CONSORT extension for herbal medicine interventions
Title and Abstract
1a – Title
Description:
The title or abstract, or both should state the herbal medicinal product’s Latin binomial, the part of the plant used, and the type of preparation.
Explanation:
CONSORT item #1 is meant to aid in the indexing and identification of reports of RCTs using electronic databases [1]. Hence, the use of the word ‘‘randomised,’’ ‘‘randomly,’’ or ‘‘random allocation’’ is suggested in the CONSORT statement. Additional language is required in the titles and abstracts of trials of herbal medicinal products. The practice of evidence-based herbal medicine requires access to the herbal scientific literature. The identification of RCTs of herbal medicinal products requires that the product’s Latin binomial, the part of the plant used, and the type of preparation be reported in the title and/or abstract. This information would allow increased specificity in the indexing and identification of RCTs of particular herbal medicine products or preparations. Some herbal medicinal products have a specific trade name or commercial name.2 Where applicable; this name should be listed, together with the Latin binomial of the ingredient herb. When the herbal medicinal product used in the trial is a combination herbal product,3 we suggest listing the product name in the title and the separate herbal medicinal species contained within this product in the abstract. In this way, the title of the trial will not be prohibitively long by listing all separate herbal species’ Latin binomials. Studies indicate that searching for CAM-related topics is challenging due to the diversity of use of controlled vocabulary and indexing procedures between different databases [22]. It has been suggested that if authors of CAM trials (e.g., botanical medicine trials) report abstracts or titles without reference to standard controlled vocabulary, indexers may not assign appropriate indexing terms for particular studies [22,23]. A further problem arises from indexers not having a sufficient number and variety of descriptors for CAM interventions [24]. When reporting RCTs of herbal medicinal products, the use of the information suggested for titles and abstracts above will likely lead to improved indexing and retrieval.
Example:
‘‘A double-blind, placebo-controlled, randomised trial of Ginkgo biloba extract EGb 761 in a sample of cognitively intact older adults: neuropsychological findings’’ [20].
1b – Abstract
Description:
Structured summary of trial design, methods, results, and conclusions
Explanation:
Clear, transparent, and sufficiently detailed abstracts are important because readers often base their assessment of a trial on such information. Some readers use an abstract as a screening tool to decide whether to read the full article. However, as not all trials are freely available and some health professionals do not have access to the full trial reports, healthcare decisions are sometimes made on the basis of abstracts of randomised trials.(66)
A journal abstract should contain sufficient information about a trial to serve as an accurate record of its conduct and findings, providing optimal information about the trial within the space constraints and format of a journal. A properly constructed and written abstract helps individuals to assess quickly the relevance of the findings and aids the retrieval of relevant reports from electronic databases.(67) The abstract should accurately reflect what is included in the full journal article and should not include information that does not appear in the body of the paper. Studies comparing the accuracy of information reported in a journal abstract with that reported in the text of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70) (71) Conversely, omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.(42) (72)
A recent extension to the CONSORT statement provides a list of essential items that authors should include when reporting the main results of a randomised trial in a journal (or conference) abstract (seetable 2).(45) We strongly recommend the use of structured abstracts for reporting randomised trials. They provide readers with information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.(73) Some studies have found that structured abstracts are of higher quality than the more traditional descriptive abstracts (74) (75) and that they allow readers to find information more easily.(76) We recognise that many journals have developed their own structure and word limit for reporting abstracts. It is not our intention to suggest changes to these formats, but to recommend what information should be reported.
Table 1 - Items to include when reporting a randomised trial in a journal abstract
Item / DescriptionAuthors / Contact details for the corresponding author
Trial design / Description of the trial design (such as parallel, cluster, non-inferiority)
Methods:
Participants / Eligibility criteria for participants and the settings where the data were collected
Interventions / Interventions intended for each group
Objective / Specific objective or hypothesis
Outcome / Clearly defined primary outcome for this report
Randomisation / How participants were allocated to interventions
Blinding (masking) / Whether participants, care givers, and those assessing the outcomes were blinded to group assignment
Results:
Numbers randomised / Number of participants randomised to each group
Recruitment / Trial status
Numbers analysed / Number of participants analysed in each group
Outcome / For the primary outcome, a result for each group and the estimated effect size and its precision
Harms / Important adverse events or side effects
Conclusions / General interpretation of the results
Trial registration / Registration number and name of trial register
Funding / Source of funding
Example:
‘‘This was a randomised, double-blind placebo controlled . The active treatment group received tablets containing 300 mg of Garlic Powder (Kwai). . This is equivalent to approximately 2.7 g or approximately 1 clove of fresh Garlic per day’’ [21].
Introduction
2a – Background
Description:
Including a brief statement of reasons for the trial with reference to the specific herbal medicinal product being used, and if applicable, whether new or traditional indications are being tested.
Explanation:
The background of reports of controlled clinical trials partially serves to lay out the rationale of the trial [1] with special reference to the specific intervention under study. There is great heterogeneity in the types of herbal medicinal products available. Two different preparations/products of the same herbal species can have different phytochemical profiles, differing pharmacokinetic properties, etc Given the variability in products, the rationale should clearly overview the scientific data concerning the specific herbal medicinal product under study (e.g., in the above example EGb 761). Where no clinical trials are available for review, extrapolation from preclinical work (i.e., animal studies, observational studies, case reports, known mechanisms) is acceptable. Where no data on the product are available, previous research on similar products to that being tested in the current trial should be reviewed. This information should be clearly stated and ideally include a description of a systematic review of previous studies using the herbal product [1,26]. Also, if the authors are testing a traditional use, a review of the theory and concepts underlying this indication should be reported. Readers with some relevant knowledge of the area should be able to determine the reasoning for the indication. For example, trials of traditional Chinese medicine (TCM) may choose to test a TCM diagnosis (e.g., liver blood deficiency) and not a Western diagnosis (hepatitis). If this is so, the authors should be explicit in their description of why the particular intervention being tested is indicated.
For example,
In traditional Chinese medicine, the ‘‘Nei-Kuan’’ acupoint (EH-6, where EH denotes equilibrium envelope of the heart meridian) has been believed to correlate with the function of the heart (Chuang, 1977). Recently, some investigators (Mah et al., 1992; Hsu et al., 1989) observed that acupuncture at Nei-Kuan can improve left ventricular function in patients with coronary heart disease [27].
Additionally, other data (i.e., clinical trials, animal studies, observational studies, case reports, known/proposed mechanisms) that would aid in creating a rationale, even for this traditional indication, can be described in the background. The assumption is that a rationale can be clearly and explicitly reported and that it may be derived from scientific, empirical, historical,4 or traditional5 sources.
Example:
The extract of Ginkgo biloba leaves entitled EGb 761 is a complex mixture that is standardised with respect to its flavonol glycoside (24%) and terpene lactone (6%) content [1,2]. These two classes of compounds have been implicated in the beneficial effects of EGb 761 in treating peripheral and cerebral vascular insufficiency, age-associated cerebral impairment, and hypoxic or ischemic syndromes [1,3]. Electron spin resonance (ESR) studies conducted in vitro have shown that EGb 761 is an efficient scavenger of various reactive oxygen species, including superoxide anion radical (O2_) and hydroxyl radical (HO_), and that it also exhibits superoxide dismutaseelike activity [4]. Recent in vitro studies with animal models have revealed that the extract may exert an anti-free radical action in myocardial ischemia reperfusion injury. In these studies [5,6], inclusion of 200 mg/l of EGb 761 in the medium that was used to perfuse isolated ischemic rat hearts significantly improved post ischemic recovery, reduced ventricular arrhythmias and enzyme leakage, and lowered the content of spin-trapped oxyradicals in the coronary effluents. Interestingly, antiarrhythmic effects were also observed when animals were treated orally with EGb 761 prior to heart perfusion, but a significant reduction in ventricular arrhythmias could be achieved only with high dosages (100 mg/kg for 10 days) [5]. In addition to these studies conducted with EGb 761 [5,6], numerous other studies with experimental animals have indicated that active reduced forms of molecular oxygen, including O2_, HO_, and hydrogen peroxide (H2O2), are involved in the pathogenesis of tissue injury that follows myocardial ischemia reperfusion [7e10] [25]. . In the present double-blind study, we tested the cardio protective efficacy of oral treatment with EGb 761, which is known to have in vitro antioxidant properties [4e6], in patients undergoing CPB surgery by manual palpation [25].
2b – Objectives
Description:
Specific objectives or hypothesis
Explanation:
Objectives are the questions that the trial was designed to answer. They often relate to the efficacy of a particular therapeutic or preventive intervention. Hypotheses are pre-specified questions being tested to help meet the objectives. Hypotheses are more specific than objectives and are amenable to explicit statistical evaluation. In practice, objectives and hypotheses are not always easily differentiated. Most reports of RCTs provide adequate information about trial objectives and hypotheses.(84)
Example:
“In the current study we tested the hypothesis that a policy of active management of nulliparous labour would: 1. reduce the rate of caesarean section, 2. reduce the rate of prolonged labour; 3. not influence maternal satisfaction with the birth experience.”(83)
Methods
3a – Trial design
Description:
Description of trial design (such as parallel, factorial) including allocation ratio
Explanation:
The word “design” is often used to refer to all aspects of how a trial is set up, but it also has a narrower interpretation. Many specific aspects of the broader trial design, including details of randomisation and blinding, are addressed elsewhere in the CONSORT checklist. Here we seek information on the type of trial, such as parallel group or factorial, and the conceptual framework, such as superiority or non-inferiority, and other related issues not addressed elsewhere in the checklist.
The CONSORT statement focuses mainly on trials with participants individually randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.(39) Also, most trials are set to identify the superiority of a new intervention, if it exists, but others are designed to assess non-inferiority or equivalence. It is important that researchers clearly describe these aspects of their trial, including the unit of randomisation (such as patient, GP practice, lesion). It is desirable also to include these details in the abstract (seeitem 1b).
If a less common design is employed, authors are encouraged to explain their choice, especially as such designs may imply the need for a larger sample size or more complex analysis and interpretation.
Although most trials use equal randomisation (such as 1:1 for two groups), it is helpful to provide the allocation ratio explicitly. For drug trials, specifying the phase of the trial (I-IV) may also be relevant.
Example:
“This was a multicenter, stratified (6 to 11 years and 12 to 17 years of age, with imbalanced randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”(85)
3b – Changes to trial design
Description:
Important changes to methods after trial commencement (such as eligibility criteria), with reasons
Explanation:
A few trials may start without any fixed plan (that is, are entirely exploratory), but the most will have a protocol that specifies in great detail how the trial will be conducted. There may be deviations from the original protocol, as it is impossible to predict every possible change in circumstances during the course of a trial. Some trials will therefore have important changes to the methods after trial commencement.
Changes could be due to external information becoming available from other studies, or internal financial difficulties, or could be due to a disappointing recruitment rate. Such protocol changes should be made without breaking the blinding on the accumulating data on participants’ outcomes. In some trials, an independent data monitoring committee will have as part of its remit the possibility of recommending protocol changes based on seeing unblinded data. Such changes might affect the study methods (such as changes to treatment regimens, eligibility criteria, randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).(87)
Some trials are set up with a formal “adaptive” design. There is no universally accepted definition of these designs, but a working definition might be “a multistage study design that uses accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”(88) The modifications are usually to the sample sizes and the number of treatment arms and can lead to decisions being made more quickly and with more efficient use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89) (90)