RCT study found that the "stroke brain awakening prescription" is ineffective, so why was it published in The Lancet?

This is the 5284th article of Da Yi Xiao Hu

Recently, The Lancet, a top international comprehensive medical journal, published a double-blind randomized controlled trial (RCT) of Chinese medicine for the treatment of cerebral hemorrhage. This is the first time that The Lancet has published a Chinese medicine RCT study in its 200 years since its founding in 1823. As we all know, The Lancet is one of the world's top medical journals and can be called the "golden signboard" of the medical community. Therefore, this article has attracted widespread attention and has even been dubbed a "milestone". However, the research conclusion shows that the stroke awakening prescription is basically ineffective for stroke. Why was such a result adopted by The Lancet? What is its significance for the treatment of cerebral hemorrhage and traditional Chinese medicine?

Let’s take a comprehensive look at this research.

1. Research subjects: patients with acute cerebral hemorrhage who are very difficult to treat clinically

Acute cerebral hemorrhage is a serious disease with no perfect treatment. Conventional treatment includes controlling blood pressure, stopping bleeding, reducing intracranial pressure and surgery. The mortality rate in the acute phase is 30% to 40%. This study included 1,648 patients with acute cerebral hemorrhage in 26 hospitals in 12 provinces in China.

2. Treatment Methods - Brain-awakening Prescriptions for Stroke

The study used a Chinese herbal compound preparation called "Zhongfeng Xingnao Fang", the main ingredients of which are red ginseng, Panax notoginseng, Chuanxiong and rhubarb, which have the effect of promoting blood circulation and unblocking collaterals in traditional Chinese medicine theory. This preparation has been used clinically for more than 20 years, especially for patients with moderate and severe cerebral hemorrhage, and the medication is taken orally.

3. Study control selection – placebo control

In order to scientifically evaluate the efficacy and safety of the "Stroke Awakening Prescription", the study used a placebo as a control. In layman's terms, the patients included in the study were randomly divided into two groups, one group used Chinese medicine, and the other group used a placebo. Placebo is a preparation that does not contain active pharmaceutical ingredients. Its appearance, smell, taste, etc. are similar to those of therapeutic drugs, but it has no therapeutic effect. Through placebo control, the interference of factors such as patients' psychological expectations and doctors' attitudes on the efficacy evaluation can be eliminated, thereby more accurately evaluating the efficacy of the drug.

IV. Outcome Indicator - Functional Recovery

The main outcome measure is the functional recovery of the patient, in addition to survival rate, health-related quality of life and other aspects. The results of the study showed that when comparing the effects of "Stroke Brain Rejuvenation Solution" and placebo, the average score of functional recovery of the two groups of patients was 0.44 points, which means that there was no significant difference in treatment between the two. In other words, the "Stroke Brain Rejuvenation Recipe" did not bring significant help to the recovery of patients with acute cerebral hemorrhage. However, the study also verified that the "Stroke Brain Rejuvenation Recipe" is safe. It is worth noting that although this study found that the "Stroke Brain Rejuvenation Recipe" may have some effect in some specific cases (such as moderate or above bleeding), overall, it did not have obvious therapeutic results.

Figure 1 Schematic diagram of the study design

V. Study Design – Randomized Controlled Trial

The study adopted a multi-center randomized, placebo-controlled double-blind design, which is currently recognized as one of the research methods with the highest level of medical evidence. This design can greatly reduce errors and interference caused by various reasons (such as researchers' expectations, patients' psychological effects, etc.), so that the conclusions obtained are closer to the actual situation and more objective and fair.

6. Does a negative result mean anything?

The Lancet published this study not because TCM itself has unique advantages, but because its research strictly followed the research methods and standards of modern medicine, and its scientificity and standardization have been recognized by the international medical community. This is not only an exploration of TCM in the treatment of intractable diseases in the modern medical system, but also an important attempt to combine traditional medicine with modern science. Most importantly, this study reminds us that if TCM wants to gain a foothold in the international medical community, it must follow the research path of modern science and conduct large-scale, systematic clinical trials.

From the perspective of medication, I am afraid that many doctors will no longer prescribe this medicine, "Stroke Brain Rejuvenation Recipe", to patients with acute cerebral hemorrhage in the future. However, the pursuit of finding more effective and safer treatments for acute cerebral hemorrhage will not stop. On the other hand, it will also inspire more doctors and scientists to pay attention to and study this extremely challenging "problem" to bring better treatment effects to patients.

At the same time, as the Lancet commentary article profoundly pointed out, due to the biological complexity of traditional Chinese medicine, the results of a study often cannot represent the results of other patients using the same type of traditional Chinese medicine, as the saying goes, "a single piece of evidence is not enough." Various factors such as drug dosage form, individual differences, severity of the disease, treatment time, and follow-up time may affect the accuracy and reliability of the results. The negative result is not meaningless. It marks an important breakthrough in the field of traditional Chinese medicine treatment of acute cerebral hemorrhage and provides a scientific evidence-based method model for evaluating traditional Chinese medicine. In the future, we need more such "heavyweight" studies to promote the development of clinical research in traditional Chinese medicine and bring hope to more patients!

Author: First Clinical Medical College of Zhejiang University of Traditional Chinese Medicine

Dai Youran, Class of 2020, Chinese Medicine

Instructor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Research Department Li Qiushuang