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The Effects of Osteopathic Manipulative Treatment on HbA1c in Type 2 Diabetes and Pre-diabetes: A Randomized-Control Clinical Trial
Sureshbabu, S. [1]
Sheflin, K. [2]
Li, T. S. [14]
Heller, M. [3]
Yusupov, E. [1]
Krishnamachari, B. [7]
Allera, A. [1]
Rivera-Martinez, S. [7]

Journal: The Journal of the American Osteopathic Association Date: 2020/12, 120(12):Pages: e11-e12. doi: Subito , type of study: randomized controlled trial

Full text    (https://www.degruyter.com/document/doi/10.7556/jaoa.2020.157/html)

Keywords:

diabetes [33]
glycated hemoglobin [3]
OMT [3102]
osteopathic manipulative treatment [3124]
randomized controlled trial [766]

Abstract:

Statement of Significance: In the United States, T2DM is a major cause of morbidity and mortality. The prevalence of this disease continues to rise despite advances in medical management. Diabetes is commonly managed using lifestyle modifications and pharmacological treatment, most commonly, metformin and insulin. Despite these strategies, lifetime control of blood glucose is both difficult and expensive. OMT techniques have been demonstrated by Dr. Bandeen, in Osteopathic Prof. published in 1949, to decrease blood glucose levels in diabetic patients. With increasing insulin prices and prevalence of diabetes, modalities such as OMT can enhance HbA1c control and mitigate financial expenses by reducing insulin requirements for patients. Research Methods: This randomized-control clinical trial was reviewed and approved by NYIT IRB (IRB number: BHS-1383). In this ongoing clinical trial, participants with or without prediabetes or T2DM diagnosed at least 5 years prior were enrolled in the study. The participants were blinded and randomized to two groups, control vs treatment. The control group received sham OMT and the treatment group received OMT demonstrated by Dr. Bandeen to treat diabetics. The techniques used in the treatment group include suboccipital release, thoracic outlet release, rib raising (left ribs 2-9, right ribs 5-12), ribless rib raising (right L1-L2), chapman's points for pancreas and liver, fascial stretch of the pancreas in longitudinal axis, test and treatment of pancreatic motility, pancreatic fascial technique, pancreatic stimulation through angle of ribs 3-5, celiac ganglion inhibition, and liver pump. The study was conducted over 6 treatment sessions which were scheduled every 2 weeks. Blood glucose levels were collected twice per treatment session (pre- and post-treatment) for a total of 12 times. HbA1c was collected during the 1st, 2nd, 4th, and 6th treatment sessions. In addition, vitals were also performed before treatment on all participants. Furthermore, all participants continued with their recommended diabetic medication regimens and medical management as prescribed by their primary provider. There were also no changes in diet or physical activity. Data Analysis: All data measurements were inputted into NYITCOM RedCap. At the time of analysis all data was extracted from RedCap into an excel spreadsheet and analysis was conducted using SAS software. All patients were analyzed using intention-to-treat methods. We stratified the participants in each group by sex and diabetes diagnosis (healthy, prediabetes, or diabetes). A repeated measures ANOVA was conducted comparing HbA1c values between control and treatment within each stratification category. Significance was determined by a threshold of (p<0.05). Results: A total of 48 participants were included in this analysis (Healthy: n=15, Prediabetic: n=10, Diabetic: n=23). The study enrolled 29 females and 19 males. The mean pre-treatment and post-treatment HbA1c values for healthy females were 4.9% and 5.1%, respectively. The mean pre-treatment and post-treatment HbA1c values in healthy males were 5.1% and 4.9%, respectively. The mean pre-treatment and post-treatment HbA1c values in prediabetic females were 5.3% and 5.1%, respectively. The mean pre-treatment and post-treatment HbA1c values in prediabetic males were 5.3% and 5.1%, respectively. The mean pre-treatment and post-treatment HbA1c values in diabetic females were 7.1% and 6.0%, respectively. The mean pre-treatment and post-treatment HbA1c values in diabetic males were 8.4% and 7.2%, respectively. There was a significant difference in HbA1c between the two treatment groups across visits in healthy females (p=0.0268) and in prediabetic and diabetic males (p=0.0357). In addition, there was a significant difference in HbA1c across visits in prediabetic and diabetic females (p=0.0052) but no significance between the two treatment groups. Conclusion: These results suggest that there was a decrease in the mean HbA1c post-treatment in the both males and females diagnosed with prediabetes or T2DM. Furthermore, there was significant difference between the sham treatment and OMT in healthy females and prediabetic and diabetic males. The data suggests that OMT can be a useful treatment modality to help patients reach target HbA1c in the prediabetic and diabetic populations. The study is limited by the small population size and loss of follow-up in patients. Further evaluation on the effects of OMT in aiding in the treatment of Type II diabetes mellitus is warranted as the management of this disease becomes more difficult due to increasing insulin prices and unwanted side-effect profiles.

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