Background: Recently, more literatures on clinical randomized controlled trial (RCT) of Pre-eclampsia treated with traditional Chinese medicine (TCM) are seen on journals. However, the quality of these reports is unknown.
Objectives: Evaluate the quality of literatures on RCT of Pre-eclampsia treated with TCM.
Methods: Search studies in which TCM was used for treating Pre-eclampsia by electronic search (Medline, EMB, CBM and Central), hand search (i.e. Chinese Journal of Obstetrics and Gynecology) and the other methods (i.e. reference list of relevant trials and reviews). Include literatures which reported "randomized allocation". Contact with authors by phone and ask detailed methods used in studies, such as methods of randomization. Evaluate the quality of literatures basing on criteria:
1. Randomization (detailed method of randomization; adequate or not)
2. Blind (single, double, triple or not used)
3. Allocation concealment
4. Withdrawal rate (did intention-to-treat analysis or not)
5. Baseline characteristic.
Results: Twenty three trials were included. Authors of four trials were failed to be contacted. The quality of these four trials was not clear. Two literatures reported as clinical trials were just conclusion of cases. Methods of random were reported in nine literatures. Random number table was used in one trial. Participants in the other sixteen were allocated by hospitalized sequence. Single blind was used in seventeen trials. Allocation concealment was not used in any trial. Intention-to-treat analysis was not done in three trials in which not all participants completed trials. Similarity of baseline was not reported in seven literatures. Baseline was comparable in the others.
Conclusions: Methodological problem existed in literatures on clinical randomized controlled trial of Pre-eclampsia treated with TCM. Most studies reporting "randomized allocation" were just quasi-randomized controlled trials. Since now, there wasnÂt high quality study on the effect of TCM in treating women with pre-eclampsia. The trials in the future should be trials with accurate randomization, allocation concealment, blinding, control, suitable sample size. Authors should know the difference between clinical trial and conclusion of cases. Publication type should be correct.