Randomized, controlled trial of qigong for treatment of prehypertension and mild essential hypertension.

CONTEXT: Hypertension treatments include sodium restriction, pharmacological management, and lifestyle modifications. Although many cases of hypertension can be controlled by medication, individuals may experience side effects or incur out-of-pocket expenses, and some may not comply with the treatment regimen. Although some previous studies have shown a favorable effect for qigong on hypertension, well-designed, rigorous trials evaluating the effect of qigong on hypertension are scarce. OBJECTIVE: This study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized, clinical trial (RCT). DESIGN: Participants were randomized to a qigong group or an untreated control group. SETTING: This study was conducted at the Oriental Medical Center of Dongeui University, in the Republic of Korea. PARTICIPANTS: Participants were individuals between the ages of 19 and 65 y with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg. INTERVENTION: The qigong group attended qigong classes 3 ×/wk and performed qigong at home at least 2 ×/wk. Participants in the control group did not receive any intervention for hypertension. OUTCOME MEASURES: Outcome measures for this study were (1) changes in blood pressure (BP); (2) quality of life (QOL) using 2 surveys: the Medical Outcomes Study (MOS) 36-item short form (SF-36) (Korean version) and the Measure Yourself Medical Outcome Profile 2 (MYMOP2); and (3) hormone levels. RESULTS: Of 40 participants, 19 were randomly assigned to the qigong group, and 21 were assigned to the control group. After 8 wk, significant differences were observed between the qigong and the control groups regarding changes in SBP (P = .0064) and DBP (P = .0003). Among the categories of the MYMOP2 questionnaire, only wellbeing was significantly different between the 2 groups (P = .0322). The qigong group showed a significantly greater improvement in the physical component score of the SF-36 compared with the control group (P = .0373). Regarding changes in hormone levels, there was no significant difference between the qigong and the control groups. This pilot study demonstrates that regarding sample size, a RCT evaluating the effect of qigong on hypertension should include 22 participants based on DBP and 285 participants based on SBP in each group, thus allowing for a loss to follow-up rate of 20%. CONCLUSION: The results indicate that qigong may be an effective intervention in reducing BP in prehypertension and mild hypertension. Further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on BP.

A trial for the use of qigong in the treatment of pre and mild essential hypertension: a study protocol for a randomized controlled trial.

BACKGROUND: Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have side effects and poor adherence. Qigong has been studied as an alternative therapy for hypertension; however, the types of qigong used in those studies were diverse, and there have not been many well-designed randomized controlled trials.Our objectives are the following: 1) To evaluate the effects of qigong on blood pressure, health status and hormone levels for pre- or mild hypertension. 2) To test the methodological appropriateness of this clinical trial and calculate a sample size for future randomized trials. METHODS: Forty subjects with pre- or mild hypertension will be randomized to either the qigong exercise group or the non-treated group. Participants in the qigong group will conduct qigong exercises 5 times per week for 8 weeks, and participants in the non-treated group will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint is a change in patient blood pressure. Secondary endpoints are patient health status (as measured by the SF-36 and the MYMOP2 questionnaires) and changes in hormone levels, including norepinephrine, epinephrine, and cortisol. DISCUSSION: This study will be the first randomized trial to investigate the effectiveness of qigong exercises for the treatment of pre- and mild hypertension. The results of this study will help to establish the optimal approach for the care of adults with pre- or mild hypertension. TRIAL REGISTRATION: Clinical Research Information Service KCT0000140.