Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial

Epilepsy is one of the most common neurological diseases all over the world. Currently, about 70 million people have epilepsy worldwide. In particular, more than 30% of epilepsy patients still have seizures even though they are treated with appropriate anti-epileptic drugs (AEDs). This number has remained unchanged even after more than 20 years with many new anti-epileptic drugs being introduced. According to International League Against Epilepsy (ILAE), drug-resistant epilepsy is defined when a patient does not achieve seizure-free the seizure with two optimal antiepileptic drugs. This clinical trial is designed to evaluate the effectiveness and safety of thread-embedding acupuncture (TEA) as palliative treatment of drug resistant epilepsy.

The objectives of this clinical trial are twofold: the effectiveness of TEA is assessed by comparing the changes in the seizure control and quality of life at 5 months between 2 groups: the TEA + baseline AEDs group and the sham-TEA (STEA) + baseline AEDs group. Adverse events (AEs) that occur during the study will be investigated to evaluate the safety of TEA.

This study is investigated by the following hypotheses:

• TEA can increase the probability of becoming seizure free.
• TEA can reduce the frequency and duration of seizures.
• TEA can improve quality of life.
• TEA is associated with adverse effects.

This clinical trial will be performed as a 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial.

Inclusion Criteria:

• People with drug resistant epilepsy
• Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

Exclusion Criteria:

• Under epilepsy surgery
• Inappropriate condition for thread-embedding acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot, and red) or hemostatic disorder (PT INR (international normalized ratio )> 2.0 or taking anticoagulant)
• Pregnant women or other inappropriate condition for thread-embedding acupuncture
• Other diseases that could affect or interfere with therapeutic outcomes, including body exhaustion, severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
• TEA within 6 months previous
• Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
• Heavy drinking (more than 3 cups per day)