The two arms were acupuncture group versus untreated control group. Participants had been recruited and were allocated one of the groups at a 1:1 ratio. Participants in the acupuncture group had received standardized acupuncture treatment 20 minutes a session, twice weekly for 8 weeks, and followed up 4 weeks after treatment completion; and participants in control group did not receive any antihypertensive related treatment during the study.
Description We used disposable stainless steel needles (diameter: 0.20 mm，length: 30 mm; DongBang Acupuncture, Inc., Seoul, South Korea). In each session, participants were given de qi sensation via manipulation right after inserting needle into the skin, plus 20 minutes of needle-retaining time.
Clinical Trial Type
an assessor-blinded, parallel 2-armed, randomized preliminary study
Adverse Effects
In this trial, it has not reported any adverse events.
Effector
Primary outcome
There was a significant difference in DBP(-5.7 mmHg; 95% CI:-10.7,-0.8; P = 0.025)but a negligible difference in SBP(-6.0 mmHg; 95% CI: -13.7, 1.7; P = 0.123) change from baseline to post-treatment between acupuncture group and control group. In the acupuncture group, there was a significant decrease in SBP(-6.5 mmHg; P= 0.042) and DBP(-4.9 mmHg; P = 0.006) from baseline to post-treatment. In the control group, the changes in SBP(-1.3 mmHg; P = 0.208) and DBP(1.2 mmHg; P = 0.934) were not statistically significant. (Table 2)
Secondary outcome
1.Blood Pressure
There were significant differences in SBP(-8.6 mmHg; 95% CI: -16.3,-0.8; P = 0.031) and DBP (-7.8 mmHg; 95% CI: -12.8, -2.8; P = 0.004) at follow-up between acupuncture group and control group. In the acupuncture group, there was a significant decrease in DBP(-4.6mmHg;P= 0.002) but not in SBP (-5.0 mmHg; P= 0.135). In the control group, neither DBP nor SBP were significantly changed.(Table 2, Figure 3) To better understand the duration of the treatment intervention, we analyzed the differences at week 4.There was a significant difference in SBP (-7.8 mmHg; 95% CI:-14.6, -0.9;P= 0.027) and DBP (-7.5 mmHg; 95% CI:-12.8,-2.2;P= 0.007) between the two groups. In the acupuncture group, there was a significant decrease in SBP(-7.1 mmHg;P= 0.027) and in DBP (-7.5 mmHg;P=0.001).In the control group, neither DBP nor SBP were significantly changed.(Table 2)
2.Heart rate variability
Among the HRV indices(TP, VLF,LF and HF),only HF showed significant differences between groups at week 4 (0.7;95% CI:0.0,1.4;P=0.047) and week 8 (0.7;95% CI:0.7, 1.3;P=0.030). In the acupuncture group, all the HRV indices changed significantly at week 8: the change in TP was 0.6 (P= 0.001), in VLF, 0.6 (P= 0.024), in LF, 0.4 (P= 0.028), and in HF, 0.5(P=0.024).The HRV indices were not significantly changed in the control group.(Table 3)
3.EQ-5D
There were no significant differences in EQ-5D scores between groups at week 4, week 8 or follow-up (P=0.499,P=0.246 and P=0.839, respectively). There were also no changes within groups.(Table 4)
4. Lipid profile and BMI
There were no significant differences in BMIl between groups at week 4, week 8 or follow-up (P = 0.988, P = 0.917 and P = 0.466, respectively). Similarly, there were no significant differences in blood lipid profile indices, namely HDL (P = 0.641), LDL (P =0.356) and total cholesterol (P = 0.172) at week8.(Table 5)
"Acupuncture lowers blood pressure in mild hypertension patients: a randomized, controlled, assessor-blinded pilot trial."
Abstract
OBJECTIVES: To preliminarily assess the effects of acupuncture on prehypertension and stage I hypertension, and to provide data for further research. DESIGN: A randomized, controlled, assessor-blinded study with an 8-week intervention period and a 4-week follow-up. INTERVENTIONS: Participants were patients with systolic blood pressure (SBP) of 120-159mmHg or diastolic blood pressure (DBP) of 80-99mmHg.Thirty participants were allocated to acupuncture group or untreated control group at a 1:1 ratio. The acupuncture group received standard acupuncture twice weekly for 8 weeks, and was followed-up for 4 weeks after treatment; the control group did not receive any type of anti-hypertensive treatment for 12 weeks. MAIN OUTCOME MEASURES: Primary outcome measure was SBP and DBP at post-treatment. The secondary outcomes were SBP and DBP at follow-up; Euro Quality of life (EQ-5D), heart rate variability (HRV), body mass index (BMI), and blood lipid profile. RESULTS: DBP (-5.7mmHg; P=0.025), but not SBP (-6.0mmHg; P=0.123), was significantly different between groups at post-treatment. Both DBP (-7.8mmHg; P=0.004) and SBP (-8.6mmHg; P=0.031) were significantly different at follow-up. Among the HRV indices, only high frequency power was significantly different between groups at weeks 4 and 8 (P=0.047 and P=0.030, respectively). There were no differences between groups in EQ-5D, BMI or lipid profile. CONCLUSION: The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies. TRIAL REGISTRATION: KCT0000496."
