Pharmacological TreatmentsType 2 Diabetes (T2D)Supplements and Vitamins
Research Summary
Analyzed using Evidence Intelligence™

Xiaoke Pill lowered hypoglycemia risk with similar HbA1c control

Last updated May 6, 2026

Key finding

In adults with type 2 diabetes and poor glycemic control, Xiaoke Pill lowered hypoglycemia risk compared with glibenclamide while delivering similar HbA1c improvement over 48 weeks.

This multicenter trial compared Xiaoke Pill, a traditional Chinese medicine compound containing low-dose glibenclamide, with glibenclamide alone in 800 adults with type 2 diabetes. Over 48 weeks, both treatments improved HbA1c and fasting glucose similarly, but Xiaoke Pill caused fewer hypoglycemia episodes, especially in drug-naive patients and in people already taking metformin.

Quick read

Study at a glance

The essential study design details in one scan.

EvidenceScore™

Moderate

Study type

Randomized Controlled Trials (RCTs)

Follow-up

Medium-Term (3–12 mo)

Risk of bias

Some Concerns

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Plain-language summary

What this paper says

A plain-language read of the study’s main message and where it applies.

Study focus

In adults with type 2 diabetes and poor glycemic control, Xiaoke Pill lowered hypoglycemia risk compared with glibenclamide while delivering similar HbA1c improvement over 48 weeks.

Published in

Journal Reference

Publication details and source links for this paper.

Ji L, Tong X, Wang H, et al; Evidence-Based Medical Research of Xiaoke Pill Study Group. Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial. PLoS One. 2013;8(2):e56703. doi:10.1371/journal.pone.0056703

Main Effects

Hypoglycemia events ↓ with Xiaoke Pill compared with glibenclamide

HbA1c ↓ similarly in both treatment arms

Fasting plasma glucose ↓ similarly in both treatment arms

Serious adverse events ↔ none were reported

Evidence network

How this study fits

Understand where this research contributes within the broader evidence network.

Evidence Context

This study contributes evidence to Glibenclamide, Xiaoke and HbA1c, Hypoglycemia events.

Primary intervention

Glibenclamide

Primary outcomes

  • HbA1c
  • Hypoglycemia events

Evidence topics

Primary intervention

Primary outcomes

Evidence relationships

Intervention and outcome relationships this study adds to the evidence network.

4
Evidence pairs
4
Relationships
1
Evidence topics
contributes_evidence

Editorial context

Why this study matters

See why this paper is useful beyond its individual results.

Evidence network role

This section describes how the study fits into the current evidence network. It does not determine whether an intervention works on its own.

Moderate contributionModerate confidenceNetwork score: 45

1

Related topics

4

Evidence pairs

205

Related studies

High relevance in at least one topic

Why it is useful

  • Contributes to 4 evidence relationships
  • Uses a randomized study design signal
  • Linked to 1 direct semantic evidence topic

Topic contributions

Evidence topic

Contributes evidence

Add related evidence to your Evidence Tracker

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Primary evidence

Evidence relationship

Sulfonylureas and HbA1c

Related evidence

Evidence relationship

Sulfonylureas and Hypoglycemia

Save evidence

Evidence topic

HbA1c Reduction

Save evidence

Core evidence

Study findings

The primary outcomes reported in this study.

HbA1c

Glibenclamide → HbA1c

Glibenclamide → HbA1c

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
55
Slightly Positive
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

Hypoglycemia events

Glibenclamide → Hypoglycemia events

Glibenclamide → Hypoglycemia events

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
50
Neutral
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

HbA1c

Xiaoke → HbA1c

Xiaoke → HbA1c

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
55
Slightly Positive
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

Hypoglycemia events

Xiaoke → Hypoglycemia events

Xiaoke → Hypoglycemia events

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
100
Very Positive
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
Add to Evidence Tracker

Evidence Library

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evidence suggest

Evidence Suggest

  • In the drug-naive group, Xiaoke Pill lowered the odds of any hypoglycemia by 38% and mild hypoglycemia by 41% versus glibenclamide.
  • In the metformin group, Xiaoke Pill lowered the annual hypoglycemia rate by 62% compared with glibenclamide.
  • HbA1c fell by 0.70% with Xiaoke Pill and 0.66% with glibenclamide in the drug-naive group, and by 0.45% versus 0.59% in the metformin group.
  • No serious adverse event was reported during the 48-week trial.
who this applies

Who this applies to

These findings apply most directly to adults aged 21 to 70 with type 2 diabetes, poor glycemic control, and either no prior glucose-lowering drugs or stable metformin use. The results are less certain for non-Chinese populations, people with advanced complications, or those using insulin or other modern drug combinations.

keep in mind

Keep in Mind

Xiaoke Pill was compared with glibenclamide alone, not with newer diabetes treatments. The trial supports similar glucose lowering and fewer hypoglycemia episodes, but it does not prove that the herbal components improve long-term complications. Treatment decisions should still consider access, safety monitoring, and whether sulfonylurea therapy is appropriate in the first place.

between the lines

Between the Lines

  • All participants were treated in China, so generalizability may be limited.
  • The study used an active comparator, not a placebo-only herbal control.
  • Xiaoke Pill already contains glibenclamide, so the herbal effect cannot be isolated fully.
  • Some secondary outcomes were subgroup-based or not fully detailed in the main text.

Evidence Library

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Connected Evidence

Explore related studies, evidence collections, and research questions.

Relationships organized using the Dediabetes Evidence Intelligence™ framework.

This study contributes to evidence on Sulfonylureas and HbA1c, Sulfonylureas and Hypoglycemia.

Related evidence relationships

Explore in Evidence Explorer

This study contributes to the evidence on the following intervention-outcome relationships.

Evidence Intelligence™
EvidenceScore™
Emerging
Score 59 · Based on 1 study
ImpactScore™
55
Slightly Positive
ConsistencyScore™
unclear
Not enough independent studies
Supporting studies: Based on 1 study
View evidence

Questions answered by this study

Generated from the study's connected evidence using Evidence Intelligence™.

Does Sulfonylureas affect hypoglycemia?

Strong Evidence

Sulfonylureas may improve Hypoglycemia.

ConsistencyScore™: Results are generally consistent across studies.

Ranked evidence signals

  1. 1

    Hypoglycemia events

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | neutral | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on 3 supporting studies with generally consistent results and a positive effect signal.

Limitations

  • Population details are unavailable.
3 supporting studiesUpdated: Jul 2026

Does Sulfonylureas improve HbA1c?

Strong Evidence

Sulfonylureas may improve HbA1c.

ConsistencyScore™: Results are generally consistent across studies.

Ranked evidence signals

  1. 1

    HbA1c

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | weak positive | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on 3 supporting studies with generally consistent results and a positive effect signal.

Limitations

  • Population details are unavailable.
3 supporting studiesUpdated: Jul 2026

Does Xiaoke affect hypoglycemia events?

Emerging Evidence

Xiaoke appears to improve Hypoglycemia events.

ConsistencyScore™: Consistency cannot yet be determined from the available evidence.

Ranked evidence signals

  1. 1

    Hypoglycemia events

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | strong positive | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on a single supporting study.

Limitations

  • Only one supporting study is available.
  • Consistency cannot yet be determined.
  • Population details are unavailable.
1 supporting studyUpdated: Jul 2026

Does Xiaoke improve HbA1c?

Emerging Evidence

Xiaoke may improve HbA1c.

ConsistencyScore™: Consistency cannot yet be determined from the available evidence.

Ranked evidence signals

  1. 1

    HbA1c

    EvidenceScore™ Emerging | EvidenceScore™ 59.0 | weak positive | ConsistencyScore™ Unclear | 1 study

Why this answer: This answer is based on a single supporting study.

Limitations

  • Only one supporting study is available.
  • Consistency cannot yet be determined.
  • Population details are unavailable.
1 supporting studyUpdated: Jul 2026
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