Table 2.
Results of new studies included in the updated review
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Results
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| Intervention | Author (Year), number of participants | Physical | Psychological | Physiological | Quality of life and general health | Drop-outs/Adverse effects | Validity score |
| Behavioural | |||||||
| CBT | Whitehead (2002)54n=65 | Fatigue: no significant difference between groups | Anxiety and Depression: no significant differences between groups | Disability: no significant differences between groups | At 6 months, 8 in treatment group and 11 in control group were lost to follow-up | 3 | |
| Rehabilitation | Cox (2002)64n=97 | Physical functioning and fatigue: no significant differences between groups | Emotional distress: no significant differences between groups | Maintaining activity and accommodating to illness: significant difference in favour of treatment group (P<0.03) | 6 months after discharge, 14 in treatment group and 16 in control group did not return questionnaires | 7 (NB controlled trial) | |
| Rehabilitation | Cox (1999)63n=130 | Physical/functional status, fatigue, pain, symptoms: significant difference between groups for fatigue symptoms (P<0.02) and pain (P<0.05) | Perceived ability, anxiety, depression, emotional distress: significant difference between groups for emotional distress (P<0.03) | Illness management: significant difference in favour of treatment group (P<0.03) | 5 withdrew from experimental group, 18 from control group | 8 (NB controlled trial) | |
| Rehabilitation | Taylor (2004)62n=47 | Symptoms: significant interaction (P<0.05) | Quality of life: significant interaction (P<0.05) | No withdrawals | 9 | ||
| CBT | Stulemeijer (2005)29n=69 | Physical functioning, fatigue, symptoms: significant difference in favour of CBT group (P<0.003) | School attendance: significant difference in favour of treatment group (P=0.04) | 6 patients dropped out during treatment. 7 were missing from CBT group and 2 from control group at final assessment | 16 | ||
| Modified CBT | Viner (2004)49n=56 | CFS severity: better result in intervention group, significance not reported | Global wellness, school attendance: significantly better in treatment group (P<0.05) | No withdrawals | 2 (NB controlled trial) | ||
| GET | Moss-Morris (2005)30n=49 | CGI, fatigue: significant difference in favour of treatment group (P<0.03) | 3/25 dropped out of treatment and 3/24 did not return questionnaires at 12 weeks | 9 | |||
| GET | Wallman (2004)31n=61 | Fatigue: significantly better in treatment group (P=0.027) | Depression, anxiety: significantly better in treatment group (P=0.027) | Resting and target heart rate and blood pressure, exercise test values: comparisons not made between groups | One excluded after randomization because BMI too high to participate in exercise test. None reported during the study | 9 | |
| Immunological | |||||||
| Inosine pranobex | Diaz-Mitoma (2003)35n=16 | Symptoms, fibromyalgia tender points: no significant difference between groups | Cognitive function: no significant differences between groups | Immune function: significant improvements in treatment group (P<0.03) | Global severity, activities of daily living, Karnofsky Performance Scale: no significant differences between groups | 1 withdrawal in each group. Transient elevation of serum uric acid (presumably in treatment group) | 6 |
| Staphylococcus toxoid | Zachrisson (2002)36n=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 questionnaire | 10 dropouts during study. 13 patients in the treatment group and 7 in the placebo group experienced side effects. | 14 | |||
| Pharmacological | |||||||
| Galantamine hydrobromide | Blacker (2004)37n=434 | Global impression, fatigue, symptoms: no significant differences between groups | Cognitive function: no significant difference between groups | 130 patients withdrew. 389 patients reported adverse events, of which 88 withdrew | 15 | ||
| Hydrocortisone | Cleare (2002)38n=120? | Fatigue: ‘significantly’ greater improvement in treatment group (P not reported) | Hormone levels: greater increase in cortisol response to HCRH in treatment group (significance not reported) | 2 | |||
| Hydrocortisone and fludrocortisone | Blockmans (2003)39n=80 | Fatigue: no significant differences between groups | Anxiety and depression: no significant differences between groups | Blood pressure: no significant differences between groups | SF-36, wellbeing: no significant differences between groups | 9 in treatment group and 11 in placebo group dropped out. Only one dropped out due to adverse events | 14 |
| Topical nasal corticosteroids | Kakumanu (2001)40n=28 | Fatigue, daytime sleepiness, muscle pain: no significant improvement with treatment | Daily activity: no significant improvement with treatment | 3 | |||
| Oral NADH | Santaella (2004)84n=20 | Symptoms: no significant difference between groups | 11 dropped out of 31 initially randomized. No adverse events were reported in treatment group | 3 | |||
| Dexamphetamine | Olson (2003)88n=20 | Fatigue, sleep: significant difference in favour of treatment group for fatigue (P<0.02) | SF36 scores: no significant difference between groups | Reduced food consumption reported by 5 patients in treatment group, one in placebo group | 8 | ||
| Clonidine | Morriss (2002)85n=10 | Cognitive function: no significant effects | One patient withdrew after GP prescribed fluoxetine | 12 | |||
| Melatonin vs phototherapy | Williams (2002)90n=30 | Symptoms, fatigue: improved sleep (P=0.03), vitality (P=0.016) and mental health (P=0.046) with melatonin, worsening of bodily pain (P=0.044) | Anxiety, depression: no significant effects of treatment | 12 of initial 42 patients withdrew, 10 due to time and social demands of the study | 5 | ||
| Complementary/Alternative | |||||||
| Homeopathy | Weatherley-Jones (2004)41n=103 | Fatigue, functional limitations: significant differences in favour of treatment group for fatigue (P=0.04) and some physical dimensions of the Functional Limitations Profile (P value not reported) | 11 withdrew from treatment arm (5 did not complete treatment) and 8 from placebo arm (6 did not complete treatment) | 17 | |||
| Supplements | |||||||
| Acetyl-L-carnitine and propionyl-L-carnitine | Vermeulen (2004)43n=90 | Global improvement, fatigue, pain: significant improvement in general fatigue in PLC (P=0.004) and combined group (P<0.001); significant improvement in mental fatigue in ALC group (P=0.015) | Attention, concentration: ‘significant’ improvements in all groups | 8 patients withdrew due to side effects and 8 withdrew due to lack of efficacy. | 10 | ||
| Acclydine and amino acids | De Becker (2001)98n=90 | Global improvement, symptoms: improvements seen in intervention group above control group but groups were not compared statistically | IGF-1 levels: significantly more improvement in intervention than placebo group (P<0.0002) | 3 (NB controlled trial) | |||
| Pollen extract | Ockerman (2000)97n=22 | Fatigue, sleep, symptoms: comparisons were not made between groups | Depression: comparisons were not made between groups | Erythrocyte fragility: comparisons were not made between groups | 1 withdrawal due to moving away. ‘Slight intestinal inconvenience’ was the only side effect for a few days in 1 or 2 patients | 9 | |
| RM-10: medicinal mushrooms | Rothschild (2002)99n=70 | Symptoms: improved more in the treatment group (measure of significance not presented) | 2 dropped out of treatment group, not reported for placebo group. | 3 | |||
| General supplements | Brouwers (2002)93n=53 | Fatigue, symptoms, improvement, functional impairment, activity: no significant differences between groups | 3 dropped out from the supplement group due to nausea, and one in each group for other reasons | 10 | |||
| Other interventions | |||||||
| Group therapy | Soderberg (2001)104n=14 | Fatigue: results not reported | Quality of life: comparisons were not made between groups | One withdrawal in control group | 1 | ||
| Low sugar low yeast diet | Hobday (2005, unpublished) n=57 | Fatigue: no significant differences between groups | Anxiety, depression: no significant differences between groups | General health: no significant differences between groups | 8 in the LSLY arm and 9 in the control arm were lost to follow-up | 11 | |