Assessment of hypoglycemic effect of homoeopathic drug Insulinum in the patients suffering from type 2 diabetes mellitus: A prospective nonrandomized single-blind clinical trial

Nivedita Pattanaik; Chaturbhuja Nayak; Xinix Xavier

doi:10.4103/jahas.jahas_2_23

ORIGINAL ARTICLE

Year : 2022 | Volume : 1 | Issue : 2 | Page : 45-50

Assessment of hypoglycemic effect of homoeopathic drug Insulinum in the patients suffering from type 2 diabetes mellitus: A prospective nonrandomized single-blind clinical trial

Nivedita Pattanaik¹, Chaturbhuja Nayak², Xinix Xavier³
¹ Department of Materia Medica, Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Udaipur, India
² Homoeopathy University, Jaipur, Rajasthan, India
³ National Homoeopathy Research Institute In Mental Health (NHRIMH), Kottayam, Kerala, India

Date of Submission	02-Mar-2023
Date of Acceptance	20-Jun-2023
Date of Web Publication	26-Sep-2023

Correspondence Address:
Dr. Xinix Xavier
Cabin No. 116, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam 686532, Kerala
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jahas.jahas_2_23

Abstract

Introduction: Diabetes mellitus (DM) is described as a metabolic disorder of multiple etiologies characterized by chronic hyperglycemia with disturbance of carbohydrate, fat, and protein metabolism resulting from defect in insulin secretion, insulin action, or both. The increasing prevalence and incidence of DM in developing countries are due to the trend of urbanization and lifestyle changes, including a “Western-style” diet. However, the exact mechanism is not clearly understood to date. DM is classified broadly into type 1 DM (insulin-dependent DM), which is 5%–10% of all cases, and type 2 DM (noninsulin-dependent DM), which accounts for 90%–95% of all cases of DM. Globally, as of 2013, an estimated 382 million people have type 2 DM making up about 90% of the cases. This is equal to 8.3% of the adult population. In 2015, there were 5 million deaths from DM, that is, in every 6 s one person dies from it. It is the eighth leading cause of death. The evidence given by American Universities Group Diabetes Program suggests that conventional treatment can contribute to early death. Alternatively, homoeopathic intervention being safe and cost-effective, it was proposed to explore the role of an organ remedy Insulinum in reducing the blood sugar level and improving the quality of life of such patients suffering from type 2 DM. Materials and Methods: It was a prospective, observational, nonrandomized, noncontrolled, single-blind clinical trial. Results: Of 155 patients, 50 patients (36 males and 14 females) with type 2 DM were enrolled in the study. After a follow-up period of 12 months of treatment, the analysis was done. In the study population, the fasting blood sugar (FBS) baseline mean value was 7.5 mmol/L, which was reduced to 6.7 mmol/L, and the postprandial blood sugar (PPBS) baseline mean value was 11.6 mmol/L, which was reduced to 10.5 mmol/L at the end of treatment. The mean haemoglobin (HbA1C)% value was 8.066% at the baseline, whereas at the end of the treatment, it was reduced to 6.656% and the baseline DM mean score (based on cardinal symptoms of DM) was 8.8, which was reduced to 2.02 at the end of the treatment. Conclusion: The hypoglycemic effect of homoeopathic organ remedy Insulinum during the treatment of type 2 DM was confirmed through this study. The medicine was also helped to improve the quality of life of the patients.

Keywords: Clinical trial, homoeopathy, Insulinum, nonrandomized, type 2 diabetes mellitus

How to cite this article:
Pattanaik N, Nayak C, Xavier X. Assessment of hypoglycemic effect of homoeopathic drug Insulinum in the patients suffering from type 2 diabetes mellitus: A prospective nonrandomized single-blind clinical trial. J Ayurveda Homeopath Allied Health Sci 2022;1:45-50

How to cite this URL:
Pattanaik N, Nayak C, Xavier X. Assessment of hypoglycemic effect of homoeopathic drug Insulinum in the patients suffering from type 2 diabetes mellitus: A prospective nonrandomized single-blind clinical trial. J Ayurveda Homeopath Allied Health Sci [serial online] 2022 [cited 2023 Dec 10];1:45-50. Available from: http://www.dpujahas.org/text.asp?2022/1/2/45/386299

Introduction

Diabetes mellitus (DM) states to a group of common metabolic disorders that share the phenotype of hyperglycemia. DM can be classified broadly into type 1 DM and type 2 DM. Both types are preceded by a phase of abnormal glucose homeostasis as the pathogenic processes progress.^[1] Type 1 DM, previously known as insulin-dependent DM (IDDM) or Juvenile-onset DM accounts for 5%–10% of all cases of DM. This type can be further classified into immune-mediated and idiopathic DM.^[2] Type 2 DM was previously known as non-IDDM or adult-onset DM. Type 2 DM is caused due to combination of resistance to insulin action and an inadequate compensatory insulin secretory response.^[3] The development of insulin resistance and impaired glucose metabolism is usually a gradual process, beginning with weight gain and ultimately resulting in obesity. The mechanism that links obesity with insulin resistance, however, is still uncertain.^[4] Classical symptoms of marked hyperglycemia are polyuria, polydipsia, weight loss, sometimes polyphagia, fatigue, recurrent infection, dry mouth, headache, blurred vision, and rarely loss of consciousness.^[5] Due to chronic hyperglycemia, there may be impairment of growth and susceptibility to certain infections and may also be associated with dysfunction, long-term damage, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels.^[6] Whenever a person eats anything, insulin secretion increases, which helps the glucose to move from the blood into muscles, liver, and fat cells. In these cells, insulin transports and metabolizes glucose for energy, stimulates the storage of glucose in the liver and muscles, signals the liver to stop the release of glucose, enhances the storage of dietary fat in adipose tissues, and accelerates the transport of amino acids into cells. Insulin also inhibits the breakdown of stored glucose, protein, and fat.^[7] Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.^[8] Globally, as of 2013, an estimated 382 million people have diabetes, with type 2 DM making up about 90% of the cases. This is equal to 8.3% of the adult population. Worldwide in 2012 and 2013, diabetes resulted in 1.5–5.1 million deaths per year, making it the eighth leading cause of death. Diabetes doubles the risk of death.^[9] In India, 69.2 million adults are living with diabetes, the second largest number worldwide, after China, and also the second largest number of children with type 1 DM in the world (70,200), after the USA.^[10] As per IDF Diabetes Atlas ^{More Details} of 2015, there is little gender difference in the global number of people with DM; there are about 215.2 million men versus 199.5 million women with diabetes.^[11] The prevalence of DM in rural areas is 252 males per 1 lakh population in comparison to 195 females.^[12] Rough estimates show that, in India, the prevalence of DM in rural populations is one-quarter than that of urban population.^[13] As per the Annual Health Survey (AHS) 2010–2011, in Rajasthan, there were only 67 persons per 1 lakh suffering from diabetes in rural areas, but now the AHS 2012–2013 shows that the number has gone up to 224 people per 1 lakh.^[12]

Homoeopathy believes in holistic model of health, taking an overview of the patient’s mind, body and spirit, life situation, and other circumstances central in evolving a curative approach to chronic disease and complex cases, which helps in selecting a remedy that suits a patient, rather than to just a disease.^[14] And, treatment of DM is no exception to this concept. There were evidences that homoeopathic medicines could control blood sugar levels, prevent and control complications such as renal failure, retinopathy, and peripheral vascular disease, and reduce the dosage of allopathic antidiabetic drugs, and insulin.^[15] A few homoeopathic medicines used empirically in DM are Abromaaugusta, Cephalandraindica, Gymnemasylvester, Syzygiumjambolanum, and Insulinum.^[16] The proving data of homoeopathic medicine Insulinum and its use in DM are documented in homoeopathic literature. But no research has been conducted so far in homoeopathy on Insulinum to know its hypoglycemic action.

Materials and Methods

Study setting

Primary data of the patients were collected by organizing diabetes camps at Rajasthan Vidyapeeth Homoeopathic Hospital, Dabok, Udaipur, Rajasthan, and the follow-ups were done at the outpatient department of the hospital.

Study design

It was a prospective, nonrandomized, noncontrolled, single-blind clinical trial.

Participants

Patients aged 40 years and above, both sexes with type 2 DM without complication, and those presenting symptomatology similar to those of Insulinum and who provided voluntary written consents were included in the study. Of 155 screened cases of type 2 DM, 50 cases were selected based on the inclusion and exclusion criteria, whereas 105 cases were excluded as 31 of them did not agree to give consent, 7 patients did not fulfill the age criteria, and 67 patients did not exhibit symptomatology of Insulinum. Data analysis of all 50 cases enrolled in the study was done. The patients were advised to report once a month; during each visit, the changes in their symptomatology as well as laboratory data were recorded. However, patients were free to report at any time if any adverse event or emergency situation arose. In case of any emergency condition, the patient was referred for appropriate medical care as required. The flowchart of the participants is given in [Figure 1].

Figure 1: Flow diagram of the study participants

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Intervention

The homoeopathic medicine Insulinum was used as an intervention in 30 C or 200 C potency; four globules (no. 30) were administered at a time. The potency, dose, and repetition of the remedy were determined based on the homoeopathic principles.^[17] Patients were advised to practice lifestyle modifications, which included a healthy diet (rich in whole grains and fibers, use of good fats such as polyunsaturated fats found in vegetable oils, nuts, and fish), limiting sugary beverages, red meat, and other sources of saturated fats; regular physical exercise; maintaining normal body weight and relieving stress by relaxation techniques, that is, deep breathing, meditation, rhythmic exercise, yoga, and to avoid smoking and alcohol.

Study duration

The duration of the study was one and a half years, from January 2015 to June 2016, including 6 months for enrollment and 12 months for follow-up.

Outcome assessment

Each patient enrolled was assessed by changes in symptoms of DM assessment scoring scale,^[18] changes in blood sugar level, that is, fasting blood sugar (FBS), postprandial blood sugar (PPBS), haemoglobin (HbA1C)%, and routine urine test for sugar, and changes in the quality of life (QOL).^[19] Parameters adopted for the assessment of response to treatment were as follows: marked improvement, 75% and above improvement in symptom score from baseline score; moderate improvement, 50% to less than 75% improvement in symptom score; mild improvement, 25% to less than 50% improvement in symptom score; no significant improvement, less than 25% improvement in symptom score; and no improvement, no change in symptom score at the end of treatment, from baseline score. Statistically data analysis was done with the help of SPSS software version 18.^[20] Proportions used for presenting descriptive data were as follows:

Mean and standard deviations were used for quantitative data.

For statistical analysis, paired t test was used to assess the difference before and after treatment with homoeopathic intervention.

The conclusions were made based on P value, that is, P value <0.001 was considered statistically significant.

Results

Of 155 screened cases of type 2 DM, 50 cases were enrolled based on the inclusion and exclusion criteria and followed up for 12 months with a frequency of every month. The following observations were made. There were 10 cases, that is, 20.0% in each of the age groups between 45 and 60 years, whereas the minimum incidence was six cases, that is, 12.0% in 65–70 years. There were 36 males (72%) and 14 females (28%). The male incidence was more in comparison with females in the study population. There was a maximum incidence of 37 cases (74.0%) reported from urban areas compared with 13 patients (26.0%) from rural areas. As regards socioeconomic status, most of the patients belonged to middle class, that is, 24 cases (48.0%); 18 cases (36.0%) belonged to upper class, whereas only eight cases (18.0%) were from lower class. Majority of patients, 32 cases (64.0%), had a family history of DM, whereas 18 cases (36.0%) did not. In all the 50 cases before treatment, FBS was ≥7 mmol/L, but after treatment, FBS ≥ 7 mmol/L was found in eight cases, whereas FBS < 7 mmol/L was in 42 cases (84.0%). The mean value of FBS before treatment was 7.5 mmol/L, whereas after treatment, it was reduced to 6.7 mmol/L. To see the pre- and posttreatment statuses of FBS in 50 cases, paired t test was applied and noted to be statistically significant with P value <0.001. The PPBS level ≥11.1 mmol/L before treatment was observed in all 50 cases, whereas after treatment, PPBS level of ≥11.1 mmol/L was seen in 10 cases (20.0%) and PPBS level < 11.1mmol/L in 40 cases (80.0%). The mean value of PPBS before treatment was 11.6 mmol/L, whereas after treatment, it was reduced to 10.5 mmol/L. The mean pretreatment value of HbA1c% was 8.066%, whereas at the end of the treatment, it was reduced to 6.656%. Paired t test showed statistically significant results with P value <0.001, that is, statistically reduced post-HbA1c% than pre-HbA1c%. Before treatment, six cases (12.0%) showed the presence of sugar in urine, and 44 cases (88.0%) had no sugar in urine, whereas after the treatment, only one case (2.0%) had sugar in urine and 49 cases (98.0%) had no sugar in urine. The assessment of DM score (DMS) in response to treatment showed that there was marked improvement in 35 cases (70.0%), moderate improvement in nine cases (18.0%), and mild improvement in six cases (12.0%). The mean value of DMS showed a pretreatment mean value of 8.8, whereas at the end of the treatment, it was reduced to 2.0. To see the changes in DMS (pre- and posttreatment), paired t test was applied, and the results were significant statistically with P value <0.001, that is, posttreatment DMS was less than pretreatment score. QOL (Part 1) (pre- and posttreatment) scores showed that the pretreatment value was 3.8, and it improved to 4.7 posttreatment. The mean value of QOL pretreatment was 5.7, and after treatment, the value improved to 5.9. The paired t test was applied to see the changes in QOL and the results were statistically significant with P value <0.001, that is, QOL (part 1 and part 2) posttreatment score improved compared with the pretreatment score. To assess the effect of Insulinum in various potencies, paired t test was done for all the patients administered with Insulinum 30 CH and 200 CH, before and after treatment, for parameters such as FBS, PPBS, and DMS. It was found that there was a statistically significant reduction in FBS after Insulinum 200 CH (P = 0.002). Statistically significant reduction was also found in PPBS after Insulinum 200CH (P = 0.001). The results also substantiated with the findings of clinical parameter, that is, significant reduction of DMS after prescribing Insulinum 200 CH (P = 0.001), see [Table 1].

Table 1: Pre - and post -treatment values of FBS, PPBS, Urine sugar and DM score of study population with Insulinum 30CH and Insulinum 200CH

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Discussion

The present study was conducted to assess the role of homoeopathic drug Insulinum in reducing the blood sugar level in patients suffering from type 2 DM by adopting the DM assessment score, and to assess the QOL of such patients by adopting the scale “Quality of life index in Diabetes.” Most of the observations in this study correlate with those of the study of the IDF Diabetic Atlas of 2015, which exhibited the following: the incidence of DM increased with age, its inclination toward male gender and urban population, and increased incidence in those with a family history of DM compared with those without a family history. Maximum patients belonged to middle class, whereas the least number of patients were from the lower class. This may be due to the trend of urbanization and lifestyle changes, including a “Western-style” diet. Most cases of type 2 DM were from the employed group compared with the unemployed persons. This may be due to environmental influences, urban migration, the economic boom, lifestyle changes, and stress.^[21] It was also ascertained that Insulinum helped to improve the QOL of the patients suffering from type 2 DM. In this study, better results were obtained with Insulinum 200 CH. However, the study conducted by Baker showed that the homoeopathic Insulinum in 3rd to 30th potencies report good results, which does not correlate with the findings of our study.^[22]

Conclusion

The study was conducted to assess the role of homoeopathic medicine Insulinum in reducing the blood sugar level and to assess the QOL of the patients suffering from type 2 DM. The results of the study showed statistically significant improvement in DMS in the patients with type 2 DM (P < 0.001) by adopting the DM assessment scale and statistically significant improvement of QOL of patients (P < 0.001) by adopting the scale “Quality of life index in Diabetes.”

For better scientific validation, it is suggested to undertake further clinical trials on type 2 DM based on randomized controlled trial study design with a greater sample size. The effects of other potencies of Insulinum in type 2 DM should also be studied.

Acknowledgement

The authors are grateful to institutional heads, both academic and hospital, for allowing them to conduct the trial.

Ethical statement

The ethical clearance was obtained from the Institutional Ethics Committee of Homoeopathy University, Jaipur, prior to conducting the study. No objection certificate was given by Janardan Rai NagarRajasthan Vidyapeeth (deemed-to-bed) University, Udaipur, Rajasthan, to conduct the research work at Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur, Rajasthan.

Financial support and sponsorship

Nil

Conflicts of interest

There are no conflicts of interest.

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