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. 2012 Dec 12;2012(12):CD008650. doi: 10.1002/14651858.CD008650.pub2

Tsuchida 2002.

Methods The study was a randomised, placebo‐controlled, double‐blind trial with a treatment to control randomisation ratio of 1:1.05
Participants INCLUSION CRITERIA:
  • BMI 24 to 30 kg/m2

  • male and female


EXCLUSION CRITERIA: NR
DIAGNOSTIC CRITERIA:
  • height

  • weight

  • BMI (calculated from previous 2 measurements)

Interventions NUMBER OF STUDY CENTRES: 6
COUNTRY/ LOCATION: Japan/Kodama Central Hospital (Kodama County), Central Hospital (Tokyo), Hiratsuka Gastroenterological Hospital, (Tokyo), Kousei Medical Clinic (Tokyo), Takanashi Clinic (Tokyo) and Isogo Central Neurosurgical Hospital and Health Management Center (Yokohama)
SETTING: clinics, hospitals, health management centre
TREATMENT BEFORE STUDY:
note: 2‐week run‐in period
Outcomes OUTCOME(S) (as stated in the protocol/registered trial documents):
PRIMARY OUTCOME(S): unknown
SECONDARY OUTCOME(S): unknown
OTHER OUTCOME(S): unknown
Study details STUDY TERMINATED BEFORE REGULAR END: no
Publication details This study was published in Japanese in the journal Progress in Medicine and no sources of funding were reported
Stated aim of study Quote from study: "In the present study, we expanded the scale of investigation so as to verify the effect of catechins on body fat reduction in a participant group that included women"
Notes BMI: body mass index
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote from study: "after a two‐week run‐in period, participants at each facility were randomly assigned, male and female by turn, into two groups"
Comment: we judged this to be an inappropriate method of randomisation, and at a high risk of bias
Allocation concealment (selection bias) Unclear risk Comment: not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote from study: "a double blind study was then conducted over two 12‐week periods..."
Comment: no mention of effectiveness of blinding efforts. No mention of whether researchers and staff were blinded to study components
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: all outcomes on which the study reported were objective and measured by assessors. Therefore, whether or not assessors were blinded, risk of detection bias was assessed as low
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: recruitment and randomisation numbers are not given, so it is unclear whether there was any attrition
Selective reporting (reporting bias) Unclear risk Comment: authors did not clearly state what they would look for, so it is difficult to be sure that there was not selective reporting
Other bias Low risk Comment: appears to be free of other bias