Study ID

Allocat'n generation

Allocat'n concealed?

Blinding

Loss to follow up

Have AE?

Clear def'n of aims

Inc & ex criteria?

Outcomes specified?

Concordance?

Fung 1999

not described

not described

'double‐ blind'

3/40 (7.5%)

clear definition

yes

clearly described

yes

not stated

Sheehan 1992(a)

not described

not described

'double‐ blind'

10/47 (21.3%)

clear definition

yes

clearly described

yes

diary cards

Sheehan 1992(b)

not described

not described

'double‐ blind'

9/40 (22.5%)

clear definition

yes

clearly described

yes

daily diary

Henderson 2000

not described

not described

open

6/32 (18.7%)

unclear

yes

unclear

yes

not stated

Trial

Statistic used

No randomised

No evaluable

Diff in erythema

95% CI

p value

Diff in surf damage

95% CI

p value

Fung 1999

median change from baseline, at four weeks (Wilcoxon rank sum test)

40

37

0.10

no data

0.775

0.18

no data

0.822

Sheehan 1992(a)

% median change from baseline (Wilcoxon‐based test)

47

37

44.9

13.4, 89.7

no data

56.9

19.2, 97.9

no data

Sheehan 1992(b)

% mean proportional change btwn end of placebo and active phases (paired t‐test)

40

31

46.0

25.2, 67.0

no data

49.0

27.0, 71.0

no data

Outcome

Trial

Statistic used

No randomised

No evaluable

Zemaphyte

Placebo

P value

Slept better

Fung (n = 37)

None

40

37

no data

no data

no data

Sheehan 1992a (n = 37)

None

47

37

19

3

no data

Sheehan 1992b (n = 31)

Difference between proportions, Wilcoxon‐ based method

40

31

15

6

0.078

Itched less

Fung (n=37)

None

40

37

no data

no data

no data

Sheehan 1992a (n = 37)

None

47

37

no data

no data

no data

Sheehan 1992b (n=31)

Difference between proportions, Wilcoxon‐ based method

40

31

14

1

< 0.01

Participant preference

Fung (n = 37)

None

40

37

14

12

no data

Sheehan 1992a (n = 37)

None

47

37

27

2

no data

Sheehan 1992b (n = 31)

Difference between proportions, Wilcoxon‐ based method

40

31

20

4

< 0.02

Zemaphyte

placebo

As used by Sheehan 1992a (sachets)

Ledebouriella seseloides, Potentilla chinensis, Anebia clematidis, Rehmannia glutinosa, Paeonia lactiflora, Lophatherum gracile, Dictamnus dasycarpus, Tribulus terrestris, Glycyrrhiza uralensis and Schizonepeta tenuifolia

Sheehan 1992b (sachets)
Used Clematis armandii

Fung 1999 (sachets)
as Sheehan 1992b

The herbs needed daily preparation by simmering the sachet in water for 90 minutes

Henderson 2000
Compared PSE 101 (herbal teabag) and PSE222 (a freeze ‐ dried extract of the herbal infusion, produced as lacquer coated granules, no simmering required)

No further information given

All formulations provided by Phytopharm, UK

As used by Sheehan 1992a (sachets)

Humulus lupulus, Hordeum distichon, Hordeum distichon ustum, baker's bran (wheat), sucrose, Salvia spp, Thymus vulgaris, Rosmarinus officianalis, Mentha pipertia, Oleum caryophylli and Glycyrrhiza uralensis

Sheehan 1992b (sachets)
no Glycyrrhiza uralensis

Fung 1999 (sachets)
as Sheehan 1992b