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NCT00719563 · OUTCOME

Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3

American Ginseng in Treating Patients With Fatigue Caused by Cancer · Source last updated 2017-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Week 4

What was measured

Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

Analysis population: Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.

Groups in this outcome

Ginseng

Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Placebo

Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ginseng25
Placebo24

Reported measurements

MFSI-SF General
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng38.823.3Not reportedNot reportedNot reported
Placebo29.221.5Not reportedNot reportedNot reported
MFSI-SF Physical
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng12.218.3Not reportedNot reportedNot reported
Placebo5.715.1Not reportedNot reportedNot reported
MFSI-SF Mental
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng8.918.8Not reportedNot reportedNot reported
Placebo2.614.9Not reportedNot reportedNot reported
MFSI-SF Emotional
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng8.014.4Not reportedNot reportedNot reported
Placebo8.716.8Not reportedNot reportedNot reported
MFSI-SF Vigor
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng13.422.6Not reportedNot reportedNot reported
Placebo12.013.8Not reportedNot reportedNot reported
BFI Total Interference
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng27.323.7Not reportedNot reportedNot reported
Placebo22.315.2Not reportedNot reportedNot reported
LASA Fatigue
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng40.927.0Not reportedNot reportedNot reported
Placebo37.019.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.3
        value
        38.8
      2. group Id
        OG001
        spread
        21.5
        value
        29.2
    title
    MFSI-SF General
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.3
        value
        12.2
      2. group Id
        OG001
        spread
        15.1
        value
        5.7
    title
    MFSI-SF Physical
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.8
        value
        8.9
      2. group Id
        OG001
        spread
        14.9
        value
        2.6
    title
    MFSI-SF Mental
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.4
        value
        8.0
      2. group Id
        OG001
        spread
        16.8
        value
        8.7
    title
    MFSI-SF Emotional
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.6
        value
        13.4
      2. group Id
        OG001
        spread
        13.8
        value
        12.0
    title
    MFSI-SF Vigor
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.7
        value
        27.3
      2. group Id
        OG001
        spread
        15.2
        value
        22.3
    title
    BFI Total Interference
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.0
        value
        40.9
      2. group Id
        OG001
        spread
        19.0
        value
        37.0
    title
    LASA Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      24
    units
    Participants
description
Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
dispersion Type
Standard Deviation
groups
  1. description
    Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
    id
    OG000
    title
    Ginseng
  2. description
    Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.
reporting Status
POSTED
time Frame
Baseline and Week 4
title
Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice