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Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (5): 455-466.doi: 10.3736/jcim20060504

• Review • Previous Articles     Next Articles

Critical appraisal of clinical studies in Chinese herbal medicine

Simon Dagenais1,2,3,Andrea C. Tricco1,4, Zhao-xiang Bian5,Wen-hua Huang6,David Moher1,2,3   

  1. 1. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    2. Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Canada
    3. Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
    4. Institute of Population Health, University of Ottawa, Ottawa, Canada
    5. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
  • Online:2006-09-30 Published:2006-09-15

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The use of complementary and alternative medicine (CAM) is currently widespread and appears to be growing. As an increasing proportion of the population turns to CAM therapies, whether singly or in combination with allopathic medicine, the need for quality research in this area is reinforced. Much of this research consists of clinical studies aimed primarily at clinicians, yet challenges arising from poor methodological quality will occur when interpreting study findings and their implications. For clinicians to be effective consumers of the scientific literature, familiarization with the principles of evidence-based medicine (EBM) is essential. The goal of this review is to introduce clinicians to the concept of critical appraisal of clinical studies and foster critical thinking when reading research articles in order to best evaluate and incorporate study findings into their daily practice. Topics discussed in this article include: (1) fundamentals of EBM; (2) types of clinical studies; (3) hierarchy of evidence; (4) Consolidated Standard of Randomized Trials (CONSORT) statement to evaluate the quality of reporting in randomized controlled trials (RCTs); (5) methodologic quality rating scales for RCTs; and (6) issues specific to evaluating studies of Chinese herbal medicine.

Key words: Evidence-based medicine, Research design, Randomized controlled trial, Chinese herbal medicine, CONSORT statement

CLC Number: 

  • R-3

"

Study design Descriptive Cohort Controlled
Subtypes Case report
-1 patient
Case series
-several patients		 Retrospective
-Data collected from prior patients by reviewing charts
Prospective
-Study designed prior to collecting data from future patients		 Non-randomized
-Intervention compared to control
Randomized
-Participants randomized to intervention or control groups
Purpose -Provide extensive information on case(s) selected due to unusual nature of intervention or disease
-Question current thinking and share new clinical observations		 -Describe outcome of similar patients who received similar intervention
-Performs initial evaluation of new treatment under ideal conditions		 -Assess the efficacy of a treatment compared to a control group in a defined population using rigorous scientific methods
-Confirm or refute findings from other clinical study designs
Typical article format -Presenting complaint
-Examination findings
-Description of treatment
-Results
-Discussion
-Conclusion		 -Disease of interest
-Definition of cohort
-Intervention protocol
-Outcome measures
-Follow-up
-Results
-Discussion
-Conclusion		 -Disease of interest
-Target population
-Inclusion/exclusion criteria
-Intervention protocol
-Sample size calculation
-Randomization and blinding
-Outcome measures
-Follow-up
-Results
-Discussion
-Conclusion
Advantages -Extensive information provided on single (few) case (s)
-More reflective of day-to-day practice focused on individual patients
-May foster new theories for further investigation		 -More standardized approach than case series
-Good starting point for clinical research involving new intervention
-Relatively inexpensive and simple to conduct		 -Control group minimizes non-treatment effects observed
-Defined inclusion/exclusion criteria help generalizability
-Randomization ensures baseline comparability
Disadvantages -Few participants
-Non-experimental
-Higher likelihood and more sources of bias
-May not be generalizable		 -Patient selection criteria often unclear
-Patients not blinded to treatment
-No control group to compare new treatment to standard of care or natural history		 -Often requires numerous participants with long recruitment and screening period
-Randomization and blinding difficult to implement in certain clinical settings
-Requires extensive support from research team and infrastructure
Cost/complexity Low Medium High
Approximate number of
participants		 1-10 100 or more 50 to 100 or more

Figure 1

Hierarchy of clinical efficacy study research evidence"

"

Item Section Comments
1 TITLE &
ABSTRACT		 Clearly state the population used, intervention studied, trial design, and outcome of interest (e.g. a 20-week randomized controlled trial of estradiol replacement therapy for women aged 70 years and older: Effect on mood, cognition and quality of life).
INTRODUCTION
2 Background Explain past scientific evidence in the field relevant to the trial (i.e. conduct a literature search). The rationale should justify the need to conduct the trial and importance of the trial.
METHODS
3 Participants State the reasons why participants were included in the trial and why others were excluded. Describe the location where the trial was conducted. Report if the trial was independent or part of a larger, multi-center trial.
4 Interventions Clearly state details such as treatments given to each group, how they were administered, and the timing of administration.
5 Objectives Report the aims of the trial as well as any a-priori hypotheses (e.g. our hypothesis is that estradiol is superior to placebo in improving the mood for women aged 70 years and older).
6 Outcomes Describe the primary and secondary outcomes and how they were measured (e.g. the primary outcome is remission from depression rated by a score of 7 or less on the Hamilton Depression Scale and the secondary outcome includes clinical response defined as a 50% decrease on Hamilton Depression scores from baseline). Report methods used to increase the quality of measurements. For example, report if training was provided to assess depression using the Hamilton Depression Scale in the trial.
7 Sample size Report the calculations used to decide the number of participants required for the trial. The sample size is related to the allowable level of a type I error (i.e. declaring that a difference exists when one does not), the incidence or prevalence of the disease being studied, the magnitude of the difference between the treatments to be detected, and the allowable level of a type II error (i.e. declaring that a difference does not exist when one does).
8 Randomization: sequence
generation		 Randomization minimizes bias associated with assigning patients to treatment. Clearly describe the method used to generate random allocation (e.g. Participants had an equal probability of assignment to the groups. The randomization code was developed using a computer random number generator). Describe details of restriction, if any were used (e.g. Random permuted blocks were selected. The block lengths were 4, 8, and 10 varied randomly).
9 Allocation concealment Report all methods pertaining to allocation concealment methods. Allocation concealment is the process used to prevent any prior knowledge of group assignment (e.g. capsules were placed in identical-looking, numbered bottles and administered sequentially; sequentially numbered opaque, sealed envelopes were used to conceal treatment allocation). Concealment prior to intervention assignment is preferred.
10 Implementation Provide details about how the trial was executed. This includes who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.
11 Blinding (masking) Report all blinding processes. Blinding refers to the process in which participants, treatment administrators, and outcome assessors are unaware of the group to which participants are assigned. For example, our study was double-blinded as the participants and the investigators were unaware of which treatment group that the participants were in.
12 Statistical methods Report all methods used to statistically analyze trial results. This includes adjustments, subgroup analyses, and any additional analyses.

"

Item Section Comments
RESULTS
13 Participant flow The participant flow is a description of the flow of participants through each stage of the trial. A diagram is strongly recommended. For each treatment group report the number of participants that were randomly assigned, received the intended treatment, completed study protocol, and analyzed for the primary outcome. Describe and explain any differences between the methods outlined in the protocol and the methods that were actually used in the trial.
14 Recruitment Report the timing of enrollment and the length of patient follow-up. For example, patients were enrolled on September 1, 2005 and followed up until December 23, 2007.
15 Baseline data State the demographics of participants in the trial (e.g. age, gender) and clinical characteristic data collected at the beginning of the study (e.g. blood pressure at the first patient visit with the physician).
16 Numbers analyzed State the total number of participants in each group. Describe whether intention-to-treat analysis was done (i.e. all patients who began the trial are used in the analysis, whether or not treatment was received for the full time period of the trial). State results in absolute numbers if feasible and not in percentages.
17 Outcomes and estimation Report the results of primary and secondary outcomes by treatment group. State the difference between treatments (i.e. effect size; e.g. relative risk) and the degree of uncertainty surrounding the effect size (i.e. 95% confidence interval).
18 Ancillary analyses Describe any additional analyses that were performed (e.g. subgroup analyses, adjusted analyses). Provide information about whether the pre-specified analysis in the trial protocol was followed. Report any additional analyses done for exploratory purposes.
19 Adverse events State all undesirable or unwanted effects of the treatment, even if they were not harmful.
DISCUSSION
20 Interpretation Describe the interpretation of the results and take into account any trial hypotheses. Report limitations of the trial such as sources of bias and multiple analyses, which increases your chances of rejecting the null hypothesis when it was in fact true (i.e., you find that a difference between the interventions exist when they were in fact the same. This is otherwise known as a "type 1" error).
21 Generalizability Generalizability relates to the degree for which the trial results can be inferred to a larger population beyond the trial participants. Another term for generalizability is external validity. Describe the extent of external validity of the trial.
22 Overall evidence Interpret and report the results within the context of the current evidence.

Figure 2

CONSORT flow diagram7 RATING SCALESThe CONSORT Group is committed to continuous improvement through the renewal and updates of their recommendations. The first set of recommendations was published in 1996 and updated in 2001[18,20]. It is now endorsed by international editorial groups, including the International Committee of Medical Jounral Editors, and used by several hundred biomedical journals[21,22,23,24]. The CONSORT Statement has also led to recommendations on the reporting of cluster trials[25], equivalence and non-inferiority trials[26], and harms (e.g. safety and adverse events) in RCTs[27]. Recently, CONSORT has been extended to reporting herbal interventions[28]. Although not intended as an assessment tool, clinicians evaluating RCTs can use the CONSORT statement checklist to assess the number of reported criteria against a standard benchmark. This can help clinicians to determine whether a study report is in fact of high quality."

"

Item Description
1 Was the study described as randomized (this includes the use of words such as randomly, random, and randomization)?
2 Was the study described as double blind?
3 Was there a description of withdrawals and dropouts?
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