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Why English? | Reporting CONSORT-CHM Formula Trials Through TCM Patterns, Formula Composition, Quality Control, Outcomes, Harms and Interpretation

WHY ENGLISH?

Describe a Chinese herbal medicine formula trial without losing the formula, the Pattern or the tested comparison

A trial of a Chinese herbal medicine formula can name a familiar formula yet leave readers unsure about ingredients, sources, preparation, dosage, quality control, permitted modification, diagnostic Pattern or comparator. English matters because each detail changes what intervention was actually tested and whether another team can understand or reproduce it.

CONSORT-CHM Formulas 2017 was published in Annals of Internal Medicine. It adds a keyword subitem, elaborates seven of the 25 CONSORT 2010 items—title and abstract, background and objectives, participants, interventions, outcomes, generalisability and interpretation—and revises the explanation of formula-specific harms.

The extension was finalised after draft publication, public comments, workshops and consensus work. This article uses it as reporting guidance, not as a claim that every formula is effective, safe, standardised or interchangeable, and not as a substitute for the current CONSORT core, regulation, quality testing or qualified clinical care.

READING ROUTE
Identity and rationale

Name the formula, disease and Pattern.

READING ROUTE
Formula reconstruction

Report ingredients, sources, preparation and dosage.

READING ROUTE
Quality and delivery

Show testing, modification, adherence and comparator.

READING ROUTE
Outcomes and interpretation

Connect Pattern, harms, transfer and limits.

Open the full article contents

Article contents

Open all chapters
  1. 1. Identify the Trial, Formula and Diagnostic Target
  2. 2. Write a Structured Abstract With Formula-Specific Detail
  3. 3. Choose Searchable, Accurate Keywords
  4. 4. Explain the Dual Rationale and Research Question
  5. 5. Define Participants and TCM Pattern Diagnosis
  6. 6. Name Every Ingredient Precisely
  7. 7. Report Sources, Authentication and Contaminant Controls
  8. 8. Describe Preparation, Manufacturing and Dosage
  9. 9. Explain Standardisation and Quality Control
  10. 10. Report Modifications and Individualisation Rules
  11. 11. Describe Co-interventions, Adherence and Actual Exposure
  12. 12. Make the Comparator Credible and Transparent
  13. 13. Define Outcomes Across Medical Frameworks
  14. 14. Report Formula-Specific Harms and Interactions
  15. 15. Discuss Generalisability Without Treating Traditions as Uniform
  16. 16. Interpret Results Without Erasing Uncertainty

ORIENTATION

What this guide owns

Current fact check

CONSORT-CHM Formulas 2017 adds the keywords subitem 1c, elaborates seven of the 25 CONSORT 2010 items and revises the harms explanation. The checklist retains the standard CONSORT flow diagram and incorporates intervention-description detail.

Canonical boundary

This article owns reporting of randomised trials of Chinese herbal medicine formulas. STRICTA owns acupuncture interventions, the broader herbal-intervention guidance owns other herbal products, and clinical care remains outside this reporting guide.

Worked example

Every chapter returns to a fictional randomised trial of a standardised herbal formula plus usual care versus placebo plus usual care for adults with a Western medicine diagnosis and a prespecified TCM Pattern. It is fictional, low-stakes and educational; it does not report a real school, clinical decision or guaranteed outcome.

Did You Know? For CONSORT-CHM Formulas, complete reporting makes appraisal possible but does not perform the appraisal, remove bias or guarantee transfer.

Warm up with eduKate’s guides to explaining scientific evidence and asking better questions in class.

CHAPTER 1 OF 16

1. Identify the Trial, Formula and Diagnostic Target

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Why this move matters

State that the study is randomised and name whether it targets a TCM Pattern, a Western medicine–defined disease or both.

Did You Know? CONSORT-CHM expands the title item to make the target visible.

Reconstruct the formula as an intervention

State that the study is randomised and name whether it targets a TCM Pattern, a Western medicine–defined disease or both. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The title names a placebo-controlled randomised formula trial for the disease with the specified Pattern. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A diagnostic label does not reveal how it was operationalised or confirmed. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Identify the Trial, Formula and Diagnostic Target”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 2 OF 16

2. Write a Structured Abstract With Formula-Specific Detail

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Why this move matters

Include the formula name and form, Pattern when applicable, design, methods, results and limitations without replacing the checklist with promotional shorthand.

Did You Know? The extension elaborates the abstract item and points to CONSORT for Abstracts.

Reconstruct the formula as an intervention

Include the formula name and form, Pattern when applicable, design, methods, results and limitations without replacing the checklist with promotional shorthand. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The abstract names a granule preparation, eligibility framework and primary outcome. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A brand or traditional name alone cannot reconstruct the tested product. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Write a Structured Abstract With Formula-Specific Detail”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 3 OF 16

3. Choose Searchable, Accurate Keywords

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Why this move matters

Use Chinese herbal medicine formula and randomised controlled trial alongside specific disease, Pattern and formula terms.

Did You Know? Item 1c is the new checklist subitem added by CONSORT-CHM.

Reconstruct the formula as an intervention

Use Chinese herbal medicine formula and randomised controlled trial alongside specific disease, Pattern and formula terms. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Keywords include the general intervention type and the exact formula name. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Keywords improve retrieval but cannot compensate for an inaccurate title or abstract. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Choose Searchable, Accurate Keywords”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 4 OF 16

4. Explain the Dual Rationale and Research Question

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Why this move matters

Describe biomedical and TCM reasoning, prior evidence, formula–Pattern relationship and the precise hypothesis.

Did You Know? The extension elaborates background and objectives for formula-specific theory.

Reconstruct the formula as an intervention

Describe biomedical and TCM reasoning, prior evidence, formula–Pattern relationship and the precise hypothesis. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The introduction explains why the formula is expected to address the Pattern and which outcome tests the trial question. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A traditional rationale and a modern mechanism are different claims and should not be collapsed. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Explain the Dual Rationale and Research Question”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 5 OF 16

5. Define Participants and TCM Pattern Diagnosis

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Why this move matters

Give Western diagnostic criteria, Pattern criteria, assessors, training, agreement procedures and whether the Pattern affects eligibility or subgrouping.

Did You Know? Participant definitions determine who the result can reasonably describe.

Reconstruct the formula as an intervention

Give Western diagnostic criteria, Pattern criteria, assessors, training, agreement procedures and whether the Pattern affects eligibility or subgrouping. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Two trained practitioners use a prespecified Pattern checklist before randomisation. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Diagnostic consensus may still vary across settings and schools of practice. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Define Participants and TCM Pattern Diagnosis”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 6 OF 16

6. Name Every Ingredient Precisely

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Why this move matters

Report accepted Latin binomial, Chinese and common names, plant part, processing method, amount and role for each ingredient.

Did You Know? Ingredient identity is the foundation of intervention reproducibility.

Reconstruct the formula as an intervention

Report accepted Latin binomial, Chinese and common names, plant part, processing method, amount and role for each ingredient. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The formula table gives species, medicinal part, processing and grams per daily dose. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Common names can refer to different species or parts. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Name Every Ingredient Precisely”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 7 OF 16

7. Report Sources, Authentication and Contaminant Controls

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Why this move matters

State suppliers, batch identifiers, authentication method, voucher specimens where applicable and testing for contaminants or adulterants.

Did You Know? Source and authentication protect readers from assuming that names alone guarantee identity.

Reconstruct the formula as an intervention

State suppliers, batch identifiers, authentication method, voucher specimens where applicable and testing for contaminants or adulterants. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Botanical identity is verified and batch records include heavy-metal, pesticide and microbial tests. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Passing one specification does not establish universal safety or equivalence across batches. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Report Sources, Authentication and Contaminant Controls”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 8 OF 16

8. Describe Preparation, Manufacturing and Dosage

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Why this move matters

Report decoction, extraction, concentration, excipients, dosage form, storage, route, frequency, duration and manufacturer standards.

Did You Know? Preparation changes the intervention, not merely its packaging.

Reconstruct the formula as an intervention

Report decoction, extraction, concentration, excipients, dosage form, storage, route, frequency, duration and manufacturer standards. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The report gives extraction ratio, granule excipients, packaging, storage and twice-daily schedule. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Equal capsule counts may contain unequal quantities of extracted material. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Describe Preparation, Manufacturing and Dosage”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 9 OF 16

9. Explain Standardisation and Quality Control

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Why this move matters

Name chemical markers, fingerprints, assays, acceptance ranges, stability checks and batch-to-batch procedures, with access to certificates when possible.

Did You Know? Quality control links the written prescription to the material participants received.

Reconstruct the formula as an intervention

Name chemical markers, fingerprints, assays, acceptance ranges, stability checks and batch-to-batch procedures, with access to certificates when possible. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Chromatographic fingerprints and marker ranges are reported for every trial batch. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A marker compound may verify consistency without proving the whole formula mechanism. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Explain Standardisation and Quality Control”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 10 OF 16

10. Report Modifications and Individualisation Rules

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Why this move matters

State whether the formula is fixed, modified or individualised, list permitted additions or removals and name who decides using which criteria.

Did You Know? Traditional flexibility can be reported transparently when its rules are visible.

Reconstruct the formula as an intervention

State whether the formula is fixed, modified or individualised, list permitted additions or removals and name who decides using which criteria. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Two modifications are allowed for prespecified secondary Patterns and are logged by participant. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Unbounded practitioner discretion makes replication and causal interpretation difficult. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Report Modifications and Individualisation Rules”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 11 OF 16

11. Describe Co-interventions, Adherence and Actual Exposure

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Why this move matters

Report usual care, dietary advice, prohibited products, dispensing, returns, diaries, biomarkers where used and deviations from intended treatment.

Did You Know? The tested package includes co-interventions and adherence conditions.

Reconstruct the formula as an intervention

Report usual care, dietary advice, prohibited products, dispensing, returns, diaries, biomarkers where used and deviations from intended treatment. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Both groups receive the same usual care, and returned sachets plus diaries estimate adherence. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Dispensing a formula is not proof that it was consumed as planned. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Describe Co-interventions, Adherence and Actual Exposure”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 12 OF 16

12. Make the Comparator Credible and Transparent

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Why this move matters

Describe placebo or active control ingredients, sensory matching, packaging, blinding evidence and the rationale for the comparison.

Did You Know? Comparator composition defines the causal contrast.

Reconstruct the formula as an intervention

Describe placebo or active control ingredients, sensory matching, packaging, blinding evidence and the rationale for the comparison. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The placebo matches colour, smell and taste without the named active herbs, and allocation concealment is reported. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A formula placebo may have biological or sensory effects and should not be called inert without evidence. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Make the Comparator Credible and Transparent”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 13 OF 16

13. Define Outcomes Across Medical Frameworks

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Why this move matters

Prespecify primary and secondary outcomes, Pattern outcomes, instruments, time points, assessors and analysis; distinguish validated measures from study-created scores.

Did You Know? CONSORT-CHM elaborates outcomes so different frameworks remain interpretable.

Reconstruct the formula as an intervention

Prespecify primary and secondary outcomes, Pattern outcomes, instruments, time points, assessors and analysis; distinguish validated measures from study-created scores. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The clinical primary outcome is separate from a prespecified Pattern score and both are timed clearly. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

A change in Pattern score does not automatically establish improvement in a biomedical outcome. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Define Outcomes Across Medical Frameworks”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 14 OF 16

14. Report Formula-Specific Harms and Interactions

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Why this move matters

Describe adverse-event definitions, active surveillance, laboratory monitoring, herb–drug interactions, attribution and results by group.

Did You Know? The extension revises the harms explanation specifically for CHM formulas.

Reconstruct the formula as an intervention

Describe adverse-event definitions, active surveillance, laboratory monitoring, herb–drug interactions, attribution and results by group. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: Liver tests, gastrointestinal symptoms and suspected interactions are reported with denominators and timing. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Traditional use does not guarantee safety for every dose, batch or combination. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Report Formula-Specific Harms and Interactions”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 15 OF 16

15. Discuss Generalisability Without Treating Traditions as Uniform

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Why this move matters

Explain how formula, Pattern criteria, manufacturing, practitioners, participants and setting affect transfer to other products and practice contexts.

Did You Know? Generalisability depends on both people and the material intervention.

Reconstruct the formula as an intervention

Explain how formula, Pattern criteria, manufacturing, practitioners, participants and setting affect transfer to other products and practice contexts. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The discussion limits transfer to products meeting the reported composition and quality specifications. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

One tested formula cannot represent all Chinese herbal medicine. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Discuss Generalisability Without Treating Traditions as Uniform”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

CHAPTER 16 OF 16

16. Interpret Results Without Erasing Uncertainty

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Why this move matters

Connect conclusions to the randomised comparison, report limitations and avoid translating one result into universal efficacy, safety or cultural authority.

Did You Know? CONSORT-CHM elaborates interpretation so the formula-specific claim stays bounded.

Reconstruct the formula as an intervention

Connect conclusions to the randomised comparison, report limitations and avoid translating one result into universal efficacy, safety or cultural authority. Connect formula name, ingredients, source, authentication, preparation, dosage, schedule, quality control, permitted modification and co-interventions.

Open one pattern-based decision

Worked example: The authors state the observed effect and uncertainty for this formula, population and duration. State whether a TCM Pattern is an eligibility criterion, treatment-selection rule, outcome, subgroup or interpretation, and show how it was assessed.

Keep reporting and efficacy separate

A reproducible formula description enables appraisal and replication. It does not establish effectiveness, safety, product equivalence or suitability for an individual person.

Respect both specificity and plurality

Complete reporting does not settle effectiveness or individual treatment choice. Report the particular formula and diagnostic framework tested without presenting it as the only legitimate form of Chinese medicine or diminishing other languages and medical traditions.

Practical reader check

  • Point to the exact source or method sentence supporting the claim.
  • Name the person, setting, date, input and decision rule that could change its meaning.
  • Label the remaining uncertainty reported, inferred, contested or unknown.

Student, parent and career transfer

Make one evidence card for “Interpret Results Without Erasing Uncertainty”: source location, plain-language meaning, limit and next question. A parent or teacher can ask for one everyday explanation and one specialist explanation; both must preserve the same conditions. This habit supports Chinese medicine research, pharmacognosy, clinical trials, pharmacy, quality assurance, journal editing, regulation and evidence appraisal without promising a grade, admission, funding decision or job.

PRACTICE LAB

Build a formula-reconstruction decision trail

Student route

  1. Choose one original report inside this guide’s scope.
  2. Copy its objective and underline actor, action, context, evidence and intended decision.
  3. Draw the specific reasoning chain used in this article.
  4. Mark each step reported, inferred, contested or unknown.
  5. Rewrite the conclusion so it preserves the narrowest important limitation.

Parent or teacher route

Ask the learner to explain CONSORT-CHM Formulas’s central reporting method twice: once to a classmate and once to a method specialist. Praise a precise correction and a well-stated unknown; both show disciplined attention to evidence.

Early-career route

Create a one-page CONSORT-CHM Formulas audit with source link, date checked, scope, method logic, decisive wording, contrary evidence, limit and next action. A colleague should be able to continue without guessing.

Decision rule

If a shorter explanation removes the condition that made the original claim true, it is not clearer yet. Restore the condition.

Continue with eduKate’s guides to reading course and career information and giving useful feedback in group projects.

USEFUL NEXT READING

Connect this narrow owner to its neighbour

Read the STRICTA acupuncture-intervention reporting guide for a related but different reader job. Return here when the question is specifically how to describe a chinese herbal medicine formula trial without losing the formula, the pattern or the tested comparison. This boundary keeps one canonical owner per intent.

For English practice across research, school and career communication, visit the English at work and in public life guide.

FREQUENTLY ASKED QUESTIONS

Questions students and parents often ask

What is CONSORT-CHM Formulas 2017?

A CONSORT extension for reporting randomised trials of Chinese herbal medicine formulas.

Does it add a new item?

It adds keyword subitem 1c and elaborates seven existing CONSORT 2010 items.

Why list every ingredient and plant part?

Common names can hide differences in species, part, processing and dose.

Can an individualised formula be reported?

Yes, when the decision rules, allowed changes and actual modifications are visible.

Does quality control prove effectiveness?

No. It supports identity and consistency, not clinical efficacy.

Does the guideline replace clinical advice?

No. It is a reporting guide and not individual medical advice.

PRIMARY SOURCES

Read the original CONSORT-CHM Formulas guidance

Facts were checked against original publications and official records on 6 November 2026. Follow the live source for later corrections, completed updates or companion material.

A cheerful final note

Precise English makes reporting with CONSORT-CHM Formulas more useful and more generous, not less. People can see how their evidence and values entered the work, where disagreement remains and what a responsible next step looks like.

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