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. 2013 Sep 3;2013(9):CD009128. doi: 10.1002/14651858.CD009128.pub3

Ludvik 2002.

Methods Parallel RCT
Randomisation ratio: 1:1
Superiority design
Participants Inclusion criteria: clinically stable T2DM on diet only
Exclusion criteria: no information
Diagnostic criteria: authors' criteria
Interventions Number of study centres: no information
Treatment before study: diabetic diet
Titration period: nil
Experimental intervention groups:
  1. Tablets each containing 168 mg powdered white‐skinned sweet potato (Ipomoea batatas)

  2. Tablets each containing 336 mg powdered white‐skinned sweet potato (Ipomoea batatas


Participants in each group received 4 tablets 3 times daily after meals for a period of 6 weeks. A total of 2 g and 4 g/day were ingested by participants in each group, respectively
Control intervention:
Placebo tablets. No information on the contents of these tablets
All patients were on diet regimen during the study
Outcomes Outcomes reported in abstract of publication:
Primary outcome(s): (as stated in the publication) change in fasting blood glucose
Seondary outcome(s): (as stated in the publication) change in plasma insulin level, serum cholesterol and weight
Additional outcome(s): incidence of adverse events
Study details Run‐in period: no information
Was s tudy terminated early (for benefit/because of adverse events): no
Publication details Language of publication: English
Commercial funding: grant from manufacturer
Publication status: peer review journal
Stated aim of study Quote from publication: "To assess the effect of caiapo on glucose metabolism, its tolerability and mode of action in male Caucasian type 2 diabetic patients".
Notes Letter to editor. Pilot study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote from publication: "randomised to receive placebo or 2 (low dose) or 4 g (high dose) caiapo"
 Comment: there was no description of generation of the random sequence; furthermore, reports of 2 other trials by the same principal investigators that used a similar intervention also provided no information about sequence generation
Allocation concealment (selection bias) Unclear risk Comment: there was no information provided about the method of allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote from publication: "double‐blind"
Comment: there was no other information available concerning blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: fasting blood glucose was specifically accessed at each visit for each participant
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: all participants completed the study, no treatment withdrawals or major adverse events reported
Selective reporting (reporting bias) Low risk Comment: primary outcomes were stated
Other bias Unclear risk Comment: there was no information about the sample size calculation or exclusion criteria; there was also insufficient information to assess other important risks of bias