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{\title Electronic Appendix A: US Preventive Services task Force (Hierarchy of Evidence)}{\author ADA}{\operator ADA}{\creatim\yr2003\mo1\dy14\hr10\min58}{\revtim\yr2003\mo1\dy14\hr10\min59}{\version1}{\edmins1}{\nofpages6}{\nofwords887}{\nofchars5061}
{\*\company American Diabetes Association}{\nofcharsws6215}{\vern113}}\widowctrl\ftnbj\aenddoc\formshade\viewkind1\viewscale100\pgbrdrhead\pgbrdrfoot \fet0\sectd \linex0\endnhere\sectdefaultcl {\*\pnseclvl1\pnucrm\pnstart1\pnindent720\pnhang{\pntxta .}}
{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl3\pndec\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang{\pntxta )}}{\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}
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\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}\pard\plain \s18\sl480\slmult1\widctlpar\tx720\adjustright \cgrid {\b\ul Electronic Appendix A: US Preventive Services task Force (Hierarchy of Evidence)
\par }{
\par }{\b I}{: Evidence obtained from at least one properly designed RCT
\par }{\b II-1}{: Evidence obtained from well-designed controlled trials without randomization
\par }{\b II-2}{: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more that one center or research group
\par }{\b II-3}{: Evidence obtained from multiple time series with or without intervention. Dramatic results in uncontrolled experiments (such as the results of the
 introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.
\par }{\b III}{: Opinion of respected authorities, based on clinical experience, descriptive studies or case reports, or reports of expert committees
\par 
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\par }{\ul 
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\par }{\ul 
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\par }{\b\ul Electronic Appendix B: American Diabetes Association (Evidence grading system)}{\b 
\par }\pard \s18\fi-720\li720\sl480\slmult1\widctlpar\tx720\adjustright {\b A}{ \tab Clear evidence from well conducted, generalizable, randomized controlled trials that are adequately powered, including:
\par }\pard \s18\sl480\slmult1\widctlpar\tx720\adjustright {\tab *Evidence from a well-conducted multicenter trial
\par \tab *Evidence from a meta-analysis that incorporated quality ratings in the analysis
\par }\pard \s18\li720\sl480\slmult1\widctlpar\tx720\adjustright {*Compelling nonexperimental evidence, ie. \ldblquote all or none\rdblquote  rule developed by the Center for Evidence Based Medicine at Oxford
\par Supporting evidence from well-conducted randomized controlled trials that are adequately powered, including:
\par }\pard \s18\sl480\slmult1\widctlpar\tx720\adjustright {\tab *Evidence from a well-conducted trial at one or more institutions
\par \tab *Evidence from a meta-analysis that incorporated quality ratings in the analysis
\par }{\b B}{ \tab Supportive evidence from well-conducted cohort studies, including:
\par \tab *Evidence from a well-conducted prospective cohort study or registry
\par \tab *Evidence from a well-conducted meta-analysis of cohort studies
\par \tab Supportive evidence from a well-conducted case-control study
\par }{\b C}{ \tab Supportive evidence from poorly controlled or uncontrolled studies
\par }\pard \s18\li720\sl480\slmult1\widctlpar\tx720\adjustright {*Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
\par *Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls)
\par }\pard \s18\sl480\slmult1\widctlpar\tx720\adjustright {\tab *Evidence from case series or case reports
\par \tab Conflicting evidence with weight of evidence supporting the recommendation 
\par }\pard\plain \s5\keepn\widctlpar\outlinelevel4 \cgrid {\b E}{ \tab Expert consensus or clinical experience\tab 
\par }\pard\plain \widctlpar \fs20\cgrid {\fs24 
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\par }{\b\fs24\ul Electronic Appendix C: Criteria used to determine if a given CAM therapy should be recommended, accepted or discouraged*
\par }{\fs24 
\par }{\b\fs24 Recommend:
\par }\pard \sl360\slmult1\widctlpar {\fs24 Evidence supports both safety and efficacy
\par 1)Three or more RCT\rquote s have evaluated the therapy
\par 2)At least 3 trials had n>50
\par 3)At least 80% of trials support efficacy or a meta-analysis of trials supports efficacy
\par 4)Evidence supporting efficacy must come from more than one research team
\par 5)Any documented adverse events associated with the therapy have been minor (ie. Not life-threatening or permanently disabling)
\par 6)Based on current information, there is no obvious theoretical potential for major adverse events
\par 
\par }{\b\fs24 Accept, consider recommending:
\par }{\fs24 Evidence supports both safety and efficacy
\par 1)At least one RCT evaluated the therapy
\par 2)More than 50% of the trials support efficacy
\par 3)Evidence supporting efficacy fails to meet the criteria for therapies that may be recommended
\par 4)Any documented adverse events associated with the therapy have been minor (ie. Not life-threatening or permanently disabling)
\par 5)Based on current information, there is no obvious theoretical potential for major adverse events
\par 
\par }{\b\fs24 Accept:
\par }{\fs24 Evidence regarding efficacy is inconclusive but evidence supports safety
\par 1)Existing evidence is inadequate to conclude whether the therapy is effective or ineffective
\par 2)Data regarding efficacy fail to meet criteria for considering recommendation
\par 3)Data regarding efficacy fail to met criteria for discouragement
\par 4)Any documented adverse events associated with the therapy have been minor (ie. Not life-threatening or permanently disabling)
\par 5)Based on current information, there is no obvious theoretical potential for major adverse events
\par 
\par }{\b\fs24 Discourage:
\par }{\fs24 Evidence indicates either inefficacy or serious risk:
\par 1)Two or more RCTs have evaluated the therapy
\par 2)At least 2 trials had n>50
\par 3)At least two 67% of trials suggest that the therapy is ineffective
\par 4)There is reliable documentation of a major (life-threatening or permanently disabling) adverse event occurring in association with the therapy
\par 5)Based on current information, there is a theoretical potential for major adverse events
\par }\pard \widctlpar {\fs24 
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\par 
\par }\pard\plain \s16\widctlpar \cgrid {*Adapted with permission from:
\par Weiger et al. Advising patients with cancer who seek complementary/alternative/integrative medical therapies: an evidence-based approach. Ann Intern Med. 2002; 137:889-903. 
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\par \hich\af0\dbch\af2\loch\f0 Electronic Appendix D:  Ongoing trials and program anouncements:
\par }{\b\fs24 \hich\af0\dbch\af2\loch\f0 NCCAM Program Announcement}{\fs24 \hich\af0\dbch\af2\loch\f0 : Chromium as adjuvant therapy for type 2 diabetes and impaired glucose tolerance (Released July 2001)
\par }{\b\fs24 \hich\af0\dbch\af2\loch\f0 NIH funded trials:}{\b\fs24\ul 
\par }\pard\plain \s18\sl480\slmult1\widctlpar\tx720\adjustright \cgrid {*Ginkgo biloba extract\rquote s effect on efficacy of three classes of diabetic medications - (Glucotrol, Glucophage and Actose). University of Texas Health Sciences Center,\~
San Antonio, Texas. PI: George B Kudolo, PhD NCCAM funded}{\ul 
\par }{*An Exploratory Study of the Effects of Oral Vitamin C Administration on Insulin Sensitivity and Vascular Reactivity in Subjects with Type 2 Diabetes. NHLBI funded.
\par }\pard\plain \sl480\slmult1\widctlpar\adjustright \fs20\cgrid {\fs24 *Phase II Randomized double-blind placebo-controlled dose-escalation study on the effects of garlic on hyperlipidemia induced by HAART in HIV-positive ind
ividuals (Glucose and insulin as secondary measures) Bastyr University Center for Natural Health,\~Seattle, Washington. PI:\~Jose Berger, MF NCCAM funded
\par }\pard\plain \s15\sl480\slmult1\widctlpar\adjustright \b\fs22\cgrid {\fs24 Privately-funded trials: 
\par }\pard\plain \s18\sl480\slmult1\widctlpar\tx720\adjustright \cgrid {*Efficacy of the diabetic supplement Gymnemosupium II, a combination of the ex
tracts of Gymnema sylvestre, Pterocarpus marsupium, Diachrome and Vanadium administered to patients with Type 2 diabetes. \~(}{\field\flddirty{\*\fldinst { HYPERLINK "http://www.diabetesincontrol.com" }{{\*\datafield 
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61006200650074006500730069006e0063006f006e00740072006f006c002e0063006f006d002f000000}}}{\fldrslt {\cs17\ul\cf2 www.diabetesincontrol.com}}}{) 
\par *Effect of Extended Release Gymnema Sylvestre Leaf Extract Alone or In Combination With Oral Hypoglycemics or Insulin Regimens for Type 1 and Type 2 Diabetes. (}{\field\flddirty{\*\fldinst { HYPERLINK "http://www.diabetesincontrol.com" }{{\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000001a0000007700770077002e006400690061006200650074006500730069006e0063006f006e00740072006f006c002e0063006f006d000000e0c9ea79f9bace118c8200aa004ba90b4400000068007400740070003a002f002f007700770077002e0064006900
61006200650074006500730069006e0063006f006e00740072006f006c002e0063006f006d002f000000}}}{\fldrslt {\cs17\ul\cf2 www.diabetesincontrol.com}}}{) Creighton University Medical Center in Omaha, NE. PI: Marc Rendell, MD 
\par }{\ul 
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {
\par }}