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Table 2 RCTs with pharmacological interventions

From: Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

Intervention

N. of participants (N. of arms, control)

Dose, period (weeks)

Primary measurement (subscale)

Statistical significance

Psychiatric drugs

 (-)-OSU6162 [16]

62 (2, placebo)

30 mg, 60 mg/day, 2

MFS, CGI

Not significant

 Duloxetine [17]

60 (2, placebo)

60–120 mg/day, 12

MFI (general fatigue)

Not significant

 Clonidine-hydrochloride [18]

188 (3, placebo, HC)

50 μg or 100 μg/day, 9

Number of steps per day

Not significant

 Methylphenidate [19]

60 (crossover, placebo)

10 mg/day, 4

CIS (fatigue, concentration) VAS (fatigue, concentration)

CIS (fatigue): P < 0.01, VAS: P < 0.01

 Galantamine hydrobromide [20]

434 (5, placebo)

7.5–30 mg/day, 16

CGI

Not significant

 Moclobemide [21]

90 (2, placebo)

450–600 mg/day, 6

Globally improved cases, KPS, POMS

Not significant

 Fluoxetine [22]

96 (2, placebo)

20 mg/day, 8

CIS (fatigue)a

Not significant

 Galantamine hydrobromide [23]

49 (2, placebo)

30 mg/day, 8

VAS (fatigue)

Not significant

Immunomodulators

 BioBran MGN-3 [24]

71 (2, placebo)

6 g/day, 8

Chalder scale(physical)

Not significant

 Staphypan Berna [25]

100 (2, placebo)

0.1–1.0 ml/week and 1.0 ml/4 weeks, 24

CGI, CPRS

CGI: P < 0.001, CPRS: P < 0.01

 Gamma globulin [26]

71 (2, placebo)

1 gm/kg 3 times/month, 8

Mean functional score

P < 0.05 (6 month)

 Poly(I):poly(C12U) [27]

92 (2, placebo)

400–800 mg/week, 24

KPSa

P < 0.05

Cortisol

 Hydrocortisone + 9-alfa-fludrocortisone [28]

80 (crossover, placebo)

5 mg + 50 μg/day, 12

VAS (fatigue)

Not significant

 Fludrocortisone acetate [29]

100 (2, placebo)

0.1 mg/day, 9

Global wellness score

Not significant

 Hydrocortisone [30]

32 (crossover, placebo)

5 or 10 mg/day, 4

Chalder scale, CGI

Chalder scale: P < 0.01

 Hydrocortisone [31]

70 (2, placebo)

16 mg/m2/day, 12

Global wellness score

Not significant

 Fludrocortisone acetate [32]

25 (crossover, placebo)

0.1–0.2 mg/day, 6

VAS, SF-36a

Not significant

Mitochondrial modulators

 KPAX002 [33]

128 (2, placebo)

12 mg/day, 12

CIS (total score)

Not significant

 CoQ10 + NADH [34]

73 (2, placebo)

200 mg + 20 mg/day, 8

FIS-40 (total score)

P < 0.05

 NADH [35]

26 (crossover, placebo)

10 mg/day, 4

Self-developed subject symptom scoring system

Not significant

Nutrients

 Acclydine [36]

57 (2, placebo)

1000–125 mg/day, 14

CIS (fatigue), SIP-8

Not significant

 Polynutrient supplement [37]

63 (2, placebo)

125 ml/day, 10

CIS (fatigue), N of CDC symptoms, SIP-8

Not significant

Others

 Anakinra [38]

50 (2, placebo)

100 mg/day, 4

CIS (fatigue)

Not significant

 Ondansetron [39]

67 (2, placebo)

16 mg/day, 10

CIS (fatigue), SIP-8

Not significant

 Homeopathic treatment [40]

103 (2, placebo)

Not fixed, 24

MFI

Not significant

  1. MFS Mental Fatigue Scale, CGI Clinical Global Impression, MFI Multidimensional Fatigue Inventory, CIS Checklist Individual Strength, VAS Visual Analogue Scale, KPS Karnofsky Performance Score, POMS Profile of Mood States, CPRS Comprehensive Psychopathological Rating Scale, SF-36 36-item Short Form health survey, FIS-40 Fatigue Impact Scale-40, SIP-8 Sickness Impact Profile-8
  2. aIn cases of no mention for primary measurements or main outcomes in original articles with ≥ 4 measurements, the most fatigue-related measurements were selected by the authors of this review study