Article type
Year
Abstract
Background: The N-of-1 trial, one of the methods of randomized controlled trial, allows for the highest level of evidence for individual patients. To date, none of the methods developed is perfect and all can be developed further to maximize use in health systems. N-of-1 trials are used to estimate safety and efficacy of interventions and may be an attractive methodology for conducting trials of Traditional Chinese Medicines (TCM) in Cancer.
Objectives: To assess potential advantages to the use of n-of-1 trials with TCM in cancer patients for better clinical decision-making.
Methods: We identified n-of-1 trial publications from electronic databases included PubMed, EMBASE, the Cochrane Library, SCI, Clinical Trials Registration and Chinese databases (CNKI, VIP, CBM). Three researchers have independently assessed these studies for there advantages using Epidata 3.1.
Results: These advantages include the ability of determining whether TCM is effective in cancer patients. In addition, n-of-1 trials allow individuals to express preference for better interventions and to get involved in balancing therapeutic benefits and adverse events. Also, about estimating population effects, combining multiple n-of-1 trials tends to require smaller sample sizes than do traditional parallel-group randomized controlled trials.
Conclusions: N-of-1 trials may be very beneficial in assessing TCM intervention in cancer patients. We should give more careful consideration on advantages and disadvantages. And researchers and TCM clinicians should do more to improve these, thereby allowing the conduct of their studies to be monitored and improved. N-of-1 trials will be well-developed in good trend of the development of Traditional Chinese Medicines in Cancer.
Objectives: To assess potential advantages to the use of n-of-1 trials with TCM in cancer patients for better clinical decision-making.
Methods: We identified n-of-1 trial publications from electronic databases included PubMed, EMBASE, the Cochrane Library, SCI, Clinical Trials Registration and Chinese databases (CNKI, VIP, CBM). Three researchers have independently assessed these studies for there advantages using Epidata 3.1.
Results: These advantages include the ability of determining whether TCM is effective in cancer patients. In addition, n-of-1 trials allow individuals to express preference for better interventions and to get involved in balancing therapeutic benefits and adverse events. Also, about estimating population effects, combining multiple n-of-1 trials tends to require smaller sample sizes than do traditional parallel-group randomized controlled trials.
Conclusions: N-of-1 trials may be very beneficial in assessing TCM intervention in cancer patients. We should give more careful consideration on advantages and disadvantages. And researchers and TCM clinicians should do more to improve these, thereby allowing the conduct of their studies to be monitored and improved. N-of-1 trials will be well-developed in good trend of the development of Traditional Chinese Medicines in Cancer.