Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

Q: What are the key findings of this study?

Chinese herbal medicine combined with conventional therapy significantly reduced 24-hour systolic blood pressure variability SD in 6 of 10 reporting RCTs (n=1,103; not pooled due to heterogeneity).

Q: What is the clinical evidence from this study?

Study design: Systematic Review. Population: Essential hypertension with blood pressure variability (BPV) (n=1103). Intervention: Oral Chinese herbal medicine (decoction, granule, capsule, or tablet) combined with conventional antihypertensive therapy vs. Conventional antihypertensive therapy alone (12 trials) or placebo plus conventional antihypertensive therapy (1 trial). Primary outcome: Blood pressure variability (24-hour, day, and night standard deviation [SD] and coefficient of variability [CV]), ambulatory blood pressure, and symptom improvement rate (qualitative synthesis only; data not pooled due to clinical heterogeneity).

Q: What does this research mean for the field?

Chinese herbal medicine combined with conventional therapy reduces blood pressure variability and lowers blood pressure in hypertension patients. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Zhuo Chen; Li‐Qiong Wang; Guoyan Yang; Hao Xu; Jianping Liu

doi:10.1155/2015/582751

January 1, 2015Evidence-based Complementary and Alternative MedicineOpen Access

Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

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Key result

Adding Chinese herbal medicine to conventional therapy reduces 24-hour systolic blood pressure variability in most trials.

n=1,103

Why the study?

Does oral Chinese herbal medicine combined with conventional antihypertensive therapy reduce blood pressure variability and ambulatory blood pressure compared with conventional therapy alone or with placebo in patients with hypertension?

Key Points

To evaluate the efficacy and safety of Chinese herbal medicine combined with conventional therapy on blood pressure variability in patients with hypertension.
Systematic review of 13 randomized clinical trials involving 1103 hypertensive patients conducted in mainland China and assessed using Cochrane standards.
Conducted a qualitative synthesis of ambulatory blood pressure variability (standard deviation and coefficient of variability) across 24-hour, daytime, and nighttime intervals due to clinical heterogeneity.
Five of nine trials reported a statistically significant reduction in 24-hour systolic standard deviation favoring combination therapy, including Xiang tian ma decoction plus benazepril (MD -5.20; 95% CI -6.37 to -4.03; n = 78) and Sangji Wendan decoction plus amlodipine (MD -2.44; 95% CI -4.38 to -0.50; n = 40).
Two of nine trials demonstrated significant reductions in 24-hour diastolic standard deviation favoring add-on therapy: Sangji Wendan decoction (MD -2.13; 95% CI -4.34 to 0.08; n = 40) and Yin gan jing decoction (MD -0.24; 95% CI -0.46 to -0.02; n = 80).
Five of nine trials demonstrated significant improvements in daytime systolic and daytime diastolic standard deviations, alongside qualitative improvements in nighttime blood pressure decrease rates and reversal of abnormal circadian rhythms.

Study Design

Type

Systematic Review (n=1,103)

Blinding

Double-blind in 1 of 13 included RCTs; outcome assessor blinding unclear in all trials

Randomization

5 of 13 included RCTs used a random number table; 2 referred to opaque sealed envelopes

Structured PICO

Does oral Chinese herbal medicine combined with conventional antihypertensive therapy reduce blood pressure variability and ambulatory blood pressure compared with conventional therapy alone or with placebo in patients with hypertension?

P

Population

1,103 patients across 13 RCTs in mainland China with essential hypertension and blood pressure variability, treated for at least 4 weeks without long-term follow-up.

I

Intervention

Oral Chinese herbal medicine (single formulation per trial as decoction, granule, capsule, or tablet; injections excluded) combined with conventional antihypertensive therapy for at least 4 weeks

C

Comparator

Same conventional antihypertensive therapy alone (12 trials; including amlodipine besylate 5 mg/day in 6 trials, levamlodipine in 1 trial, nifedipine controlled-release tablet in 1 trial, CCB plus ACEI in 2 trials, ACEI in 2 trials) or matching placebo plus amlodipine besylate tablet (1 trial)

O

Outcome

Blood pressure variability (BPV) measured by ambulatory blood pressure monitoring (ABPM) as standard deviation (SD) and coefficient of variability (CV) at 24 hours, day, and night; ambulatory blood pressure (24 hours, day, and night); and symptom improvement rate (antihypertensive effect per Clinical Research Guideline of New Drugs for Traditional Chinese Medicine)surrogate

Limitations

Poor methodological quality of included trials (unclear randomization in most, only 1 double-blind trial, no sample size calculation)
Clinical heterogeneity in herbal prescriptions, dosage forms, treatment courses, and control drugs prevented meta-analysis
No follow-up visits reported, preventing evaluation of long-term effects on BPV
No published trial protocols to rigorously assess selective outcome reporting bias
Small total sample size (1,103 patients across 13 trials, average 85 per trial) and underreporting of comorbidities
Generally low methodological quality of included RCTs (unclear randomization in 8/13 trials, allocation concealment in only 2/13, double-blinding in only 1/13, and no sample size calculations)
High clinical heterogeneity in Chinese herbal medicine prescriptions, dosage forms, duration, and background antihypertensive drugs precluded quantitative meta-analysis
Focus on short-term BPV with no follow-up visits in any included trial to evaluate long-term effects
Lack of published trial protocols and inability to construct funnel plots (<9 studies per outcome) to assess publication bias
Small sample sizes (13 trials, n=1,103 total) and incomplete baseline reporting of comorbidities such as coronary heart disease or hyperlipidemia

Implication

This systematic review of 13 Chinese RCTs suggests oral Chinese herbal medicine added to conventional antihypertensive therapy may reduce short-term blood pressure variability, though high risk of bias and clinical heterogeneity preclude pooled effect estimates or definitive clinical recommendations.

Abstract

Objective. The aim of this systematic review is to evaluate effect of Chinese medicine combined with conventional therapy on blood pressure variability (BPV) in hypertension patients. Methods. All randomized clinical trials (RCTs) comparing Chinese medicine with no intervention or placebo on the basis of conventional therapy were included. Data extraction, analyses, and quality assessment were performed according to the Cochrane standards. Results. We included 13 RCTs and assessed risk of bias for all the trials. Chinese medicine has a significant effect in lowering blood pressure (BP), reducing BPV in the form of standard deviation (SD) or coefficient of variability (CV), improving nighttime BP decreased rate, and reversing abnormal rhythm of BP. Conclusions. Chinese medicine was safe and showed beneficial effects on BPV in hypertension patients. However, more rigorous trials with high quality are warranted to give high level of evidence before recommending Chinese medicine as an alternative or complementary medicine to improve BPV in hypertension patients.

Discussion

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Cite This Study

Chen et al. (2015) conducted a systematic review in Essential hypertension with blood pressure variability (BPV) (n=1,103). Oral Chinese herbal medicine (decoction, granule, capsule, or tablet) combined with conventional antihypertensive therapy vs. Conventional antihypertensive therapy alone (12 trials) or placebo plus conventional antihypertensive therapy (1 trial) was evaluated on Blood pressure variability (24-hour, day, and night standard deviation [SD] and coefficient of variability [CV]), ambulatory blood pressure, and symptom improvement rate (qualitative synthesis only; data not pooled due to clinical heterogeneity). Chinese herbal medicine combined with conventional therapy significantly reduced 24-hour systolic blood pressure variability SD in 6 of 10 reporting RCTs (n=1,103; not pooled due to heterogeneity).

synapsesocial.com/papers/6a7b8cf284d0f3193c75d48b https://doi.org/10.1155/2015/582751

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Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Chinese Herbal Medicine Combined with Conventional Therapy for Blood Pressure Variability in Hypertension Patients: A Systematic Review of Randomized Controlled Trials

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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