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Acupuncture for primary hypercholesterolaemia

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Appendices

Appendix 1. Search strategies

Search terms and databases

Unless otherwise stated, search terms are free text terms.

Abbreviations:

'$': stands for any character; '?': substitutes one or no character; adj: adjacent (i.e. number of words within range of search term); exp: exploded MeSH; MeSH: medical subject heading (MEDLINE medical index term); pt: publication type; sh: MeSH; tw: text word.

The Cochrane Library

#1   MeSH descriptor Hypercholesterolemia explode all trees
#2   MeSH descriptor Hyperlipoproteinemias explode all trees
#3   MeSH descriptor Cholesterol explode all trees
#4   (hypercholesterol?emia* in All Text or hyperlipoprotein?emia* in All Text)
#5   (HDL in All Text near/6 elevat* in All Text)
#6   (HDL in All Text near/6 ris* in All Text)
#7   (HDL in All Text near/6 increas* in All Text)
#8   (HDL in All Text near/6 improv* in All Text)
#9   (LDL in All Text near/6 elevat* in All Text)
#10 (LDL in All Text near/6 ris* in All Text)
#11 (LDL in All Text near/6 increas* in All Text)
#12 (LDL in All Text near/6 improv* in All Text)
#13 (cholesterol in All Text near/6 elevat* in All Text)
#14 (cholesterol in All Text near/6 ris* in All Text)
#15 (cholesterol in All Text near/6 increas* in All Text)
#16 (cholesterol in All Text near/6 improv* in All Text)
#17 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16)
#18 MeSH descriptor Acupuncture explode all trees
#19 MeSH descriptor Acupuncture therapy explode all trees
#20 MeSH descriptor Acupressure explode all trees
#21 (acupuncture in All Text or acupressure in All Text or acupoint in All Text)
#22 MeSH descriptor Electroacupuncture explode all trees
#23 (electro‐acupuncture in All Text or electroacupuncture in All Text)
#24 (#18 or #19 or #20 or #21 or #22 or #23)
#25 (#17 and #24)

MEDLINE

1.    exp Acupuncture/
2.    exp Acupuncture Therapy/
3.    exp Acupressure/
4.    (acupuncture or acupressure or acupoint).tw,ot.
5.    exp Electroacupuncture/
6.    (electro‐acupuncture or electroacupuncture).tw,ot.
7.    or/1‐6
8.    exp hypercholesterolemia/ or exp hyperlipoproteinemias/
9.    exp Cholesterol/
10.  (hypercholesterol?emi$ or hyperlipoprotein?emia).tw,ot.
11.  ((HDL or LDL or cholesterol) adj6 (elevat$ or ascend$ or increase$ or improve$)).tw,ot.
12.  or/8‐11
13.  7 and 12
14.  randomized controlled trial.pt.
15.  controlled clinical trial.pt.
16.  randomi$ed.ab.
17.  placebo.ab.
18.  drug therapy.fs.
19.  trial.ab.
20.  groups.ab.
21.  or/14‐20
22.  meta‐analysis.pt.
23.  exp Technology Assessment, Biomedical/
24.  exp. Meta‐analysis/
25.  exp Meta‐analysis as topic/
26.  hta.tw,ot
27.  (health technology adj6 assessment$).tw,ot.
28.  (meta analy$ or metaanaly$ or meta?analy$).tw,ot.
29.  ((review$ 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.
30.  or/22‐29
31.  (comment or editorial or historical‐article).pt
32.  30 not 31
33.  21 or 32
34.  13 and 33
35.  (animals not (animals and humans)).sh.
36. 34 not 35

EMBASE

1.    exp acupuncture/
2.    exp acupressure/
3.    (acupuncture or acupressure or acupoint).tw,ot.
4.    exp electroacupuncture/
5.    (electro‐acupuncture or electroacupuncture).tw,ot.
6.    or/1‐5
7.    exp hypercholesterolemia/
8.    exp hyperlipoproteinemia/
9.    exp cholesterol/
10.  (hypercholesterol?emi$ or hyperlipoprotein?emia$).tw,ot.
11.  ((HDL or LDL or cholesterol) adj3 (elevat$ or ascend$ or ris$ or increase$ or improve$)).tw,ot.
12.  or/7‐11
13.  6 and 12
14.  exp Randomized Controlled Trial/
15.  exp Controlled Clinical Trial/
16.  exp Clinical Trial/
17.  exp Comparative Study/
18.  exp Drug comparison/
19.  exp Randomization/
20.  exp Crossover procedure/
21.  exp Double blind procedure/
22.  exp Single blind procedure/
23.  exp Placebo
24.  exp Prospective Study/
25.  ((comparative$ or prospective$ or randomi$ed) adj3 (trial$ or stud$)).ab,ti.

26.  (random$ adj6 (allocate$ or assign$ or basis or order$)).ab,ti.
27.  ((singl$ or doubl$ or trebl$ or tripl$) adj6 (blind$ or mask$)).ab,ti.
28.  (cross over or crossover).ab,ti.
29.  or/14‐28
30.  exp meta analysis/
31.  (metaanaly$ or meta analy$ or meta?analy$).ab,ti,ot.
32.  ((review$ 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$)).ab,ti,ot.
33.  exp Literature/
34.  exp Biomedical Technology Assessment/
35.  hta.tw,ot.
36.  (health technology adj6 assessment$).tw,ot.
37.  or/30‐36
38.  (comment or editorial or historical‐article).pt.
39.  37 not 38
40.  29 or 39
41.  13 and 40
42. limit 41 to human

Chinese National Knowledge Infrastructure

1. exp Randomized Controlled trials / all subheadings
2. Random*
3. 1 or 2
4. exp acupuncture / all subheadings
5. exp acupressure / all subheadings
6. exp electroacupuncture / all subheadings
7. or/ 4‐6
8. hypercholesterolemia
9. cholesterol
10. or/8‐9
11. Human
12. 3 and 7 and 10 and 11

All of the search terms were translated to Chinese terms when we conducted the searches in CNKI database.

Chinese BioMedical Literature Database

#1 hypercholesterolemia
#2 cholesterol
#3 #1 or #2
#4 acupuncture

#5 acupressure

#6 electroacupuncture

#7 #4 or #5 or #6
#8 random
#9 #3 and #7 and #8
#10 exp animals/ not humans.sh.
#11 #9 not #10

 

All of the search terms were translated to Chinese terms when we conducted the searches in CBM database.

VIP database for Chinese Technical Periodicals

Title/Topic/Keyword=("hypercholesterolemia" or "cholesterol") AND Title/Topic/Keyword=(" acupuncture " or " acupressure " or " electroacupuncture ")

Timespan= 1979 to June 2012

 

All of the search terms were translated to Chinese terms when we conducted the searches in VIP database.

China's important Conference Papers Database

Title/Topic/Keyword=("hypercholesterolemia" or "cholesterol") AND Title/Topic/Keyword=(" acupuncture " or " acupressure " or " electroacupuncture ")

Timespan= 1979 to June 2012

 

All of the search terms were translated to Chinese terms when we conducted the searches in Chinese Conference Papers Database.

China Dissertation Database

Title/Topic/Keyword=("hypercholesterolemia" or "cholesterol") AND Title/Topic/Keyword=(" acupuncture " or " acupressure " or " electroacupuncture ")

Timespan= 1979 to June 2012

 

All of the search terms were translated to Chinese terms when we conducted the searches in Chinese Dissertation Database.

'My NCBI' alert service

("acupuncture"[MeSH Terms] OR "acupuncture"[All Fields] OR "acupuncture therapy"[MeSH Terms] OR ("acupuncture"[All Fields] AND "therapy"[All Fields]) OR "acupuncture therapy"[All Fields]) AND ("hypercholesterolaemia"[All Fields] OR "hypercholesterolemia"[MeSH Terms] OR "hypercholesterolemia"[All Fields])

Appendix 2. Characteristics of included studies table: template

Methods

PARALLEL/CROSS‐OVER/CLUSTER/FACTORIAL RANDOMISED CONTROLLED CLINICAL TRIAL

RANDOMISATION RATIO:

SUPERIORITY DESIGN

NON‐INFERIORITY DESIGN (specify 1‐ or 2‐sided confidence interval)

EQUIVALENCE DESIGN (specify 1‐ or 2‐sided confidence interval)

CONTROLLED CLINICAL TRIAL (CCT)

Participants

INCLUSION CRITERIA:

EXCLUSION CRITERIA:

DIAGNOSTIC CRITERIA:

Interventions

NUMBER OF STUDY CENTRES:

TREATMENT BEFORE STUDY:

TITRATION PERIOD:

(FOR COMPLEX INTERVENTIONS: DETAILED DESCRIPTION OF ALL INTERVENTIONS)

Outcomes

OUTCOMES REPORTED IN ABSTRACT OF PUBLICATION:

Study details

RUN‐IN PERIOD:

STUDY TERMINATED BEFORE REGULAR END: yes/no

Publication details

LANGUAGE OF PUBLICATION:

COMMERCIAL/NON‐COMMERCIAL/OTHER FUNDING

PUBLICATION STATUS (PEER REVIEW JOURNAL/JOURNAL SUPPLEMENT/ABSTRACT/OTHER)

Stated aim of study

Quote from publication: "...".

Notes

Abbreviations:

Appendix 3. Description of interventions

Characteristic

Study ID

Intervention(s)
[route, frequency, total dose/day]

Control(s)
[route, frequency, total dose/day]

Study 1

Intervention 1

Control 1

Intervention 2

Control 2

Study 2

Intervention 1

Control 1

Intervention 2

Control 2

Study 3

Intervention 1

Control 1

Intervention 2

Control 2

Study 4

Intervention 1

Control 1

Intervention 2

Control 2

Footnotes

"‐" denotes not reported

Appendix 4. Baseline characteristics (I)

Characteristic

Study ID

Intervention(s) and
control(s)

Duration of intervention
(duration of follow‐up)

Participating
population

Year of study

Country

Setting

Ethnic groups
[%]

Duration of disease
[mean/range years (SD), or as reported]

Study 1

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 2

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 3

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 4

Intervention 1

Intervention 2

Control 1

Control 2

all:

Footnotes

"‐" denotes not reported

SD: standard deviation

Appendix 5. Baseline characteristics (II)

Characteristic

Study ID

Intervention(s) and
control(s)

Sex
[female %]

Age
[mean/range years (SD),
or as reported]

BMI
[mean kg/m2 (SD)]

Co‐medications/
Co‐interventions

Co‐morbidities

Study 1

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 2

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 3

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 4

Intervention 1

Intervention 2

Control 1

Control 2

all:

Footnotes

"‐" denotes not reported

BMI: body mass index; SD: standard deviation

Appendix 6. Matrix of study endpoints (publications)

Characteristic

Study ID

Endpoint

Time of measurementa

Outcome reportingb
[analysed and reported as not significant (e.g. P > 0.05)]

Outcome reportingb
[analysed but not reported]

Outcome reportingb
[measured and not analysed or analysed but not reported because of non‐significant results ]

Outcome reportingb
[not mentioned but likely to have been measured and analysed but not reported because of non‐significant results]

Example

Cardiovascular events (P/S/O)

0, 12 mo

x

Total serum cholesterol levels (P/S/O)

0, 3, 6, 12 mo

x

Health‐related quality of life (P/S/O)

0, 12 mo

x

Study 1

Footnotes

aUnderlined times of measurement denote data as reported in the results section of the publication (other times represent planned but not reported points in time).

bConstitutes 'high risk of bias' according to the Outcome Reporting Bias In Trials (ORBIT) study classification system for missing or incomplete outcome reporting in reports of randomised trials (Kirkham 2010).

(P) primary or (S) secondary endpoint(s) refer to verbatim statements in the publication, (O) other endpoints relate to outcomes which were not specified as 'primary' or 'secondary' outcomes in the publication

endpoint in bold = review primary outcome

mo: months

Appendix 7. Matrix of study endpoints (protocol/trial documents)

Characteristic

Study ID (trial identifier)

Endpoint

Time of measurement

Example

Cardiovascular events (P/S/O)

0, 12 mo

Total serum cholesterol levels (P/S/O)

0, 3, 6, 12 mo

Health‐related quality of life (P/S/O)

0, 12 mo

Study 1

Footnotes

(P) primary or (S) secondary endpoint(s) refer to verbatim statements in the protocol/trial documents, (O) other endpoints relate to outcomes which were not specified as 'primary' or 'secondary' outcomes in the protocol/trial documents

endpoint in bold = review primary outcome

mo: months

Appendix 8. Definition of endpoint measurement

Characteristic

Study ID

Cardiovascular
events

Myocardial infarction

Angina pectoris

Stroke

Peripheral arterial disease

Health‐related
quality of life

Severe/serious
adverse events

Study 1

Study 2

Study 3

Study 4

Footnotes

"‐" denotes not reported

Appendix 9. Adverse events (I)

Characteristic

Study ID

Intervention(s) and
control(s)

[n] Randomised /
Safety

Deaths
[n]

Deaths
[%]

All adverse
events
[n]

All adverse
events
[%]

Severe/serious
adverse events
[n]

Severe/serious
adverse events
[%]

Study 1

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 2

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 3

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 4

Intervention 1

Intervention 2

Control 1

Control 2

all:

Footnotes

"‐" denotes not reported

Appendix 10. Adverse events (II)

Characteristic

Study ID

Intervention(s) and
control(s)

[n] Randomised/safety

Left study due to adverse events
[n]

Left study due to adverse events
[%]

Hospitalisation
[n]

Hospitalisation
[%]

Out‐patient treatment
[n]

Out‐patient treatment
[%]

Study 1

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 2

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 3

Intervention 1

Intervention 2

Control 1

Control 2

all:

Study 4

Intervention 1

Intervention 2

Control 1

Control 2

all:

Footnotes

"‐" denotes not reported

Appendix 11. STRICTA 2010 items of information for clinical trials of acupuncture

Study ID

Characteristic

Study 1

Study 2

Study 3

Study 4

Study 5

Study 6

Study 7

1. Acupuncture rationale

Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese, Korean, Western medical, Five Element, ear acupuncture, etc)

Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate

Extent to which treatment was varied

2. Details of needling

Number of needle insertions per subject per session (mean and range where relevant)

Names (or location if no standard name) of points used (uni/bilateral)

Depth of insertion, based on a specified unit of measurement, or on a particular tissue level

Response sought (e.g. de qi or muscle twitch response)

Needle stimulation (e.g. manual, electrical)

Needle retention time

Needle type (diameter, length, and manufacturer or material)

3. Treatment regimen

Number of treatment sessions

Frequency and duration of treatment sessions

4. Other components of treatment

Details of other interventions administered to the acupuncture group (e.g. moxibustion, cupping, herbs, exercises, lifestyle advice)

Setting and context of treatment, including instructions to practitioners, and information and explanations to patients

5. Practitioner background

Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience)

6. Control or comparator interventions

Rationale for the control or comparator in the context of the research question, with sources that justify this choice

Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture‐like control was used, details as for items 1 to 3 above

Footnotes

"‐" denotes not reported

STRICTA: standards for reporting interventions in clinical trials of acupuncture (MacPherson 2010)

de qi:

Appendix 12. Survey of authors providing information on trials

Characteristic

Study ID

Study author contacted

Study author replied

Study author asked for
additional information

Study author provided data

Study 1

Study 2

Study 3

Study 4

Footnotes

n: no; y: yes

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Table 1. Overview of study populations

Characteristic

Study ID

Intervention(s) and
control(s)

[n] screened/eligible

[n] randomised

[n] safety

[n] ITT

[n] finishing study

[%] randomised
finishing study

Study 1

intervention 1

intervention 2

control 1

control 2

total:

Study 2

intervention 1

intervention 2

control 1

control 2

total:

Study 3

intervention 1

intervention 2

control 1

control 2

total:

Study 4

intervention 1

intervention 2

control 1

control 2

total:

Total

All interventions

...

...

All controls

...

...

All interventions and controls

...

...

"‐" denotes not reported

ITT: intention‐to‐treat

Figures and Tables -
Table 1. Overview of study populations