Table 1

Summary of randomised clinical studies of complementary and alternative medicine for patients with chronic fatigue syndrome

First author (year)

Sample size

Diagnosis

Intervention group (Regime)

Control group (Regime)

Main outcomes

Intergroup differences

Adverse events

Gender (M/F)

Mean age (range)


Clollinge (1998) [10]

70

Fukuda

(A) Qigong (2 hr weekly for 9 weeks, n = 37) plus mindfulness meditation and group discussion

(B) No treatment (n = 33)

SF-36 Heath transition score

No between group analysis

n.r.

(10/50)

27-61

Dybwad (2007) [11]

31 (4/27)

CDC

(A) Qigong (2 hr weekly for 12 weeks), plus meditation, n = 15)

(B) No treatment (n = 16)

1) Work capacity (VO2max)

1) P = 0.01

n.r.

17-62

2) Fatigue severity

2) P < 0.05

3) SF36

3) NS

Surawy (2005) [12]

18

Oxford

(A) MBSR (once weekly for 8 weeks, n = 8)

(B) Wait-list (once weekly for 8 weeks, n = 9)

1) HADS Anxiety

1) P = 0.00

n.r.

10/8

2) HADS Depression

2) NS

18~65

3) Chalder Fatigue Scale

3) NS

(n.r)

4) SF36 Physical Functioning

4) NS

Walach (2008) [13]

409

Fukuda or Oxford

(A) Distant healing (blinded, n = 105)

(C) No distant healing (blinded, n = 95)

SF-36

NS for both the mental and physical component

n.r.

(B) Distant healing (not blinded, n = 102)

(D) No distant healing (not blinded, n = 109)

Field (1997) [14]

20

Not stated

(A) Massage therapy (twice weekly for 5 weeks, n = 10)

(B) Sham TENS (twice weekly for 5 weeks, n = 10)

1) CESD

1) P < 0.005

n.r.

4/16

2) Fatigue

2) P < 0.05

n.r.

3) Pain

3) P < 0.005

-47

4) Sleep

4) P < 0.05

Wang (2009) [15]

182

Fukuda

(A) Intelligent-turtle massage (5 times weekly, 10 times as a course, for 2 courses with a one-week interval in between, n = 91)

(B) Massage(45 min, 5 times a week, 10 times as a course, n = 91)

Physical Symptoms

P < 0.05

n.r.

141/40

21-62

(n.r)

Liu (2010) [16]

90 (44/46)

Fukuda

(A) Tuina (once 2 days for 15 times, n = 30)

(C) Fluoxetine (20 mg/d, 1 month, n = 30)

Total effective rate

A vs. B, NS; A vs. C, P < 0.05; B vs. C, NS

(C); 17 insomnia dizziness vexation nausea, hypodynamia

26.4~46.2

(B) Tai chi (n.r., 1 month, n = 30)

(n.r.)

Weatherley-Jones (2004) [17]

103/92

Oxford

(A) Homeopathy (6 months, n = 47)

(B) Placebo(6 months, n = 45)

1) MFI

1) NS except general fatigue, P = 0.04

n.r.

n.r.

2) FIS

2) NS

Over 18 years

3) FLP

3) P = 0.04

(n.r)

Awdry (1996) [18]

64/61

Oxford

(A) Homeopathy (1 year, n = 30)

(B) Placebo (n = 31)

1) Daily graphs

1-2) No between

n.r.

18/43

2) Symptoms score

group analysis

<65

(n.r.)

Hartz Hartz (2004) [19]

96/76

Fukuda

(A) Ginseng (Siberian, 2 months, n = 40

(B) Placebo (16 weeks, 2 month, n = 36)

RVI

NS

n.r.

n.r.

21~65

(n.r)

Forsyth (1999) [20]

26

CDC

(A) NADH (10 mg, once daily for 4 weeks, n = 26, cross over design)

(B) Placebo(n = 26)

Symptom score

P < 0.05

Overly stimulated, mild loss of appetite, heartburn, increased incidence of gas and an odd taste and dryness (1)

(9/17)

26-57

-39.6

Santaella (2004) [21]

31

Fukuda

(A) NADH or nutritional

(B) Psychological therapy (24 months, n = 11)

Symptom score (month 3)

P < 0.001

n.r.

n.r.

supplements (5-10 mg, 24 months, n = 20)

22~54

(n.r)

Brouwers (2002) [22]

53

CDC

(A) General nutritional supplement (twice a day for 10 weeks, n = 27)

(B) Placebo(n = 26)

1) Fatigue severity

1)-3) NS

n.r.

(16/37)

2) Functional impairment

n.r.

3) Physical activity levels

-39.3

De Becker (2001) [23]

90

Fukuda or Holmes

(A) Acclydine (250 mg, 4 times daily for 1st 4 weeks and 250 mg, twice daily for 2nd 4 weeks, n = 45)

(B) Placebo (n = 45)

CGI

No between group analysis

n.r.

n.r.

n.r.

(n.r.)

The (2007) [24]

57

CDC

(A) Food supplement (Acclydine 1000 mg to 250 mg for 14 weeks, n = 30)

(B) Placebo (n = 27)

1) Fatigue severity

1)-4) NS

Mild nausea (1), exacerbation of CFS symptoms (1) and irritable bowel symptoms (1)

(20/37)

2) Function impairment

n.r.

3) Activity level

(n.r.)

4) Daily fatigue level

McDertmott (2006) [25]

71

CDC

(A) Food supplement (Biobran 2 mg three times per day for 8 weeks, n = 37)

(B) Placebo(n = 34)

1) Fatigue scale

1) NS

(20/51)

2) QOL

2) NS

n.r.

(WHOQOL_BREF)

(n.r.)

Stewart (1987) [26]

12

Not stated

(A) Supplements (subjects given supplements for 3 weeks, after first 3 weeks cross-over treatment arms for further 3 weeks, 2 multi-digestive enzymes, crossover design n = 12)

(B) Placebo(n = 12)

1) Fatigue

1)-2) No between group analysis

n.r.

n.r.

2) Bowel movements

n.r.

(n.r.)

Rothschild (2002) [27]

70/68

CDC

(A) Supplement (mushrooms plus aloe vera and cat's claw, processed and fermented, 3 caplets taken 3 times daily before meals, n = 33)

(B) Placebo (n = 35)

Symptoms

No between

n.r.

20/50

group analysis

n.r.

(n.r.)

Vermeulen (2004) [28]

90

CDC

(A) Acetyl-L-carnitine (2 g daily for 24 weeks, n = 30)

(B) Propionyl-L-carnitine (n = 30)

1) Fatigue scale

No between group analysis

n.r.

(21/69)

(C) A plus B (n = 30)

2) Pain

n.r.

3) Attention/concentration

(n.r.)

Behan (1990) [29]

63

Not stated

(A) Fatty acids((Efamol Marine, 8 capsules per day, n = 39)

(B) Placebo (n = 24)

1) Symptom measure

1) P < 0.001

n.r.

27/36

2) General health

2) P < 0.0001

21-63

3) n.r.

-40

Warren (1999) [30]

50

Oxford

(A) Essential fatty acids (Efamol Marine 1000 mg 4 times a day for 3 months, n = 25)

(B) Placebo (n = 25)

1) Physical symptom

1) NS

n.r.

(21/29)

2) Depression (Beck Depression Inventory)

2) NS

18-59

-35.7

Kaslow (1989) [31]

14

CDC

(A) Liver extract-folic acid-cyanocobalamin (intramuscular injection 2 ml for 1-week, n = 14, crossover design)

(B)Placebo (n = 14)

Functional status questionnaire

NS

None

(3/11)

30-48

(n.r.)

Ockerman (2000) [32]

22

CDC

(A)Antioxidant treatment (pollen and pistil 7 tablets per day for 3 months, n = 22, cross-over design)

(B) Placebo (3 month, n = 22)

1) Total well-being

1) No between group analysis

n.r.

(3/19)

2) Clinical symptoms

2) No between group analysis

27-70

-50

Cox (1991) [33]

34/31

other

(A) Vitamin and minerals (Magnesium, 6 weeks, n = 14)

(B) Placebo (6 weeks, n = 17)

Mean Nottingham

P = 0.001

n.r.

11/23

health profile score

18~56

(n.r.)

Tiev (1999)

326

Not stated

(A) Sulbutiamine (400 mg

(C) Placebo (n = 109)

1) MFI

1) Sleep disturbance

(A):9,(B):6,(C):12 diarrhoea, cystitis, bronchitis, arthritic pain, back pain, asthma, abdominal pain, insomnia, constipation, gastroenteritis, diffuse pain, sinusitis, headache, renal coli, vertigo, pharyngitis, tracheitis.

daily, n = 106)

2) Clinical global impression

(p = 0.03)

(B) Sulbutiamine (600 mg

3) Baecke's measure of activity

Pain (p = 0.044)

daily, n = 111)

4) Illness severity

2) NS

3) NS

Willams (2002) [35]

30

Oxford

(A) Melatonin (5 mg in the

(B) phototherapy (2500 Lux for 1

1) VAS for symptom severity; SF-36

1) Sleep disturbance(p = 0.03);Pain (p = 0.044)

n.r.

13/17

evening, 12 week, n = 30)

hour in the morning, 12 weeks, n = 30)

2) Mental fatigue

2) NS

n.r.

3) HADS

3) NS

-44.5


CDC: Centers for Disease Control and Prevention; CESD: Center for Epidemiological Studies Depression Scale; CFS: Chronic Fatigue Syndrome; CGI: Clinician's Global Impression Scale; FIS: Fatigue Impact Scale; FLP: Functional Limitations Profile; HADS: Hospital Anxiety and Depression Scale; MBSR: Mindfulness-Based Stress Reduction; MFI: Multidimensional Fatigue Inventory; n.r.: not reported; NS: Not significant; RVI: Rand Vitality Index; NADH: Nicotinamide adenine dinucleotide; QoL: Quality of life; SF-36: Short Form 36; VAS: Visual Analogue Scale; WHOQOL-BREF: WHO Quality of Life-BREF.

Alraek et al. BMC Complementary and Alternative Medicine 2011 11:87   doi:10.1186/1472-6882-11-87

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