Dongbai-Tonglin-Fang

What It Is

Name / origin

• Dongbai-Tonglin-Fang (often abbreviated DBTL, or in Chinese “冬柏通淋方” / “冬柏通淋合剂”) is a Chinese herbal formula / prescription used in traditional Chinese medicine (TCM) for urinary system disorders.
• The formula or mixture is, in some hospitals (especially in Shanghai), an “院内制剂” (in-hospital preparation) derived from a clinical experience formula attributed to Professor Ye Jinghua (叶景华) at Shanghai’s Seventh People’s Hospital.

Traditional indication / clinical use

• Clinically, it is used to treat urinary tract infections (UTIs), lower urinary tract symptoms, cystitis, pyelonephritis (upper urinary infection), and related urological inflammation.
• It has also been trialed in chronic prostatitis (for “湿热下注型” — a TCM syndrome pattern) with some reported efficacy.
• In recent press, it is described as a signature hospital preparation (a “明星产品”) used over 40 years for acute and chronic pyelonephritis and other urinary infections.

Constituent herbs / composition

• A published “名医验方” version lists its ingredients roughly as:
• Huangbai (黄柏) 75 g
• Ren Dong Teng (忍冬藤) 250 g
• Qu Mai (瞿麦) 150 g
• Bian Xu (萹蓄) 150 g
• Wu Yao (乌药) 75 g
• Che Qian Cao (车前草) 150 g
• Chen Pi (陈皮) 50 g
• Gan Cao (甘草) 25 g
• With modifications (additions) if symptoms include chills/fever or constipation (e.g. adding Xiao Chai Hu, Huang Qin, etc).
• In a related pharmaceutical development context, a granule (“冬柏通淋颗粒”) version was developed, and the research on it lists the same core herbs: e.g. Huangbai, Ren Dong Teng, Qu Mai, Bian Xu, Che Qian Cao, Wu Yao, etc.

Dosage / formulation

• The formula is classically administered as a decoction (water infusion) in TCM context, usually twice daily.
• The granule form has been standardized in some contexts; the pharmacology study describes converting it to granules (粉剂 / 颗粒剂) for ease of use, with extraction protocols, quality control, stability testing, etc.

In short: DBTL is a multi-herb TCM herbal formula for urinary system disorders, developed in hospital settings, used for decades, with both traditional decoction and more modern granule forms.

How It Works (Mechanism / Proposed Effects)

Because this is a traditional medicine formula, the mechanistic understanding is partly speculative and based on preclinical and some limited clinical studies. Below is a summary of what is known or hypothesized.

In vivo / animal model evidence (preclinical studies)

A published experimental study used a rat model of urinary tract infection induced by E. coli, and tested different doses of DBTL. The findings included:

1. Reduction of bacterial / inflammatory markers in urine: lower white blood cell (WBC) count in urine, lower nitrite, less occult blood, etc. researchonline.ljmu.ac.uk
2. Pathological improvement in kidney tissues (less infiltration, less damage) via histology (HE staining) compared to untreated controls. researchonline.ljmu.ac.uk
3. Raising urine pH. researchonline.ljmu.ac.uk
4. Anti-inflammatory effects (shown via ear swelling / foot swelling models) and analgesic effects (hot plate tests, body twist tests) in rodents. researchonline.ljmu.ac.uk

In the granule-form pharmacology study, DBTL granules at doses of 1, 2, and 4 g/kg showed effects of raising urine pH, reducing urinary WBC and bacterial count, mitigating kidney damage, and demonstrating anti-inflammatory / analgesic effects in animal models of inflammation and pain. med.wanfangdata.com.cn

Putative modes of action (mechanistic hypotheses)

Given the multi-herb nature, several potential actions are plausible (though not definitively proven):

1. Antibacterial / anti-pathogen action: Some of the herbs may have direct or indirect antimicrobial properties, which help reduce bacterial load in the urinary tract.
2. Anti-inflammatory / immunomodulation: The formula may suppress inflammatory responses in urinary tract tissues, reduce cytokine / immune activation, and thus reduce tissue damage and symptoms.
3. Diuretic / urinary promotion / clearance: Some component herbs may promote urine flow, help flush pathogens, reduce stasis, or aid in excretion of inflammatory mediators.
4. pH modulation: The observed increase in urine pH (in animal models) may make the urinary environment less favorable for certain pathogens.
5. Analgesia / symptomatic relief: The formula appears to have pain-relieving effects (in animal tests) which may help reduce discomfort from urinary irritation.
6. Barrier protection / tissue repair: By reducing oxidative stress, inhibiting microvascular damage, or promoting tissue recovery, it may reduce further injury to urinary tract epithelium.

However, the detailed molecular targets (e.g. signaling pathways, cytokines, receptor binding, microbiome interactions) are not well elucidated in the published literature. The primary mechanistic study to date emphasizes observational endpoints (bacterial counts, histology, inflammatory markers) rather than deep molecular assays. Liverpool John Moores University

Clinical evidence / observed effects in humans

• Clinical observational / interventional reports (though limited in rigor) report symptom improvements (reduced urinary frequency, pain relief, improved quality of life) and, in some studies (e.g. chronic prostatitis), reductions in inflammatory markers in prostatic fluid (lower white blood cell counts) and improved NIH-CPSI scores. d.wanfangdata.com.cn
• In the chronic prostatitis trial: after 8 weeks of DBTL, patients had greater reductions in NIH-CPSI score (overall, as well as subdomains: urinary, pain/discomfort, quality of life) compared to a control group taking another drug (前列泰片). Also, prostatic fluid WBC declined and the level of “egg phospholipid bodies” (SPL) increased (a favorable marker). The “overall effective rate” in the DBTL group was ~88.9% vs ~70.2% in the control group (P < 0.05). d.wanfangdata.com.cn

In sum: the working hypothesis is that DBTL acts by a combination of antimicrobial, anti-inflammatory, diuretic / urinary-promoting, pH-modifying, and symptomatic (analgesic) effects—but many mechanistic details remain to be validated in rigorous clinical or molecular studies.

Why It’s Important (Significance, Advantages, Potential Role)

Addressing limitations of standard therapies

• Urinary tract infections (UTIs) and related urological inflammations are common, and antibiotic resistance is an increasing problem. Having complementary or alternative therapies (especially herbal ones) with efficacy could help reduce antibiotic burden, provide adjunctive relief, or serve as options in recurrent / chronic cases.

Long clinical use & institutional support

• DBTL has over 40 years of clinical use in at least one major hospital (Shanghai Seventh) and is considered a signature in-hospital formulation (“明星产品”) for urinary infections. thepaper.cn Its longevity of use and institutional backing lend weight (in TCM circles) to its continued relevance.

Potential to improve symptom relief and quality of life

• Because it appears to have symptomatic (analgesic, inflammation-modulating) effects, it might help patients not only by reducing pathogen load but also by alleviating pain, urinary irritation, and discomfort. In chronic prostatitis, quality-of-life and symptom metrics improved more in the DBTL group versus control. d.wanfangdata.com.cn

Translatability / modernization

• The development of a granule form (冬柏通淋颗粒) shows an effort to modernize and standardize the formulation, improve patient convenience, stability, and quality control. med.wanfangdata.com.cn This helps facilitate broader use, dosing standardization, and more consistent pharmacological study.

Potential for integrative / adjunct therapy

• In integrative medicine settings, DBTL could potentially be used in combination with conventional antibiotics or other therapies to enhance outcomes, reduce recurrence, or mitigate side effects—if safety and interactions are well studied.

Overall, DBTL is important as a candidate TCM herbal therapy with a long clinical history, potential multi-modal actions, and relevance in a field (urology / urinary infections) where complementary alternatives are of interest.

Considerations (Limitations, Cautions, Gaps, Safety Issues)

While DBTL is promising, several caveats and considerations must be kept in mind:

Limited high-quality clinical evidence

• Many published reports are observational or non-blinded, with small sample sizes.
• Randomized, double-blind, placebo-controlled trials are scarce or lacking.
• In reviews of Chinese herbal medicine for recurrent UTIs, overall evidence quality is rated low or very low, calling for caution in interpretation. Andrew Flower
• Mechanistic and pharmacokinetic data in humans are minimal.

Herb–drug interactions and safety

• Because DBTL includes multiple bioactive herbs (e.g. Huangbai, Gan Cao, etc.), interactions with conventional drugs (e.g. antibiotics, diuretics, NSAIDs, cardiovascular drugs) are possible, though not well documented.
• Gan Cao (licorice root) is known to have effects on electrolyte balance and can potentiate corticosteroids, induce hypokalemia, or cause blood pressure elevation in some individuals. Any use of licorice-containing formulas should monitor for such side effects.
• The formula’s safety profile, toxicity thresholds, and adverse event reporting in rigorous clinical trials are insufficiently characterized.

Standardization and consistency

• Herbal quality, sourcing, processing, and batch-to-batch consistency can vary. The move toward granule formulations is an attempt to standardize, but variants may exist in different hospitals or manufacturers. med.wanfangdata.com.cn
• Stability is a concern under high humidity; one study showed the granule formulation is sensitive to moisture and should be sealed and stored carefully. med.wanfangdata.com.cn

Appropriate patient/syndrome differentiation

• In TCM practice, the herb formula should match the patient’s syndrome pattern (e.g. “湿热下注” — damp-heat descending) rather than be used indiscriminately for all UTIs. Using it in mismatched patterns may reduce efficacy or risk harm.
• Patients with other underlying conditions (e.g. kidney impairment, metabolic disorders, electrolyte imbalance) may require extra caution.

Not a substitute for conventional therapy in serious cases

• In acute or severe urinary tract infections (especially pyelonephritis, complicated UTIs, or when systemic infection is suspected), conventional antibiotic / medical therapy is essential. DBTL should not be relied on as monotherapy in such settings without strong evidence or physician oversight.
• Use in immunocompromised patients or those with structural urinary tract abnormalities needs careful evaluation.

Regulatory / clinical translation hurdles

• For broader adoption in non-China settings, regulatory approval, safety data, and controlled clinical trials would be needed.
• Translation from hospital preparation to widely available standardized drug form may raise challenges in scaling, quality control, consistency, and regulatory compliance.

Monitoring and evaluation needed

• When used clinically, patients should be monitored (urine culture, inflammatory markers, kidney function, electrolytes, symptom scales) to assess efficacy and safety.
• Adverse effects should be documented and reported in more rigorous studies to build safety profiles.