Qiming Granule

What It Is

Definition / composition

• Qiming Granule (Chinese: 启明颗粒, QiMing Keli) is a proprietary Chinese patent medicine (a fixed formula herbal granule) developed in China (with approval number Z20090036 in China) for ophthalmic and microvascular conditions.
• Its ingredients (herbal components) typically include: Astragalus (Radix Astragali), Pueraria lobata (Radix Puerariae), Rehmannia (Radix Rehmanniae), Lycium (Goji / Wolfberry), Cassia seed (Semen Cassiae), Leonurus (Motherwort), Pollen Typhae, and leech (Hirudo).

Regulatory / usage background

• It is used in Chinese medicine practice particularly for diabetic retinopathy (DR) and other eye-related microvascular conditions.
• It has also been studied for dry eye disease (DED) in Chinese literature, though the evidence there is weaker and more preliminary.

Pharmacological / active constituents

• Because it is a multi-herb formula, the “active” elements are many and operate through multiple pathways. Some of the purported components include isoflavones (from Pueraria), catalpol and phenylethanol glycosides (from Rehmannia), astragalosides and polysaccharides (from Astragalus), Lycium polysaccharides, flavonoids from Typha, and anticoagulant peptides from leech (hirudin) among others.

How It Works (Mechanisms / Proposed Modes of Action)

Because Qiming Granule is a herbal mixture, its mechanisms are complex, and many are based on preclinical or network pharmacology analyses rather than definitive proof in humans. The main proposed mechanisms include:

Microcirculation and hemorheology improvement

• One of the often-cited effects is better microvascular blood flow, improvement of blood viscosity, dilation of small vessels, reduction of microcirculatory stasis.
• In animal / in vitro models, some constituents are believed to enhance microcirculation in the retina or reduce capillary damage. Europe PMC

Anti-inflammatory and antioxidant effects

• Some ingredients in Qiming Granule are known (from pharmacological studies) to have anti-inflammatory or antioxidative capabilities, which could help in reducing retinal injury or vascular damage induced by diabetic hyperglycemia. Europe PMC

Neuroprotection / protection of retinal cells

• In the context of diabetic retinopathy, there is increasingly recognized a neurodegenerative component (damage to retinal neurons, nerve fiber layer) in addition to vascular damage. Some of the purported actions of Qiming Granule include protecting retinal ganglion cells, reducing apoptosis, and preserving nerve fiber thickness. SpringerLink
• A recent clinical trial specifically looked at nerve injury associated with non-proliferative diabetic retinopathy (NPDR) and found that Qiming Granule was “non-inferior” to calcium dobesilate in preserving retinal nerve fiber layer thickness. SpringerLink+2SpringerLink+2

Lipid / metabolic modulation

• In systematic reviews, Qiming Granule (especially when used with conventional treatment) has been associated with reductions in triglycerides, total cholesterol, LDL, etc., which may help in reducing diabetic vascular strain. Frontiers

Modulation of vascular endothelial / angiogenesis / barrier function

• Some network pharmacology models suggest that Qiming Granule may influence signaling pathways relating to VEGF (vascular endothelial growth factor), endothelial cell function, and maintenance of vascular integrity (blood–retina barrier). ScienceDirect

Synergistic / multi-target effects

• Because it is a multi-herb formula, the concept is that its effects are synergistic or multiplicative across pathways (vascular, neural, metabolic, inflammatory). That means any one herb alone might have modest effect, but together they might produce a more balanced effect (though this is still theoretical). ScienceDirect

Thus, the “how it works” is not through a single mechanism but through multiple interlinked pathways—vascular protection, anti-inflammatory, antioxidative, metabolic modulation, and neuroprotection.

Why It’s Important (Clinical / Therapeutic Relevance)

In the context of diabetic retinopathy (DR)

• Diabetic retinopathy remains a major cause of vision impairment and blindness worldwide among people with diabetes. Standard treatments (laser photocoagulation, anti-VEGF injections, surgical interventions) have limitations, side effects, cost burdens, and do not directly address early microvascular or neurodegenerative damage. Frontiers
• Qiming Granule offers a potential adjunct or alternative therapy in earlier stages, aiming to slow progression of microvascular and neural injury without as invasive interventions. Frontiers

Evidence of efficacy

• A recent meta-analysis of 33 randomized controlled trials (3,042 patients) showed that Qiming Granule (QM) had superior “overall efficacy” when used alone vs conventional treatment; and when combined with conventional treatment, it improved outcomes such as visual acuity, macular thickness, retinal circulation time, and certain lipid parameters. Frontiers
• In a more rigorous clinical trial, Qiming Granule was shown to be non-inferior to calcium dobesilate (a drug sometimes used in microvascular / vascular protective therapy) in a 24-week trial of nerve injury in non-proliferative diabetic retinopathy, in terms of preserving retinal nerve fiber layer thickness and other retinal structural measures. SpringerLink

Relative safety and tolerability

• In the aforementioned trial, adverse drug reactions (ADRs) occurred in about 9.76% of the Qiming group versus 2.44% in the control, but no serious adverse events were reported. SpringerLink
• In systematic reviews, incidence of adverse events in experimental (Qiming) groups was reportedly lower than or similar to control groups. Frontiers

Potential for earlier intervention / disease modification

• Because Qiming Granule is thought to act on early microcirculatory damage and neural injury, it may help slow progression from early to more advanced diabetic retinopathy—a valuable role in preventive ophthalmologic care.

Complementary / integrative medicine appeal

• For patients or clinicians who favor integrative or TCM-based approaches, Qiming Granule offers an herbal option with (some) clinical trial support, potentially integrating with existing Western medical care.

In sum: Qiming Granule is important because it is a promising herbal therapy targeting early vascular and neural damage in diabetic retinopathy, with some clinical trial support and a relatively favorable safety signal, potentially filling a gap in early-stage, less invasive interventions.

Considerations (Limitations, Risks, Gaps in Evidence, Practical Concerns)

Because Qiming Granule is not (currently) a mainstream biomedical therapy globally, there are many caveats and caveats to interpret the data carefully. Here are key considerations:

Quality of evidence / bias risk

• Many of the clinical trials are small, single-centre, or lacking in rigorous design (blinding, allocation concealment, placebo control). The meta-analysis authors note that much of the evidence is of “low” quality. Frontiers
• There is potential publication bias (i.e., positive studies more likely published). Frontiers

Generalizability beyond Chinese populations / settings

• Most research is from China, in Chinese populations, often in TCM hospitals or integrative medicine settings. It is unclear if results generalize across ethnicities, disease severities, or health systems.

Regulatory / standardization issues

• Herbal products vary depending on source, preparation, purity, standardization of active constituents, batch consistency, and adulteration risks. Ensuring quality, reproducibility, and safety (e.g. absence of contaminants) is crucial but not always guaranteed.
• Also, regulatory approval outside China may be limited or absent, making use in many countries off-label or in a supplementary status.

Drug-herbal interactions / safety concerns

• Because Qiming Granule contains multiple herbs, there is risk of interaction with conventional medications (e.g. for diabetes, anticoagulants, antihypertensives). For example, the leech component (hirudo) is anticoagulant in nature, which could enhance bleeding risk in patients on antithrombotic therapy or cause complications in certain states.
• Some herbal components may affect liver metabolism, kidney clearance, or interact with other medications.
• Because the evidence base is limited, rare adverse events might not yet have been identified.

Dose, duration, timing uncertainties

• The optimal dose, duration of therapy, timing vis-à-vis disease stage, and whether it should be combined with conventional therapies (and how) are not yet well established. The trial I cited used 4.5 g three times daily for 24 weeks. SpringerLink

Placebo / sham control lacking in many studies

• Many trials compare Qiming Granule + conventional therapy vs conventional therapy, rather than Qiming Granule vs placebo (with blinding). This raises the risk of bias from expectancy, non-specific effects, etc. Frontiers+1

Safety in special populations

• Its safety in pregnant or breastfeeding women, children, patients with severe renal or hepatic disease, or those with bleeding disorders is not well studied.
• Long-term safety (beyond the durations studied, e.g. beyond 6 months) is less known.

Endpoint relevance / clinical meaningfulness

• Many trials focus on surrogate endpoints (retinal nerve fiber thickness, macular thickness, circulation time) rather than hard endpoints such as preservation of visual acuity over many years, prevention of progression to proliferative disease, or avoidance of blindness. Whether these surrogate improvements translate into meaningful long-term visual benefit remains to be definitively proven.

Cost / access / standard of care integration

• In some settings, the cost to patients, insurance coverage, availability of high-quality granules, and clinician experience may limit adoption. Integration with standard ophthalmology care may require careful coordination (e.g. when combining with anti-VEGF therapy).

Regulatory and ethical oversight

• In many countries, herbal medicines are regulated less strictly than conventional pharmaceuticals, so oversight, post-market surveillance, adverse event reporting, and standardization may be weaker.