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January 31, 2023Open Access

The Effect of Qi-Shao-Tong-Mai-An-Shen (QSTMAS) Herbal Paste in Coronary Heart Disease Patients with Depression and/or Anxiety: A Randomized Controlled Clinical Trial Protocol

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Key result

Planned RCT evaluates QSTMAS herbal paste for depression and anxiety in coronary heart disease.

  • n=99

Why the study?

Psycho-cardiology diseases aggravate CHD progression, but antidepressant adverse effects necessitate safe and effective early intervention methods.

Population

99 CHD patients with Qi deficiency and blood stasis syndrome combined with depression and/or anxiety

Comparison

Standard western medicine plus QSTMAS herbal paste vs standard western medicine alone

Design

Single-blind, single-center, randomized controlled trial protocol

Follow-up

12 weeks

Authors

YCYing ChenXXXiang XiaoCXChongxiang Xue

Discussion

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Overview

Does not yet support clinical use of QSTMAS in coronary heart disease; upcoming RCT will extend evidence on herbal effects on mood.

Study Design

Type

RCT (n=99)

Blinding

Single-blind

Randomization

1:2 ratio

Multicenter

No

PICO

P
Population
Coronary heart disease with depression and/or anxiety (n=99)
I
Intervention / Comparator
QSTMAS herbal paste vs Standard western medicine treatment (30ml twice daily)
O
Primary Outcome
Changes in GAD-7 and PHQ-9 scores

Limitations

  • Exploratory study with no similar studies for reference to calculate sample size
  • No placebo control group

Cite This Study

Chen et al. (2023) conducted an RCT in Coronary heart disease with depression and/or anxiety (n=99). QSTMAS herbal paste vs. Standard western medicine treatment was evaluated on Changes in GAD-7 and PHQ-9 scores. QSTMAS herbal paste will be evaluated in a planned 99-patient randomized controlled trial to determine its effect on depression and anxiety scores in patients with coronary heart disease.

synapsesocial.com/papers/6a10ef9439dd87f6d0ee9888https://doi.org/10.21203/rs.3.rs-2376982/v1
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The effect of Xinkeshu tablets on depression and anxiety symptoms in patients with coronary artery disease: Results from a double-blind, randomized, placebo-controlled study2019 · 23 citations
  2. 2Effect of Exercise, Escitalopram, or Placebo on Anxiety in Patients With Coronary Heart Disease2021 · 47 citations
  3. 3Depression and Anxiety as Predictors of 2-Year Cardiac Events in Patients With Stable Coronary Artery Disease2008 · 578 citations
  4. 4Antidepressant Use by Class: Association with Major Adverse Cardiac Events in Patients with Coronary Artery Disease2018 · 38 citations
  5. 5CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration2017 · 357 citations