Article type
Year
Abstract
Background: Public interest in botanical medicines has generated an increasing number of trials evaluating their efficacy. Trials with poor methodological quality have exaggerated estimates of treatment effect and incomplete reporting of trials causes difficulties in assessing trial methodological quality.
Objectives: To examine the quality of reporting of randomized controlled intervention trials (RCTs) of botanical medicine.
Methods: Medline (1966 Feb 2003) was searched for RCTs of nine botanical medicines. Two individuals (JG, JD) independently assessed trials using the CONSORT (Consolidated Standard of Reporting Trials) checklist. Disagreements were resolved by consensus. Inter-rater reliability was assessed with percentage agreement. Mean number of checklist items reported across all and for individual botanicals was calculated. The influence of time (1970s, 1980s, 1990s, 2000s) was explored with logistical regression.
Results: A total of 206 RCTs of botanical medicine were included. Inter-rater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. Greater than half of the items extracted were reported in less than half of the trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual botanical species differed in the total number of items reported, with Echinacea, Ginkgo, St. John s wort and Kava trials reporting the most items.
Conclusions: Quality of reporting of RCTs of botanical medicines is poor. Also, key information unique to these trials may be missing, such as percentage of active constituents. We suggest trialists consult the CONSORT statement when designing and reporting RCTs of botanical medicines.
Objectives: To examine the quality of reporting of randomized controlled intervention trials (RCTs) of botanical medicine.
Methods: Medline (1966 Feb 2003) was searched for RCTs of nine botanical medicines. Two individuals (JG, JD) independently assessed trials using the CONSORT (Consolidated Standard of Reporting Trials) checklist. Disagreements were resolved by consensus. Inter-rater reliability was assessed with percentage agreement. Mean number of checklist items reported across all and for individual botanicals was calculated. The influence of time (1970s, 1980s, 1990s, 2000s) was explored with logistical regression.
Results: A total of 206 RCTs of botanical medicine were included. Inter-rater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. Greater than half of the items extracted were reported in less than half of the trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual botanical species differed in the total number of items reported, with Echinacea, Ginkgo, St. John s wort and Kava trials reporting the most items.
Conclusions: Quality of reporting of RCTs of botanical medicines is poor. Also, key information unique to these trials may be missing, such as percentage of active constituents. We suggest trialists consult the CONSORT statement when designing and reporting RCTs of botanical medicines.