Table 2Results of immunological treatment trials

InterventionAuthor (Year), number of participantsResults
Resource UsePhysicalPsychologicalPhysiologicalQuality of life and general healthDrop-outs/Adverse effectsValidity score
AntihistamineTerfenadineSteinberg (1996)176
n=30
Functional: no significant differences between groupsSymptoms: no significant differences between groups1 participant from each group withdrew due to non-improvement12
AntiviralAcyclovirStraus (1988)170
n=27
Rest: no significant differences between groupsMood: greater improvement in control group for anxiety, depression and confusion (p<0.05). No difference for anger, vigour or fatigueOral temperature: no significant differences between groupsPersonal well-being: no significant differences between groups3 participants had reversible renal failure during acyclovir infusions and were withdrawn from the study15
GancyclovirLerner (2001)171
n=11
Symptoms, energy: no significant differences between groupsAntibody titres: no significant differences between groups2 patients had serious pericardial bleeding during ventricular endomyocardial biopsies. Study was ended prematurely.1

Inosine pranobex
Diaz-Mitoma (2003)175
N=16
Symptoms, fibromyalgia tender points: no significant difference between groupsCognitive function: no significant differences between groupsImmune function: significant improvements in treatment group (p<0.03)Global severity, activities of daily living, Karnofsky Performance Scale: no significant differences between groups1 withdrawal in each group. Transient elevation of serum uric acid (presumably in treatment group)6
ImmunoglobulinLloyd (1990)164
n=49
Depression: no significant differences between groupsSymptom measure: greater improvement in treatment group for symptom scores and functional capacity (p=0.03)
QOL: no significant differences between groups
2 immunoglobulin recipients withdrew from the study, one because of mild but transient abnormal liver function tests, the other withdrew voluntarily after phlebitis had occurred with the first infusion13
ImmunoglobulinPeterson (1990)165
n=30
Functional: no significant differences between groupsImmune outcomes: IgG levels of all participants receiving IgG fell within normal range, not observed in placebo group.Symptom measure: no significant differences between groups2 participants dropped out due to adverse effects, 1 from each treatment group15
ImmunoglobulinVollmer Conna (1997)166
n=99
Functional: no significant differences between groupsMood: no significant differences between groupsImmune outcomes: no significant differences between groupsQOL: no significant differences between groups2 immunoglobulin recipients withdrew from study after severe constitutional reaction to infusion. One participant was withdrawn after developing skin eruption.13
ImmunomodulatorsInterferonBrook (1993)167
n=20
Activity: 3 participants recovered completely, 2 participants improved in treatment group, none of the participants in the control group recovered significantly. Improvement remained after 8 months follow up.1 participant in the treatment group withdrew after 3 weeks therapy because of increased fatigue, 1 participant in control group decided not to be treated6
Alpha interferonSee (1996)168
n=30
Immune outcomes: NK function increased significantly (p<0.05) in treatment group but not in control. No differences in %NLP, CD4 or CD8 countsQOL: no significant changes in either group4 participants on interferon treatment withdrew: 2 had neutropenia, one palpitations and one worsened fatigue11
Leukocyte extractLloyd (1993)149
n=49
Physical capacity & functional measure: no significant differences between groupsMood: no significant differences between groupsImmune outcomes: no significant differences between groupsGeneral health: group in which DLE combined with CBT showed greater improvement than other intervention groups2 participants dropped out, however, no participants dropped out due to adverse effects, although 1 participant developed puritic skin eruption that did not necessitate discontinuation of therapy13
AmpligenStrayer (1994)169
n=92
Medication use: use of 3 classes of drugs & all medications increased ‘significantly’ in placebo group compared to treatment group (p value not reported)Functional, exercise duration, activity, exercise and work: greater improvement in treatment group (p<0.04)Cognitive function: greater improvement in treatment group (p=0.05)
Depression: no significant differences between groups
8 participants dropped out, 4 in each group, however no participants dropped out due to adverse effects12
VaccineStaphylococcus toxoidAndersson (1998)173
n=28
Depression and pain: no significant differences between groups Psychological assessment: some improvement in treatment group but no significant differences between groupsClinical global impression: greater improvement in treatment group (p<0.05)4 participants were excluded, 3 on placebo: 1 because of malignancy, 2 because of severe depression, and 1 on vaccine treatment because of a psychotic reaction9 (NB controlled trial)
Zachrisson (2002)174
n=98
Global impression, symptoms, pain: statistically significant difference in favour of treatment group for CGI (p<0.001) and ‘feeling good’ item on fibromyalgia impact qre.10 dropouts during study. 13 patients in the treatment group and 7 in the placebo group experienced side effects.14

Results in bold indicate statistically significant differences between treatment groups (p<0.05)

From: Appendix 1, Systematic Evidence Review to support the development of the NICE clinical guideline for CFS/ME in adults and children

Cover of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy)
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy): Diagnosis and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy) in Adults and Children [Internet].
NICE Clinical Guidelines, No. 53.
National Collaborating Centre for Primary Care (UK).
Copyright © 2007, Royal College of General Practitioners.

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