"Even Medical Professors Take 'Choline-Based Drugs'... Efficacy Should Not Be Judged by Short-Term Trials"

Moonseon Park, Professor at Daejeon Eulji University Hospital

"Early administration can slow progression or even improve the condition; Long-term follow-up in clinical practice shows tangible benefits"

"Assessing the efficacy of brain drugs with short-term trials is unreasonable... At least five years of observation is needed"

"For patients with mild cognitive impairment (MCI), choline-based drugs are virtually the only medications that can be used preventively over the long term. If these too are excluded from reimbursement, it is essentially the same as telling us to simply watch as dementia progresses without intervention. This is why the ongoing clinical re-evaluation must be conducted with utmost caution and precision."

The major products in the domestic choline alfoscerate market: Chong Kun Dang's "Gliatilin" (left) and Daewoong Bio's "Gliatamin". AI-generated images by each company

On April 29, during an interview at Daejeon Eulji University Hospital, Moonseon Park, Professor of Neurosurgery, commented on the conversion of choline alfoscerate drugs—commonly referred to as "choline-based drugs"—to selective reimbursement and the full-scale implementation of a reimbursement re-evaluation.

Choline-based drugs are medications involved in the metabolism of phospholipids in neuronal cell membranes. In the brain, they are broken down into choline, which then helps synthesize acetylcholine—a neurotransmitter related to memory and cognitive function. In Korea, these drugs are widely prescribed to alleviate aftereffects of cerebrovascular disease, mild cognitive impairment, and early symptoms of dementia, and are often called "brain nutrients." The annual prescription market for these drugs exceeds 500 billion won.

However, as controversy over their efficacy emerged, they became subject to re-evaluation by health authorities starting in 2020. Last year, the Ministry of Health and Welfare decided to shift indications other than dementia to selective reimbursement. At the same time, the Ministry of Food and Drug Safety instructed manufacturers of choline-based drugs to conduct clinical re-evaluations, requiring new randomized controlled trials (RCTs) over one year to prove efficacy once again. If they are deemed to lack sufficient evidence, approval for indications other than dementia, such as mild cognitive impairment, may be revoked.

Some in the medical community have criticized the methodology for the clinical re-evaluation of choline-based drugs. Physicians who have monitored patients with mild cognitive impairment over the long term say they have observed slower cognitive decline in patients who consistently took these drugs. They argue that such changes are difficult to capture solely through the clinical trials included in the current re-evaluation.

Moonseon Park, Professor of Neurosurgery at Daejeon Eulji University Hospital. Daejeon Eulji University Hospital

Professor Park is among the doctors who believe that the government's current approach to clinical re-evaluation cannot accurately confirm the efficacy of choline-based drugs. In particular, he raised concerns about the evaluation system's emphasis on short-term randomized controlled trials.

He stated, "The brain is not an organ like those affected by hypertension or diabetes, where you see immediate changes in numbers after taking medication. Judging the effectiveness of a brain function improvement drug through randomized controlled trials lasting less than a year is not an appropriate standard." He continued, "In actual patient care, I've often seen cases where there is no change in test scores for the first one or two years, with improvement only appearing later. At least five years of follow-up testing are needed to obtain accurate data."

Professor Park explained that the effects of choline-based drugs are being tracked using standardized assessment tools. He said, "We conduct annual follow-up assessments using tools such as the MMSE (Mini-Mental State Examination), GDS (Global Deterioration Scale), and CDR (Clinical Dementia Rating). In patients who take the medication consistently, their scores are maintained, and in rare cases, even improve." He added that when patients with early signs of dementia take the medication consistently, the rate of progression slows, or in early-stage cases, improvement has been observed.

Professor Park expressed concern that, depending on the results of the clinical re-evaluation, if the indications for choline-based drugs are further reduced or if the drugs are effectively withdrawn from the market, the entire treatment system for mild cognitive impairment could be undermined. He stressed that, for patients in the pre-dementia stage, choline-based drugs are virtually the only medications available for long-term preventive use.

He also pointed out the financial burden faced by patients. Professor Park stated, "Many elderly patients, lacking financial means, find it difficult to afford dementia medications and often give up taking them. If choline-based drugs are also removed, patients with mild cognitive impairment will essentially be left with no option but to watch their condition worsen without intervention," he said with a sigh.

Having treated cerebrovascular patients for decades, Professor Park shared that he himself has been taking choline-based drugs for nearly 10 years to prevent dementia. "Doctors prescribe medications to patients that they trust enough to take themselves," he said. "Policies that restrict patient access to drugs with well-established and accumulated trust in their efficacy must be based on more sophisticated and sufficient evidence," he emphasized.

This content was produced with the assistance of AI translation services.