic syndrome, 46 studies included T2DM with no oral glycemic drugs, and 116 included T2DM with oral drugs. Blood sugars (fasting and postprandial) were the most measured outcomes. Outcomes such as HbA1c, lipid profiles, anthropometric measures, adverse effects were also assessed. Among complications, ulcer healing in diabetic foot ulcers was a commonly reported.
Future investments for research in CAM may focus on assessing the quality of existing trials and finding out an optimal dose, frequency, and duration of CAM that is beneficial, both as an alternative and complementary approach (or not) by carrying out a systematic review.
Complementary and alternative medicine, Type II diabetes mellitus, Scoping review
Following edits were made in the abstract: Frequency counts were added for the countries and the minor edits in the conclusion section.
There were no edits made in table, figures and manuscript main body.
To read any peer review reports and author responses for this article, follow the "read" links in the Open Peer Review table.
Type 2 diabetes mellitus (T2DM) is one of the important public health problems and accounts for 90-95% of all diabetes.1 T2DM is a long-lasting metabolic disease caused as a result of a combination of resistance to insulin action and an insufficient compensatory insulin secretory response.2,3 Globally, the number of people having diabetes mellitus is rising.4,5 In 2017, 6.28% of the world’s population had T2DM, which is equivalent to approximately 462 million individuals. Furthermore, these estimates are expected to rise to 7,079 individuals per 100,000 by the year 2030.4 T2DM ranked seventh and ninth in the year 2017, among the leading causes of disability adjusted life years lost and deaths, respectively, as compared to the nineteenth and eighteenth position, respectively, in 1990.4
Diabetes in general has a significant effect on individuals' functional capacities and quality of life (QoL).4 Individuals with diabetes are vulnerable to many health-related complications such as cardiovascular diseases, kidney failure, delayed wound healing (leading to diabetic foot and ultimately to leg amputation if not treated), vision loss, nerve damage2,6 and microvascular damage.5,7 It is also known to reduce life expectancy.2 Diabetes and its complications bring about significant financial loss to individuals with diabetes and their families through direct medical cost and loss of work and wages, and in some cases catastrophic health spending.2 Increased duration of treatment, presence of complications, hospitalization, surgery and insulin therapy leads to increased expenditure8 affecting the health system and national economy.2
Alternative treatments with potential anti-hyperglycemic effects are commonly used for chronic diseases such as T2DM. “Complementary and Alternative Medicine” (CAM) is defined by the World Health Organization as “broad set of health care practices that are not part of that country’s own tradition or conventional medicine and are not fully integrated into the dominant health-care system”.9 CAM includes various types of therapies such as acupuncture, body work (e.g., massage), energy healing (e.g., reiki), herbal or traditional medicines (e.g., naturopathy, Ayurveda, Chinese medicine), mind body techniques (e.g., meditation, yoga), faith healing and music therapy.10,11
The global use of CAM varies between 9.8% and 76% of the population.12–14 Every four out of five individuals living in developing countries still depend on CAMs for treatment of certain health conditions.10 A recently published meta-analysis found a global prevalence of CAMs to be 51% (95% confidence interval 43, 59). Use of CAM as a complementary medicine in addition to conventional therapy was found to be 78%. However, as an alternative to conventional medicine was found to be 21%.9 CAM has been used extensively also for other conditions, for instance, 40% cancer patients using CAM.15 A review also found that about 67% of the people who use CAMs did not disclose its use to healthcare professionals.9 Furthermore, individuals with diabetes are 1.6 times more likely to use CAMs than non-diabetics as reported in 2014.10 Similarly, diabetes is one of the main diseases, for which patients consult Ayurvedic practitioners and consume Ayurvedic medications.6 In the United States, around 2-3.6 million people depend on CAMs for the treatment of diabetes, whereas in Australia and the United Kingdom about 46% rely on it. India showed a very high use of CAMs among diabetics accounting for 67% in 2014.10 Reasons for the high proportion of individuals with diabetes using CAMs are multi-faceted. These reasons could be higher cost, high level of medication adherence and fear of side-effects of modern allopathic medicines, dissatisfaction with healthcare providers, and easy availability of CAMs without doctor’s prescription.10
Diabetes, a complex disease, caused due to pathophysiological changes that affects the whole-body glucose homoeostasis, is a typical example requiring an integrative medicine method for its holistic (complete) management. The pathophysiological web of diabetes along with obesity, inflammation and insulin resistance is a challenge for its management. The current diabetes treatment based on modern medicine focusses on reducing hyperglycemia through targeted molecular medications, which needs long-term use and adherence, along with a continuous increase in dose.16 CAMs may act as complementary to modern medicines and help in contributing to a holistic approach. Table 1 provides the list of some of the CAMs and its possible effect in lowering blood glucose levels.
CAM | Description of the CAM | How CAM might work in T2DM? |
---|---|---|
Ayurveda | Ayurveda includes all facets of life, be it physical, psychological, spiritual or social.8 The main goal of Ayurveda is to maintain a balance between the five basic elements of life such as earth, water, fire, air and vacuum.6 The management of disease by Ayurveda involves a personalized diet, lifestyle, medicines and systemic cleansing therapies.17 It promotes the use of various herbal preparations such as decoctions, juices and powders, all of which are of plant origin, but may also contain animal and inorganic products.8 Approximately 21,000 ayurvedic medicinal plants have been registered by the WHO around the world, out of which 2500 types are of Indian origin and 800 have an antidiabetic potential.7 | Antihyperglycemic medications of Ayurveda uses mixtures of different herbs that lower blood sugar level.16 Systematic reviews of clinical trials and case reports of several Ayurvedic drugs reveals beneficial effects of Ayurvedic medications on T2DM related outcomes, including reducing blood sugar levels with no major side-effects.6,18 Ayurveda plant extracts may also protect the organs and eventually improving the overall health and wellbeing of an individual.19 Some of the herbal products used in Ayurveda e.g., curcumin influences insulin resistance and hyperglycemia, and it has shown to prevent harmful complications of diabetes.20 Bitter gourd juice or decoction are known to lower blood sugar levels.1 Research suggests that some herbs may regenerate ß-cells and overcome insulin resistance.21 Some of the herbs are known to lower cholesterol levels and act as antioxidants.21 |
Yoga | Yoga is a branch of CAM that is built on the principle that the body, mind and spirituality are closely related to each other. Yoga helps to balance and harmonize the body, mind and emotions of an individual. Yoga consists of various components such as cleansing processes, postures, controlled breathing, meditation, relaxation, chanting mantras, yogic diet and spirituality.22 | Yoga poses and breathing exercises enhance strengthening of muscle strength, flexibility, uptake of oxygen and blood circulation.23 Yoga in daily life is known to help in the management of T2DM by tackling the pathophysiologic mechanism of diabetes. This helps in glucose utilization22 and achieving glycemic control and reducing the risk of complications in T2DM.9,24,25 It is hypothesized that yoga may influence stress and relaxation mechanisms of the body thereby, benefiting an individual with T2DM. It may enhance insulin sensitivity and decrease insulin resistance.21 |
Unani | Unani system of medicine considers imbalance in certain fluids (e.g., blood and bile) as the main cause of diseases.8 | Unani medicines have shown significant reduction in blood sugar level in individuals with T2DM.26 |
Siddha | Siddha emphasizes on maintaining a balance between environment, climatic conditions, physical activity and stress to guarantee good health.8 Herbal (plant based). Inorganic (metals and minerals) and animal products are the common elements used in the treatment of many diseases by the Siddha system of medicine. | Preparations from Siddha elements have shown to have an anti-hyperglycemic effect.27 |
Homoeopathy | Homoeopathy is practiced globally8 and millions of individuals use it in many diseased conditions as CAM.28 Homoeopathy system of treatment considers a holistic approach towards the patient, to promote inner balance at the physical, mental, emotional and spiritual level.8 | The use of homoeopathy for the treatment of diabetes is common.28 Mechanisms through which homeopathic medicines act on glycemic control are explained by using high dilution effects (physicochemical models).29 |
Massage | It is one of the relaxation therapies whereby muscles and connective tissues are manipulated,23 which may decrease heart rate and blood pressure. Massage may release muscle tension is based on patient reported outcome measures and an electromyographic testing.21 | Massage therapy may benefit in normalizing blood glucose and managing symptoms of diabetic neuropathy, by improving the blood circulation. Additionally, serum insulin action can be enhanced by massaging at the site of insulin injection.21,23,30 Massage was found to be having stress reducing benefits, which in turn may cause the body to use insulin in an effective way.21 |
Naturopathy | Naturopathy (the healing power of nature) refers to an integral, self-organizing curative process in living systems that creates, preserves and re-establishes health.31 In aromatherapy, inhalation and topical application of essential oils over the skin has been used therapeutically. It is often used alongside massage.21 Using water (cold or hot) for therapeutic purposes is referred to as hydrotherapy. It causes muscle relaxation and helps release toxins.21 | Naturopathy can have an anti-hyperglycemic effect in an individual with diabetes. Aromatherapy may act as coping mechanism in dealing with long standing disease like T2DM. Oils used in aromatherapy may influence the person to feel relaxed and get good sleep.21 Hot tub therapy (a form of hydrotherapy) may increase the blood circulation to the muscles and hence can be beneficial to be used in T2DM.21,23 |
Acupuncture | It is one of the most commonly used CAMs for chronic pain.21,23 In acupuncture, certain body points (acu-points) are pressed or penetrated to stimulate flow of energy or make the person sleep.23,32 There are various types of acupuncture.32 | Mechanisms through which acupuncture act in T2DM is unknown.23 However, studies on animal have demonstrated that acupuncture can activate glucose-6-phosphate. It may also influence pancreas to produce insulin and speed-up better use of insulin thereby lowering the blood glucose.21 It is used mostly in the management of diabetic neuropathy.23,32 |
Reducing premature mortality from non-communicable diseases including T2DM by one-third, achieving universal health coverage and providing access to affordable essential medicines to all by 2030 are the targets set by member states as a part of the agenda for 2030 Sustainable Development.2 The emergence of T2DM into global epidemic and accessibility and availability issues of modern medicines to many individuals in low resource-settings have encouraged low-cost, easily available alternative therapies. Most of these alternative therapies claim to manage diabetes in no or minimal side-effects, due to which, most of the people using CAMs for T2DM use it along with conventional therapy.21
Evidence on assessing the effectiveness or efficacy of CAM has increased in recent years. For instance, systematic reviews assessing the efficacy of CAMs on chronic kidney diseases.33,34 CAMs are also being evaluated for blood pressure control, chronic pelvic pain and symptom management in palliative cancer care.35–37 Furthermore, it is recommended by the American Diabetes Association position statement that a CAMs can be used based on evidence from research.38 To make the process of implementation of global partnership stronger, SDG 17 is persuading collection, monitoring and accountability of the data.39 Therefore, timely, good quality and reliable data on CAM therapies for T2DM will help subsequent governments and organizations to take effective steps. Good quality data are also essential in framing the clinical practice guidelines. To inform policymakers, CAMs and the outcomes measured among T2DM and its complications should be known for implementing findings for policy, program development and direct future research. A scoping review can contribute to prioritizing evidence needs as suggested by SDG goal number 17. Scoping reviews map and summarize the extent of literature available on a given topic and identify gaps, which are important for informing future research.40,41 To the best of our knowledge, till date there is no scoping review in the area of CAMs and T2DM. Therefore, this scoping review intends to map the evidence on effectiveness of CAMs for T2DM and its associated complications. We will also identify research gaps in key outcomes and CAMs.
We followed the Joanna Briggs Institute guidelines to undertake the scoping review and adhered to “PRISMA-ScR (Preferred Reporting Items for Systematic review and Meta-Analyses extension for Scoping Reviews) Checklist”.42 The protocol was registered with Open Science Framework (DOI 10.17605/OSF.IO/6CNH7).
Evidence source: Publications that were eligible for inclusion were randomized controlled trials (RCTs) and quasi randomized controlled trials (QRT) (i.e., interventional studies having two groups assessed pre and post and might not have adhered to strict randomization procedures) published until March 2020. Single group pre-post studies, systematic reviews and observations studies were excluded.
Population: Adults (>/= 18 years of age) with a confirmed diagnosis of T2DM (based on appropriate standards such as American Diabetic Association), metabolic disorder or prediabetic condition (marked by elevated levels of blood glucose) were eligible for inclusion. Additionally, individuals experiencing complications, which are associated with DM were included. We excluded adults living with T2DM with multiple organ dysfunction and failure, and those with life support. Additionally, we excluded studies involving type-1 DM, gestational diabetes or diabetes insipidus. In case of mixed population, we coded information of individuals with population of this review interest, if information on the subgroup was provided. If information on the subgroup was not available or in the case of missing information, the study was excluded.
Concept or interventions: Considering the heterogeneity in types, and investigators’ limited resources and experience and knowledge related to other forms of CAM, this review restricted the inclusion of specific types of CAM therapies. The included CAM modalities were Ayurveda, herbal medications, homeopathy, yoga, Unani, Siddha, massage therapy and naturopathy involving multiple modalities. Although CAMs included a wide range of strategies, we did not include vitamin and mineral nutritional supplementations and other CAMs such as Chinese traditional medicines, qigong, tai-chi and reiki. Additionally, a combination of CAM or CAM administered along with conventional medications and lifestyle modifications were eligible. However, these interventions had been equally distributed in all the arms of clinical trials. For orally administered therapy, a drug could be mono- or combi-preparation of any dose, frequency or duration, but it should have been restricted to one type of therapy (e.g., Ayurveda). Similarly, for yoga and massage therapy there was no restriction on type, length per session, frequency and duration. Any mode of administration of these therapies were eligible to be included such as oral or topical application.
Comparison: No intervention, placebo or lower dose of the same intervention, comparison between different therapy and active medications of conventional medicines (e.g., oral hypoglycemic medications) were eligible for inclusion. In case of co-intervention, one arm should have received at least one CAM.
Outcome measures: We considered the following outcomes after reviewing the literature, after consulting the CAM practitioners (who are known to authors).
a. Clinical outcomes:
○ Glycemic control: glycosylated hemoglobin (HbA1c), blood sugar levels: fasting blood sugar levels (FBSL) and 2-hour post-prandial blood sugar levels (PPBSL)
○ Serum insulin
○ Anthropometric measures such as body mass index, body weight, waist circumference
○ Adverse effects (e.g., hypoglycemia)
○ Lipid profiles
○ Diabetic complications and related outcomes: retinopathy, neuropathy, cardio-vascular complications, nephropathy, ketosis, wound healing etc.
b. Quality of life (QoL)
c. Activities of daily living
d. Economic outcomes: Cost-benefit Analysis (e.g., monetary units or QALY)/Cost-effectiveness Analysis/ Cost-utility Analysis/ Cost-identification/Cost-minimization/Cost-consequence.
Context: We did not impose any geographic or setting restriction. Studies could have been hospital or community-based.
A comprehensive search was conducted to locate relevant records in electronic bibliographic databases, using a comprehensive search strategy. The scoping review included published studies on CAMs. However, due to time and financial constraints we considered only English publications. Search was undertaken in the following list of databases from their inception till March, 2020.
1. Electronic databases- Medline (PubMed- NCBI), Web of Science (Clarivate)), “Cochrane Central (Wiley)”, “Cumulative Index to Nursing and Allied Health Literature (EBSCO)”, “SCOPUS (Elsevier)”, and “ProQuest (Central)”.
2. Database of trial registry.
3. Reference list of included studies was searched for eligible records (backward and forward citations in April 2021).
Search terms such as “Alternative Medicine”, “Alternative Therapies”, “Complementary Medicine”, “Complementary Therapy”, “Ayurveda”, “Yoga”, “Homoeopathy”, “Massage therapy”, “Diabetes” etc. were used to identify relevant literature. A pre-set search strategy was formed by referring to previous studies and trial search carried out initially in PubMed, which was modified with incorporating more keywords and MESH terms. A search string that was resulted from the process was altered to fit the identifiers of each database separately. The PubMed search strategy as an example can be found in the Extended data - DOI: 10.6084/m9.figshare.19512349.v2.43
Search results of all databases and records identified from other sources were exported to EndNote X7 software and duplicates were removed. Screening, coding and presentation of data was undertaken in Microsoft Excel.
Screening was undertaken at three stages (title, abstract and full texts) by two review authors, independently. A thorough discussion was held between the review authors until consensus, in the case of any discrepancies on the exclusion of eligible records. We followed an extensive screening protocol. The review team did not have expertise in Naturopathy, Unani and Sowa-Rigpa therefore, once the screening was completed, a list of medicines was prepared to be confirmed by professionals working in the field (through our extensive contacts). Based on the experts' recommendations CAMs were categorized.
A pretested coding list was used that consisted of the following variables in details; citation details, study design, country, population (number, age, duration of diabetes, history of oral hypoglycemics and details on the complications), CAM therapies (type, dose, frequency, duration), comparator and outcomes. Data charting was done by six authors. As data charting was not done independently, each study extraction was cross-checked by the second author. Any discrepancy on charted data was resolved with discussion until consensus. We did not carry out critical appraisal of included studies.
On conducting searches in various databases, registers and reference searches, we retrieved 3245, 105 and 448 citations, respectively. Of which 249 records are included finally. The study selection process is shown in Figure 1 with reasons for exclusion.
As per Figure 2, the published studies assessing the effect of CAM on diabetes/prediabetes have gradually increased over the years. Additionally, there are three protocols44–46 that we did not consider while summarizing the findings.
Table 2A contains detailed characteristics of included studies and citations and is provided in the Extended data – DOI: 10.6084/m9.figshare.19512349.v2.43 In the below text, we have summarized the characteristics of included studies.
Study design: Majority of the studies were RCTs, however we also included quasi-randomized/non-randomized studies having an intervention and control group. Twenty-one studies were efficacy, feasibility or pilot interventional studies.
Country: Studies were carried out in various parts of the world. The geographical distribution of the studies is depicted in Figure 3. As seen in the figure, most of the studies were conducted in India and Iran; both contributing to three-fourths of the identified studies. About four-fifth studies were conducted in Asia compared to other continents.
Extended data: 10.6084/m9.figshare.19512349.v243 includes PubMed search strategy, characteristics of included studies, study IDs of included studies cited in tables 2-5 and bibliography of included studies as well as PRISMA-ScR checklist.
Population details: Population comprised of prediabetes/metabolic syndrome (n = 28 studies), T2DM not on any hypoglycemic drugs (n = 46), T2DM with hypoglycemic drugs (n = 116) and T2DM with comorbidity (n = 59). Most commonly studied comorbidity was diabetic foot ulcer (n = 27 studies), followed by peripheral neuropathy (n = 11) and other conditions (n = 21). Fifteen studies included newly diagnosed T2DM population (within one year of diagnosis) and remaining others (n = 113) included chronically diagnosed T2DM, however, ninety-three studies did not report the duration of T2DM diagnosis. Majority of the studies (n = 167) included populations with mean ages ranging between 45 to 60 years, however, some studies included older adults or mean ages > 60 years (n = 37) and mean ages younger than 45 years (n = 16), while remaining others (n = 29) included adult population with varying ages. The sample size employed by the studies ranged between 10 and 375. We categorized the studies into sample size of 20 or less (n = 15), 21-50 (n = 84), 51-100 (n = 104), 101-200 (n = 31), and greater than 200 (n = 15).
Intervention details: Herbal or Ayurveda products were assessed by majority of the studies (n = 146), followed by yoga therapies (n = 52), other CAM including massage and topical applications of herbal products (n = 52), Unani medicines (n = 2), Sowa-Rigpa (n = 1) and Homeopathy (n = 1). Within these broad categories various unique complementary therapies were identified and are listed using botanical or trade names in the Extended data – DOI: 10.6084/m9.figshare.19512349.v2.43
With the help of tables, we have mapped the studies that measured the effectiveness of various CAMs on outcomes among individuals known to have prediabetes or metabolic syndrome, T2DM without any comorbidities and T2DM with comorbidities.
a) Prediabetes or metabolic syndrome: Effectiveness of yoga was measured on following outcomes; FBSL (n = 8), anthropometric measures (n = 5), HbA1c (n = 4), lipid profile (n = 4), PPBSL (n = 3), insulin (n = 3), and QoL (n = 3).
b) T2DM without any comorbidity: Most measured outcome was FBSLs (n=31), followed by HbA1c (n = 21), lipid profile (n = 16), QoL (n = 16), PPBSL (n = 15), anthropometric measures (n = 12), insulin or insulin resistance (n = 7) and adverse events (n = 2). Table 2 depicts the number of studies that measured the effect of yoga on various health outcomes.
a) Prediabetes or metabolic syndrome: Curcuma longa (turmeric) was studied by three studies, followed by Cuminum cyminum (cumin), Ayurveda polyherbal medication and other products.
b) T2DM without any associated comorbidity: T2DM population were further classified as taking hypoglycemic modern medicines or not. Momordica charantia L. (bitter melon), Trigonella foenum-graecum (fenugreek seed), Cuminum cyminum (cumin), as compared to other products were mostly studied among individuals having T2DM who were newly diagnosed or had no history of oral hypoglycemic drugs as standard therapy. Whereas cinnamon, Crocus sativus L. (saffron), Juglans regia (walnut), Momordica Charantia, and Trigonella foenum-graecum were majorly identified as herbal products that assessed glycemic indices, lipid profile, anthropometric measures and other outcomes among individuals with T2DM on hypoglycemic agents.
Table 3 depicts the number of studies that measured the effect of Ayurveda or herbal products on various health outcomes.
FBSL | PPBSL/OGTT | HbA1c | Insulin resistance/insulin | Lipid profile | Anthropometric measures | Adverse events | |
---|---|---|---|---|---|---|---|
Prediabetes/metabolic syndrome | |||||||
Barberry | 1 | 1 | 1 | ||||
Cinnamon | 1 | 1 | |||||
Crocus sativus (Saffron) | 1 | 1 | 1 | 1 | |||
Curcuma longa (Turmeric) | 3 | 2 | 3 | 1 | |||
Cuminum cyminum (Cumin) | 2 | 2 | 2 | 2 | 2 | ||
Elettaria cardamomum-Cardamom | 1 | ||||||
Eugenia jambolana | 1 | 1 | 1 | 1 | 1 | ||
PDBT/Rashara1 | 2 | 2 | 2 | 1 | 1 | 1 | 1 |
Nigella sativus (Black seeds) | 1 | 1 | 1 | ||||
Nutraceuticals2 | 1 | 1 | 1 | 1 | 1 | ||
Solacia | 1 | 1 | 1 | ||||
Zingiber officinale (ginger) | 1 | 1 | 1 | ||||
T2DM with no h/o hypoglycemic drugs | |||||||
Andrographis paniculata (Burm. f.) Wall. ex Nees | 1 | 1 | 1 | 1 | 1 | ||
Allium sativum (garlic) | 1 | 1 | |||||
Allium sativum + Curcuma | 2 | 2 | 2 | 2 | 2 | 1 | 1 |
Aloe vera gel powder | 1 | 1 | 1 | 1 | |||
Ayurvedic extract# | 2 | 1 | 2 | 2 | 1 | ||
Berberis integerrima | 1 | 1 | 1 | 1 | |||
Polyherbal Ayurvedic Sugaradik | 1 | 1 | 1 | ||||
Ayurveda- PDM011011 | 2 | 1 | 2 | 1 | |||
Cinnamon | 2 | 2 | 1 | 1 | 1 | ||
Cuminum cyminum (Cumin) | 3 | 2 | 1 | 2 | 1 | ||
Curcuminoid extract | 1 | 1 | 1 | 1 | |||
Eclipta Alba | 1 | 1 | |||||
Eugenia jambolana seed | 1 | 1 | 1 | 1 | |||
Ipomoea Batatas (Caiapo) | 3 | 2 | 2 | 3 | 3 | 2 | 1 |
Inolter capsule | 1 | 1 | 1 | ||||
Momordica charantia L. (Bitter Melon) | 6 | 5 | 3 | 1 | 1 | 3 | 3 |
Moringa oleifera Leaf capsules | 1 | 1 | 1 | 1 | 1 | ||
Syzygium cumini (L.) Skeels | 1 | 1 | 1 | 1 | |||
Pterocarpus marsupium (Vijayasar) | 2 | 2 | 1 | 1 | 1 | ||
Tea- green (Granulated Gymnema) | 1 | 1 | 1 | ||||
Trigonella foenum-graecum (Fenugreek seed) | 3 | 2 | 2 | 2 | 2 | 1 | |
Trigonella foenum + Nigella sativa | 1 | ||||||
Zingiber officinale (ginger) | 1 | 1 | 1 | 1 | 1 | 1 | |
T2DM with hypoglycemic drugs | |||||||
Aegle Marmelos (L.) Correa (Bael) Leaf Juice | 2 | 2 | 2 | 2 | 2 | ||
Allium Sativum (garlic) | 2 | 1 | 1 | 1 | |||
Azadirachta Indica | 1 | 1 | 1 | ||||
Bell pepper juice | 1 | 1 | 1 | ||||
Barberry | 1 | 1 | 1 | 2 | |||
Boswellia serrata gum | 1 | 1 | 1 | 1 | |||
Capparis spinosa L. (Caper) fruit extract | 2 | 1 | 2 | 2 | 1 | 1 | |
Cinnamon | 8 | 1 | 6 | 4 | 5 | 4 | 1 |
Cinnamon & Caucasian whortleberry | 1 | 1 | 1 | 1 | 1 | 1 | |
Citrullus colocynthis (Schrad Fruit) | 2 | 2 | 1 | 2 | |||
Crocus sativus L. (Saffron) | 6 | 1 | 4 | 3 | 3 | 6 | 1 |
Cuminum cyminum - cumin | 1 | 1 | 1 | ||||
Curcuma longa Linn./Curcumin (Turmeric) | 2 | 2 | 1 | 3 | 3 | 1 | |
DB Care tab# | 1 | 1 | 1 | 1 | |||
Elettaria cardamomum (green cardamom) | 2 | 1 | 2 | 1 | 1 | 3 | |
Gymnema Sylvestre | 1 | 1 | 1 | 1 | 1 | ||
Hibiscus sabdariffa (sour) tea | 1 | 1 | 2 | 1 | |||
Ipomoea batatas L. (sweet potato) | 1 | 1 | 1 | 1 | |||
Juglans regia (walnut) leaves/capsules/nut | 5 | 2 | 5 | 4 | 3 | 3 | 1 |
Momordica Charantia (bitter gourd) | 4 | 2 | 2 | 1 | 3 | 1 | 1 |
Moringa Oleifera | 1 | 1 | 1 | ||||
Pancreas tonic# | 1 | 1 | |||||
Phyllanthus emblica | 1 | 1 | |||||
Pomegranate (Punicagranatum) juice | 2 | 1 | 1 | 1 | |||
Salacia oblonga extract | 1 | 1 | |||||
Salacia reticulata Kothala Himbutu tea | 1 | 1 | 1 | 1 | |||
Tribulus terrestris | 1 | 1 | 1 | 1 | |||
Terminalia Chebula | 1 | 1 | |||||
Herbal combination capsule## | 1 | 1 | 1 | 1 | |||
Trigonella foenum-graecum (fenugreek) | 8 | 3 | 6 | 1 | 4 | 3 | 1 |
Withania somnifera | 1 | 1 | |||||
Zingiber officinale (Ginger) | 3 | 2 | 1 | 2 | 3 | 1 | |
Poly herbal^ | 1 | 1 | 1 | ||||
Poly herbal^^ | 1 | 1 | 1 | 1 | 1 |
Effect of acupuncture on glycemic indices was mostly studied among those identified and studied (See Table 4).
We identified studies that assessed the effect of various CAMs on comorbidities that are associated with T2DM. These are mapped in Table 5. Massage for diabetic peripheral neuropathy, laser therapy and honey dressing for diabetic foot ulcer were most studied CAMs.
Table 3D in Extended data43 provides the citation details of these studies.
This scoping review provides an up-to-date evidence on studies conducted to identify the effectiveness of CAMs on various health outcomes among T2DM and individuals who had prediabetes. Multiple CAMs were identified, of which yoga and Ayurveda or herbal products were most studied. Majority of these studies were conducted in India and Iran. One of the reasons for identifying a higher number of studies from these countries on Ayurveda, herbal products and yoga could be that these products are deeply rooted in the tradition and thus are culturally accepted by the people. Additionally, there might be higher awareness among academic and research communities and promotion of these products by some of the international organizations such as the WHO. For instance, one-hundred and seventy WHO members have admitted to promoting and integrating traditional and complementary medicines into their health services.47 Recently, the WHO has also established, ‘Global Centre for Traditional Medicine’ in Jamnagar, India.48 Furthermore, yoga has also been promoted by the United Nations, which in its general assembly established, June 21 st as International Yoga Day.49
Although we identified a lot of literature on the effectiveness of CAMs for T2DM, there is a lack of standardization of preparation of these medicines and interventional modalities. This leads to a great setback in the acceptance of CAM for the management of T2DM among the scientific fraternity. Unlike modern medicines, the concept of most of CAMs’ mode of action over any disease is not solely based on the active principles. Each CAM is, however, based on its own principles and approach through a personalized medicine. For example, in Ayurveda, parameters like Rasa (taste of substance), Guna (properties), Veerya (active principle), Vipaka (final transformation), Prabhava (specific or special power of the drug) are important while deciding the medicines; and each patients gets a tailored medicine, diet and lifestyle advice.6,18 It might be because of the tailored approach of many CAMs, it is difficult to design a robust RCT, which might be the reasons for not identifying or limited evidence on some of the CAMs in the current scoping review. We did not identify any studies on the Siddha system of medicine. Also, the evidence on Unani, Homeopathy and Sowa-Rigpa is limited.
Although some of the CAMs are found to have used complementary to conventional therapies,50 there are many CAM formulations available in the market that haven't been tested for efficacy or effectiveness.23 There is also evidence of toxicity, e.g., hepatotoxicity, associated with some of the CAMs;51,52 nevertheless, such toxicities were not identified by this review as it was not reported by the included studies. Lack of high standard, quality CAM clinical trials with inadequate suitable methodology and systematic documentation and reporting have led to lack of credibility of evidence-based science. Owing to the poor quality of some of the CAM trials, they are often published in journals having lower impact.53 It is one of the reasons we identified almost three-fifth studies through reference searching of included studies. Furthermore, almost two-fifths of identified studies employed a 50 or less sample size and many studies were of short duration, which may be due to lack of adequate funding. Despite this, as discussed previously in the introduction section, vast majority of people (e.g., Asian) use CAMs and, in many cases, do not disclose its use23 with the fear of disapproval by the conventional healthcare professional.54
To validate the potential benefits of CAM, robust research with suitable methodology such as high quality RCTs55,56 and systematic reviews57,58 can bridge the gap of CAM therapies in delivering a holistic approach to the wellbeing of humankind. Future investments for research in CAM should be focused on assessing the quality of existing trials and finding out optimal dose, frequency, and duration of CAM, both as an alternative and complementary approach. It is also important to carry out rigorous systematic reviews of CAMs and our scoping review can provide the base for such reviews. Also, researchers should consider carrying out cost-effectiveness studies on CAM. In this scoping review, we did not identify any of the studies that measured economic outcomes of CAM. Some of the outcomes that might be important for patients such as nausea and vomiting associated with oral CAMs (were not assessed by the current review) could also be explored in future research. In the recent past the “National Health and Medical Research Council, Australia” has banned practice of homeopathy in Australia as there was no evidence to demonstrate the effectiveness of Homeopathy and this was achieved through conducting a robust systematic review.59
Our extensive scoping review provided the groundwork for a systematic review in coming times to investigate the effect of CAMs on important health outcomes. Our intent was to map the evidence by following JBI methods40,41 hence, we did not critically appraise the included studies. We also did not group the multiple publications arising from the same studies. However, future researchers intending to do systematic reviews could overcome these shortcomings. Although we carried out extensive exercise of identifying the literature, databases such as EMBASE and other important subject specific databases were not freely accessible, and had language barriers. Additionally, while searching we did not use unique names (or botanical names) of the individual drugs. Due to the aforementioned reasons, we do not refute the possibility of missing important publications.
Changes from protocol: We changed the title and throughout the manuscript terminology of ‘AYUSH system’, which has restricted usage in India to ‘Complementary and alternative system’ of medicine so as to focus globally. At the protocol stage, we had an intent of mapping systematic reviews, however, due to large volumes of studies we excluded at a full text screening stage.
This scoping review summarized Ayurveda and herbal products, yoga, naturopathy and other complementary and alternative therapies for prediabetes and T2DM by including 249 interventional studies. Most studies were conducted in India and Iran. This scoping review also identified gaps in evidence in effectiveness of CAMs and outcomes. Designated ministries and governmental agencies must train CAM practitioners in clinical trial methodologies as it would help in thoroughly appraising the evidence to guide future practice. Research of this magnitude should be collaborative in nature where physicians from allopathic systems of practice, methodologists and practitioners of CAM should work in parallel to systematically synthesize literature on clinical conditions of interest. Although funding for evidence synthesis for CAM is generally low across countries, it is a need of the hour to direct resources to support evidence-based practice.
Figshare. Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review. DOI: https://doi.org/10.6084/m9.figshare.19512349.v2.43
This project contains the following underlying data:
• This review aims to map the evidence on the effectiveness of Complementary and Alternative Medicine (CAM) for Type 2 Diabetes Mellitus (T2DM) and its associated complications and identify research gaps in key outcomes and CAMs. The protocol was registered with Open Science Forum with DOI: 10.17605/OSF.IO/6CNH7.
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
Figshare. PRISMA-ScR checklist. DOI: https://doi.org/10.6084/m9.figshare.19512349.v2.43
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
SSP, NG and BH conceptualized the research. Search and data management was undertaken by SSP. Title screening was done by SSP and NG, abstract and full text screening was done by SSP, NG, AH, and AN. Reference search and screening of additional studies was done by SSP and SCW. Data extraction was done by SSP, NG, SCW, PDS, AH and AN. Analysis was undertaken by SSP and NG. First draft was written by SSP, SCW and NG. All authors critically read, edited and approved the final manuscript.
We acknowledge Manipal Academy of Higher Education for providing technical support to carry out this scoping review.
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Complementary and alternative medicine
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Complementary and alternative medicine
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
No
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Partly
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
References
1. Teo WY, Chu SWF, Chow LY, Yeam CT, et al.: Role of Alternative Medical Systems in Adult Chronic Kidney Disease Patients: A Systematic Review of Literature.Cureus. 2022; 14 (12): e32874 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Complementary and alternative medicine
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Endocrine, therapeutics, study designs
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Version 2 (revision) 28 Nov 23 |
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Please see my notes below:
1) The topic is of very high importance on account of both the condition the review focuses ... Continue reading Thank you for submitting this scoping review.
Please see my notes below:
1) The topic is of very high importance on account of both the condition the review focuses on and the societal relevance of CAM therapies
2) In the introduction, the authors do a good job in highlighting the importance of T2DM and CAM
3) Note: Many practitioners of traditional/non-allopathic schools of medicine resent the terms CAM as it reinforces the primacy of Allopathy or Modern Medicine and also clubs disparate traditions with diverse origins and evolution pathways into a basket term. Perhaps the authors can add a small note acknowledging the politics of the term.
4) As a reviewer, I was surprised that there were no previous scoping reviews on T2DM and CAM. Perhaps this statement needs to be preceded by some elaboration and acknowledgement of the types of reviews looking at T2DM and CAM in the past. That will both add credence to the statement and serve to educate the interested reader.
5) Methods are well laid out.
6) Results section
- Fig 2: Since the methods section states that only studies upto 2020 were included, there is no need for the bar showing 2019-2022. It gives the potentially erroneous impression that the number of studies on CAM and PreDM/T2DM have fallen since 2019.
- Population subgroups in which studies were conducted, the country of origin of the studies, and the type of CAM studied are very interesting/insightful.
- Tables 2,3,4,5 are useful
7) Discussion, Limitations, and Conclusion sections - adequate. However, a box of the key take home points for clinicians would have been useful. It may be useful to see and adopt some of the concepts PURLs (Priority Updates from the Research Literature) use: https://www.fpin.org/what-are-purls-
A note to clinicians that addresses how this scoping review potentially contributes to "Change in Practice" and "Clinically meaningful use of CAMs for PreDM/T2DM will be useful and may also enhance the readability of the paper.
I conclude by commending the authors on picking an area that is complex, conflicting, and cacophonous but of great relevance to clinical practice, health seeking behavior, and health systems.
Please see my notes below:
1) The topic is of very high importance on account of both the condition the review focuses on and the societal relevance of CAM therapies
2) In the introduction, the authors do a good job in highlighting the importance of T2DM and CAM
3) Note: Many practitioners of traditional/non-allopathic schools of medicine resent the terms CAM as it reinforces the primacy of Allopathy or Modern Medicine and also clubs disparate traditions with diverse origins and evolution pathways into a basket term. Perhaps the authors can add a small note acknowledging the politics of the term.
4) As a reviewer, I was surprised that there were no previous scoping reviews on T2DM and CAM. Perhaps this statement needs to be preceded by some elaboration and acknowledgement of the types of reviews looking at T2DM and CAM in the past. That will both add credence to the statement and serve to educate the interested reader.
5) Methods are well laid out.
6) Results section
- Fig 2: Since the methods section states that only studies upto 2020 were included, there is no need for the bar showing 2019-2022. It gives the potentially erroneous impression that the number of studies on CAM and PreDM/T2DM have fallen since 2019.
- Population subgroups in which studies were conducted, the country of origin of the studies, and the type of CAM studied are very interesting/insightful.
- Tables 2,3,4,5 are useful
7) Discussion, Limitations, and Conclusion sections - adequate. However, a box of the key take home points for clinicians would have been useful. It may be useful to see and adopt some of the concepts PURLs (Priority Updates from the Research Literature) use: https://www.fpin.org/what-are-purls-
A note to clinicians that addresses how this scoping review potentially contributes to "Change in Practice" and "Clinically meaningful use of CAMs for PreDM/T2DM will be useful and may also enhance the readability of the paper.
I conclude by commending the authors on picking an area that is complex, conflicting, and cacophonous but of great relevance to clinical practice, health seeking behavior, and health systems.