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. Author manuscript; available in PMC: 2013 Jul 22.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Dec 7;(12):CD008288. doi: 10.1002/14651858.CD008288.pub2

Adverse events

Study ID
Characteris-
tic		 Agrawal 2002 Dubey 1993 Elder 2006 Hsia 2004 Mohan 1998 Poongothai 2002 Shekhar 2002
Interven-
tion(s) & con-
trol(s)		 I: Inolter®
C: Placebo		 I:Diabecon®
(D-400)
C: Placebo		 I:
MA471 (mix-
ture of herbs)
, meditation,
diet, exercise
C: None
(usual care
only)		 I: Pancreas
tonic
C: Placebo		 I:Diabecon®
(D-400)
C: Placebo		 I: Hyponidd®
C: Placebo		 I: Cogent DB
®
C:
No additional
treatment
Diabetes
related deaths
[n]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C: 0/16
T: 0/47		 I: 0/20
C: 0/20
T: 0/40		 I: 0/20
C: 0/20
T: 0/40		 I: 0/30
C: 0/30
T: 0/60
Death from
any cause [n]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C: 0/16
T: 0/47		 I: 0/20
C: 0/20
T: 0/40		 I: 0/20
C: 0/20
T: 0/40		 I: 0/30
C: 0/30
T: 0/60
Adverse events
[n/N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 - I: 6/31
C: 5/16
T: 11/47		 I: 2/20
C: 3/20
T: 5/40		 I: -
C: -
T: 3/40		 I: 0/30
C: 0/30
T: 0/60
Serious ad-
verse events [n
/N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C: 0/16
T: 0/47		 I: 2/20
C: 3/20
T: 5/40		 I: -
C: -
T: 3/40		 I: 0/30
C: 0/30
T: 0/60
Drop-outs
due to adverse
events [n /N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C: -
T: -		 I: 2/20
C: 3/20
T: 5/40		 I: -
C: -
T: 3/40		 I: 0/30
C: 0/30
T: 0/60
Hospitalisa-
tion due to ad-
verse event [n /
N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 - I: 0/31
C: 0/16
T: 0/47		 - - I: 0/30
C: 0/30
T: 0/60
Out-patient
treatment [n /
N]		 I: 0/30
C: 0/30
T: 0/60		 - - I: 0/31
C: 0/16
T: 0/47		 - - -
Hypo-
glycemic
episodes [n /
N]		 I: 0/30
C: 0/30
T: 0/60		 - - I:1/31
C:0/16
T:1/47		 - - -
Severe hypo-
glycaemic
episodes [n /
N]		 I: 0/30
C: 0/30
T: 0/60		 - - I:0/31
C:0/16
T:0/47		 - - -
Definition
of severe hy-
poglycaemia		 - - - - - - -
Nocturnal hy-
poglycaemic
episodes [n /
N]		 I: 0/30
C: 0/30
T: 0/60		 - - - - - -
Hematolog-
ical toxicity [n
/N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C: 0/16
T: 0/47		 I: 0/17
C: 0/15
T: 0/32		 - I: 0/30
C: 0/30
T: 0/60
Liver toxicity
[n/N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 I: 0/27
C: 0/28
T: 0/55		 I: 0/31
C:0/16
T: 0/47		 - I: 1/20
C: 0/20
T: 1/40		 I: 0/30
C: 0/30
T: 0/60
Hypersen-
sitivity or drug
allergy [n / N]		 I: 0/30
C: 0/30
T: 0/60		 I: 0/14
C: 0/14
T: 0/28		 - I: 0/31
C: 0/16
T: 0/47		 I: 1/20
C: 0/20
T: 1/40		 - -
Gastrointesti-
nal side effects
[n/N]		 I: 0/30
C: 0/30
T: 0/60		 - - - I: 1/20
C: 0/20
T: 1/40		 - -
Renal toxicity
[n/N]		 - - - I: 0/31
C: 0/16
T: 0/47		 I: 0/20
C: 0/20
T: 0/40		 I: 0/20
C: 0/20
T: 0/40		 I: 0/30
C: 0/30
T: 0/60
Other side ef-
fects [n / N]		 I: 0/30
C: 0/30
T: 0/60		 - - - - - -

Footnotes “-” denotes not reported

C: control; I: intervention; T: total