OBJECTIVES: This study aimed at assessing whether there are differences in the reporting of ethical aspects of complementary and alternative medicine (CAM) and mainstream medical research. DESIGN: Review of published literature. SETTING: Research department of medical school. MAIN OUTCOME MEASURES: Reports of ethical aspects including adherence to clinical guidelines, ethical approval from ethics committees, consent of the patient, declaration of conflict of interest, and declaration of funding for a study. RESULTS: We included 21 articles from CAM journals, as well as 16 from equal impact factor mainstream (EIF) journals and 27 from high impact factor (HIF) journals. A statistically significant difference was found in the reporting of ethical approval: 62% of all CAM articles, 75% of the EIF and 93% of the HIF journal articles reported approval from ethics committees [chi2 = (2, n = 64) 6.631, p<0.05]. Regarding the reporting of obtaining patients' consent there were no statistically significant differences: 48% of all CAM articles, 38% of the EIF mainstream and 67% of the HIF mainstream journal articles explicitly stated that patients signed a consent form [chi2 = (2, n = 64) 3.813, p>.05]. High impact factor journals were more likely to report on ethical standards than other journals on conflicts of interests and sponsorship. However, they were less likely to report a reference to ethical guidelines. Articles from CAM journals had more strict reporting requirements than mainstream medicine journals with comparable impact factors. CONCLUSIONS: Differences exist between complementary and orthodox medical journals in the reporting of ethical aspects of trial design.
OBJECTIVES: This study aimed at assessing whether there are differences in the reporting of ethical aspects of complementary and alternative medicine (CAM) and mainstream medical research. DESIGN: Review of published literature. SETTING: Research department of medical school. MAIN OUTCOME MEASURES: Reports of ethical aspects including adherence to clinical guidelines, ethical approval from ethics committees, consent of the patient, declaration of conflict of interest, and declaration of funding for a study. RESULTS: We included 21 articles from CAM journals, as well as 16 from equal impact factor mainstream (EIF) journals and 27 from high impact factor (HIF) journals. A statistically significant difference was found in the reporting of ethical approval: 62% of all CAM articles, 75% of the EIF and 93% of the HIF journal articles reported approval from ethics committees [chi2 = (2, n = 64) 6.631, p<0.05]. Regarding the reporting of obtaining patients' consent there were no statistically significant differences: 48% of all CAM articles, 38% of the EIF mainstream and 67% of the HIF mainstream journal articles explicitly stated that patients signed a consent form [chi2 = (2, n = 64) 3.813, p>.05]. High impact factor journals were more likely to report on ethical standards than other journals on conflicts of interests and sponsorship. However, they were less likely to report a reference to ethical guidelines. Articles from CAM journals had more strict reporting requirements than mainstream medicine journals with comparable impact factors. CONCLUSIONS: Differences exist between complementary and orthodox medical journals in the reporting of ethical aspects of trial design.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach