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Isoflavones for hypercholesterolemia

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Appendices

Appendix 1. Search strategies

Search terms

Unless otherwise stated, search terms are free text terms; MeSH = Medical subject heading (MEDLINE medical index term); exp = exploded MeSH; the dollar sign ($) stands for any character(s); the question mark (?) substitutes one or no characters; tw = text word; pt = publication type; sh = MeSH; adj = adjacent (i.e. number of words within range of search term).

The Cochrane Library:

#1 MeSH descriptor Hypercholesterolemia explode all trees

#2 MeSH descriptor Hyperlipoproteinemias explode all trees

#3 MeSH descriptor Cholesterol, HDL explode all trees

#4 MeSH descriptor Cholesterol, LDL explode all trees

#5 MeSH descriptor Lipoproteins, HDL explode all trees

#6 MeSH descriptor Lipoproteins, LDL explode all trees

#7 (hypercholesterolaemi* in All Text or hypercholesterolemi* in All Text or hyperlipoproteinaemi* in All Text or hyperlipoproteinemi* in All Text or hyperlipaemi* in All Text or hyperlipemi* in All Text)

#8 (HDL in All Text or LDL in All Text or cholesterol in All Text)

#9 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8)

#10 MeSH descriptor Isoflavones explode all trees

#11 MeSH descriptor Soybeans explode all trees

#12 (biochanin* in All Text or formononetin* in All Text or prunetin* in All Text)

#13 ((red in All Text and glover* in All Text) or (alfalfa in All Text and sprout* in All Text))

#14 soybean* in All Text

#15 (coumestrol in All Text or pterocarpans in All Text or rotenone in All Text)

#16 (daidzin* in All Text or daidzein* in All Text or genistin* in All Text or genistein* in All Text or glycetin* in All Text or glycetein* in All Text)

#17 (#10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16)

#18 (#9 AND #17)

  

MEDLINE:

1     exp hypercholesterolemia/ or exp hyperlipoproteinemias/

2     (hypercholesterol?emi* or hyperlipoprotein?emi* or hyperlip?emi*).tw,ot.

3     (HDL or LDL or cholesterol).tw,ot.

4     exp Lipoproteins, HDL/ or exp Cholesterol, HDL/

5     exp Cholesterol, LDL/ or exp Lipoproteins, LDL/

6     or/1‐5

7     exp Isoflavones/

8     exp Genistein/ or exp Soybeans/

9     (daidzin* or daidzein* or genistin* or genistein* or glycetin* or glycetein*).tw,ot.

10     (biochanin* or formononetin* or prunetin*).tw,ot.

11     (coumestrol or pterocarpans or rotenone).tw,ot.

12     (red glover* or alfalfa sprout* or soybean*).tw,ot.

13     or/7‐12

14     randomized controlled trial.pt.

15     controlled clinical trial.pt.

16     randomi?ed.ab.

17     placebo.ab.

18     drug therapy.fs.

19     randomly.ab.

20     trial.ab.

21     groups.ab.

22     or/14‐21

23     Meta‐analysis.pt.

24     exp Technology Assessment, Biomedical/

25     exp Meta‐analysis/

26     exp Meta‐analysis as topic/

27     hta.tw,ot.

28     (health technology adj6 assessment$).tw,ot.

29     (meta analy$ or metaanaly$ or meta?analy$).tw,ot.

30     ((review$ or search$) adj10 (literature$ or medical database$ or medline or pubmed or embase or  cochrane or cinahl or psycinfo or psyclit or healthstar or biosis or current content$ or systemat$)).tw,ot.

31     or/23‐30

32     22 or 31

33     (comment or editorial or historical‐article).pt.

34     32 not 33

35     (animals not (humans and animals)).sh.

36     34 not 35

37     6 and 13 and 36

 

EMBASE:

1     exp hyperlipidemia/

2     exp high density lipoprotein/

3     exp low density lipoprotein/

4     exp high density lipoprotein cholesterol/

5     exp low density lipoprotein cholesterol/

6     (hypercholesterol?emi* or hyperlipoprotein?emi* or hyperlipid?emi*).tw,ot.

7     exp cholesterol/

8     ((HDL or LDL) adj6 (lipoprotein* or cholesterol*)).tw,ot.

9     or/1‐8

10     exp isoflavone derivative/

11     exp isoflavone/

12     exp genistein/

13     exp soybean/

14     exp daidzin/

15     exp daidzein/

16     exp genistin/

17     exp glycitein/

18     exp biochanin A/

19     exp formononetin/

20     exp prunetin/

21     isoflavone*.tw,ot.

22     (coumestrol or pterocarpans or rotenone).tw,ot.

23     (genistein* or genistin* or soybean* or daidzein* or glycitein* or biochanin* or formononetin*  or prunetin*).tw,ot.

24     (red glover* or alfalfa sprout*).tw,ot.

25     or/10‐24

26     exp Randomized Controlled Trial/

27     exp Controlled Clinical Trial/

28     exp Clinical Trial/

29     exp Comparative Study/

30     exp Drug comparison/ 

31     exp Randomization/

32     exp Crossover procedure/

33     exp Double blind procedure/

34     exp Single blind procedure/

35     exp Placebo/

36     exp Prospective Study/

37     ((clinical or control$ or comparativ$ or placebo$ or prospectiv$ or randomi?ed) adj3 (trial$ or stud$)).ab,ti.

38     (random$ adj6 (allocat$ or assign$ or basis or order$)).ab,ti.

39     ((singl$ or doubl$ or trebl$ or tripl$) adj6 (blind$ or mask$)).ab,ti.

40     (cross over or crossover).ab,ti.

41     or/26‐40

42     exp meta analysis/

43     (metaanaly$ or meta analy$ or meta?analy$).ab,ti,ot.

44     ((review$ or search$) adj10 (literature$ or medical database$ or medline or pubmed or embase or  cochrane or cinahl or psycinfo or psyclit or healthstar or biosis or current content$ or systematic$)).ab,ti,ot.

45     exp Literature/

46     exp Biomedical Technology Assessment/

47     hta.tw,ot.

48     (health technology adj6 assessment$).tw,ot.

49     or/42‐48

50     41 or 49

51     (comment or editorial or historical‐article).pt.

52     50 not 51

53     9 and 25 and 52

54     limit 53 to human

China National Knowledge Infrastructure:

#1 (soy or soya):ti,ab,kw

#2 (tofu):ti,ab,kw

#3 (red clover):ti,ab,kw

#4 (isoflavone or isoflavones):ti,ab,kw

#5 (daidzin or daidzein):ti,ab,kw

#6 (genistin or genistein):ti,ab,kw

#7 (glycetin or glycetein):ti,ab,kw

#8 #1 or #2 or #3 or #4 or #5 or $6 or #7

#9 (cholesterol):ti,ab,kw

#10 (triglyceride):ti,ab,kw

#11 (lipid or lipids):ti,ab,kw

#12 (LDL‐C or HDL‐C):ti,ab,kw

#13 #9 or #10 or #11 or #12

#14 #8 and #13

Appendix 2. Description of interventions

Characteristic

study ID1

study ID2

study ID3

study ID4

study ID5

study ID6

study ID7

study ID8

study ID9

Intervention(s)

[route, frequency, total dose/day]

e.g. isolfavones

Control(s)

[route, frequency, total dose/day]

e.g.
placebo

Footnotes

./. : not reported

Appendix 3. Baseline characteristics

Characteristic

study ID1

study ID2

study ID3

study ID4

study ID5

study ID6

study ID7

study ID8

study ID9

Intervention(s)

e.g. isolfavones

Control(s)

e.g. placebo

Participating population

Country

Sex [female%]

I:

C:

T:

I:

C:

T:

I:

C:

T:

I:

C:

T:

I:

C:

T:

I:

C:

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C:

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I:

C:

T:

I:

C:

T:

Age [mean years (SD); range]

I:

C:

T:

I:

C:

T:

I:

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I:

C:

T:

I:

C:

T:

I:

C:

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I:

C:

T:

I:

C:

T:

Duration of disease [mean years (SD); range]

I:

C:

T:

I:

C:

T:

I:

C:

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Ethnic groups [%]

I:

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T:

Duration of intervention [mean (SD); range]

I:

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Duration of follow up [mean (SD); range]

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Co‐medications

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Co‐interventions

I:

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T:

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Co‐morbidities

I:

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Footnotes

./. : not reported

C: control; I: intervention; SD: standard deviation; T: total

Appendix 4. Matrix of study endpoints

Characteristic

study ID1

study ID2

study ID3

study ID4

study ID5

study ID6

study ID7

study ID8

study ID9

Intervention(s)

e.g. isolfavones

Control(s)

e.g. placebo

Primary1 endpoint(s)

Secondary2 endpoint(s)

Other3 endpoint(s)

Footnotes

1,2 verbatim statement in the publication; 3 not explicitly stated as primary or secondary endpoint(s) in the publication

./. : not reported

Appendix 5. Adverse events

Characteristic

study ID1

study ID2

study ID3

study ID4

study ID5

study ID6

study ID7

study ID8

study ID9

Intervention(s)

e.g. isolfavones

Control(s)

e.g. placebo

Deaths [n / N]

I:

C:

T:

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C:

T:

I:

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I:

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All adverse events [n / %]

I:

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Severe / serious adverse events [n / %]

I:

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Drop‐outs due to adverse events [n / %]

I:

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Hospitalization [n / %]

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Out‐patient treatment [n / %]

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Symptoms [n / %]

I:

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Footnotes

./. : not reported

C: control; I: intervention; T: total

Appendix 6. Survey of authors' reactions to provide information on trials

Characteristic

study ID1

study ID2

study ID3

study ID4

study ID5

study ID6

study ID7

study ID8

study ID9

Study author contacted

Study author replied

No communication possible

Footnotes

n: no; y: yes

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Table 1. Overview of study populations

Study ID

Intervention(s) & control(s)

[n] screened

[n] randomized

[n] safety

[n] ITT

[n] finishing study

[%] of randomized participants
finishing study

ID1

I1: e.g. isoflavones

C1: e.g. placebo

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID2

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID3

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID3

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID4

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID5

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID6

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID7

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID8

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

ID9

I1:

C1:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

I1:

C1:

T:

Total

I1:

C1:

T:

I1:

C1:

T:

./. : not reported

C: control; I: intervention; ITT: intention‐to‐treat; T: Total

Figuras y tablas -
Table 1. Overview of study populations