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Table 1 General characteristics of included trials and HM-placebo use in trials

From: Qualified placebo for trials of herbal medicine treatment in rare diseases? A cross-sectional analysis

Category

Descriptive characteristics

N = 55 (%)

Characteristics of the trial design

Diseases

Multiple sclerosis

18 (32.7)

Generalized myasthenia gravis

14 (25.5)

Idiopathic pulmonary fibrosis

13 (23.6)

Amyotrophic lateral sclerosis

7 (12.7)

Systemic sclerosis

2 (3.6)

Familial Mediterranean fever

1 (1.8)

Trials design

N-of-1

1 (1.8)

Crossover

4 (7.3)

Parallel placebo control

50 (90.9)

Type of comparison

non-inferiority

1 (1.8)

superiority

49 (89.1)

Not reported

5 (9.2)

Allocation ratio

1:1:1

1 (1.8)

2:1

1 (1.8)

1:1

53 (96.4)

HM intervention

Single herbal

13 (23.6)

HM formula

42 (76.4)

Ethics approval

Yes

28 (50.9)

Not reported

27 (49.1)

Inform consent

Yes

44 (80.0)

Not reported

11 (20.0)

Characteristics of placebo use

Dosage form

Granule

24 (43.6)

Capsule

8 (14.5)

Decoction

2 (3.6)

Tablet

8 (14.5)

Injection

2 (3.6)

Oral-liquid

5 (9.1)

Spray

3 (5.5)

Plaster

1 (1.8)

Bath

1 (1.8)

Not reported

1 (1.8)

Administration route

Oral

53 (96.4)

Externala

2 (3.6)

Sample size of placebo groupb

1—30

29 (52.7)

31—60

15 (27.3)

61—90

8 (14.5)

91—120

1 (1.8)

121—150

2 (3.6)

Duration of placeboc

 ≤ One month

10 (18.2)

 ≤ Three months

28 (50.9)

 ≤ Six months

8 (14.5)

 ≤ One year

6 (10.9)

 > One year

3 (5.5)

Controlled treatment methods (only placebo or add-on)

Only placebo

32 (58.2)

Add-on therapy

23 (41.8)

  1. aThis category refers to the HM for external use or application, such as injection, plaster, and bath
  2. bSome trials had not yet completedrecruitment and were analyzed as estimated numbers
  3. cWe convert 'weeks' into 'months' in terms of a month with 30 day