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Augmentation of Immune Response to COVID-19 mRNA Vaccination Through Osteopathic Manipulative Treatment

Journal: Journal of Osteopathic Medicine Date: 2022/12, 122(12):Pages: A86-A88. doi: Subito , type of study: randomized controlled trial

Free full text   (https://www.degruyter.com/document/doi/10.1515/jom-2022-2000/html)

Keywords:

covid-19 [76]
immune response [6]
OMT [2951]
osteopathic manipulative treatment [2973]
randomized controlled trial [710]
vaccination [16]

Abstract:

Statement of Significance: In response to COVID-19, scientists mobilized to produce vaccines and treatments in record time, which have provided relief.(1) However, protection against the virus has since waned as multiple new variants continue to lead to higher levels of vaccine escape, higher transmissibility, and increased virulence.(2) Past research utilizing lymphatic pump techniques has shown an ability to enhance vaccine delivery with improved antibody titers for the Hepatitis B vaccine.(3) Research Methods: The participants were recruited at the WesternU free vaccination clinic open to the public and community at large in Pomona, California. Each participant was vaccinated with the Pfizer mRNA COVID-19 vaccine (BNT 162b2) following the FDA recommendations (2 injections 3 weeks apart). All subjects had blood drawn on day 0 (1st vaccine), day 7, day 21 (2nd vaccine), day 28, and day 90. Subjects were randomly assigned to either the control group or the OMT intervention arm, who received a session of OMT the day of and the day after each administration of the vaccines. The OMT protocol consisted of myofascial release of the thoracic inlet, pectoral traction, diaphragm release with MFR, splenic pump, and thoracic pump. Each technique was administered over a one-minute time frame. Participants were compensated with a nominal gift card per blood draw. Descriptive statistics were used to determine if randomization was valid and if the two groups were similar. Blood was drawn, and plasma was biobanked. The Abbott AdviseDx SARS-CoV-2 IgG II assay was used to measure the anti-spike IgG immunoglobulin titer. Some subjects were found to have detectable anti-spike IgG titer (AS IgG) on the initial blood draw, prior to the first vaccine injection, suggesting previous exposure to SARS CoV-2. Therefore, the population was further stratified to account for pre-exposure. Participants were contacted by phone once a week and surveyed for potential side effects and medication use. These data were analyzed using nonparametric Mann-Whitney statistical analyses, and all statistical analysis was done using SPSS (v28). This research study was approved by WesternU IRB committee, protocol # FB21/IRB026. Data Analysis/Results: 104 participants were recruited and 91 were retained throughout the duration of the study. Demographic data of the participants enrolled shows a diverse population representative of the Pomona, CA community. 41 participants are male (45.1%), and 50 participants are female (54.9%). The participants in the study identified themselves as Hispanic (59.3%), Non-Hispanic White (18.7%), Asian/Pacific Islander (13.1%), Black (5.5%), and American Indian (3.3%). The experimental group age ranges from 19 to 61 years old (median: 30 years old) with 59.1% females and the control group age is 18 to 63 years old (median: 32 years old) with 53.2% females. Reported side effects and medication usage after each of the vaccines have been very similar between the two groups with no significant differences identified for any reported side effects (p>0.1). The population was stratified based upon AS IgG measured in the first blood draw before the 1st vaccination into 2 groups: previously exposed to SARS-CoV-2, and naive to COVID-19. The initial blood draw titer is similar in the OMT or non-OMT arm whether or not you are previously exposed to COVID-19 (852 ± 154 AU/mL OMT, 2132 ± 803 AU/mL non-OMT) or not (undetectable in both groups). In the group naive to COVID-19, the AS IgG rises after the second vaccine injection and peaks one week after the 2nd injection (34804 ± 6622 AU/mL, OMT group, 26144 ± 3986 AU/mL, Non-OMT group). In the group that was previously exposed to COVID-19, the AS IgG rises immediately after the 1st injection and also peaks one week after the 2nd injection (69700 ± 10630 AU/mL OMT group, 54929 ± 9957 AU/mL Non-OMT group). For each time point in all groups, the average AS IgG in patients who received OMT is higher compared to those in the control group. Two-way ANOVA analysis showed statistical significance (p <0.001) when comparing titer 1 week after 2nd injection in the population naive to previous COVID-19 infection. Conclusion: No significant differences were observed between the two groups regarding side effects or adverse events from vaccines or OMT. This indicates that OMT is safe when used adjunctively with COVID-19 mRNA vaccination. We also confirm that lymphatic pump OMT provided a trend that enhanced the vaccine’s efficacy as seen from the higher AS IgG measured in the experimental group compared to the control group over the three months duration of our study whether the participants were naive or not infected with COVID-19 at the time of the vaccination. Our study is underpowered to obtain statistical significance across all time points. A Future investigation should include a larger group of participants and should be confirmed using other immunizations such as Hepatitis B or other vaccinations. Future analysis of the biobank serum will also look at anti-nucleocapsid IgG to confirm previous COVID-19 infections. The inclusion of a true sham treatment arm (i.e. hand contact over the identified regions) could help the identification of a placebo effect. This study is ongoing, and each participant is followed for a period of one year. The experimental protocol has been amended to include the recommended booster and will now measure the effectiveness of OMT in participants who choose to receive it.


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