Ayurvedic treatment for diabetes
Patients with diabetes frequently use complimentary and alternative medications including Ayurvedic medications and hence it is important to determine their efficacy and safety.
To assess the effects of Ayurvedic treatments for diabetes mellitus.
We searched The Cochrane Library (issue 10, 2011), MEDLINE (until 31 August 2011), EMBASE (until 31 August 2011), AMED (until 14 October 2011), the database of randomised trials from South Asia (until 14 October 2011), the database of the grey literature (OpenSigle, until 14 October 2011) and databases of ongoing trials (until 14 October 2011). In addition we performed hand searches of several journals and reference lists of potentially relevant trials.
We included randomized trials of at least two months duration of Ayurvedic interventions for diabetes mellitus. Participants of both genders, all ages and any type of diabetes were included irrespective of duration of diabetes, antidiabetic treatment, comorbidity or diabetes related complications.
Data collection and analysis
Two authors independently extracted data. Risk of bias of trials was evaluated as indicated in the Cochrane Handbook for Systematic Reviews of Intervention.
Results of only a limited number of studies could be combined, in view of different types of interventions and variable quality of data. We found six trials of proprietary herbal mixtures and one of whole system Ayurvedic treatment. These studies enrolled 354 participants ( 172 on treatment, 158 on controls, 24 allocation unknown). The treatment duration ranged from 3 to 6 months. All these studies included adults with type 2 diabetes mellitus.
With regard to our primary outcomes, significant reductions in glycosylated haemoglobin A1c (HbA1c), fasting blood sugar (FBS) or both were observed with Diabecon, Inolter and Cogent DB compared to placebo or no additional treatment, while no significant hypoglycaemic response was found with Pancreas tonic and Hyponidd treatment. The study of whole system Ayurvedic treatment did not provide data on HbA1c and FBS values. One study of Pancreas tonic treatment did not detect a significant change in health-related quality of life. The main adverse effects reported were drug hypersensitivity (one study, one patient in the treatment arm); hypoglycaemic episodes (one study, one participant in the treatment arm; none had severe hypoglycaemia) and gastrointestinal side effects in one study (1 of 20 in the intervention group and 0 of 20 participants in the control group). None of the included studies reported any deaths, renal, hematological or liver toxicity.
With regard to our secondary outcomes, post prandial blood sugar (PPBS) was lower among participants treated with Diabecon, was unchanged with Hyponidd and was higher in patients treated with Cogent DB. Treatment with Pancreas tonic and Hyponidd did not affect lipid profile significantly, while patients treated with Inolter had significantly higher HDL- and lower LDL-cholesterol as well as lower triglycerides. Cogent DB treated participants also had lower total cholesterol and triglycerides.
Studies of treatment with Diabecon reported increased fasting insulin levels; one study of treatment with Diabecon reported higher stimulated insulin levels and fasting C-peptide levels in the treatment group. There was no significant difference in fasting and stimulated C-peptide and insulin levels with Hyponidd, Cogent DB and Pancreas tonic treatment. The study of Inolter did not assess these outcomes.
No study reported on or was designed to investigate diabetic complications, death from any cause and economic data.
Although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.
PLAIN LANGUAGE SUMMARY
Ayurvedic treatments for diabetes mellitus
People with diabetes and other chronic diseases often use complementary and alternative medicines. This review examines the efficacy and safety of the use of various Ayurvedic treatments for diabetes mellitus. We found seven trials which included 354 participants (172 on treatment, 158 on control, 24 could not be classified). All these studies included adults with type 2 diabetes mellitus. Six studies tested five different types of herbal mixtures (proprietary drugs) and only one tested ‘whole system’ Ayurvedic treatment. The duration of treatment ranged from three to six months. One study each of Diabecon, Inolter and Cogent DB (proprietary herbal mixtures) found significantly lower glycosylated haemoglobin A1c (HbA1C) levels at the end of the treatment period compared to controls. Two studies of Diabecon, and one study of Cogent DB (proprietary herbal mixtures) found significantly lower fasting blood sugar levels at the end of the study period in the treatment group. No deaths were observed in these trials and side effects did not differ significantly between intervention and control groups. One study of Pancreas tonic reported no significant change in health-related quality of life. No study reported on or was designed to investigate diabetic complications, death from
any cause and costs. Despite positive results in some studies, and absence of serious side effects, firm conclusions cannot be drawn due to weak methods and small number of participants in the evaluated studies. Further research is needed to assess the efficacy of these treatments. Ayurvedic physicians generally use a mixture of various herbs or proprietary preparations along with diet, exercise and mode of living. The treatments are usually individualised taking into account the balance of three ‘doshas’. It is possible that the interventions in the trials analysed have not replicated actual Ayurvedic practice but only assessed some components individually.
Description of the condition
Diabetes mellitus is a metabolic disorder resulting from a defect in insulin secretion, insulin action, or both. A consequence of this is chronic hyperglycaemia (that is elevated levels of plasma glucose) with disturbances of carbohydrate, fat and protein metabolism. Long-term complications of diabetes mellitus include retinopathy, nephropathy and neuropathy. The risk of cardiovascular disease is increased. For a detailed overview of diabetes mellitus, please see under ‘Additional information’ in the information on the Metabolic and Endocrine Disorders Group in The Cochrane Library (see ‘About’, ‘Cochrane Review Groups (CRGs)’). For an explanation of methodological terms, see the main glossary in The Cochrane Library .
There are two types of diabetes mellitus: type 1 insulin dependent (IDDM) and type 2 non-insulin dependent (NIDDM). Type 2 diabetes mellitus, the most common form, is the fourth leading cause of death in developed countries with a two fold excess mortality and two to four fold increased risk of coronary heart disease and stroke (McKinlay 2000 ). Diabetes affects women and men of all ages and every ethnic category, and many cases of diabetes remain undiagnosed for an average of 4 to 7 years (McKinlay 2000 ). Diabetes profoundly affects health-related quality of life and represents a life-long burden on a patient’s social support system. Diabetes places large financial demands on the health care system (Alberti 1998 ).
Description of the intervention
Ayurveda which means ‘Science of life’ is derived from the Sanskrit words ‘Ayur’ meaning life and ‘Veda’ meaning knowledge. It takes an integrated view of the interactions of the physical, mental, spiritual and social aspects of the life of human beings. Ayurveda was first referred to in the Vedas (Rigveda and Atharva Veda 1500 BC). It was originally composed by Agnivesa around 1000 BC, and subsequently comprehensively documented in the Charaka Samhita around 300 BC ( Ayush 2007; Subbarayappa 2001 ). According to Ayurveda all objects and living bodies are composed of five basic structural elements (Panchamahabhutas), namely earth, water, fire, air and vacuum (ether). Ayurveda believes in the theory of tridoshas, namely vata (ether and air), pitha (fire) and kapha (earth and water). These three doshas are physiological entities in living beings. Ayurveda aims to keep the structural and physiological entities in a state of equilibrium, which signifies good health. Any imbalance due to internal or external factors may cause disease (Ayush 2007). Ayurvedic treatment aims to restore the equilibrium through various techniques, procedures, regimens, diet and medicines. Ayurvedic treatment consists of drugs, diet, exercise and general mode of life. Ayurveda largely uses plants as raw material for the manufacture of drugs, though materials of animal and marine origin, metals and minerals are also used.
Diabetes mellitus (Madhumeha) was known to ancient Indian physicians and an elaborate description of its clinical features and management appears in Ayurvedic texts (Upadhyay 1984 ). Ayurvedic practitioners treat diabetes with a multi-pronged approach, using diet modification, Panchkarma to cleanse the system, herbal preparations, yoga and breathing exercises. The herbs which are used to treat diabetes include shilajit, turmeric, neem, coccinea indica, amalaki, triphala, bitter gourd, rose apple, leaves of bilva, cinnamon, gymnema, fenugreek, bay leaf and aloe vera (McWhorter 2001 ; Saxena 2004 ). Decoctions of triphala, fenugreek and Shilajit are commonly used. Powders (Churana) used include Amalaki Churna, Haldi powder (Turmeric powder) and Naag Bhasma. The Ayurvedic preparations ‘Vasanta Kusumakar Ras’ and ‘Chandraprabhavati’ are believed to lower sugar levels. Proprietary Ayurvedic medications are also used to treat diabetes.
How the intervention might work
It is postulated that Ayurvedic medications may act through potential pancreatic as well as extrapancreatic effects. The probable mechanisms of action include: delaying gastric emptying, slowing carbohydrate absorption, inhibition of glucose transport, increasing the erythrocyte insulin receptors and peripheral glucose utilization, increasing glycogen synthesis, modulating insulin secretion, decreasing blood glucose synthesis through depression of the enzymes glucose-6-phosphatase, fructose-1, and 6-bisphosphatase, and enhanced glucose oxidation by the enzyme glucose-6-phosphatase-dehydrogenase pathway (McWhorter 2001 ).
Adverse effects of the intervention
There are reports of heavy metal contamination (such as lead) in herbal preparations resulting in intoxication (Keen 1994 ). There are also reports of spurious herbal products contaminated with oral hypoglycaemic agents (Kulambil 2009 ) which could lead to adverse effects, such as hypoglycaemic episodes. The safety profile of these drugs has not been fully investigated. It is also not clear, whether these preparations might interact with other drugs or diagnostic tests.