Scientific Research

Assessment of Efficacy of Constitutional Treatment in the Management of Prediabetes by Analysing Hba1c Values

Assessment of Efficacy of Constitutional Treatment  in the Management of Prediabetes  by Analysing Hba1c Values

Dr. Shwetha Bhatt shares her research of Assessment of Efficacy of Constitutional Treatment in the Management of Prediabetes by Analysing Hba1c Values. Paired ‘t’ test measures were used to evaluate results.

BACKGROUND : prediabetes is a condition of blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes.(1) It  is also a  state of latent impairment of carbohydrate metabolism in which not all the criteria for diabetes are satisfied.(2) The increasing prevalence of diabetes is a major health problem. The detection and treatment of prediabetes can delay the onset of diabetes and presents an important diabetes prevention strategy.(3) Many studies are being conducted by the scientific fraternity regarding the management of prediabetes as a primary preventive. The present study is unique as no clinical studies have so far been published regarding the effect of homoeopathic medicines in prediabetes.

OBJECTIVE: To evaluate the efficacy of constitutional treatment in prediabetes.

METHODOLOGY:

The study design adopted was quasi experimental pre and post treatment without controls. 45 individuals of prediabetes were selected as per the inclusion criteria. Diagnosis was based on positive F/H of DM and individuals with BMI ≥30. HbA1c values were obtained during the first visit according to ADA criteria. Based on totality of symptoms constitutional homoeopathic medicine was prescribed and followed for a minimum period of 3 months. Remedies were selected based on the totality of symptoms. The hypothesis was statistically analysed using Paired‘t’ test.

RESULTS:

Paired ‘t’ test measures showed a ‘p’ value of 0.000 which denoted a highly significant reduction in HbA1c values after a minimum 3 months duration of homoeopathic treatment with constitutional remedies in prediabetes.

CONCLUSION:

There is significant reduction in HbA1c levels in cases of prediabetes after homoeopathic treatment.

Key Words: Prediabetes, HbA1c, ADA, Constitutional Remedy.

INTRODUCTION

Diabetes mellitus is a chronic metabolic disorder characterized by hyperglycemia with or without glycosuria, resulting from an absolute or relative deficiency of insulin.(4) prediabetes is a condition of blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes.(1) It is defined as a state of latent impairment of carbohydrate metabolism in which not all the criteria for diabetes are satisfied.(2)It has been observed that prediabetes is a risk factor for impending diabetes and cardiovascular complications as those with frank diabetes.(5),(6),(7) these facts highlight the importance of addressing health care and prevention issues to the high risk subjects. Hence screening of prediabetes patients is essential for the prevention or delaying the occurrence of Type2 Diabetes mellitus.(9)Type2 diabetes mellitus has become one of the world’s most important public health problems. An epidemic of Type2 DM is underway in both developed and developing countries. Diabetes is now present in 40% of adults globally, the number of people with diabetes is expected to rise from 285 million in 2010 to 438 million in 2030.(9)

The treatment for prediabetes is currently controversial in the conventional mode of treatment because of the financial burden involved, drug dependency and its safety profiles being unknown.

Homoeopathy is a system of medicine which is based on ‘Law of Similars’ and the patients are being treated through a holistic approach by individualizing their characteristic symptoms and through symptom similarity wherein chronic diseases of this type can be better approached constitutionally by considering the totality of symptoms.(10) Thus this study is an attempt in that direction to estimate the efficacy of a constitutional remedy in the management of prediabetes.

OBJECTIVES

To evaluate the efficacy of constitutional treatment in prediabetes.

METHODOLOGY

SOURCE OF DATA:

This study was conducted on patients who attended the Out Patient Department and peripheral centres of Father Muller Homoeopathic Medical College and Hospital, Derelakatte and Kankanady Mangaluru.

PERIOD OF STUDY:

The study was conducted on the cases available from April 2016-January 2018

SAMPLE SIZE:

110 patients were screened, 45 cases were selected as per criteria for the study.

TYPE OF STUDY

Quasi experimental pre-and post-test, without controls.

INCLUSION CRITERIA:

  • Patients aged from 30-70 years
  • Patients with HbA1c levels of 5.7-6.4%
  • Patients of both sexes, any ethnic group

EXCLUSION CRITERIA:

  • Patients who are already diagnosed as prediabetes and are on treatment
  • Patients who are dependent on some allopathic or ayurvedic drugs.

MATERIALS AND METHOD:

45 cases of prediabetes which satisfied the above criteria were selected for the study. Cases were taken in detail and were recorded in the Standardized Case Record of Father Muller Homoeopathic Medical College and Hospital.

Patients who came to OPD with positive family history and BMI ≥30 were screened by sending them for HbA1c investigation. Patients whose HbA1c levels ranging in between 5.7-6.4 % were included in the study. Consent was taken from each individual who participated in this study.

Cases which fit the above criteria were further assessed for a detailed history and clinical examination. Cases were taken in detail and recorded in the Standardized Case Record of Father Muller Homoeopathic Medical College and Hospital. Homoeopathic prescriptions were made based on the availability of patient specific or characteristic symptoms and if not, on disease specific ones. Due reference to the Homoeopathic Materia Medica and Repertory was made as required by the case. The potency selection and repetition of the medicine was done according to the demands of the case, with consideration of potency selection criteria such chronic, susceptibility, vitality and suppression (if any), changes in structural and functional level and the degree of correspondence to the remedies selected.

REMEDIES

The remedies prescribed were all manufactured at Father Muller Homoeopathic Pharmaceutical Division and dispensed at Father Muller Homoeopathic Medical College and Hospital, Mangalore and its allied peripheral centres.

FOLLOW UP AND ASSESSMENT:

Patients were followed up and HbA1c were repeated after a period of 3 months.

RESEARCH HYPOTHESIS:

Homoeopathic constitutional treatment is effective in prediabetes.

Null hypothesis

Homoeopathic constitutional treatment is not effective in treating prediabetes.

STATISTICAL ANALYSIS:

The collected data was analyzed by Mean, Standard deviation, Paired ‘t’ test, by using IBM SPSS 23.0 software.

SAMPLE SIZE ESTIMATION

Sample size necessary has been estimated using the below formula:

Prevalence of prediabetes in India: 10·3%(11)

n = Zα2 p (1-p)

e2

P = 0.103

e (allowable error) = 10%

n = 92

In the present study we have included 110 subjects after randomised screening

RESULTS

Of a total of 110 individuals who were screened, 45 were found to be prediabetic. These individuals were tested for HbA1c levels before and after three months of treatment.

Distribution of cases based on age group.

In the subjects screened, 42.9% were found to have prediabetes in the age group of 30-40yrs., between the age group of 41-50 years, 45.5%, between the age group of 51-60 years, 37.1% and above the age of 60 years, 38.1% had prediabetes. The total measured ‘p’ value was 0.899 which denotes there is no significant prevalence of prediabetes among any age group between 30-70 years. (Table 1)

Table 1: Distribution of cases based on age group.

Age in

years

StatusTotal
PresentAbsent
30-409

42.9%

12

57.1%

21

100.0%

41-5015

45.5%

18

54.5%

33

100.0%

51-6013

37.1%

22

62.9%

35

100.0%

Above 608

38.1%

13

61.9%

21

100.0%

Total45

40.9%

65

59.1%

110

100.0%

Distribution of cases based on gender

Among 110 screened individuals, 64 were females, out of which 26 were prediabetic. Out of the 46 male subjects, 19 were prediabetic. The total measured ‘p’ value was 0.943 which denotes there is no significant predominance of gender in prediabetes.

Table 2: Distribution of cases based on gender

SexStatus 

Total

PresentAbsent
Female26

40.6%

38

59.4%

64

100.0%

Male19

41.3%

27

58.7%

46

100.0%

Total45

40.9%

65

59.1%

110

100%

 

Distribution of cases based on family history of DM

Of 110 screened subjects, 30 didn’t have F/H of DM, of which 9 (30.0%) were found to have prediabetes. Of the 80 subjects that had F/H of DM, 36(45.0%) were found to be prediabetic. The measured ‘p’ value of 0.154 denotes there is no significant prevalence of correlation between F/H and prediabetes.

Table 3: Distribution of cases based on family history of Diabetes Mellitus

Family History of Diabetes MellitusStatus 

Total

PresentAbsent
Absent9

30.0%

21

70.0%

30

100.0%

Present36

45.0%

44

55.0%

80

100.0%

Total45

40.9%

65

59.1%

110

100%

 Distribution according to BMI

Among 110 screened subjects, 56 of them had BMI < 30, of which 19(33.9%) of them were prediabetic. The remaining 54 subjects whose BMI was > 30, 26 (48.1%) of them were prediabetic. The total measured ‘p’ value of 0.129 denotes there is no significant correlation between obesity and prediabetes in this study. .(Table 4)

Table 4: Distribution according to BMI

BMIStatus 

Total

PresentAbsent
<3019

33.9%

37

66.1%

56

100.0%

>3026

48.1%

28

51.9%

54

100.0%

Total45

40.9%

65

59.1%

110

100%

 Prevalence of prediabetes In this study a total of 110 individuals were screened of which 40.9% were prediabetic, 59.1% were not. (Table 5)

 Table 5: Prevalence of prediabetes

FrequencyPercent
Present4540.9
Absent6559.1
Total110100.0

Statistical analysis

Mean of HbA1c levels (%) before and after the Homoeopathic treatment

The mean of HbA1c levels before treatment was 5.933% with a standard deviation of 0.2078.

The mean of HbA1c levels after treatment was 5.771% with a standard deviation of 0.2312. The mean difference of before and after treatment was 0.1622% and the mean change in HbA1c values before and after treatment was 2.73%.

Using paired ‘t’ test, the calculated ‘t’ value was 6.366 and the ‘p’ value was 0.000. This denotes a highly significant reduction in mean HbA1c values before and after treatment.

Hence this study proves the research hypothesis (alternate hypothesis) i.e., homoeopathic constitutional treatment is effective in prediabetes. (Table 6)

Table 6: Analysis of HbA1c levels

NMeanStd. DeviationMean differenceS.D of differenceChange (%)‘t’ value‘p’ value
HbA1c level before455.933.2078.1622.17092.736.366.000

HS

HbA1c level after455.771.2312

DISCUSSION

A total of 110 subjects were screened for prediabetes which showed 40.9% (45 subjects) prevalence of prediabetes. In the subjects screened 42.9% were found to have prediabetes in the age group of 30-40yrs, between the age group of 41-50 years, 45.5%, between the age group of 51-60 years, 37.1% and above the age of 60 years, 38.1% had prediabetes. The total measured ‘p’ value was 0.899 which denotes there is no significant prevalence of prediabetes among any age group between 30-70years. Among 110 screened individuals 64 were females, out of which 26 were prediabetic. Out of the 46 male subjects, 19 were prediabetic. The total measured ‘p’ value was 0.943 which denotes there is no significant predominance of genders in prediabetes. The results correspond with a study done in Bangladesh by Shamima Akter and others.(12)   Another study by Sabina et al, found that the mean HbA1c levels of screened prediabetic  individuals was similar among men and women.(13)

Of 110 screened subjects, 30 didn’t have F/H of DM, of which 9 (30.0%) were found to have prediabetes. Of the 80 subjects that had F/H of DM, 36(45.0%) were found to be prediabetic. The measured ‘p’ value of 0.154 denotes there is no significant prevalence of correlation between F/H and prediabetes.

Among 110 screened subjects, 56 of them had BMI <30, of which 19(33.9%) of them were prediabetic. The remaining 54 subjects whose BMI was >30, 26 (48.1%) of them were prediabetic. The total measured ‘p’ value of 0.129 denotes there is no significant correlation between obesity and prediabetes in this study. A similar study conducted by Ian et al. observed that there was no significant association between obesity and prediabetes.(14)

The study has seen a significant reduction of HbA1c levels in 40 patients i.e. from the mean HbA1c levels of 5.933% and standard deviation of 0.2078 before treatment to the mean HbA1c levels to 5.771% and standard deviation of 0.2312 after treatment. But the HbA1c levels remained the same in 3 patients and increased in 2 patients after homoeopathic treatment.

Paired ‘t’ test was used for analysis, which showed statistical significance with ‘p’ value of 0.000, this denotes there is a high significant reduction in mean HbA1c values after treatment. Hence, this study proves the research hypothesis (alternate hypothesis) i.e. homoeopathic constitutional treatment is effective in prediabetes.

Further studies need to be done to observe the utility of HbA1c Levels as a screening tool and prognostic factor for prediabetes.

Comparison with another study

In a study conducted among 34 patients of both genders and age group among 30-70 years statistical analysis showed significant reduction in HbA1c values after the homoeopathic treatment which established the efficacy of homoeopathic system in reducing HbA1c values in diabetic patients.(15)

LIMITATIONS

  • The duration of study was short, to evaluate for prognosis of study group.
  • No control group was included along with the study group to compare test results.

RECOMMENDATIONS

  • A study on a larger scale with control group could be undertaken.
  • Bigger sample with extended time of research would provide better results.
  • Comparative study could be conducted between a group with only homoeopathic treatment and another group homoeopathic treatment along with life style intervention.

CONCLUSION

Out of 110 individuals who were screened for prediabetes, 45 (40.9%) subjects had prediabetes. Mean HbA1c level before treatment was 5.933% and after treatment it reduced to 5.771% with a mean difference of 0.1622. Subjects between the age group of 30-70years were screened. The total measured ‘p’ value of 0.899 denotes there is no significant prevalence of prediabetes among any particular age group. The study also showed no significant predominance of genders in prediabetes where in total measured ‘p’ value was 0.943.This study revealed that there is no significant correlation between relevant F/H of diabetes (‘p’ value of 0.154) and BMI≥ 30’ (p’ value of 0.129) in prediabetes

The mean HbA1c level before treatment was 5.933% and post treatment it reduced to 5.771 % with mean difference of 0.1622 and the mean change of before & after treatment of HbA1c levels was 2.73%. Statistical analysis with paired ‘t’ test showed ‘p’ value is 0.000 which denotes there is statistically significant reduction of HbA1c levels after homoeopathic treatment.

REFERANCE

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  12. Akter Shamima, Rahman Mizanur M, Abe Krull Sarah SP. Prevalence of diabetes and prediabetes and their risk factors among Bangladeshi adults: a nationwide survey. Bulletin of the World Health Organization.2013. Available from: http://www.who.int/bulletin/volumes/92/3/13-128371/en/ Accesssed on 2.02.2018
  13. Paglialunga S, Bond R, Jaycox SH. Evaluation of HbA1c screening during outreach events for prediabetes subject recruitment for clinical research.Trials; 2018;19(1):60.
  14. Bayula B. Efficacy Of Homoeopathy In Treating Type2 Diabetes Mellitus Evaluated Using Glycosylated Hemoglobin and Serum Lipid Profile-An Investigative Study. Rajiv Gandhi University of Health Sciences , Karnataka, Bangalore; 2015: 31.
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About the author

Shwetha Bhat

Shwetha Bhat

Dr Shwetha Bhat, B.H.M.S., M.D (Department of Practice of Medicine) works as Assistant Professor at Father Muller Homoeopathic Medical College and Hospital, Deralakatte, Mangaluru, Karnataka.

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