To assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Acupuncture has been widely used for blood pressure management. Its effect on the cardiovascular-related targeted metabolome is still unknown. This pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Inclusion Criteria:

• aged between 45 and 75 years;
• were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;
• without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;
• the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;
• didn't administer any drugs or herbs in at 15 days before the start of the study;
• didn't participate in any study other than this;
• agreed to cooperate with researchers in all research procedures after they were introduced this study; and
• provided with written informed consent.

Exclusion Criteria:

• age≤45 or age≥75;
• with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;
• had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;
• accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;
• with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);
• pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;
• with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;
• with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;
• alcoholics or drug abusers, or vegetarians;
• used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;
• used to administer any drug that may potentially impaired renal or hepatic function;
• with cardiovascular disease that had been treated with acupuncture within recent three months; or
• undergoing other clinical trials.

Individual Patient Data will be shared upon request.