A Series of N-of-1 Trials of Traditional Chinese Medicine Based on Bayesian Method

Summary

The guiding role of parallel randomized controlled trials in clinical practice is limited due to the insufficiency of individual information. Our previous studies showed that Single case randomized controlled trials (referred to as N-of-1 trials) could reflect the individualized characteristics of traditional Chinese medicine (TCM) syndrome differentiation with good feasibility, but the sensitivity was low.

This study aims to compare the efficacy of treatment based on syndrome differentiation with controlled decoctions (placebo, and the method of strengthening the body resistance and removing phlegm) among patients with stable bronchiectasis through a series of N-of-1 trials (single-patient, double-blind, randomized, multiple crossover design), with the 7 point-likert scale of the most concerned symptoms as the main outcome. Hierarchical Bayesian statistical methods and some parameters and variables will be introduced, such as TCM syndrome type, potential residue effect of TCM, etc. The sensitivity and applicability of various mathematical models (Hierarchical Bayesian, paired t-test and Meta-analysis) for N-of-1 trials of TCM will be tested, for the purpose of improving the sensitivity and applicability of N-of-1 trials of TCM both on individual and group levels.

Conditions

• Bronchiectasis
• Quality of Life
• Traditional Chinese Medicine
• Sputum
• Symptoms
• Individuality

Interventions

DRUG

Individualized Decoction

Applied in the Tested Drug Observation Period. It is the highly individualized treatment of TCM, the modification of Bronchiectasis Stabilization Decoction (Rhizoma Fagopyri Cymosi 30g, Radix Lithospermi 15g, Radix Ophiopogonis 15g, Poria cocos 15g, Radix Astragali 20g, Rhizoma Bletillae 10g, Platycodon grandiflorum 10g, Semen Coicis 30g) based on syndrome differentiation. For example, for patients with qi and yin deficiency syndrome, the investigators added Adenophora Root, Radix Glehniae and Radix Rehmanniae Recens etc. For patients with phlegm-heat syndrome, the investigators added Radix Scutellariae and Viola Yedoensis etc. Besides, the herbs in a prescription could be changed according to different symptoms of individual patients.

DRUG

placebo

Applied in the placebo Observation Period. Placebo is made by dextrin, bitter agent, edible pigment etc. and added 5% test drug. The test drug and control drug have no differences in dosage form, appearance, color, specification, label, and so forth.

DRUG

Tested drug minus heat-clearing herbs

It is the decoction of the Syndrome Differentiation Decoction (tested drug) minus heat-clearing herbs. For example, heat-clearing herbs such as Scutellaria Baicalensis, Rhizoma Coptidisor Herba Violae will be removed from the Syndrome Differentiation Decoction.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai University of Traditional Chinese Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2021-12-31

Completion

2022-12-31

Countries

• China

Study Locations