Evidence map›Paper›PMID 24476345›Full record

Trial reportJournal of alternative and complementary medicine (New York, N.Y.)2014

A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.

Babita Bisht, Warren G Darling, Ruth E Grossmann, E Torage Shivapour, Susan K Lutgendorf, Linda G Snetselaar, Michael J Hall, M Bridget Zimmerman, Terry L Wahls

5 registry-linked trialsOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Journal of alternative and complementary medicine (New York, N.Y.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02914964 nacompletednot on this mapstarted 2016, after this paper: background citation

Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

TypeinterventionalSponsorTerry L. WahlsRan2016 to 2025Enrolled95ConditionsMultiple Sclerosis, Multiple Sclerosis, Relapsing-RemittingArmsSwank Diet, Wahls Elimination Diet
NCT03659422 nawithdrawnnot on this mapstarted 2019, after this paper: background citation

Dietary Approach to Improving QoL in ALS

TypeinterventionalSponsorTerry L. WahlsRan2019 to 2021Enrolled0ConditionsDiet Modification, Amyotrophic Lateral SclerosisArmsModified Paleolithic diet
NCT04009005 naactive not recruitingnot on this mapstarted 2020, after this paper: background citation

Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

TypeinterventionalSponsorTerry L. WahlsRan2020 to 2027Enrolled44ConditionsClinically Isolated Syndrome, Relapsing Remitting Multiple SclerosisArmsTherapeutic diet and lifestyle
NCT05007483 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy of Diet on Quality of Life in Multiple Sclerosis

TypeinterventionalSponsorTerry L. WahlsRan2022 to 2026Enrolled162ConditionsMultiple Sclerosis, Relapsing-RemittingArmsBodyBio Balance Oil, Kirunal Fish Oil, BodyBio PC, Modified Paleolithic Elimination diet, Time Restricted Olive Oil Based (TROO) Ketogenic Diet
NCT05057676 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

Evaluation of an Online Course Designed to Support the Adoption of Healthier Diet and Self-Care Routines in Multiple Sclerosis Patients

TypeinterventionalSponsorTerry L. WahlsRan2021 to 2027Enrolled400ConditionsMultiple Sclerosis, Clinically Isolated Syndrome, Fibromyalgia, Post Acute Sequelae of COVID-19ArmsImmediate Autoimmune Intervention Mastery Course (AIM), Immediate Question and Answer sessions. (AIM Q and A sessions), Delayed Autoimmune Intervention Mastery Course (delayed AIM course), Delayed AIM Question and Answer sessions
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Observational
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Italian translation and validation of fatigue symptoms and impacts questionnaire in relapsing multiple sclerosis (FSIQ-RMS).Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  14. Review
  15. The Wahls Behavior Change Model for Complex Chronic Diseases: A Clinician's Guide.Degenerative neurological and neuromuscular disease · 2022
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Babita Bisht1 Department of Health and Human Physiology, University of Iowa College of Liberal Arts and Sciences , University of Iowa, Iowa City, IA.
Warren G Darling
Ruth E Grossmann
E Torage Shivapour
Susan K Lutgendorf
Linda G Snetselaar
Michael J Hall
M Bridget Zimmerman
Terry L Wahls
University of Iowa · USUnited States Department of Veterans Affairs · US

Funding

University of Iowa Clinical and Translational Science ProgramUL1TR000442 · NCATS · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2012 to 2013
$10.0M
Nutrition Sciences and HealthT32DK007734 · NIDDK · EMORY UNIVERSITY · PI RAMAKRISHNAN, USHA · 1997 to 2016
$2.5M
Metabolomic Biomarkers of a Nutritional Intervention to Prevent Weight GainK01GM109309 · NIGMS · UNIVERSITY OF IOWA · PI GROSSMANN, RUTH ELIZABETH · 2013 to 2016
$619k
NCATS NIH HHS 2 UL1 TR000442-06NCATS NIH HHS UL1 TR000442NIDDK NIH HHS T32 DK007734NIGMS NIH HHS K01 GM109309
6 · The paper itself

Abstract

backgroundMultiple sclerosis is an autoimmune disease influenced by environmental factors.

objectivesThe feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/

settingThis was a single-arm, open-label intervention study in an outpatient setting.

interventionsA multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES: Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12.

resultsTen (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months.

conclusionsIn this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.

Indexed as

Diet, PaleolithicBody WeightCombined Modality TherapyElectric Stimulation TherapyExercise TherapyFatigueFeasibility StudiesHumansMassageMiddle AgedMultiple Sclerosis, Chronic ProgressiveOutpatientsPatient CompliancePilot Projects

Identifiers

PMID24476345
PMCPMC4011484
OpenAlexW1975470847

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.