How do TCM injections differ from modern medicines in testing?

Question

Accepted Answer

TCM Injections Face Different Testing Standards Compared to Modern Medicines

Traditional Chinese Medicine (TCM) injections in China have historically been subject to less stringent testing requirements than modern Western medicines, leading to concerns about their safety and efficacy. While modern drugs typically undergo rigorous multi-stage clinical trials involving thousands of patients, many TCM injections approved decades ago were not required to meet such standards. This disparity in testing protocols has resulted in a significant portion of TCM injections lacking comprehensive evaluation of their potential adverse reactions in the bloodstream.
Historical Regulatory Loopholes for TCM Injections

Many TCM injections currently on the market were approved under regulatory frameworks that did not mandate extensive human trials. For instance, injections registered in the 1990s, such as those developed by Shineway Pharmaceutical Group, faced very simple requirements for clinical trials at the time. Even with subsequent regulatory reforms, drugs approved decades ago have not been retroactively subjected to full-fledged testing. It was only for therapies approved after 2008 that the requirement for three stages of human trials was introduced.
Limited Scientific Evaluation and Unknown Reactions

A significant challenge stems from the fact that numerous TCM injections have not undergone strict scientific clinical trials. This means their precise effects and potential side effects when introduced directly into the bloodstream are not fully understood. Unlike TCM taken orally, which allows the digestive system to act as a buffer, injected formulations bypass this protective mechanism, potentially amplifying adverse reactions. Estimates suggest that less than 10% of TCM injections currently sold have passed through this stringent review process.
Evolving Regulatory Scrutiny and Overhaul Efforts

Regulators in China are actively pushing for an overhaul of the TCM injection sector, acknowledging the safety concerns. The China Food and Drug Administration has declared that traditional therapies prepared with contemporary methods should be reported, reviewed, and regulated as modern medicine, demonstrating greater benefits than risks in clinical trials. The agency has pledged to reassess the quality of all marketed TCM injections within the next decade. However, this comprehensive reassessment is a complex process that is expected to take up to ten years to complete.
Adverse Reactions and Usage Concerns

The less stringent testing standards have been linked to a rise in adverse reactions. Government data indicated that adverse reactions to TCM injections doubled to approximately 133,000 cases last year from 2011. A notable example is Shineway's Qingkailing injection, which has logged a high number of adverse reactions. This injection, originally intended for oral use, is often prescribed by doctors for various conditions based on experience, despite not having been studied in late-stage trials. In some instances, off-label use and untested combinations of TCM injections have led to severe outcomes, including fatalities from allergic reactions.

Reading history

Hide →

This history is cleared when the page is closed.

How do TCM injections differ from modern medicines in testing?

Loading

Was this article helpful?

Helpful

Not helpful

Report an issue

1

0

0

Share with friends