Objective:

2

To evaluate the effectiveness and safety of oral Chinese herbal medicine (OCHM) for heart failure with preserved ejection fraction (HFpEF).

Methods:

2

PubMed

Excerpta Medica Database (EMBASE)

Cochrane Library

Chinese Biological Medicine Database (CBM)

Wanfang Database

Chongqing VIP Information (VIP) and China National Knowledge Infrastructure (CNKI) were searched for appropriate articles from respective inceptions until June 3

2018. Randomized controlled trials (RCTs) investigating the effectiveness of OCHM for the patients with HFpEF were eligible. Quality assessment was performed by employing the Cochrane Risk of Bias assessment tool. Papers were independently reviewed by two reviewers and analyzed using Cochrane software Revman 5.3. Dichotomous data were analyzed by relative risk (RR) with a 95% confidence interval (CI)

while continuous variables were analyzed by using mean difference (MD) with 95% CI for effect size.

Results:

2

A total of 16 RCTs involving 1

320 participants were identified. Fourteen of the trials used conventional Western medicine (CWM) as the control

the control of 1 trial was no treatment

and another was placebo. Three of the trials served Chinese patent medicine (CPM) as interventions

and other OCHM were Chinese medicine decoctions (CMDs). Only limited evidence showed experimental group with OCHM may get better effect on brain natriuretic peptide (BNP: MD –37.29

95% CI –53.08 to –21.50

P

<

0.00001) or N terminal pro B type natriuretic peptide (NT-proBNP: MD –236.04

95% CI –356.83 to –115.25

P

=0.0001)

Minnesota Living with Heart Failure questionnaire (MLHFQ

MD –9.94

95% CI –16.77 to –3.11

P

=0.004)

but the results had high heterogeneities. With concerns on 12 of 16 trials

the meta-analysis found that the adjuvant therapy of OCHM might be more effective in increasing overall response rate (RR 1.17

95% CI 1.11 to 1.24

P

<

0.00001)

when compared with CWM alone. Subgroup meta-analysis between CPMs and CMDs showed that the two CPMs may have more therapeutic effect on MLHFQ

but not on NT-proBNP

and CMD came to the opposite conclusion. No significant differences were found between experimental groups and control groups on 6-min walk test (6MWT). Adverse events

such as more defecation

weakness

cardiopalmus

edema

cough and hypotension

were mild in all groups and disappeared after the easement of pharmacological intervention.

Conclusions:

2

Due to the insufficient quality of trials that were analyzed

it is not appropriate to confirm or deny the potency of OCHMs in treating HFpEF at the present time. More rigorously designed RCTs focusing on primary endpoints with long-term followup are warranted to validate the effect of OCHMs for patients with HFpEF.