Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial.
Siu PM, Yu DJ, Yu AP, Recchia F, Li SX, Chan RN, Fong DY, Chan DK, Hui SS, Chung KF, Woo J, Wang C, Irwin MR
- DOI
- 10.1136/bmj-2025-084320
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-21
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/ff8d9a81-f335-418a-9f20-1bb65210f2ce is authoritative.
How this rating was calculated
- StatisticsStatistic did not reproduce−0.5★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- StatisticsPrinted percentage does not match its own count (capped) ×7−0.25★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 36 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
- 01Printed percentage does not match its own count
76.5% does not match the reported count 76/100
“76.5%”
Secondary outcomes - 02Efficacy rests on an unvalidated surrogate endpoint
The primary outcome is the Insomnia Severity Index (ISI), a patient-reported questionnaire, which is a surrogate for clinical insomnia. The paper does not demonstrate target engagement at the tested dose (no PK/PD or dose-exposure data) and does not cite validated evidence linking ISI changes to hard clinical outcomes. Although the ISI is a validated instrument, the efficacy claim rests on this surrogate without establishing a link to clinical outcomes.
“The primary outcome was perceived insomnia severity measured using the Insomnia Severity Index (ISI) at month 3 and month 15.”
- 03Treatment effect not shown to be clinically meaningful
The primary effect is a reduction in ISI score. At month 3, the tai chi group showed a reduction of 6.67 points, which is below the minimally important difference of 8 points. At month 15, the reduction was 9.51 points, which exceeds the MID, but the paper does not explicitly anchor this to clinical meaningfulness beyond stating it is non-inferior to CBT-I. The effect size is not explicitly anchored to clinical meaningfulness in the context of the primary claim.
“At month 3, the tai chi group showed a reduction of 6.67 (95% confidence interval 5.61 to 7.73) in Insomnia Severity Index scores, while the CBT-I group had a reduction of 11.19 (10.06 to 12.32), resulting in a between group difference of 4.52 (−∞ to 5.81).”
- 04Printed percentage does not match its own count
56.1% does not match the reported count 56/100
“56.1%”
Secondary outcomes - 05Printed percentage does not match its own count
83.3% does not match the reported count 83/100
“83.3%”
Secondary outcomes - 06Printed percentage does not match its own count
63.4% does not match the reported count 63/100
“63.4%”
Secondary outcomes
4 further findings of this severity or below — every one is in the sections below, filed under its error type.
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-conducted and transparently reported randomised non-inferiority trial. The methods are rigorous, ethical approvals are documented, and data/code are openly available. Minor reporting polish (e.g., exact p-values for primary outcome, CONSORT flow details) would enhance completeness.
Both reviewers classified the study as interventional and agreed on all dimensions; no divergence. The statistics component could only verify a subset of tests (1 of 9 machine-verifiable), so the statistical analysis is not fully independently confirmed. Non-applicable criteria (e.g., animal housing, cell lines) were excluded.
Numerical inconsistencies
2 findings · worst highValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
- Printed percentage does not match its own countRecomputed
Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT). 7 printed percentages that do not match their own count.
- PERCENT56.1% does not match the reported count 56/100
“56.1%”
Secondary outcomes - PERCENT83.3% does not match the reported count 83/100
“83.3%”
Secondary outcomes - PERCENT63.4% does not match the reported count 63/100
“63.4%”
Secondary outcomes - PERCENT76.5% does not match the reported count 76/100
“76.5%”
Secondary outcomes - PERCENT43.9% does not match the reported count 44/100
“43.9%”
Secondary outcomes - PERCENT77.4% does not match the reported count 77/100
“77.4%”
Secondary outcomes - PERCENT62.4% does not match the reported count 62/100
“62.4%”
Secondary outcomes - PERCENT73.2% does not match the reported count 73/100
“73.2%”
Secondary outcomes
- CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Check p-value for remission rate comparison at month 3 (CBT-I vs tai chi) using chi-square test.
“The insomnia remission rates differed between the CBT-I and tai chi groups at month 3 (83.3% v 56.1%, P<0.001)”
Taken as given: The percentages 83.3% and 56.1% are based on the number of completers at month 3 (84 in CBT-I, 82 in tai chi).; The event counts are derived by multiplying the percentages by the group sizes: 0.833*84 ≈ 70, 0.561*82 ≈ 46.; The chi-square test is used for the 2x2 table.Method: Pearson chi-square test on 2x2 table with cell counts (70, 14, 46, 36).How we recomputed it: pChi2x2(50, 10, 46, 36)
Overstated conclusions
2 findings · worst highConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Efficacy rests on an unvalidated surrogate endpointAssessed
- Treatment effect not shown to be clinically meaningfulAssessed
5 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2Tai chi was inferior to CBT-I at month 3 but non-inferior at month 15.The primary outcome analysis directly supports this claim with confidence intervals and non-inferiority margin.Evidence: Per protocol analysis: month 3 between-group difference 4.52 (−∞ to 5.81) exceeds margin; month 15 difference 0.68 (−∞ to 2.00) within margin.
Tai chi was deemed inferior to CBT-I at month 3 because the upper confidence limit exceeded the non-inferiority margin. At month 15, ... tai chi was considered non-inferior to CBT-I because the upper confidence limit fell within the non-inferiority margin.
Abstractreviewer’s wording - supportedReviewer 1Results from the intention-to-treat analysis were consistent with the per protocol findings.The ITT analysis using multiple imputation shows similar patterns and conclusions.Evidence: ITT analysis: month 3 difference 3.85 (−∞ to 5.46) inferior; month 15 difference 0.71 (−∞ to 2.28) non-inferior.
“Results of the intention-to-treat analysis were consistent with the per protocol findings.”
ResultsFind in source - supportedReviewers 1, 2No adverse events occurred during the intervention period.The paper explicitly states no adverse events were observed.Evidence: Results section states 'No adverse events were observed in either group during the intervention period.'
“No adverse events were observed in either group during the intervention period.”
ResultsFind in source - supportedReviewer 1Tai chi can be used as an alternative approach for the long term management of chronic insomnia.The non-inferiority at month 15 supports this claim, though the short-term inferiority is acknowledged.Evidence: Non-inferiority at month 15 with upper CI within margin.
“Our study supports tai chi as an alternative treatment approach for the long term management of chronic insomnia in middle aged and older adults.”
ConclusionFind in source - supportedReviewer 2Tai chi can be used as an alternative approach for long-term management of chronic insomnia.The non-inferiority at month 15 supports this claim, though the short-term inferiority is acknowledged.Evidence: Non-inferiority at month 15 and comparable secondary outcomes.
“This finding supports the use of tai chi as an alternative approach for the long term management of chronic insomnia in middle aged and older adults.”
ConclusionFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary outcome is the Insomnia Severity Index (ISI), a patient-reported questionnaire, which is a surrogate for clinical insomnia. The paper does not demonstrate target engagement at the tested dose (no PK/PD or dose-exposure data) and does not cite validated evidence linking ISI changes to hard clinical outcomes. Although the ISI is a validated instrument, the efficacy claim rests on this surrogate without establishing a link to clinical outcomes.
“The primary outcome was perceived insomnia severity measured using the Insomnia Severity Index (ISI) at month 3 and month 15.”
- INADEQUATEEffect sizeThe primary effect is a reduction in ISI score. At month 3, the tai chi group showed a reduction of 6.67 points, which is below the minimally important difference of 8 points. At month 15, the reduction was 9.51 points, which exceeds the MID, but the paper does not explicitly anchor this to clinical meaningfulness beyond stating it is non-inferior to CBT-I. The effect size is not explicitly anchored to clinical meaningfulness in the context of the primary claim.
“At month 3, the tai chi group showed a reduction of 6.67 (95% confidence interval 5.61 to 7.73) in Insomnia Severity Index scores, while the CBT-I group had a reduction of 11.19 (10.06 to 12.32), resulting in a between group difference of 4.52 (−∞ to 5.81).”
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites prevalence, burden, and limitations of CBT-I, and reviews prior tai chi trials, noting the lack of direct comparisons with first-line treatments. The rationale for non-inferiority is clearly stated, and the hypothesis follows logically. Limitations of prior research (e.g., passive control designs) are explicitly acknowledged.
“Previous clinical trials and meta-analyses support the beneficial effects of tai chi in middle aged and older adults with insomnia, with improvements that can be sustained for up to 24 months. However, most studies used passive control designs (eg, stretching) or compared it with other exercise modalities (eg, aerobic exercise), while direct comparisons with first line insomnia treatments (eg, CBT-I) in middle aged and older adults with primary chronic insomnia are currently lacking.”
“To validate the use of tai chi as an alternative approach to manage chronic insomnia in middle aged and older adults, this study aimed to examine whether a three month tai chi intervention (experimental treatment) is non-inferior to a three month CBT-I intervention (first line treatment for chronic insomnia) for treating insomnia; and whether tai chi is non-inferior to CBT-I in sustaining beneficial improvements 12 months after the intervention.”
“Previous clinical trials and meta-analyses support the beneficial effects of tai chi in middle aged and older adults with insomnia, with improvements that can be sustained for up to 24 months. However, most studies used passive control designs (eg, stretching) or compared it with other exercise modalities (eg, aerobic exercise), while direct comparisons with first line insomnia treatments (eg, CBT-I) in middle aged and older adults with primary chronic insomnia are currently lacking.”
“We hypothesised that tai chi is non-inferior to CBT-I for treating insomnia in middle aged and older adults, and sustaining the sleep improvements 12 months after the intervention.”
Randomization used an online random generator with block sizes, allocation concealment via sealed envelopes, and independent researchers. Outcome assessors were blinded; participants and instructors were not, which is expected for behavioral interventions. Sample size was calculated with explicit parameters. Inclusion/exclusion criteria were detailed. Missing data handling (per protocol, ITT, LOCF, multiple imputation) is described, addressing outlier/missing-data concerns. No independent replication is reported, but this is not required for a single pivotal trial.
“Randomisation was conducted using an online random generator ( https://www.sealedenvelope.com/ ) with block sizes of four to six. The computer generated randomised allocation sequence was securely placed in sealed opaque envelopes and kept by an independent researcher who did not interact with the participants during recruitment or during the interventions.”
“The sample size estimation was based on a primary comparison of perceived insomnia severity measured by ISI between the two groups using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors to account for multiplicity.”
“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”
“Randomisation was conducted using an online random generator ( https://www.sealedenvelope.com/ ) with block sizes of four to six. The computer generated randomised allocation sequence was securely placed in sealed opaque envelopes and kept by an independent researcher who did not interact with the participants during recruitment or during the interventions.”
“The sample size estimation was based on a primary comparison of perceived insomnia severity measured by ISI between the two groups using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors to account for multiplicity.”
“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”
The study reports sex (77% female in tai chi, 84% in CBT-I), age (mean 64.83 and 63.76), and comorbidities (physical and mental). Since both sexes are enrolled, sex justification is not applicable. Age, weight, and health status are covered by demographics and comorbidity reporting. Species/strain and housing are not applicable for a human trial.
“Female, n (%) | 77 (77) | 84 (84) | | Age (years) | 64.83 (6.31) | 63.76 (6.15)”
“Presented with physical comorbidities, n (%) | 62 (62) | 59 (59) | | Presented with mental comorbidities, n (%) | 13 (13) | 7 (7)”
“Female, n (%) | 77 (77) | 84 (84) | | Age (years) | 64.83 (6.31) | 63.76 (6.15)”
“Presented with physical comorbidities, n (%) | 62 (62) | 59 (59)”
The study was approved by a named IRB with protocol number, written informed consent was obtained, and adherence to the Declaration of Helsinki is stated. All applicable criteria are met.
“The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621).”
“Written informed consent was obtained on a voluntary basis before baseline assessments.”
“The study was conducted in accordance with the Declaration of Helsinki.”
“The study was approved by the University of Hong Kong/Hospital Authority Hong Kong West institutional review board (IRB approval No UW 18-621).”
“Written informed consent was obtained on a voluntary basis before baseline assessments.”
“The study was conducted in accordance with the Declaration of Helsinki.”
As a behavioral trial, the key resources are the interventions themselves, which are described in detail (24-form Yang style tai chi, CBT-I components, session structure). The statistical software (SAS OnDemand for Academics) is identified. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.
“The programme adopted the 24 form Yang style of tai chi, the most common style adopted in the literature.”
“The intervention covers typical CBT-I components, including sleep education, stimulus control, sleep restriction, relaxation training, and cognitive therapy.”
“All statistical analyses were performed using SAS OnDemand for Academics (SAS Institute).”
“The programme adopted the 24 form Yang style of tai chi, the most common style adopted in the literature.”
“All statistical analyses were performed using SAS OnDemand for Academics (SAS Institute).”
The paper names the tests used (GEE, logistic regression, non-inferiority analysis) and reports effect sizes with 95% CIs. P-values are reported as exact values (e.g., P<0.001, P=0.067). Assumptions are handled by design (GEE, logistic regression). Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks were not possible for most continuous outcomes, but no obvious errors were found.
“We used generalised estimating equations analyses to examine the treatment effects on the quantitative secondary outcomes, adjusting for baseline values.”
“At month 3, the tai chi group showed a reduction of 6.67 points (95% confidence interval 5.61 to 7.73) in ISI scores, while the CBT-I group had a reduction of 11.19 (10.06 to 12.32), resulting in a between group difference of 4.52 (−∞ to 5.81).”
“The insomnia remission rates differed between the CBT-I and tai chi groups at month 3 (83.3% v 56.1%, P<0.001) but were similar at month 15 (63.4% v 76.5%, P=0.067).”
“At month 3, the tai chi group showed a reduction of 6.67 points (95% confidence interval 5.61 to 7.73) in ISI scores, while the CBT-I group had a reduction of 11.19 (10.06 to 12.32), resulting in a between group difference of 4.52 (−∞ to 5.81).”
“The insomnia remission rates differed between the CBT-I and tai chi groups at month 3 (83.3% v 56.1%, P<0.001) but were similar at month 15 (63.4% v 76.5%, P=0.067).”
The data availability statement provides a direct link to a Figshare repository with a DOI, and states that statistical code is available from the corresponding author and in supplementary files. This meets the criteria for data availability and repository deposit. Accession numbers are not applicable for this type of data.
“The data underlying the findings in this paper are openly and publicly available and can be found here: https://doi.org/10.6084/m9.figshare.29203967.v3 .”
“Statistical code and dataset are available from the corresponding author at pmsiu@hku.edu.hk . The code used to analyse the data in the paper can be found in the supplementary files.”
“The data underlying the findings in this paper are openly and publicly available and can be found here: https://doi.org/10.6084/m9.figshare.29203967.v3 .”
“Statistical code and dataset are available from the corresponding author at pmsiu@hku.edu.hk . The code used to analyse the data in the paper can be found in the supplementary files.”
The trial is registered at ClinicalTrials.gov (NCT04384822). The paper adheres to CONSORT extension for non-inferiority trials. All pre-specified outcomes are reported, including null results. Limitations are discussed. Conclusions are proportional to the evidence. Funding and competing interests are declared.
“Trial registration ClinicalTrials.gov NCT04384822 (https://clinicaltrials.gov/ct2/show/NCT04384822)”
“This randomised, assessor blinded, non-inferiority trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) extension for non-inferiority and equivalence trials.”
“A large proportion (77.5%, n=155) of the study participants were older adults aged ≥60 years, which might limit the generalisability of our results when considering younger populations.”
“Trial registration ClinicalTrials.gov NCT04384822 (https://clinicaltrials.gov/ct2/show/NCT04384822)”
“This randomised, assessor blinded, non-inferiority trial adhered to the Consolidated Standards of Reporting Trials (CONSORT) extension for non-inferiority and equivalence trials.”
“A large proportion (77.5%, n=155) of the study participants were older adults aged ≥60 years, which might limit the generalisability of our results when considering younger populations.”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
Checked 44 references by DOI: 43 verified — 1 no DOI (shown, not verified).
- NO DOIEffectiveness of exercise, cognitive behavioral therapy, and pharmacotherapy on improving sleep in adults with chronic insomnia: a systematic review and network meta-analysis of randomized controlled trialsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- dataFigshareLIVEHTTP 202https://doi.org/10.6084/m9.figshare.29203967.v3Resolves to Figshare (data repository).
Copyediting
2 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 2 minor suggestions below.
2 copyedit issues flagged: mostly consistency.
- MINORconsistencyAbstract, Results“At month 3, the tai chi group showed a reduction of 6.67 (95% confidence interval 5.61 to 7.73) in Insomnia Severity Index scores”→ Consider adding 'points' after the number for consistency with the main text.Minor wording inconsistency.
- MINORconsistencyAbstract, Results“The per protocol principle was adopted.”→ Consider rephrasing to 'The per-protocol principle was adopted.' for consistency with the rest of the text.Minor hyphenation inconsistency.
The published work is robust and well-reported; an informed reader can rely on the main conclusions. Minor reporting gaps (exact p-values for primary outcome, CONSORT flow details) are worth noting but do not undermine the findings. No erratum appears warranted based on this audit.
- 1.MEDIUMstatisticsReport exact p-values for the primary outcome comparisons (month 3 and month 15) in the Results section, not just confidence intervals.Exact p-values facilitate meta-analyses and allow readers to assess statistical significance precisely.
- 2.MEDIUMreportingInclude the CONSORT flow diagram in the main text (or ensure it is clearly referenced and available) showing numbers screened, excluded, and reasons for exclusion.A complete flow diagram is a CONSORT requirement and improves transparency of participant disposition.
- 3.MEDIUMdata codeDeposit the statistical analysis code in a public repository (e.g., GitHub) with a DOI, in addition to supplementary files.A versioned public code repository enhances reproducibility and discoverability beyond supplementary files.
- 4.MEDIUMstatisticsProvide a more detailed description of the multiple imputation model, including number of iterations and convergence diagnostics.Detailed imputation methods improve reproducibility and allow readers to assess the robustness of missing-data handling.
- 5.MEDIUMstatisticsReport the intraclass correlation coefficient (ICC) for the group-based interventions to account for potential clustering effects.Group-based interventions may induce clustering; reporting ICC helps readers assess whether clustering was adequately addressed.
- 6.LOWreportingAdd a statement about the availability of the full trial protocol in the data availability section.Linking the full protocol enhances transparency and allows verification of pre-specified outcomes.
- 7.LOWcopyeditAdd 'points' after the number in the Abstract Results for consistency with the main text (e.g., 'reduction of 6.67 points').Minor wording consistency improves readability.
- 8.LOWcopyeditChange 'per protocol' to 'per-protocol' in the Abstract for consistency with the rest of the text.Hyphenation consistency avoids ambiguity.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
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