Critical appraisal of the SHARP acupuncture hypertension clinical trial

¶ … Scientific Admissibility and Merit of Published Articles

CRITICAL APPRAISAL FORM

Section a: Reference of Article

Eric a. Macklin, Peter M. Wayne, Leslie a. Kalish, Peter Valaskatgis, James Thompson, May C.M. Pian-Smith, Qunhao Zhang, Stephanie Stevens, Christine Goertz, Ronald J. Prineas, Beverly Buczynski, Randall M. Zusman

Stop Hypertension with the Acupuncture Research Program (SHARP): Results of a Randomized, Controlled Clinical Trial

Journal: Hypertension: Journal of the American Heart Association

Volume and Page Numbers: Vol. 48;

General Methodological Issues

For each criterion, check the appropriate box, according to how you think it is addressed: (Y=yes, S=substandard, N=No, NA=Not applicable, NQ=Not Qualified to Assess)

Criteria

NQ

Comments priori hypothesis clearly stated

Source population identified

Inclusion criteria described and appropriate (same in all groups)

Exclusion criteria described and appropriate (same in all groups)

Number of excluded or refusal (before study) reported

Withdrawals (during study) reported, explained, and reasonable

Withdrawals equal in groups

Sample size preplanned to provide adequate statistical power

Statistical analysis appropriate

Adjustment for multiple comparisons

Adjustment for important values

Results verifiable from raw data

Section G: Brief Summary of Paper: Descriptive information (short sentences)

Treatments being compared:

Check: [ two treatment arms [ great than two treatment arms

Design:

Check: [x] efficacy trial [ effectiveness trial

Method of assignment to treatment group: Random, stratified according to use of antihypertensives in previous six months.

Outcomes ascertained: BP increased modestly between measurements taken before and after an acupuncture session (by 2.1/0.8 mm Hg for a participant with pre-acupuncture BP of 143/88 mm Hg). No significant difference was found in the immediate effect of active vs. sham acupuncture. The risk of developing BP levels that required initiation of antihypertensive drugs did not differ significantly among participants randomly assigned to the 3 treatment groups. During follow-up, 2 STD participants experienced hypertensive urgencies, and 1 CNTL participant experienced congestive heart failure. No deaths occurred. The risk of any (n=98) or study-related (n=50) adverse events did not differ among treatment groups.

Main Source of Subjects: Subjects were recruited from outpatient clinics, referrals from Boston-area physicians, advertising in local periodicals and public transportation, and through mass mailings.

Inclusion Criteria: Untreated blood pressure (BP) of 140/90 to 179/109 mm Hg. No acupuncture in the previous six months.

Exclusion Criteria: Less than 18 years of age. Medical contraindications to acupuncture. Those individuals lacking follow-up data were subsequently excluded.

Main Source of Data: TCM individualized (IND), TCM standardized (STD), or control (CNTL) acupuncture

Duration of follow-up: 35 to 65 days

Number considered for enrollment: 424

Number enrolled: 192

Number included in analysis: 188

Statistic methods: linear mixed model; subgroup analyses for age, race, gender, baseline BP, history of antihypertensive use, obesity, primary TCM diagnoses

Other relevant information:

Strengths of Paper

Treatment randomization and BP responses were effectively masked thanks to the usage of separate diagnosing and treating acupuncturists, as well as the use of an independent vascular medicine team. This gives the results validity. Thanks to the inclusion of STD and IND treatment groups, the differential benefit of the three acupuncture treatments could be effectively evaluated. Careful blood pressure monitoring throughout, clear eligibility criteria, and objective randomization all contribute to the effectiveness of the presentation and the validity of the results.

Weaknesses of Paper

The SHARP trial was not designed for the detection of small effects. For subjects with stage 2 hypertension, the use of acupuncture without the use of antihypertensives is not reflective of usual practice among acupuncturists. In general, further research is required in order to determine whether acupuncture enhances the management of hypertension when used in combination with antihypertensives.

Reviewer's conclusions (if different from author's)

Clinical Relevance

Highly relevant [

Relevant [x]

Questionable relevant [

Irrelevant [

Not qualified to evaluate [

Scientific Merit

Very good [x]

Good [

Scientifically admissible [

Scientifically inadmissible [