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Case reports of adverse effects of herbal medicinal products (HMPs): a quality assessment
Shao Kang Hung1, Sarah Hillier, Edzard Ernst
1Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK. shao.hung@pms.ac.uk
Background:
Case reports provide essential information on adverse effects. Yet there is little consistency in the quality and format of reporting them.
Aim:
In this study, we aimed to assess the quality of case reports of adverse effect of herbal medicinal products (HMPs) published during three time periods, 1986-1988, 1996-1998, and 2006-2008.
Methods:
We conducted literature searches in four major databases: Medline, EMBASE, AMED, and CINALH. Each case report was subject to specific inclusion criteria related to the intervention (i.e. herbal medicine) and outcome measurement (i.e. adverse effect). A 21-item scale was used to assess the quality of all included reports. Each report was categorised into low quality (score between 0 and 14), lower medium quality (score between 15 and 21), upper medium quality (score between 22 and 28), and high quality (score between 29 and 42).
Results:
In total, 137 case reports were included. The percentage of high quality case reports rose from 0% in 1986-1988 to 27.9% in 1996-1998 and 34.2% in 2006-2008; conversely, the percentages of low quality case reports dropped from 13.3% in 1986-1988 to 0% in 1996-1998 and 2.5% in 2006-2008.
Conclusion:
These findings are consistent with the notion that the quality of case reports is improving. However, due to several caveats, our data should be interpreted with caution.
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