Assessing the quality of RCTs on the effect of beta-elemene, one ingredient of a Chinese herb, against malignant tumors.
OBJECTIVE
To evaluate the quality of randomized controlled trials (RCTs) for Elemene injections, one ingredient of Chinese herb Curcuma wenyujin, for malignant tumors widely used in clinical practice in China.


METHODS
We used a systematic sample of 127 reports of RCTs that used Elemene injections as an intervention. The quality of each report was assessed using the number of Consolidated Standards for Reporting of Trials (CONSORT) checklist items included, the frequency of allocation concealment and a 5-point quality assessment instrument (Jadad).


RESULTS
69.44% of the CONSORT checklist items was included in the reports. Only 2 (1.57%) RCTs reported allocation concealment by sealed envelopes. 123 (96.85%) reports described baseline demographic and clinical characteristics of each group. But only 5 (3.94%) of 127 RCTs reported statistics analysis results of baseline data. None of the reports stated in the methods section that intention-to-treat (ITT) analysis was used, although 111 (87.40%) reports described the number of participants (denominator) in each group included in each analysis. Information regarding adverse events was reported in 83.46% of the RCTs. However the quality of reports were low as assessed by the Jadad scale.


CONCLUSIONS
The methodological quality of RCTs of Elemene injection against malignant tumors was low. Therefore, the effect of Elemene injection being used in clinical settings needs to be confirmed by further RCTs. Meanwhile, there is a need to supervise and urge researchers in China to conform to Good Clinical Practice (GCP) and CONSORT guidelines when reporting.
Peng
Xiaoxia
X
School of the Public Health and Family Medicine, Capital University of Medical Sciences, Beijing 100054, China.
Zhao
Yali
Y
Liang
Xiaoyun
X
Wu
LiJuan
L
Cui
Shuqi
S
Guo
Aimin
A
Wang
Wei
W
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D030024:Curcuma; D016208:Databases, Factual; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D012717:Sesquiterpenes / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D004365:Drugs, Chinese Herbal; D012717:Sesquiterpenes; C445979:beta-elemene