Reporting Quality of Randomized Controlled Trials Published in Integrative Cancer Therapies : Evaluation Against CONSORT 2010 and Perspectives for CONSORT 2025

Abstract

Consolidated Standards of Reporting Trials (CONSORT) 2025 Statement was issued in April 2025, however, no dedicated CONSORT extension currently exists for integrative oncology. It is therefore essential to provide practical recommendations, grounded in the CONSORT 2025 Statement and in an analysis of randomized controlled trials (RCT) reporting quality against CONSORT 2010, to guide future RCTs. This study presents a literature-based analysis of RCTs published in Integrative Cancer Therapies between 2010 and 2025, describing study characteristics and overall weighted adherence to CONSORT 2010 of 72 included RCTs. The annual number of publications exhibited an overall upward trend over the past 15 years; overall weighted adherence to CONSORT 2010 across the 72 studies was 67.9%, and the mean per-manuscript adherence was 67.2%. Drawing on this analysis and the CONSORT 2025 update, several specific measures are proposed to improve the reporting quality of RCTs in integrative oncology.

Keywords

randomized controlled trial integrative oncology CONSORT statement report quality

Introduction

According to Cancer Statistics, 2025, 2,041,910 new cancer cases and 618,120 cancer deaths are projected to occur in the United States. The national cancer mortality rate continued to decline through 2022.¹ The near future will present new challenges associated with a growing population of cancer survivors, an aging survivor cohort, and the unknown adverse effects of novel treatments.² Addressing these issues requires a holistic approach, such as integrative cancer, defined as patient-centered, evidence-based cancer care that uses mind and body practices, natural products, and lifestyle modifications from different traditions alongside conventional cancer treatments.^3,4

On April 14, 2025, The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine simultaneously published the updated CONSORT (Consolidated Standards of Reporting Trials) 2025 statement,^5-9 accompanied by an explanatory and elaboration article in BMJ.¹⁰ The update comprises a 30-item checklist of essential reporting items and a participant flow diagram, reflects recent methodological advancements and user feedback, and aims to improve the use, understanding, and dissemination of CONSORT by providing authors with guidance to enhance the completeness and transparency of randomized trial reports.¹¹ Following the CONSORT 2010 Statement—the previous version—approximately 20 CONSORT extensions were developed.¹² However, the interval for developing or updating CONSORT extensions is uncertain and can be prolonged; for example, the CONSORT 2010 Extension for Chinese Herbal Medicine Formulas was published in 2017, seven years after the issue of CONSORT 2010.¹³ Moreover, apart from the CONSORT Extension for Chinese Herbal Medicine Formulas, no dedicated CONSORT extension currently exists for integrative oncology.

Given the rapid development of integrative oncology trials, it is essential to offer practical recommendations grounded in the CONSORT 2025 Statement and in an analysis of the reporting quality of randomized controlled trials (RCTs) conducted between 2010 and 2025 against CONSORT 2010, to guide future RCTs.

Methods

Search Strategy

The article search was conducted in the PubMed database to obtain clinical trial reports published in Integrative Cancer Therapies, and followed by manual searching. The following inclusion filters were applied in the search: Adaptive Clinical Trial, Clinical Study, Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Clinical Trial, Phase III, Clinical Trial, Phase IV, Controlled Clinical Trial, Randomized Controlled Trial. Two authors (Yang GL and Guo ST) systematically reviewed the search results using EndNote 2025 software. Inclusion criteria were as follows: (1) the study was an interventional clinical trial involving human participants, including randomized controlled trials and phase I-IV clinical trials; (2) the full-text article was published in Integrative Cancer Therapies; and (3) the publication date was between June 1, 2010, and April 14, 2025. Exclusion criteria included the following: non-randomized studies (e.g., single-arm studies), review, meta-analysis, literature analysis, commentary, letter, retrospective studies, pilot studies, secondary analysis of completed studies, follow-up studies, protocol studies, and articles with insufficient data.

Data Extraction

For each publication, two authors (Yang GL and Guo ST) independently extracted the following information: first author’s geographic origin, category of complementary and alternative medicine (classified according to the National Center for Complementary and Integrative Health system into: alternative medical systems [e.g., acupuncture, homeopathic treatment, etc], biologically based therapies [e.g., chelation therapy, folk medicine, etc], manipulative and body-based therapies [e.g., massage, movement therapies, etc], mind-body therapies [e.g., yoga, tai chi], and energy healing therapies [Reiki, etc]),^14,15 an “other” category was also included for interventions not fitting these groups), sample size, type of control group (conventional treatment, placebo, best supportive care, blank control, or other), study design (single-center or multicenter), and blinding method (open-label, single-blind, double-blind, or other).

Two authors (Yang GL and Guo ST) independently assessed the reporting quality of the included articles using the 25-item CONSORT 2010 checklist.¹⁶ Each checklist item was scored dichotomously as “Yes” or “No,” based on whether the required information was reported. For each item, adherence was calculated as the percentage of included articles scoring “Yes.” Discrepancies between the two primary reviewers were resolved by consensus, with arbitration by a third author (Zhang HQ) when necessary.

Calculation of Adherence

Overall weighted adherence to CONSORT 2010 was calculated by aggregating item-level reporting across all included studies. Items judged as entirely not applicable (NA) were excluded from the calculation. For items with limited applicability, a normalized weight factor was applied to standardize their contribution across the full sample. For items with full applicability, the weight factor was 1. Overall weighted adherence was then calculated as the sum of weighted compliant counts divided by the sum of applicable study-item instances across all included items.

Mean per-manuscript adherence was calculated at the study level. For each manuscript, the adherence rate was defined as the number of CONSORT items adequately reported divided by the number of applicable items after excluding NA items. The mean per-manuscript adherence was then obtained by averaging the adherence rates across all included manuscripts.

Study Aim

The primary objective of the study is to evaluate overall adherence to the CONSORT 2010 Statement among randomized trials published in Integrative Cancer Therapies between 2010 and 2025, and the secondary objective is to offer practical recommendations aligned with CONSORT 2025 to guide future RCTs.

Statistical Analysis

Data were extracted from the included RCTs to capture study characteristics and adherence to each CONSORT 2010 checklist item. Categorical variables (e.g., study characteristics and checklist adherence) were summarized using frequencies and percentages. Continuous variables, including sample size, were described using medians. For each CONSORT 2010 item, the number and percentage of studies meeting the reporting requirement were calculated to quantify reporting quality. All analyses were performed using SPSS 26.0 software (Chicago, IL, USA).

Results

A total of 234 records were initially identified from Integrative Cancer Therapies. After screening titles and abstracts, with full-text review as needed, 162 records were excluded for not meeting the inclusion criteria. Reasons for exclusion were: 59 pilot studies, 26 nonrandomized trials, 23 prospective observational studies, 21 feasibility studies, and 33 studies deemed not evaluable, included 15 secondary analysis or follow-up studies, 9 protocol studies, 4 qualitative studies, 3 retrospective studies, and 2 studies classified as other (Figure 1).

Figure 1.

Flow diagram showing the selection process for this study

Across the 72 included articles, key study characteristics were as follows. The annual number of publications increased overall from 2010 to 2025, peaking in 2023 (Figure 2). Most studies were conducted in Asia (47/72, 65.3%). Regarding intervention category, “alternative medical systems” were most prevalent (27/72, 37.5%), followed by “biologically based therapies” (14/72, 19.4%) and “manipulative and body-based therapies” (14/72, 19.4%). The mean sample size per trial was 87.3 participants. The most common control conditions were conventional treatment (24/72, 33.3%) and placebo (21/72, 29.2%). The majority of trials were single-center (57/72, 79.2%). With respect to blinding, more than half of the studies were open-label (37/72, 51.4%), whereas 19/72 (26.4%) employed double-blind designs (Table 1).

Figure 2.

Publication year distribution of included studies

Table 1.

Characteristics of the Included Studies (n=72)

Factors
First author origin, n (%)
Asia	47	65.3
Europe	13	18.1
America	5	6.9
Other	7	9.7
Type of Intervention, n (%)
Alternative medical systems	27	37.5
Biologically based therapies	14	19.4
Manipulative and body-based therapies	14	19.4
Mind-body therapies	13	18.1
Energy healing therapies	0	0
Other^α	2	2.8
Sample size, mean ± standard	87.3 ± 42.2
Type of control group, n (%)
Conventional treatment	24	33.3
Placebo	21	29.2
Best support care	11	15.3
Blank	3	4.2
other^α	13	18.1
Type of study, no (%)
Single center	57	79.2
Multi center	15	20.8
Type of blinding method, no (%)
Open label	37	51.4
Double blind	19	26.4
Single blind	14	19.4
Other^β	2	2.8

^α“Other” primarily encompasses comparisons between different complementary and alternative medicine therapies.

^βThe “Other” category refers to triple-blind studies.

Assessment of CONSORT item adherence across the 72 included studies (Table 2) revealed some heterogeneity in reporting quality. Several core items—structured abstracts (Item 1b), background and objectives (Item 2a), eligibility criteria for participants (Item 4a), interventions (Item 5), and funding (Item 25)—were completely reported (100%). Reporting of random sequence generation (Item 8a) and statistical methods (Item 12a) was also high, exceeding 88%. By contrast, key methodological details were frequently underreported. Only 11.1% of studies fully identified the personnel responsible for sequence generation, participant enrollment, and assignment (Item 10), and allocation concealment mechanisms (Item 9) were reported in 54.2% of studies. Reporting in the Results section was similarly limited: effect estimates with measures of precision (e.g., 95% confidence intervals; Item 17a) and specification of the analysis set for each analysis (Item 16) were provided in only 43.1% and 36.1% of studies, respectively. Discussion of trial limitations was also sparse, particularly regarding imprecision of estimates (Item 20; 1.4%). Overall weighted adherence to CONSORT 2010 across the 72 studies was 67.9%, and the mean per-manuscript adherence was 67.2%. To explore temporal changes in reporting quality, the included trials were divided into two publication periods (2010–2018 and 2019–2025). The overall weighted adherence increased from 58.7% in 2010–2018 to 69.6% in 2019–2025, and the mean per-manuscript adherence increased from 63.4% to 68.5%.

Table 2.

CONSORT 2010 Assessment of Included Randomized Controlled Trials (n=72)

Section/Topic	Item no	Checklist item	N (%)
Title and abstract
	1a	Identification as a randomized trial in the title	54/72 (75)
	1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance, see CONSORT for abstracts)	72/72(100)
Introduction
Background and objectives	2a	Scientific background and explanation of rationale	72/72(100)
Background and objectives	2b	Specific objectives or hypotheses	67/72(93.1)
Methods
Trial design	3a	Description of trial design (such as parallel, factorial), including allocation ratio	48/72(66.7)
Trial design	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons	NA
Participants	4a	Eligibility criteria for participants	72/72(100)
Participants	4b	Settings and locations where the data were collected	24/72(33.3)
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they were actually administered	72/72(100)
Outcomes	6a	Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed	68/72(94.4)
Outcomes	6b	Any changes to trial outcomes after the trial commenced, with reasons	1/1(100)
Sample size	7a	How sample size was determined	51/72(70.8)
Sample size	7b	When applicable, explanation of any interim analyses and stopping guidelines	NA
Randomization
Sequence generation	8a	Method used to generate the random allocation sequence	64/72(88.9)
Sequence generation	8b	Type of randomization; details of any restriction (such as blocking and block size)	31/72(43.1)
Allocation concealment mechanism	9	Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned	39/72(54.2)
Implementation	10^α	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions	8/72(11.1)
Blinding	11a	If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how	35/37(94.6)
Blinding	11b	If relevant, description of the similarity of interventions	22/25(88)
Statistical methods	12a	Statistical methods used to compare groups for primary and secondary outcomes	70/72(97.2)
Statistical methods	12b	Methods for additional analyses, such as subgroup analyses and adjusted analyses	15/72(20.8)
Results
Participant flow (a diagram is strongly recommended)	13a	For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome	38/72(94.4)
Participant flow (a diagram is strongly recommended)	13b	For each group, losses and exclusions after randomization, together with reasons	70/72(97.2)
Recruitment	14a	Dates defining the periods of recruitment and follow-up	80/72(69.4)
Recruitment	14b	Why the trial ended or was stopped	NA
Baseline data	15^β	A table showing baseline demographic and clinical characteristics for each group	70/72(97.2)
Numbers analysed	16	For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups	26/72(36.1)
Outcomes and estimation	17a^γ	For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)	31/72(43.1)
Outcomes and estimation	17b	For binary outcomes, presentation of both absolute and relative effect sizes is recommended	7/29(24.1)
Ancillary analyses	18	Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory	9/72(12.5)
Harms	19	All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)	32/72(44.4)
Discussion
Limitations	20	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses	1/72(1.4)
Generalisability	21	Generalisability (external validity, applicability) of the trial findings	22/72(30.6)
Interpretation	22	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	72/72(100)
Other information
Registration	23	Registration number and name of trial registry	53/72(73.6)
Protocol	24	Where the full trial protocol can be accessed, if available	NA
Funding	25	Sources of funding and other support (such as supply of drugs), role of funders	72/72(100)

^αOmission of the personnel responsible for randomization generation, enrollment, and/or intervention assignment.

^βOmission of a baseline characteristics table.

^γOmission of a precision measure (e.g., 95% CI) for the effect size.

Discussion

To our knowledge, this is the first study to evaluate overall adherence to the CONSORT 2010 Statement among randomized trials published in Integrative Cancer Therapies between 2010 and 2025. Using a PubMed search, we identified 72 eligible studies. Overall weighted adherence to CONSORT 2010 was 67.9%, and the mean per-manuscript adherence was 67.2%.

Overall, adherence to CONSORT 2010 among studies published in Integrative Cancer Therapies was suboptimal, with approximately one-third of checklist items not reported on average. These findings are consistent with reports from other medical journals, which likewise document modest adherence to CONSORT and related reporting guidelines.^17-20 Such modest adherence may reflect the absence of a dedicated CONSORT extension for integrative oncology and limited awareness or implementation of CONSORT guidance by authors. Underreporting was most pronounced for critical methodological details, as well as elements of the Results and Discussion sections.

The rising overall weighted adherence and the mean per-manuscript adherence suggest that reporting in integrative oncology trials has improved over the past 15 years. In addition, the annual number of publications increased over time. Compared with prior literature analyses of complementary and alternative medicine RCTs in oncology, we observed obvious improvements in sample size, reporting of sample size calculations, and use of blinding.^21,22

Update of CONSORT 2025

Building on CONSORT 2010, CONSORT 2025 Statement introduces seven new checklist items, revises three items, deletes one item, and integrates several elements from key CONSORT extensions.¹¹ The main changes can be summarized as follows: (1) enhanced transparency regarding statistical analysis plans, funding, and conflicts of interest; (2) explicit requirements for data and material accessibility and sharing; (3) detailed descriptions of patient and public involvement across all stages of the trial; (4) clearer definitions and assessments of harms, including both systematically collected and non-systematic reports; and (5) requirements to report protocol and methodological changes and to clearly present group assignments and participant numbers to ensure transparent randomized trials.¹²

With the publication of CONSORT 2025, the design and reporting of randomized trials in integrative oncology should adhere to the latest version, with particular attention to the new and revised items.

Besides, on April 28, 2025,JAMA, BMJ, Nature Medicine and PLOS Medicine simultaneously published the updated guideline for protocols of randomized trials of SPIRIT 2025 statement, with an evidence-based checklist of 34 minimum items and a diagram.^23-26 As living guidelines for improving clinical trial quality, CONSORT and SPIRIT have different emphases. CONSORT requires transparent reporting of completed randomized trials regarding design, methods and results, whereas SPIRIT informs the development of ethically appropriate and scientifically rigorous trial protocols prior to study initiation.^27-30 Investigators are recommended to apply the updated CONSORT and conventional SPIRIT guidelines simultaneously.¹¹

Adoption of CONSORT 2025 in Integrative Oncology: Perspectives and Recommendations

Undoubtedly, all CONSORT 2010 items retained in CONSORT 2025 warrant rigorous adherence, particularly those historically underreported.^31,32

Among the seven newly added checklist items, Items 4,³³ 5b,³⁴ 12b,³⁵ and 21³⁶ primarily address data sharing; financial and other conflicts of interest; eligibility criteria for sites and investigators; and the definition of grouping and analysis of missing data. These requirements are not specific to integrative oncology and should therefore be straightforward for investigators and clinicians to adhere to. Item 8 emphasizes patient and public involvement in the design, conduct, and reporting of trials, which may pose challenges for investigators given global disparities in health literacy. Given that 51.4% of integrative oncology RCTs in our analysis were open-label, patient involvement may be more feasible than in blinded interventional trials. Item 15 clarifies approaches to assessing harms and other unintended effects.³⁷ In cancer-related randomized trials, including integrative oncology, the Common Terminology Criteria for Adverse Events (CTCAE) are widely used to grade adverse events and their severity.³⁸ As of January 1, 2026, CTCAE version 6.0 is scheduled to replace version 5.0. Item 24 adds requirements to report how the intervention and comparator were actually administered, as well as details of concomitant care received during the trial.³⁹ Because integrative oncology interventions are diverse and often combined with conventional therapies, investigators should specify interventions clearly. Reporting of concomitant care remains uncommon; investigators should incorporate plans for capturing concomitant care into trial design.

The three fully revised checklist items—Items 3,⁴⁰ 10,⁴¹ and 26⁴²—Primarily address the statistical analysis plan, reporting of important trial changes, and specification of each primary and secondary outcome. None of these items are specific to integrative oncology.

Furthermore, Items 17a and 17b are consistent with those in the CONSORT 2010 statement. Given the generally low reporting rates regarding the type of randomization and details of any randomization restrictions, we encourage the involvement of design and biostatistics experts in clinical trials at the design stage.

Limitation

This study has several limitations. First, the RCTs of integrative oncology included in the analysis were drawn exclusively only from Integrative Cancer Therapies, which may limit generalizability to the broader literature. Second, although some checklist items—particularly in the Methods and Randomization domains—are more consequential than others, our analysis weighted all CONSORT items equally. All biostatistical analyses were descriptive only, no statistical tests, subgroup analyses, or regression modeling were performed to explore predictors of improved reporting. Third, our recommendations regarding the seven newly added and three revised CONSORT 2025 items only reflect expert opinion, which should be supported by empirical evidence or official guidance.

Conclusion

Drawing on our analysis of randomized trials published in Integrative Cancer Therapies against the CONSORT 2010 Statement, and informed by the CONSORT 2025 update, we propose several specific measures to improve the reporting quality of RCTs of integrative oncology. We also encourage the CONSORT Group to develop a dedicated extension to support the design, conduct, and reporting of randomized trials in integrative oncology.

Footnotes

ORCID iD

Geliang Yang

Ethical Considerations

This study does not involve any human participants, human tissue samples, or animal experiments. Therefore, no ethical approval was required for this study.

Author Contributions

YGL, GST, and ZHQ contributed to the study’s conception, design, conduct, and interpretation of the data. WF and HX prepared the tables and data for analysis. YGL and GST performed the statistical analysis. YGL and GST drafted the initial version of the manuscript, while HX and ZHQ provided feedback on all revisions. All authors reviewed and approved the final manuscript.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.*

Generative AI Usage Statement

The authors declare that no generative AI or AI-assisted technologies were used in the preparation, drafting, editing, or visualization of this manuscript.

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