Polygala Tenuifolia: Is It Safe for Teens? Research Findings

observational-study PMID: 30576772

Quick Summary: A recent study looked at the safety of a Polygala tenuifolia root extract (BT-11) in young people aged 9-19. The study found that taking 300mg of BT-11 daily for 12 weeks didn't cause any more side effects than a placebo (a sugar pill).

What The Research Found

The research showed that BT-11, a root extract from the Polygala tenuifolia plant, appears safe for teenagers. Researchers gave some teens BT-11 and others a placebo (a pill with no active ingredients) for 12 weeks. They checked for side effects and other health changes. The study found:

Similar Side Effects: Both groups had a similar number of minor side effects.

No Serious Problems: Any serious health issues that occurred were not linked to taking BT-11.

No Changes in Health Markers: Blood tests, vital signs (like blood pressure), and heart tests remained normal in both groups.

Study Details

Who was studied: 121 young people, aged 9 to 19 years old.

How long: The study lasted for 12 weeks (about 3 months).

What they took: Participants took either 300mg of BT-11 daily or a placebo (a pill with no active ingredients).

What This Means For You

If you're considering using Polygala tenuifolia (BT-11) for yourself or a teen, this study suggests it's likely safe for short-term use. However, it's always best to:

Talk to a doctor: Discuss any supplements with your doctor, especially if you have existing health conditions or take other medications.

Consider the dosage: The study used 300mg daily.

Be aware of the limitations: This study only looked at short-term safety.

Study Limitations

It's important to remember that this study has some limitations:

Short-term: The study only looked at safety for 12 weeks. We don't know the long-term effects.

Small group: The study involved a relatively small number of participants, so rare side effects might not have been detected.

Missing details: The study didn't provide detailed information about the participants (like their gender or health status).

More research needed: Further studies are needed to confirm these findings and explore the potential benefits of Polygala tenuifolia.

Key Findings

The study found no significant differences in adverse reaction incidence between the BT-11 group (16.4%: 10/61 subjects) and placebo group (10%: 6/60 subjects) over 12 weeks. Serious adverse events (acute appendicitis in BT-11, acute viral gastroenteritis in placebo) were unrelated to the test product. No clinically meaningful changes in hematology, blood chemistry, urinalysis, vital signs, body weight, or ECG parameters were observed. The authors concluded BT-11 is safe for adolescents aged 9–19 years.

Study Design

This was a randomized, placebo-controlled observational study conducted over 12 weeks. A total of 121 participants (61 receiving BT-11, 60 placebo) aged 9–19 years were included. The study design aimed to evaluate safety through adverse event monitoring and clinical laboratory assessments. Demographics (e.g., gender, baseline health status) were not detailed in the provided summary.

Dosage & Administration

Participants received 300 mg/day of Polygala tenuifolia root extract powder (BT-11) or a matching placebo, administered as a single daily dose. The extract was standardized, though specific active compounds (e.g., saponins, flavonoids) were not quantified in the summary.

Results & Efficacy

Adverse reactions: 11 events in BT-11 group (10 subjects) vs. 7 in placebo (6 subjects).
Severity: All non-serious adverse reactions resolved spontaneously; serious events in both groups were deemed unrelated to the intervention.
Safety markers: No statistically significant differences in blood tests (hemoglobin, liver/kidney function), vital signs, or ECG readings between groups.
Conclusion: BT-11 did not demonstrate increased risk of adverse effects compared to placebo in adolescents.

Limitations

Study type discrepancy: Described as observational but included randomization and controlled intervention, suggesting possible misclassification.
Sample size: 121 participants may be insufficient to detect rare adverse events.
Short duration: Safety beyond 12 weeks remains unexamined.
Demographic gaps: No data on gender, race, or pubertal stage, which could influence outcomes.
Adverse event reporting: Reliance on self-reported data may introduce bias.
Placebo matching: Details on placebo composition were not provided.

Clinical Relevance

This trial supports the short-term safety of BT-11 (300 mg/day) in adolescents, with no significant risks to physiological or biochemical parameters. Parents or clinicians considering Polygala tenuifolia for cognitive or CNS-related benefits may use this data to justify cautious administration in this age group. However, long-term safety, effects on neurodevelopment, and lower/upper age ranges (e.g., under 9 or over 19) require further investigation. The lack of efficacy outcomes in the summary limits conclusions about therapeutic benefits, though safety remains the primary focus.

Note: The study’s design inconsistencies (observational vs. interventional) and limited demographic reporting highlight the need for larger, more rigorous trials to confirm these findings.