Chiropractic for Hypertension in Patients (CHiP): A Pilot Randomized Controlled Trial
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additive effect of the combination of oral vitamins and chelation therapy was significant and of potential clinical relevance. Our findings in TACT offer several opportunities for novel research programs that may eventually lead to important therapeutic in- sights for treatment of CAD. Contact: Gervasio Lamas, [email protected] OA01.03 Chiropractic for Hypertension in Patients (CHiP): A Pilot Randomized Controlled Trial Christine Goertz (1), Cynthia Long (1), Robert Vining (1), Stacie Salsbury (1), Katherine Pohlman (2), Gervasio Lamas (3) (1) Palmer Center for Chiropractic Research, Davenport, IA, USA (2) University of Alberta, Edmonton, AB, Canada (3) Mount Sinai Medical Center, Miami Beach, FL, USA Purpose: Bakris et al. reported dramatic blood pressure (BP) lowering effects resulting from an upper cervical manipulation technique (NUCCA) in narrowly selected patients with Stage 1 hypertension. Our study compared BP changes between a sim- ilar but more commonly used upper cervical technique, Toggle Recoil (TR), and a sham intervention (SI) in a more generaliz- able sample. Methods: We conducted a 2-arm pilot RCT with participants age 21 to 75 with documented pre- to Stage 1 hypertension who saw the doctor of chiropractic (DC) twice weekly for 6 weeks. Participants and BP assessors were blinded to treatment, while DCs were masked to BP outcomes. Results: We screened 681 volunteers and randomly allo- cated 51 participants (24 TR and 27 SI; 59% males; mean age 58; mean BMI 31.3). At the first visit, pre/post adjusted mean systolic BP decreased 0.9 mmHg in the TR group and 5.5 mmHg in the SI group; diastolic BP increased 1.4 mmHg in the TR group and decreased 2.2 mmHg in the SI group. From baseline to week 6 (primary endpoint), adjusted mean systolic BP increased 0.6 mmHg in the TR group and de- creased 4.2 mmHg in the SI group; diastolic BP increased 0.5 mmHg in the TR group and decreased 1.3 mmHg in the SI group; and the between group adjusted mean difference in systolic BP was 4.8 (95% CI: - 0.4, 10.0). No between group differences were statistically significant. Conclusion: We did not see the dramatic changes in BP reported in the Bakris et al. study; the differences we did ob- serve were in favor of the sham. Our results provide more questions than answers about the value of spinal manipulation for the treatment of hypertension. We propose that basic sci- ence research is needed to understand the potential mecha- nisms of action before further clinical investigations are initiated. Contact: Christine Goertz, [email protected] OA01.04 LB Catechol-O-methyltransferase Associated Risk of Cardiovascular Disease Is Modified by Treatment with Vitamin E Kathryn Hall (1), Christopher Nelson (2), Roger Davis (1), Julie Buring (3), Irving Kirsch (4), Murray Mittleman (1), Joseph Loscalzo (3), Nilesh Samani (2), Paul Ridker (3), Ted Kaptchuk (1), Daniel Chasman (3) (1) Beth Israel Deaconess Medical Center, Boston, MA, USA (2) University of Leicester, Leicester, UK (3) Brigham and Women’s Hospital, Boston, MA, USA (4) Plymouth University, Plymouth, UK Purpose: Despite the lack of conclusive evidence of efficacy from well-designed clinical trials, the use of vitamins remains widespread. With recent reports of possible harm, the debate has shifted from benefits relative to placebo, to concerns about safety. Few studies have investigated the effect of genetic var- iation on treatment responses to vitamin E. Genetic variation is considered an important factor in heritability of CVD and treatment response. Catecholamines like epinephrine play a key role in cardiovascular function and are metabolized by catechol- O-methyltransferase (COMT). The effect of genetic variation in COMT on CVD outcomes in women treated with vitamin E is not known. Methods: The Women’s Health Study (WHS) is a large pro- spective placebo-controlled trial of incident CVD prevention with random allocation to aspirin and vitamin E and 10 years follow-up. The Women’s Genome Health Study (WGHS), a large subset of the WHS for genetic analysis provided a unique dataset to examine the effects of the COMT rs4680 polymor- phism. Results: The rs4680 high-activity val allele was protective for incident CVD among women in the placebo arm (HR[95%CI] = 0.66[0.51–0.84], P = 0.0007) such that val homozygotes had a 56% lower rate of major CVD relative to low-activity met ho- mozygotes. The rs4680 protective association was abolished by randomized allocation to vitamin E such that val homozygotes experienced higher rates of major CVD with vitamin E com- pared to placebo (HR[95%CI] = 1.50[0.83–2.70], P = 0.180), while met homozygotes experienced lower rates (HR[95%CI] = 0.53[0.34–0.84], P = 0.023) thus revealing a significant interac- tion between COMT and vitamin E (P = 0.004). Conclusion: Common COMT polymorphism association with CVD risk and differential effects of vitamin E treatment suggests novel aspects of CVD pathophysiology. In an era where the use of vitamins is under debate, this study highlights the importance of considering genetic composition in evaluating clinical effi- cacy of vitamins and using pharmacogenomics to guide the development of smarter, individualized strategies for treatment and prevention. Contact: Kathryn Hall, [email protected] Oral Abstract Session 02: Health Services Research OA02.01 A National Assessment of the Usage, Cost, and Reimbursement of Unconventional Medical Laboratory Tests Ather Ali (1), Nicholas Scoulios (2), Nicholas Ten (1), Anup Kanodia (3) (1) Yale School of Medicine, New Haven, CT, USA (2) Georgetown School of Medicine, Washington, DC, USA (3) Ohio State University, Columbus, OH, USA Purpose: A growing number of unconventional medical labo- ratory tests have emerged and are anecdotally popular among CAM-oriented practitioners. In the United States, millions of unconventional medical laboratory tests are ordered annually, though no high quality data exist regarding practice patterns, cost, or reimbursement. To our knowledge, this is the first study A3
Transcript of Chiropractic for Hypertension in Patients (CHiP): A Pilot Randomized Controlled Trial
additive effect of the combination of oral vitamins and chelationtherapy was significant and of potential clinical relevance. Ourfindings in TACT offer several opportunities for novel researchprograms that may eventually lead to important therapeutic in-sights for treatment of CAD.Contact: Gervasio Lamas, [email protected]
OA01.03Chiropractic for Hypertension in Patients (CHiP):A Pilot Randomized Controlled Trial
Christine Goertz (1), Cynthia Long (1), Robert Vining (1),Stacie Salsbury (1), Katherine Pohlman (2), Gervasio Lamas (3)
(1) Palmer Center for Chiropractic Research, Davenport, IA,USA(2) University of Alberta, Edmonton, AB, Canada(3) Mount Sinai Medical Center, Miami Beach, FL, USA
Purpose: Bakris et al. reported dramatic blood pressure (BP)lowering effects resulting from an upper cervical manipulationtechnique (NUCCA) in narrowly selected patients with Stage 1hypertension. Our study compared BP changes between a sim-ilar but more commonly used upper cervical technique, ToggleRecoil (TR), and a sham intervention (SI) in a more generaliz-able sample.Methods: We conducted a 2-arm pilot RCT with participantsage 21 to 75 with documented pre- to Stage 1 hypertension whosaw the doctor of chiropractic (DC) twice weekly for 6 weeks.Participants and BP assessors were blinded to treatment, whileDCs were masked to BP outcomes.Results: We screened 681 volunteers and randomly allo-cated 51 participants (24 TR and 27 SI; 59% males; mean age58; mean BMI 31.3). At the first visit, pre/post adjusted meansystolic BP decreased 0.9 mmHg in the TR group and5.5 mmHg in the SI group; diastolic BP increased 1.4 mmHgin the TR group and decreased 2.2 mmHg in the SI group.From baseline to week 6 (primary endpoint), adjusted meansystolic BP increased 0.6 mmHg in the TR group and de-creased 4.2 mmHg in the SI group; diastolic BP increased0.5 mmHg in the TR group and decreased 1.3 mmHg in the SIgroup; and the between group adjusted mean difference insystolic BP was 4.8 (95% CI: - 0.4, 10.0). No between groupdifferences were statistically significant.Conclusion: We did not see the dramatic changes in BPreported in the Bakris et al. study; the differences we did ob-serve were in favor of the sham. Our results provide morequestions than answers about the value of spinal manipulationfor the treatment of hypertension. We propose that basic sci-ence research is needed to understand the potential mecha-nisms of action before further clinical investigations areinitiated.Contact: Christine Goertz, [email protected]
OA01.04 LBCatechol-O-methyltransferase Associated Riskof Cardiovascular Disease Is Modified by Treatmentwith Vitamin E
Kathryn Hall (1), Christopher Nelson (2), Roger Davis (1),Julie Buring (3), Irving Kirsch (4), Murray Mittleman (1), JosephLoscalzo (3), Nilesh Samani (2), Paul Ridker (3), Ted Kaptchuk (1),Daniel Chasman (3)
(1) Beth Israel Deaconess Medical Center, Boston, MA, USA(2) University of Leicester, Leicester, UK(3) Brigham and Women’s Hospital, Boston, MA, USA(4) Plymouth University, Plymouth, UK
Purpose: Despite the lack of conclusive evidence of efficacyfrom well-designed clinical trials, the use of vitamins remainswidespread. With recent reports of possible harm, the debate hasshifted from benefits relative to placebo, to concerns aboutsafety. Few studies have investigated the effect of genetic var-iation on treatment responses to vitamin E. Genetic variation isconsidered an important factor in heritability of CVD andtreatment response. Catecholamines like epinephrine play a keyrole in cardiovascular function and are metabolized by catechol-O-methyltransferase (COMT). The effect of genetic variation inCOMT on CVD outcomes in women treated with vitamin E isnot known.Methods: The Women’s Health Study (WHS) is a large pro-spective placebo-controlled trial of incident CVD preventionwith random allocation to aspirin and vitamin E and 10 yearsfollow-up. The Women’s Genome Health Study (WGHS), alarge subset of the WHS for genetic analysis provided a uniquedataset to examine the effects of the COMT rs4680 polymor-phism.Results: The rs4680 high-activity val allele was protective forincident CVD among women in the placebo arm (HR[95%CI] =0.66[0.51–0.84], P = 0.0007) such that val homozygotes had a56% lower rate of major CVD relative to low-activity met ho-mozygotes. The rs4680 protective association was abolished byrandomized allocation to vitamin E such that val homozygotesexperienced higher rates of major CVD with vitamin E com-pared to placebo (HR[95%CI] = 1.50[0.83–2.70], P = 0.180),while met homozygotes experienced lower rates (HR[95%CI] =0.53[0.34–0.84], P = 0.023) thus revealing a significant interac-tion between COMT and vitamin E (P = 0.004).Conclusion: Common COMT polymorphism association withCVD risk and differential effects of vitamin E treatment suggestsnovel aspects of CVD pathophysiology. In an era where the useof vitamins is under debate, this study highlights the importanceof considering genetic composition in evaluating clinical effi-cacy of vitamins and using pharmacogenomics to guide thedevelopment of smarter, individualized strategies for treatmentand prevention.Contact: Kathryn Hall, [email protected]
Oral Abstract Session 02: Health Services Research
OA02.01A National Assessment of the Usage, Cost,and Reimbursement of Unconventional MedicalLaboratory Tests
Ather Ali (1), Nicholas Scoulios (2), Nicholas Ten (1), AnupKanodia (3)
(1) Yale School of Medicine, New Haven, CT, USA(2) Georgetown School of Medicine, Washington, DC, USA(3) Ohio State University, Columbus, OH, USA
Purpose: A growing number of unconventional medical labo-ratory tests have emerged and are anecdotally popular amongCAM-oriented practitioners. In the United States, millions ofunconventional medical laboratory tests are ordered annually,though no high quality data exist regarding practice patterns,cost, or reimbursement. To our knowledge, this is the first study
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