To evaluate the effect of Manipur chakra stimulation on Glycemic control in diabetes mellitus patients as compared to Mindfulness meditation therapy

After the permission of institutional ethical committee and procuring informed written consent from the patients of both the groups the study was executed.

Study design

Open label randomized control trial

Study settings

120 patients of diabetes mellitus were selected from the outpatient department for a period of 1 year and were divided into 2 groups and studied for a period of 3 months.

Criteria for selection of patients

Participants were adult male and female, already diagnosed, known cases of DM.

Inclusion criteria-

1. 30-60 year old patients of DM on OHA, not on insulin.
2. HbA1c >6.5 &<8.5
3. Fasting blood sugar >150 mg and PP>180
4. Absence of severe psychotic disorders.

Exclusion criteria-

1. Change in medication, diet, exercise 3 month prior to intervention.
2. Patients doing any current meditation practice.
3. Diabetic for less than 5 year.
4. Patients who do not give consent to participate in the study.

SAMPLE SIZE ESTIMATION Sample size was determined on the basis of following assumptions considering HbA1c as the main outcome.

Assumptions     

1. Mean reduction in HbA1c in control group from baseline at 3 months =0.48% +-0.08

(Source Steven Rosenzweig et.al mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study ALTERNATIVE THERAPIES, sep/oct 2007, VOL. 13, NO. 5(36))

2. Mean reduction in HbA1c in experimental group from baseline at 3 months =0.53% +-0.08
3. Effect size (mean difference)=0.05%
4. Confidence interval=95% (alpha 2 sided=5%)
5. Power=90% (beta=10%)
6. Ratio =e:c=1:1

Sample size required in each group is 54.

Assuming 10% loses to follow up in 3 months, the effective sample size will be 60 per group. Therefore total 120 subjects will be included in the study.

SAMPLING

120 patients were randomly allocated in 2 groups i.e. experimental and control group on the basis of pre-determined computer generated random allocation plan.

No protocol deviation or change in medication, diet and exercise was found after allocation to the study.

INTERVENTION

 In experimental group, 60 subjects under the supervision of Yoga experts were made to follow prescribed chakra stimulation routine, 6 days a week for an hour for 3 months which comprises of following Asanas, Pranayama and Meditation.

Asanas- Pawanmuktasana, Hasta padasana and shavasana.        

Pranayama- Anulomvilom, Bhastrika, Bhramari

Meditation-

1. Concentration of Manipura Chakra
2. Visualization of Yellow Colour
3. Pronunciation of Beej Mantra of Manipura Chakra Simultaneously.

In control group, 60 subjects were made to follow mindfulness based meditation particularly (awareness of breathing) for 6 days a week for 45mins for 3 months in which they observe there breathing without adjusting it. They just have to focus on rise and fall of the chest wall or the sensation of breathing through nostrils.

OUTCOME

Reduction in HbA1c levels, average blood sugar levels.

STATISTICAL ANALYSIS

The collected data was entered in MS excel worksheet. Data analysis was performed using statistical software STATA, version 10.1 (2011)

Descriptive statistics like standard deviation and mean were used to summarize quantitative variables i.e. age HbA1c, blood sugar level.

Inferential statistics procedure includes test of significance for comparing difference in effects. (Glycemic control) in two groups i.e. experimental and control group. Chi square test was used to compare difference in proportions of 2 groups.

2 independent sample t-test was used to compare the mean differences of continuous outcome measures i.e. HbA1c, BSL.

Within the group comparison of mean change from baseline to 4 weeks, 8 weeks and 12 weeks was performed using paired t-test.

Repeated measure ANOVA (analysis of variance) was also performed to compare mean changes at various points of time in each group.

 P value less than 0.05 was considered statistically significant.

Blood Sugar (Fasting)

Comparison of mean Blood sugar (fasting) between the 2 groups at the time interval of 4 wks, 8 wks, and 12 wks were done. The p values are 0.6538, 0.3769 and 0.4086 at 4 wks, 8 wks, and 12 wks respectively. However, there is statistically significant difference is seen when within the group comparison of mean Blood sugar (fasting) is done. The p value for group A is 0.0001 and 0.0001 for group B. so there is significant decrease in blood sugar level in both the groups at the interval of 4 wks, 8 wks, and 12 wks from the baseline.

Table-2

Blood Sugar (Post-Prandial)

Comparison of mean Blood sugar (PP) between the 2 groups at the time interval of 4 wks, 8 wks, and 12 wks were done. The p values are 0.7280, 0.8042 and 0.9399 at 4 wks, 8 wks, and 12 wks respectively. However, there is statistically significant difference is seen when within the group comparison of mean Blood sugar (PP) is done. The p value for group A is 0.0001 and 0.0001 for group B. So, significant decrease in blood sugar level is observed in both the groups at the interval of 4 wks, 8 wks, and 12 wks from the baseline.

Table-3

HbA1c test (Blood Sugar)

Comparison of mean HbA1c test between the 2 groups at the time interval of 12 wks from the baseline was done. The p values are 0.6003 at the baseline and 0.5605 at 12 wks respectively. No statistically significant decrease in HbA1c is observed in group A as compared to group B. However, there is statistically significant difference is seen when within the group comparison of mean HbA1c is done. The p value for group A is 0.0001 and 0.0001 for group B. so there is significant decrease in HbA1c levels in both the groups at the interval of 12 wks from the baseline.

Table no.4 Comparison of mean reduction in Blood Sugar (Fasting) between two groups from baseline to 4 wks, 8 wks and 12 wks of time interval

 This is clearly seen that the mean reduction in blood glucose level in both the group is nearly equal at different time intervals. Comparison of mean reduction in blood sugar fasting between the 2 groups from the baseline to 4 wks, 8 wks, and 12 wks of time interval were done. The p values are 0.8903, 0.7893 and 0.9705 at 4 wks, 8 wks, and 12 wks from the baseline respectively. So there is no statistically significant difference is seen when both the groups were compared.

Table-5

Comparison of mean reduction in Blood Sugar (Post-Prandial) between two groups from baseline to 4 wks, 8 wks and 12 wks of time interval

It is clearly seen that the mean reduction in blood glucose level in group B is more as compared to group A at different time intervals. Comparison of mean reduction in blood sugar PP between the 2 groups from the baseline to 4 wks, 8 wks, and 12 wks of time interval were done. The p values are 0.4269, 0.3645 and 0.3067 at 4 wks, 8 wks, and 12 wks from the baseline respectively. So there is no statistically significant difference is seen when both the groups were compared.

Table no.6         Effect of two treatments on Fasting Blood Sugar by time

• Effect size = % difference from baseline (BT) to 12 weeks (AT)

In group A, 60 patients were having >110 mg of fasting BS, which is reduced to 56 after 12 weeks of intervention. In group B, 60 patients found having >110 mg of fasting BS, which is reduced to 57 after 12 weeks. Thus the effect size after 12 weeks of intervention is 4 and 3 in group A and B respectively. The p value is 0.6969, which shows that the comparison between both interventions is statistically insignificant and effect of both the interventions in reduction of blood sugar from baseline at 12 weeks may be considered nearly equal. Thus clinically and statistically both treatments A and B were producing non significant effects in blood sugar reversal to normal range; but whatever small effect is seen in reduction of blood sugar, it is found similar in both treatment groups A and B.

Table-7             Effect of two treatments on Post Prandial Blood Sugar by time

• Effect size = % difference from baseline (BT) to 12 weeks (AT)

The effect size after 12 weeks of intervention is 2 in both the groups. The p value is 1.00, which shows that the comparison between both interventions is statistically insignificant and effect of both the interventions in reduction of PP blood sugar from baseline at 12 weeks may be considered nearly equal. Thus it is observed that clinically also both treatments: A and B was producing non significant effects in PP blood sugar reversal up to the normal range (140mg/dL); but small effect is seen in reduction of PP blood sugar, it is found similar in both treatment groups A and B.

Table-8             Effect of two treatments on HbA1C by time

• Effect size = % difference from baseline (BT) to 12 weeks (AT)

In group A and group B, 60 patients were having > 6 HbA1C. After 12 weeks of intervention in both the group, the glycemic index could not be reversed below 6. Thus the effect size after 12 weeks of intervention is 0 in both the groups. The p value is 1.00, which shows that the comparison between both interventions is statistically insignificant. There is no effect of 12 weeks of intervention on HbA1C in both the groups in reversing the HbA1c to normal range. Effect of both the interventions in reduction of HbA1C at 12 weeks is same. It is observed that statistically both treatments A and B were producing no significant effects in HbA1C reversing the glycemic index to normal range.

As per table no.1, it is found that mean fasting sugar in Group A at the baseline was 204 mg/dL and after intervention the fasting levels were reduced and found to be 152 mg/dL in 12 weeks. Whereas in group B, the mean fasting sugar was 208 mg/dL at baseline and it was 156 mg/dL after 12 weeks.

As per Table no. 2, mean blood sugar levels PP in group A at baseline was 278 mg/dL whereas in group B, 289 mg/dL. After 12 weeks of intervention in group A and B, the pp levels were reduced to 210 mg/dL. Thus, within the group, the results are significant but between the groups, the results are not significant.

Previous researches (Jerath R et al.2008) show that Mindfulness based stress reduction shows significant improvements in weight, diabetes distress, glycemic and blood pressure control.5 Another study based on meditation therapies reveals significant improvements in body weight, glycemic control, waist circumference and blood pressure 6.

Multiple researches enlisted by (GaganPriya and Sanjay Kalra, 2018) shows improvements in all domains of holistic care- social, biological and psychological through mindfulness meditation based intervention7.

In present study, table no.3 shows HbA1c was also recorded in the both groups at baseline and after 12 weeks of intervention in group A and B, a significant decrease is found within the groups but the values are not statistically significant between the groups. Studies revealed that mindfulness training improved the quality of mental health and lowered glycemic control indices in patients with type 2 diabetes mellitius8. But studies conducted by Hartmann et al and Van Son et al revealed that although mindfulness training reduces anxiety and stress and improves patients quality of life, it has no significant effect on blood pressure indices, including HbA1C(9,10).

In present study, although in both the groups intervention has shown results in individuality because when within the group comparisons of all parameters at all points (baseline, 4 weeks, 8 weeks and 12 weeks) were done in each group separately, at every point there is a decrease in blood sugar levels and the P value is less than 0.05.

LIMITATIONS

Covid 19 limitations were present during the study that affected the personal interaction with subjects on frequent basis.

The following are the six causes that destroys the effect of yoga:- over eating,  physical exertion, talkativeness, not following rules (like taking cold bath in the early morning, eating late at night, or eating unhealthy junk food only), company of men, and unsteadiness11.

Other obstacles in the path of yoga and meditation are diseases, lack of aim, doubt, insensibility, laziness, greed, illusion, failure to concentrate, instability explained by Patanjali yog darshana12.

Similarly, the Process of kundalini Awakening has to be done from the base or root chakra for better results. Although, mind body interaction researches and self healing therapies focus on individual chakra but in all vedic and yoga literature, meditation on the chakra starts from Mooladhara chakra where the kundalini shakti resides then to Swadhisthana and then to Manipura. In present study, directly Manipur chakra was selected for mediation. The results would have been different may be if meditation was done in sequence from Mooladhara chakra to Manipur chakra.

STRENGTH OF THE STUDY

The present study reveals the practical and clinical application of chakra meditation on diabetes mellitus patients.

Meditation is primarily considered as a tool for spiritual achievements practiced by saints, however, secular meditation practices for stress reduction, mental relaxation, self improvement are now a day’s used very commonly.

Various meditation based techniques have been developed like transcendental meditation, Mindfulness based stress reduction (MBSR), mind fullness based cognitive therapy (MBCT), and mindfulness based Art therapy (MBAT). Transcendental meditation involves silently chanting of specific mantra (repetition of words, syllables or phrases). Through multiple techniques researchers were trying to find out the complete cure for physical disorders with biomedical approach and holistic approach.

Present study though did not prove the superiority of any interventions, is the only clinical study on chakra meditation in Ayurveda researches and its effect on diabetes mellitus to our knowledge. Various researches in the field of psychoneurobics done by Dr. B. K Chandrasekhar suggest tremendously good effect of activation of Manipur chakra and good control over diabetes13.

In group A, fasting blood glucose levels of more than 5% (4 subjects out of 60) is reduced to normal and post Prandial glucose levels of less than 5% (2 subjects out of 60) is reduced to normal after 12 weeks of Manipur chakra meditation in diabetics.

In group B, (3 out of 60 subjects) 5% decrease is seen in fasting blood glucose levels and (2 out of 60 subjects) less than 5% decrease is observed in post prandial glucose levels after 12 weeks of Mindfulness meditation in diabetics.

• In group A, mean HbA1c is reduced from 7.96 to 7.68 after 12 weeks of intervention with p valve of 0.0001 which is highly significant.

In group B, mean HbA1c is reduced from 7.9 to 7.61 after 12 weeks of intervention and p valve of 0.0001 which is highly significant.

Although Manipur chakra meditation and mindfulness meditation both are effective in reducing blood glucose levels and HbA1c but they are not effective in reversing the blood sugar levels to normal in 12 weeks of intervention.

Thus based on our study findings, we can conclude that treatment A (Manipur Chakra Stimulation)  is equally effective as treatment B (Mindfulness meditation) in mean  reduction of Blood Sugar fasting,  Blood Sugar PP and HbA1C.

Future scope of the study:

Researches with improved methodology considering the Yama and Niyama of Yoga, the sequence of chakra awakening from Mooladhara onwards and long term meditation protocols may show more promising results in lowering the glycemic index and delaying the complications of diabetes mellitus.

Yoga and meditation is the integral part of Ayurveda, incorporating Chakra meditation along with traditional Ayurvedic treatment may give a breakthrough in overcoming the stress and complications of diabetes mellitus.

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