Skip to main content

Table 3 Characteristics of placebo compositions in CHM trial registrations

From: Placebo design in WHO-registered trials of Chinese herbal medicine need improvements

Placebo composition

N = 46(%)

Examples

With CHM ingredients

17 (37.0)

Placebo Chinese herbal which Containing 2% of Chinese herbal medicine.

With all ingredients of tested formula

13 (28.3)

Low doses of basic decoction.

With some of ingredients of tested formula

4 (8.7)

Placebo will constitute granules with 10% active core ingredients as below: White Peony Root 10 g Processed Liquorice 3 g Immature Bitter Orange 8 g White Atractylodes Rhizome 15 g.

With CHM ingredients plus other ingredients (e.g. excipients, coloring agents, flavoring agents)

4 (8.7)

We compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors.

Dosage

9 (19.6)

2% (n = 2): Containing 2% of Qing’E pills;

5% (n = 4): Placebo made from 1/20 doses;

10% (n = 3): 10% of the original dose.

Without CHM ingredients

29 (63.0)

Placebo composition of maltodextrin, lactose, edible pigment, taste masking agent.

Excipients

28 (60.8)

Flour, starch, dextrin, cornstarch, rice starch, Lactose, maltodextrin, wheat powder, medical carbon, etc.

 Coloring agents

11 (23.9)

food color, Lemon yellow powder, brown powder, coloring materials, caramel, etc.

 Flavoring agents

12 (26.1)

artificial flavors, citric acid, tea essence, taste masking agent, bitter taste agent, etc.

 Other agents

5 (10.9)

polyethylene glycol 6000, denatonium benzoate, Silicon dioxide, Iron oxide black, Iron oxide red, etc.

Pharmacological tests

2 (4.3)

Placebo has no therapeutic effect.