- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 55
- Slightly Positive
- ConsistencyScore™
- unclear
- Not enough independent studies
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.
This study contributes evidence to
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.
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.
1
Related topics
4
Evidence pairs
205
Related studies
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
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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.
- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 50
- Neutral
- ConsistencyScore™
- unclear
- Not enough independent studies
- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 55
- Slightly Positive
- ConsistencyScore™
- unclear
- Not enough independent studies
- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 100
- Very Positive
- ConsistencyScore™
- unclear
- Not enough independent studies
Evidence Library
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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 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
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
- 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 ExplorerThis study contributes to the evidence on the following intervention-outcome relationships.
Sulfonylureas → HbA1c
Medications
- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 55
- Slightly Positive
- ConsistencyScore™
- unclear
- Not enough independent studies
Sulfonylureas → Hypoglycemia
Medications
- EvidenceScore™
- Emerging
- Score 59 · Based on 1 study
- ImpactScore™
- 50
- Neutral
- ConsistencyScore™
- unclear
- Not enough independent studies
Included in these evidence collections
Curated evidence collections and hubs this study is part of.
HbA1c Evidence Hub
All studies measuring HbA1c
Measures HbA1c as a key outcome.
Hypoglycemia Evidence Hub
All studies measuring Hypoglycemia
Measures Hypoglycemia as a key outcome.
Sulfonylureas Evidence Hub
All studies on Sulfonylureas
Contributes to Sulfonylureas evidence base.
Explore more in Evidence Explorer
Jump to pre-filtered views in Evidence Explorer.
All studies on Glibenclamide and HbA1c
1 results
All studies on Glibenclamide and Hypoglycemia events
1 results
All studies on Glibenclamide
1 results
All studies measuring HbA1c
1 results
All studies measuring Hypoglycemia events
1 results
Questions answered by this study
Generated from the study's connected evidence using Evidence Intelligence™.
Does Sulfonylureas affect hypoglycemia?
Sulfonylureas may improve Hypoglycemia.
ConsistencyScore™: Results are generally consistent across studies.
Ranked evidence signals
- 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.
Does Sulfonylureas improve HbA1c?
Sulfonylureas may improve HbA1c.
ConsistencyScore™: Results are generally consistent across studies.
Ranked evidence signals
- 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.
Does Xiaoke affect hypoglycemia events?
Xiaoke appears to improve Hypoglycemia events.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
- 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.
Does Xiaoke improve HbA1c?
Xiaoke may improve HbA1c.
ConsistencyScore™: Consistency cannot yet be determined from the available evidence.
Ranked evidence signals
- 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.
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