Trial Outcomes & Findings for Effects of SAMe in Patients With Alcoholic Liver Disease (NCT NCT00573313)

Results Overview

Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

94 participants

Primary outcome timeframe

Week 0 to week 24

Results posted on

2017-05-30

Participant Flow

Subjects were recruited between July 1, 2005 and June 30, 2009 through the emergency room and clinics of the University of California Davis Health System.

Three (3) participants with alcoholic liver disease dropped out before randomization. Participants (128) excluded because did not meet recruitment criteria, (105) because had not telephone or other means of contact, or (24) declined to participate.

Participant milestones

Participant milestones
Measure	S-adenosylmethionine (SAMe) Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.	Healthy Subjects were enrolled into this arm for baseline measurement only.	Sugar Pill ALD subjects receiving Placebo three times daily for 24 weeks.	Lifestyle Counseling Subjects were enrolled into this arm for baseline measurements only.
Overall Study STARTED	18	28	19	26
Overall Study COMPLETED	13	28	13	26
Overall Study NOT COMPLETED	5	0	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	S-adenosylmethionine (SAMe) Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.	Healthy Subjects were enrolled into this arm for baseline measurement only.	Sugar Pill ALD subjects receiving Placebo three times daily for 24 weeks.	Lifestyle Counseling Subjects were enrolled into this arm for baseline measurements only.
Overall Study Protocol Violation	5	0	6	0

Baseline Characteristics

Effects of SAMe in Patients With Alcoholic Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	S-adenosylmethionine (SAMe) Treatment n=18 Participants The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.	Healthy n=28 Participants Healthy subjects without alcoholism or liver disease.	Lifestyle Counseling n=26 Participants Active drinkers non liver disease subjects	Sugar Pill Placebo n=19 Participants The placebo group received a sugar pill identical in appearance that was taken three times daily.	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	28 Participants n=7 Participants	25 Participants n=5 Participants	19 Participants n=4 Participants	89 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	26 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	13 Participants n=4 Participants	65 Participants n=21 Participants
Region of Enrollment United States	18 participants n=5 Participants	28 participants n=7 Participants	26 participants n=5 Participants	19 participants n=4 Participants	91 participants n=21 Participants

PRIMARY outcome

Timeframe: Week 0 to week 24

Population: Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease.

Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.

Outcome measures

Outcome measures
Measure	S-adenosylmethionine (SAMe) n=13 Participants Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.	Sugar Pill n=13 Participants ALD subjects receiving Placebo three times daily for 24 weeks.
Changes in Serum AST Levels	-13.5 Units per liter (U/L) Full Range 51.344 • Interval -35.0 to 156.0	-56 Units per liter (U/L) Full Range 18.243 • Interval -140.0 to 5.0

SECONDARY outcome

Timeframe: September 2005- June 2009

Population: Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables.

We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.

Outcome measures

Outcome measures
Measure	S-adenosylmethionine (SAMe) n=13 Participants Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.	Sugar Pill n=13 Participants ALD subjects receiving Placebo three times daily for 24 weeks.
Changes in Serum SAM	54 nmol/liter Full Range 92.535 • Interval -19.0 to 393.0	7 nmol/liter Full Range 150.5 • Interval -261.0 to 97.0

Adverse Events

S-adenosylmethionine (SAMe) Treatment

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Sugar Pill Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	S-adenosylmethionine (SAMe) Treatment n=18 participants at risk The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.	Sugar Pill Placebo n=19 participants at risk The placebo group received a sugar pill identical in appearance that was taken three times daily.
Gastrointestinal disorders Diarrhea	22.2% 4/18 • Number of events 4 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	21.1% 4/19 • Number of events 4 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.
Nervous system disorders Headache	11.1% 2/18 • Number of events 2 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	0.00% 0/19 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.
Gastrointestinal disorders Abdominal bloating	16.7% 3/18 • Number of events 3 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	10.5% 2/19 • Number of events 2 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.
Gastrointestinal disorders Nausea	0.00% 0/18 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	10.5% 2/19 • Number of events 2 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.
Nervous system disorders Night sweats, hair loss, xerostomia	5.6% 1/18 • Number of events 1 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	0.00% 0/19 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.
Gastrointestinal disorders Abdominal pain	16.7% 3/18 • Number of events 3 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.	10.5% 2/19 • Number of events 2 Adverse events were only measured in participants with alcoholic liver disease who were randomized to receive intervention.

Additional Information

Dr. Charles H. Halsted

University of California Davis

Phone: 530-752-4054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place