Yin 2007.
Methods |
Groups: A: active acupuncture, B: sham acupuncture (all participants were antihypertensive). Blinding: assessor and participants (a single assessor made the measurements including BP, psychologic factors, and lifestyle). Dropouts/withdrawals: in treatment: after 4 weeks: 3/21 in A, 1/20 in B had dropped for job‐related reasons; 1/19 in A, 1/19 in B for distance to hospital; 0/18 to A, 1/18 to B for severe gonalgia; 1/18 in A, 1/17 in B for uncertainty about effectiveness of treatment; 0/17 in A, 1/16 in B for personal reasons; after 8 weeks: 1/17 in A, 1/15 in B dropped out for job‐related reasons. Duration of intervention: 8 weeks. After 4 weeks: 3/21 in A, 1/20 in B dropped for job‐related reasons; 1/19 in A, 1/19 in B discontinued for far distance to hospital; 0/18 in A, 1/18 in B for severe gonalgia; 1/18 in A, 1/17 in B for uncertainty about effectiveness of treatment, 0/17 in A, 1/16 in B for personal reasons; after 8 weeks: 1/17 in A, 1/15 in B dropped out for job‐related reasons; no follow‐up. |
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Participants |
Number of participants screening/included/analyzed: not reported/41/30. Number of participants in each group: 21:20. Demographics: mean age 52 years in A, mean age 54 years in B; number of women 11:10. Number of participants who used antihypertensives: all. Course of disease: 3.4 years in A, 4.2 years in B. Setting: institutional review board at Kyung Hee University Hospital of Oriental Medicine, Seoul, Korea. |
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Interventions |
Acupuncture points: acupuncture formula based on and modified from the Saam acupuncture theory of Korean acupuncture. The 4 formulas were: 1. ST36, LI11 and BL25 for toning the large intestine (L1) meridian energy; 2. SP3, LU9, and BL13 for the lung (LU); 3. K17, K12, and CV4 for the kidney (K1); 4. LI1, GV14, and GB20 for the bladder (BL). L1, LU, KI, or BL energy is typically considered deficient when a body is in a state of dampness, dryness, cold or hot, respectively. Optionally, PC6 and HT7 were added when a psychologic factor was considered of importance. Information on acupuncturists: no information. Deqi achieved?: yes. Control group intervention: using Park's sham needle (a new non‐penetrating sham acupuncture device), needle did not penetrate skin, but was twisted slowly to imitate real acupuncture. After the Deqi sensation detected, the needle was withdrawn immediately. All participants were encouraged to follow the instructions for 10 min' deep, slow breathing exercise and to walk for 30 min a day at an easy pace during the 8‐week period. |
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Outcomes |
Primary outcome:
Secondary outcome:
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Study detail |
Position for measuring BP: supine. BP measurements: automated sphygmomanometer (model T4, Omron, Japan). Time of each session: needles retained for 30 min, stimulated every 5 min. Number of treatment sessions: 17. Frequency of treatment sessions: once daily, 3‐ to 4‐day interval between sessions for 8 weeks. Time of recruiting: 1 January to 31 May 2004. Adverse events: spot‐bleeding (8 in A). |
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Publication detail |
Language or publication: English. Commercial funding: no. Non‐commercial funding: yes (supported by the SRC program of KOSEF, Korea). Publication status: peer review journal. |
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Notes | BP measured on right upper arm, mean of 3 readings with a 5‐min interval. BP was taken 6 times for the baseline measurement and 3 times for the outcome measurement. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerized random allocation. |
Allocation concealment (selection bias) | Unclear risk | No detail mentioned. |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding unlikely to have been achieved as sham procedure did not involve needle penetration. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Reported number of dropouts and related reasons, but no intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | Relevant outcome reported. |
Other bias | Unclear risk | No description. |