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:
EXCLUSION CRITERIA: NR DIAGNOSTIC CRITERIA:
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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 |
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Outcomes |
OUTCOME(S) (as stated in the protocol/registered trial documents): PRIMARY OUTCOME(S): unknown SECONDARY OUTCOME(S): unknown OTHER OUTCOME(S): unknown |
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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 |