Rigor Reviewed

Rigor-Reviewed Manuscript

Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial.

Name: Αlpha¹ Rigor Record — Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial.
Item: Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial.
Rating: 39
Author: Αlpha¹

Li J, Liao Y, Zhang SY, Jin L, Congdon N, Fan Z, Zeng Y, Zheng Y, Liu Z, Liu Y, Liang L

Paper source

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Αlpha¹ Rigor Review — 1★ (Critical), 3 critical, 3 high issues for “Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial.”

Links back to this Rigor Record.

Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 16, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×3−3★
IntegrityIntegrity concern ×2−1★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 44 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.
No data or code availability links were detected to verify.

Problems surfaced5 types

Numerical inconsistencies2

Values 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
Internal contradictions in the reported numbersAssessed

Overstated conclusions2

Conclusions 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

Reporting gaps1

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

This Αlpha¹ Rigor Review uses AI 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.

Critical findings

• PERCENT: 74% does not match the reported count 78/299
• PERCENT: 73% does not match the reported count 60/149
• PERCENT: 75% does not match the reported count 62/150

This is a well-conducted non-inferiority RCT with rigorous design, clear reporting, and appropriate statistical methods. The main weaknesses are the vague data availability statement and minor reporting gaps (e.g., no CONSORT mention, incomplete resource identification).

Both reviewers classified the study as interventional, and no divergence was noted. The evaluation covered all eight dimensions; non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification covered only a subset of tests; the 3 inconsistent recomputations were not specified and did not constitute demonstrable errors.

4 major claims checked against the paper's own evidence: all adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks. 3 reported summary statistics mathematically impossible for the stated N (PERCENT).

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites multiple studies on dry eye disease, artificial tears, and laughter therapy, acknowledging both the economic burden and the psychological associations. The rationale for using laughter exercise is well-argued, linking positive emotions to potential benefits. The hypothesis is clearly stated as a non-inferiority margin of 6 points. Limitations of prior research are implicitly addressed by the pilot studies and the design choice.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the study hypothesis.

Evidence

direct quote[Introduction, paragraphs 1-4]

“Abundant evidence suggests that laughter therapy alleviates depression, anxiety, stress, and chronic pain, while strengthening immune function”