Yes – through a manual process of randomisation
Yes – process of randomisation not specified
Yes – through an electronic process of randomisation
Were all of the patients who entered the trial properly accounted for at its conclusion?
Yes – as per flowchart (p.840)
Yes – as per flowchart (p.3124)
Yes – as per flowchart (p.1149)
Yes – as per flowchart (p.919)
Yes – as per flowchart (p.3)
Yes – as per flowchart (p.415)
Were patients and study personnel ‘blind’ to treatment?
No
No
No
No
No
No
Were the groups similar at the start of the trial?
Yes – most participants identified as ‘White’, but there were no other significant differences
Yes – there were no significant differences between the groups at baseline
Yes – there were no significant differences between the groups at baseline
Yes – there were no significant differences between the groups at baseline
Yes – there were no significant differences between the groups at baseline
Yes – there were no significant differences between the groups at baseline
Aside from the experi-mental intervention, were the groups treated equally?
Yes
Yes
Yes
Yes
Yes
Yes
How large was the treatment effect?
Measured to the nearest 0.1 mmHg
Measured to the nearest 0.1 mmHg
Measured to the nearest 0.01 mmHg
Measured to the nearest 0.0+1 mmHg
Measured to the nearest 0.01 mmHg
Measured to the nearest 0.1 mmHg
How precise was the estimate of the treatment effect?
Precise: measured using p-values with confidence intervals
Precise: measured using p-values with confidence intervals
Precise: measured using p-values with confidence intervals
Precise: measured using p-values with confidence intervals
Precise: measured using p-values
Precise: measured using p-values with confidence intervals
Can the results be applied to the local population, or in your context?
Yes – showed active acupuncture is no more effective than sham acupuncture for reducing systolic or diastolic BP
Yes – showed active acupuncture is more effective than sham acupuncture for reducing systolic or diastolic BP. However, the effects of the acupuncture are notsustained
Yes – showed active acupuncture is more effective than sham acupuncture for reducing BP
Yes – showed active acupuncture may be more effective than sham acupuncture for reducing nighttime diastolic BP only
Yes – showed active acupuncture may be more effective than sham acupuncture for reducing systolic BP only
Yes – showed active acupuncture is more effective than sham acupuncture for reducing BP
Were all clinically-important outcomes considered?
Yes – age, race, gender, baseline BP, history of anti-hypertensive medication use, obesity, primary TCM diagnosis
Uncertain – there was a focus on baseline BP only
Uncertain – the potential confounders controlled for in analysis (if any) were not specified
Uncertain – the potential confounders controlled for in analysis (if any) were not specified
Uncertain – the potential confounders controlled for in analysis (if any) were not specified
Uncertain – the potential confounders controlled for in analysis (if any) were not specified
Are the benefits worth the harms and costs?
Two patients in the active acupuncture group experienced “hypertentive urgencies” (p.842); the risk of adverse events in the intervention vs. control groups was not significant (p>0.68).
Two patients in the active acupuncture group experienced pain.
No risks/harms identified
Some patients experienced minor injection-site pain and bleeding.
No risks/harms identified
Participants in both the intervention and the control groups experienced nausea during acupuncture and haematoma after acupuncture; the risk of adverse events between the groups was not significant (p=0.147).
