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Research Article
Revised

Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review

[version 3; peer review: 1 approved, 1 not approved]
PUBLISHED 25 Jan 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Manipal Academy of Higher Education gateway.

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Keywords

Complementary and alternative medicine, Type II diabetes mellitus, Scoping review

Revised Amendments from Version 2

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.

Introduction

Description of the condition

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

Description of the intervention

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.1214 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

How the intervention might work

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.

Table 1. Some of the examples of CAMs and its possible anti-hyperglycemic effects.

CAMDescription of the CAMHow CAM might work in T2DM?
AyurvedaAyurveda 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.7Antihyperglycemic 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
YogaYoga 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.22Yoga 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
UnaniUnani system of medicine considers imbalance in certain fluids (e.g., blood and bile) as the main cause of diseases.8Unani medicines have shown significant reduction in blood sugar level in individuals with T2DM.26
SiddhaSiddha 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
HomoeopathyHomoeopathy 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.8The 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
MassageIt 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.21Massage 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
NaturopathyNaturopathy (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
AcupunctureIt 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.32Mechanisms 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

Why it is important to do this scoping review?

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.3537 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.

Methods

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).

Eligibility criteria

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.

Source of evidence selection

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

Data management

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: applying inclusion and exclusion criteria

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.

Data charting

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.

Analysis of the evidence

The extracted information was mapped descriptively using tables. Frequencies of population, intervention, study details, and country have been reported.

Results

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.

44cb5d95-2a3b-4497-9c71-199c091307e5_figure1.gif

Figure 1. PRISMA flow diagram.

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 protocols4446 that we did not consider while summarizing the findings.

44cb5d95-2a3b-4497-9c71-199c091307e5_figure2.gif

Figure 2. Distribution of studies across publication years.

Characteristics of included studies

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.

44cb5d95-2a3b-4497-9c71-199c091307e5_figure3.gif

Figure 3. Country-wise distribution of studies.

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

Mapping the interventions and outcomes

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.

Yoga for prediabetes and T2DM

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.

Table 2. Number of studies that assessed effect of yoga interventions on health outcomes among prediabetes or T2DM.

Yoga typeFBSLPPBSL/OGTTHbA1cInsulin resistance/insulinLipid profilesAnthropometric measuresQoL, wellbeingAdverse events
Prediabetes or metabolic syndrome
Yoga Asana8343453
Type-2 diabetes mellitus
Hatha yoga1121
Restorative yoga211222
Vinyasa yoga111
Iyengar yoga111111
Laughter yoga11
Sudarshan Kriya yoga3332
Yoga Asana2291541012101
Ayurveda or herbal products for prediabetes and T2DM

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.

Table 3. Number of studies that assessed effect of Ayurveda or herbal products on health outcomes among prediabetes or T2DM.

FBSLPPBSL/OGTTHbA1cInsulin resistance/insulinLipid profileAnthropometric measuresAdverse events
Prediabetes/metabolic syndrome
Barberry111
Cinnamon11
Crocus sativus (Saffron)1111
Curcuma longa (Turmeric)3231
Cuminum cyminum (Cumin)22222
Elettaria cardamomum-Cardamom1
Eugenia jambolana11111
PDBT/Rashara12221111
Nigella sativus (Black seeds)111
Nutraceuticals211111
Solacia111
Zingiber officinale (ginger)111
T2DM with no h/o hypoglycemic drugs
Andrographis paniculata (Burm. f.) Wall. ex Nees11111
Allium sativum (garlic)11
Allium sativum + Curcuma2222211
Aloe vera gel powder1111
Ayurvedic extract#21221
Berberis integerrima1111
Polyherbal Ayurvedic Sugaradik111
Ayurveda- PDM0110112121
Cinnamon22111
Cuminum cyminum (Cumin)32121
Curcuminoid extract1111
Eclipta Alba11
Eugenia jambolana seed1111
Ipomoea Batatas (Caiapo)3223321
Inolter capsule111
Momordica charantia L. (Bitter Melon)6531133
Moringa oleifera Leaf capsules11111
Syzygium cumini (L.) Skeels1111
Pterocarpus marsupium (Vijayasar)22111
Tea- green (Granulated Gymnema)111
Trigonella foenum-graecum (Fenugreek seed)322221
Trigonella foenum + Nigella sativa1
Zingiber officinale (ginger)111111
T2DM with hypoglycemic drugs
Aegle Marmelos (L.) Correa (Bael) Leaf Juice22222
Allium Sativum (garlic)2111
Azadirachta Indica111
Bell pepper juice111
Barberry1112
Boswellia serrata gum1111
Capparis spinosa L. (Caper) fruit extract212211
Cinnamon8164541
Cinnamon & Caucasian whortleberry111111
Citrullus colocynthis (Schrad Fruit)2212
Crocus sativus L. (Saffron)6143361
Cuminum cyminum - cumin111
Curcuma longa Linn./Curcumin (Turmeric)221331
DB Care tab#1111
Elettaria cardamomum (green cardamom)212113
Gymnema Sylvestre11111
Hibiscus sabdariffa (sour) tea1121
Ipomoea batatas L. (sweet potato)1111
Juglans regia (walnut) leaves/capsules/nut5254331
Momordica Charantia (bitter gourd)4221311
Moringa Oleifera111
Pancreas tonic#11
Phyllanthus emblica11
Pomegranate (Punicagranatum) juice2111
Salacia oblonga extract11
Salacia reticulata Kothala Himbutu tea1111
Tribulus terrestris1111
Terminalia Chebula11
Herbal combination capsule##1111
Trigonella foenum-graecum (fenugreek)8361431
Withania somnifera11
Zingiber officinale (Ginger)321231
Poly herbal^111
Poly herbal^^11111

1 Ayurveda poly herbal product.

2 Bitter melon fruit, Fenugreek seed, Cinnamon stem bark, & other chemicals.

++ Securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis & coriandrium sativum.

# Poly herbal formulation.

## Terminalia chebula fruit extract, Commiphora mukul, and Commiphora myrrhaoleo-gum-resin.

^ Capparis spinose, Rosa canina, Securidaca securigera, Silybum marianum, Urtica dioica, Trigonella foenum-graecum and Vaccinium arctostaphylos.

^^ Nettle leaf, berry leaf, onion and garlic, fenugreek seed, walnut leaf, and cinnamon bark.

Other CAMs for prediabetes and T2DM

Effect of acupuncture on glycemic indices was mostly studied among those identified and studied (See Table 4).

Table 4. Number of studies that assessed effect of Unani, Sowa-Rigpa and other CAMs on health outcomes.

InterventionFBSLPPBSLHbA1cInsulin/insulin resistanceLipid profileAdverse eventsQOLAnthropometric measures
T2DM with no h/o hypoglycemic drugs
Tibetan medicine (Kyura-6, Aru-18, Yungwa-4, & Sugmel- 19)1111
T2DM with hypoglycemic drugs
Unani Medicine (Vernonia cinerea root)1111
Unani: Poly herbal1111
Electro-acupuncture or acupuncture61411
Peripheral electric stimulation111
Self-Acupoint Massage1111
Tactile Massage2212
Foot reflexology1
Foot reflexologyda Silva et al., 2015: indicators of feet impairment related to skin and hair, blood circulation, sensibility, and tissue temperature
CAM for T2DM with associated comorbidity

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 5. Number of studies that assessed effect of CAM on diabetes related complications.

InterventionGlycemic control & HbA1cABI, Arterial BP, blood flowLipid profileQoLWound healingAdverse eventsNeuropathy related outcomeKidney function testSigns of periodontitisGastrin and other enzymesErectile functionAnxiety
Diabetic nephropathy
Dioscorea bulbifera1111
Fosinopril1111
T2DM with bladder dysfunction
Acupuncture1
T2DM with dyslipidemia/hyperlipidemia
Allium Sativum (Garlic) powder1
G-400: poly herbal11
Trigonella foenumgraecum (Fenugreek)111
T2DM with gastroparesis
Acupuncture111
Diabetic peripheral neuropathy
Topical Citrullus Colocynthis (bitter apple) extract oil111
Topical Nutmeg extract1
Acupuncture1121
Warm saltwater footbath11
Aromatherapy Massage11
Massage13
Yoga11
T2DM with periodontitis
Topical Aloe vera Gel11
Zingiber officinale (ginger)111
Customized medicines for each patient1
Diabetic foot or ulcer
Topical Aloe vera (Plantago major) Gel111
Oral Centella asiatica extract1
Curcumin1
Phototherapy/polarized light4
Polarized light1
Pulsed Electromagnetic Field v/s Laser therapy1
Electro-magnetic field2
Laser therapy6
Honey dressing26
Beri (Ziziphus jujuba) Honey dressing1
Olive oil2
Kiwi fruit dressing1
Herbal ointment1
T2DM with Peripheral arterial disease
Connective Tissue Reflex Massage1
Hydrotherapy1
T2DM with erectile dysfunction
Topical Saffron (Crocus sativus L) Gel1
T2DM with cognitive dysfunctions/mental health disorder
Polyherbal11
Crocus sativus1
T2DM with Kidney disease
Turmeric1

Table 3D in Extended data43 provides the citation details of these studies.

Discussion

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

Strengths and limitations

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.

Conclusion

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.

Data availability

Underlying data

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).

Extended data

Reporting guidelines

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).

Authors' contributions

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.

Comments on this article Comments (2)

Version 3
VERSION 3 PUBLISHED 25 Jan 2024
Revised
Version 1
VERSION 1 PUBLISHED 16 May 2022
Discussion is closed on this version, please comment on the latest version above.
  • Reader Comment 17 Nov 2023
    Ramakrishna Prasad, Family Medicine, Academy of Family Physicians of India (AFPI), Bangalore, India
    17 Nov 2023
    Reader Comment
    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 ... Continue reading
  • Reader Comment 17 Nov 2023
    Prince Peprah, University of New South Wales, Sydney, Australia
    17 Nov 2023
    Reader Comment
    This paper is well-written and has significant policy and practice implications. My only concern is the section 'how the intervention might work?' Because I do not see any intervention introduced ... Continue reading
  • Discussion is closed on this version, please comment on the latest version above.
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Parsekar SS, Gudi N, Walke SC et al. Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review [version 3; peer review: 1 approved, 1 not approved]. F1000Research 2024, 11:526 (https://doi.org/10.12688/f1000research.118147.3)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 3
VERSION 3
PUBLISHED 25 Jan 2024
Revised
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Reviewer Report 15 Feb 2024
Jun Jie Benjamin Seng, MOH Holdings Private Ltd, Singapore, Singapore 
Not Approved
VIEWS 13
Dear editor,
I am unable to see the point by point response to comments highlighted by previous reviewers. 

Abstract
- Please use PRISMA checklist for abstract 
-> There are multiple missing information e.g. database ... Continue reading
CITE
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HOW TO CITE THIS REPORT
Seng JJB. Reviewer Report For: Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review [version 3; peer review: 1 approved, 1 not approved]. F1000Research 2024, 11:526 (https://doi.org/10.5256/f1000research.160765.r240877)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 2
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PUBLISHED 28 Nov 2023
Revised
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Reviewer Report 29 Nov 2023
Jun Jie Benjamin Seng, MOH Holdings Private Ltd, Singapore, Singapore 
Not Approved
VIEWS 16
Suggest for authors to provide point by point response to previous comments. 

Additional comments remains

Abstract
  • include statistics for percentage where studies were conducted
     
  • Results
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Seng JJB. Reviewer Report For: Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review [version 3; peer review: 1 approved, 1 not approved]. F1000Research 2024, 11:526 (https://doi.org/10.5256/f1000research.158379.r226365)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 1
VERSION 1
PUBLISHED 16 May 2022
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32
Cite
Reviewer Report 25 Aug 2023
Jun Jie Benjamin Seng, MOH Holdings Private Ltd, Singapore, Singapore 
Not Approved
VIEWS 32
The authors describe a fairly extensive review of use of CAM in T2DM patients. 

Abstract
  • Please include relevant statistics in the results section. 
     
  • Results can be better elaborated
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Seng JJB. Reviewer Report For: Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review [version 3; peer review: 1 approved, 1 not approved]. F1000Research 2024, 11:526 (https://doi.org/10.5256/f1000research.129989.r190280)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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23
Cite
Reviewer Report 20 Apr 2023
Shrilatha Kamath, Department of Kayachikitsa, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karnataka, India 
Approved
VIEWS 23
The present article is above average level in terms of scoring. The study is intended with a view of highlighting the necessity of other branches of medicine in integration with allopathic medicine. The review article topic is rightly selected as it ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Kamath S. Reviewer Report For: Complementary and alternative system of medicine for type 2 diabetes mellitus and its complications: A scoping review [version 3; peer review: 1 approved, 1 not approved]. F1000Research 2024, 11:526 (https://doi.org/10.5256/f1000research.129989.r168045)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (2)

Version 3
VERSION 3 PUBLISHED 25 Jan 2024
Revised
Version 1
VERSION 1 PUBLISHED 16 May 2022
Discussion is closed on this version, please comment on the latest version above.
  • Reader Comment 17 Nov 2023
    Ramakrishna Prasad, Family Medicine, Academy of Family Physicians of India (AFPI), Bangalore, India
    17 Nov 2023
    Reader Comment
    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 ... Continue reading
  • Reader Comment 17 Nov 2023
    Prince Peprah, University of New South Wales, Sydney, Australia
    17 Nov 2023
    Reader Comment
    This paper is well-written and has significant policy and practice implications. My only concern is the section 'how the intervention might work?' Because I do not see any intervention introduced ... Continue reading
  • Discussion is closed on this version, please comment on the latest version above.
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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