INTRODUCTION:

Diabetes Mellitus comprises of series of metabolic disorders that share the common characteristic of hyperglycaemia. Both genetic as well as environmental factors play a crucial role in the etiopathogenesis of Diabetes Mellitus. Main factors contributing to the pathogenesis of Diabetes Mellitus are reduced insulin secretion, reduced utilization of glucose and rapid glucose production.

With an ever-increasing incidence worldwide, Diabetes Mellitus is a forerunner of morbidity and mortality in the future.¹

Epidemiology:

The worldwide prevalence of type-2 Diabetes Mellitus has risen dramatically over past 2 decades.

Although the prevalence of both type-1 and type-2 Diabetes Mellitus is increasing worldwide, the prevalence of type-2 Diabetes is rising much more rapidly because of physical inactivity, mental as well as physical stress and obesity.¹

Classification:

The 2 broad categories of Diabetes Mellitus are designated as Type-1 and Type-2 Diabetes Mellitus. In both the types, there is a phase of abnormal glucose homeostasis as the pathogenic process progresses.

In Type-1 Diabetes Mellitus there is complete insulin deficiency. Whereas in type-2 Diabetes Mellitus there is presence of insulin resistance, impaired insulin secretion and increased glucose production.^1,2

Diagnosis:^1,2,3

World Health Organization have laid down the diagnostic criteria for Diabetes Mellitus based on the following parameters:

1. Symptoms of Diabetes Mellitus plus random blood sugar level more than or equal to 200 mg/dl.

2. Fasting Plasma Glucose more than or equal to 126 mg/dl.

3. Two Hour plasma glucose more than or equal to 200 mg/dl during oral glucose tolerance test.

4. Random blood sugar level has been defined as without regard to time since last meal.

5. Fasting has been defined as no caloric intake for at least 12 hours.

6. Fasting plasma glucose between 100-125 mg/dl is defined as impaired fasting glucose.

7. Based on oral glucose tolerance test, impaired glucose tolerance is defined as plasma glucose levels between 140-199 mg/dl 2 hour after 75g oral glucose. Some individuals have both, impaired fasting glucose as well as impaired glucose tolerance. These individuals are labelled as prediabetic and have high risk of migrating to type-2 Diabetes Mellitus.

Current criteria for the diagnosis of Diabetes Mellitus emphasize that fasting plasma glucose is the most reliable and convenient test for diagnosing Diabetes Mellitus in asymptomatic patients. Some health professionals also recommend haemoglobin A1C as diagnostic test for Diabetes Mellitus.

Timely diagnosis and treatment of Diabetes Mellitus is a must as it has profound implications on an individual as well as their families from both financial and medical standpoint.^3,4

The aim of this study was to evaluate which of the two scales of potencies namely LM Potency and Centesimal Potency of homoeopathic medicine Acid Phosphoricum could produce any significant hypoglycaemic effect in patients with type-2 Diabetes Mellitus by comparing the lowering of blood sugar levels.

MATERIALS AND METHODS:

Study Design:

It was a randomized parallel group study, wherein 50 patients satisfying the case definition and inclusion and exclusion criteria were s selected for the study of which 25 patients were administered LM Potency of homoeopathic medicine Acid Phosphoricum and remaining 25 patients were administered Centesimal potency of homoeopathic medicine Acid Phosphoricum

Written Informed consent was obtained from each study subject.

Ethics Approval: The study was approved by the Institutional ethics committee as well as the scientific research committee.

Study setting:

Hyperglycaemic subjects without target organ damage attending the author OPD’s and OPD/IPD of Dr. D.Y. Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune were included in the study.

Case Definition:

Type 2 Diabetes Mellitus with fasting blood sugar levels between 120-140mg/dl and post-prandial blood sugar levels between 140-160mg/dl and HbA1C 6-10mg %

Sample size:

50 patients satisfying the case definition were selected for the study of which 25 patients were administered LM Potency of Acid Phosphoricum and remaining 25 patients were administered Centesimal potency of homoeopathic medicine Acid Phosphoricum.

Sampling Technique:

Simple Random sampling without replacement

Study Population:

Patients were recruited from the general population by screening

Inclusion Criteria:^5,6,7

· Both males and females

· Age group between 18 and 60 years,

· Blood sugar levels- a. Fasting- 120-140 mg/dl b. Post-prandial- 140-160 mg/dl

· HbA1C 6-10mg%

· Subjects off all oral hypoglycemic agents during the entire duration of study with prior written consent.

· Subjects willing and providing written informed consent.

Exclusion Criteria:^8,9,10

· Patients with 2 or more episodes of severe hypoglycaemia within past 1 year requiring assistance or hospitalization.

· Patients hospitalized within past 6 months owing to poor diabetic control.

· Patients with diabetes specific complications like retinopathy, peripheral neuropathy

· History of active haematological and cardiovascular diseases

· History of cardiovascular surgery over the past 1 year

· History of any significant neuropsychiatric disorder.

· Chronic Alcoholis, drug abuse

· Patients on Insulin injections

· History or presence of co-morbidities emerging as a potent risk factor

· Participation in any other clinical trial within past 6 months.

· Pregnant and lactating mothers

· Gestational Diabetes Mellitus

· Type-1 Diabetes Mellitus

Criteria for Improvement:

The outcome measures were changes in the blood sugar levels at a timeline of every 1 month. HbA1C was measured after every 3 months.

The effect size was considered as the lowering of fasting BSL by a minimum of 20 mg/dl respectively.

Thus, cases where this lowering in BSL or HbA1C was observed were ascribed as ‘improved’ and the rest as ‘not improved’.

The estimated end‑point was lowering of blood sugar levels and haemoglobin A1C for 1year following intervention.

Any adverse event in both the study groups was considered to be safety end point of the study.

Marked deterioration of health and/or constant increase in BSL among subjects in both groups, appearance of complications, and adverse events (if any) was considered as stopping guideline.^11,12

Follow-up:

The subjects were clinically assessed every week and their Blood sugar level readings were recorded every month and HbA1C level was measured every 3 months till the completion of the study period

The data was analyzed at interval of 3 months and 6 months of the study.

Diet and Regimen:¹³

All the participants were given additional instructions regarding the diet and regimen, keeping in mind their socioeconomic status and level of education.

These included restricting sugar and salt intake and saturated fats in diet.

They were advised to restrict specific foods and fruits that are known to increase the blood sugar levels.

They were advised to increase fruit and fibre intake.

Physical activity or exercise was made compulsory activity of daily routine.

These additional measures were advised to all the participants to minimize bias.

The following marks were given to the clinical features of cases-

Table 1-Scores before treatment-

Sr. No.	Clinical Features	Score
1	Presence of any sign	3
2	Presence of any symptom	2
3	Raised BSL/HbA1C	4

Table 2-Scores after treatment-

Sr. No.	Clinical Features	Score
1	Disappearance of sign	2
2	Ameliorationof symptoms	1
3	Aggravation of symptoms	3
4	Lowered BSL/HbA1C	4

Observations and Statistical Analysis:

A sample of 50 cases from patients who attended the OutPatient Department of the authors as well as OPD/IPD of Dr. D.Y. Patil Homoeopathic Medical College was taken for this study. All the 50cases were followed up for a period of 6 months to 1 year. These cases were subjected to statistical study. The following tables reveal the observation and result of this study.

Table no. 3: Distribution of cases according to their Gender

Gender	Number of cases	Percentage
Female	15	30%
Male	35	70%
Total	50	100%

Figure:1-Distribution of cases according to their Gender

Table no.4- Distribution of cases according to their presentation

Type of Case presentation	No. of Patients	Percentage %
Recently Diagnosed (6 months)	12	24
Diabetic more than 1 year	38	76
Total	50	100

Figure 2: Distribution of cases according to their presentation

Table no.5: Distribution of cases according to their age

Age (in years)	Number of patients	Percentage
20-30	0	0%
30-40	11	22%
40-50	17	34%
50-60	22	44%
Total	50	100%

Figure 3: Distribution of cases according to their age

Statistical Analysis:

Intention to treat (ITT) population were subjected to statistical analysis.

The analysis was performed on demographic data and treatment outcomes to test the group differences using paired t test.

X = Score before treatment Y= score after treatment

A = Difference between the scores.

Ā = Mean of the difference between the scores

S = S.D of Differences S E= Standard Error of Mean

Now we assume

Ho – null hypothesis states that Centesimal Potencies are more useful in management of type-2 Diabetes Mellitus.

H1 – alternate hypothesis states that LM Potencies are useful in management of type-2 Diabetes Mellitus.

For Patients treated with LM Potency of Acid Phosphoricum

Ā = Σ A / n = 5.76

S = √Σ (A - Ā) ² / n-1 = √244.57/24 =3.19

SE= S /√n = 0.6384

t = Ā / SE= 5.76/0.6384= 9.022

Thus t =9.022

At 5% level for 24 degrees of level of freedom the value of t = 2.06

At 1% level for 24 degrees of level of freedom the value of t = 2.80

Thus, the value obtained is more than the above values so; we reject the null hypothesis and accept the alternative hypothesis.

For Patients treated with Centesimal Potency of Acid Phosphoricum

Ā = Σ A / n = 4.33

S = √Σ (A - Ā) ² / n-1 =12

SE= S /√n = 1.69

t = Ā / SE= 4.33/1.69= 2.56

Calculated t= 2.56

At 5% level for 24 degrees of level of freedom the value of t = 2.06

At 1% level for 24 degrees of level of freedom the value of t = 2.80

Thus, the difference in values obtained is not much significant.

Therefore, LM Potencies are more useful in management of type-2 Diabetes Mellitus as compared to Centesimal Potencies.

DISCUSSION:

In this study, the effectiveness of L.M. Potency versus Centesimal scale of potency in the treatment of type-2 Diabetes Mellitus was evaluated over a time period of 1year on 50 patients fulfilling the case definition, inclusion and exclusion criteria. The evaluation was based on improvement with respect to BSL, HbA1C, signs and symptoms and, on the statistical verification the scores taken before and after.

Out of the 50 patients selected for the study, 25 patients were administered the homoeopathic medicine Acid Phosphoricum LM potency starting from 0/1 and gradually increasing the potency as per the susceptibility of the patient. The remaining 25 patients were administered the homoeopathic medicine Acid Phosphoricum in Centesimal potency starting with 30 C and then gradually increasing the potency as per the need of the case.

Out of the 25 patients treated with LM Potency of Acid Phosphoricum, none showed any complications.

Significant decrease in the blood sugar levels and HbA1C was reported in 20 cases out of the 25 cases. 5 cases showed no significant change.

Out of the 25 patients treated with Centesimal Potency of Acid Phosphoricum, 19 cases showed no significant improvement in the blood sugar levels.

Significant decrease in the blood sugar levels and HbA1C was reported in only 6 cases out of the 25 cases which were administered Acid Phosphoricum in Centesimal potency.

If we were to refer to the Homoeopathic Materia Medica of Acid Phosphoricum, it is one of the leading homoeopathic medicine prescribed for Diabetes Mellitus. “Debility” which is the forerunner of Diabetes Mellitus is the frontier of this homoeopathic medicine. Mental debility precedes physical debility. It is indicated in people who tend to frow rapidly, and who are mentally as well as physically burdened. In the urinary complaints of Acid Phosphoricum, there is profuse frequent urination which is watery and milky. Dr. William Boricke has specifically mentioned “Diabetes” in the urinary complaints of this homoeopathic medicine. Nocturia with phosphaturia is leading sign of this homoeopathic medicine. If we were to corelate these symptoms of Acid Phosphoricum homoeopathic medicine with those of Type-2 Diabetes Mellitus we will see that the drug picture of Acid Phosphoricum completely matches with the symptomatology of type-2 Diabetes Mellitus. Therefore, the homoeopathic medicine Acid phosphoricum was selected for this study.¹⁴

One of the major advantages in selecting the LM Potency was that it could be repeated frequently even in case of chronic progressive diseases like Diabetes Mellitus which is not possible in cases of Centesimal Potency. Also, there is no gap in LM Potencies like there is in Centesimal Potencies. In 50-millesimal (LM) scale of potency, the potencies are serially arranged in 0/1,0/2,0/3 and so on. This is not the case in Centesimal scale of potencies. Under the Centesimal Scale, we have 30C followed directly by 200C and then followed by 1000 C. Thus, there is a chance of homoeopathic aggravation with Centesimal Potencies which is to a great extent minimised in case of LM Potencies.

Also, medicinal aggravation for a long time is a common feature with Centesimal potencies unless the potency is appropriate and exact quantity of medicine which is most similar to the case is administered. With LM potencies, medicinal aggravation is nominal and controllable due to very less medicinal quantity.^15,16

SUMMARY AND CONCLUSION:

From the statistical analysis it is evident that LM Potencies are more effective in management of type-2 Diabetes Mellitus as compared to Centesimal potencies of the homoeopathic medicine Acid Phosphoricum.

Statistical analysis also shows that there is great difference in scores before treatment and after treatment in cases treated with LM potency of the homoeopathic medicine Acid Phosphoricum.

Total time duration required for complete relief of symptoms and decrease in the blood sugar levels and HbA1C levels was also greatly reduced with the help of LM potencies as compared to centesimal potencies of homoeopathic medicine Acid Phosphoricum.

To conclude, LM potency can prove to be more effective in management of chronic diseases like type-2 Diabetes Mellitus as compared to Centesimal potency.

The very reason Dr. Samuel Hahnemann invented LM potency and introduced it in the 6^th Edition of Organon of Medicine was that he was not satisfied with the disadvantages of the Centesimal scale of potency when he himself had invented it in the preceding 5^th edition of Organon of Medicine.

More research in this field of LM potency will surely help young homoeopaths to overcome the dilemma of which potency to choose in chronic progressive diseases like type-2 Diabetes Mellitus.

ABBREVIATIONS:

LM- 50- Millesimal

C- Centesimal

HbA1C- Haemoglobin A1C

g- gram

mg- milli-gram

mg/dl- milli-gram per decilitre

BSL- Blood Sugar Levels

ACKNOWLEDGEMENT:

Firstly, we would like to thank Hon’ble Chancellor of Dr. D.Y. Patil Vidyapeeth, Pune, Dr. P.D. Patil Sir for giving us the opportunity to take up this research project. We would like to thank Hon’ble Trustee Dr. Smita Jadhav Mam for her constant support. We would also like to thank the Vice-Chancellor of Dr. D.Y. Patil Vidyapeeth, Pune, Prof. Dr. N.J. Pawar Sir for his constant support and guidance. We would also like to thank the registrar of Dr. D.Y. Patil Vidyapeeth, Dr. A.N. Suryakar Sir for his support and guidance throughout this research project. We would also like to thank the Ethics committee of Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune for approving this research project. Last but not the least, we would also like to thank all the patients and their relatives for giving written consent and participating in this study.

CONFLICT OF INTEREST:

There is no conflict of interest amongst the authors

Limitations of the Study:

The study explores and compares the action of LM Potencies with Centesimal potencies of homoeopathic medicine Acid Phosphoricum in management of Type-2 Diabetes Mellitus. The study needs to be expanded to all other homoeopathic medicines indicated for management of type-2 Diabetes Mellitus and compare their efficacy between LM Potency and Centesimal potency. Then only we will be able to establish the efficacy of LM Potency over Centesimal potency in management of type-2 Diabetes Mellitus. Second limitation is the sample size. There is further scope of research by increasing the sample size.

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Received on 20.01.2021 Modified on 13.12.2021

Research J. Pharm. and Tech 2023; 16(4):1689-1694.

DOI: 10.52711/0974-360X.2023.00277