apple cider vs salicylic-lactic acid v2

7/30/2019 Apple Cider vs Salicylic-Lactic Acid v2

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STATISTICAL ANALYSIS/ RESULTS

Power Calculation:

Based on the cure rates of the phase II clinical trial on the efficacy of the apple cider

vinegar vs salicylic lactic acid in the treatment of common warts, which yielded 36%

and 74%, and setting alpha at 0.05, sample size of at least 51 lesions per group has

98% power.

A. Patients/ Subjects & Common Warts Sample – Descriptives

Sex Total

Apple Cider 5 23% 17 77% 22 49%

Salicylic Lactic Acid 11 48% 12 52% 23 51%

Total 16 36% 29 64% 45 100%

Male Female

Out of the total 45 subjects, 36% are male and 64% are female. On either group,

most of the patients are female (A = 77%, B = 52%). The mean age of the patients

who received apple-cider vinegar treatment is 22.68 + 15.8 years, while those of

the patients who received salicylic-lactic acid treatment is 24.61 + 15.5 years.

104 common warts in 45 patients were included in the study. 53 common warts in

22 patients were subjected to Apple Cider Vinegar treatment while 51 common

warts in 23 patients were subjected to Salicylic-Lactic Acid treatment. In the apple

cider group, the mean number of warts per patient was 2.41 + 1.9. In the salicylic-

lactic acid group, the mean number of warts per patient was 2.22 + 1.9.

Three patients (two from apple-cider group, one from salicylic-lactic acid group)

with a total of four common warts (3 from apple cider group, 1 from salicylic-lactic

acid group) were not able to comply with the 4-week maximum clinical trial.

Duration of Lesions (% per group)1 Mo - 3 Mos 4 - 6 Mos 7 - 11 Mos 1 Yr 2 Yrs > 2 Yrs TOTAL

Apple Cider Vinegar 6 (27%) 5 (23%) 4 (18%) 4 (18%) 3 (14%) 0 (0%) 22 (100%)

Salicylic-Lactic Acid 12 (52%) 4 (17%) 0 (0%) 4 (17%) 1 (4%) 2 (9%) 23 (100%)

TOTAL 18 (40%) 9 (20%) 4 (9%) 8 (18%) 4 (9%) 2 (4%) 45 (100%)

Most of the lesions in both groups had a duration of 1 month to 3 months (27% in

apple cider; 52% in salicylic-lactic acid).

B. Cure Rate

Apple Cider Vinegar 5 9% 45 85% 3 6% 53 51%

Salicylic-Lactic Acid 11 22% 39 76% 1 2% 51 49%

TOTAL 16 15% 84 81% 4 4% 104 100%

Not Cured Cured TOTALMissing/ Inc



The cure rate for the apple cider group and salicylic-lactic acid group were 85%

(45/53) and 76% (39/51), respectively. Overall, cure rate for the clinical trial was

81%. Excluding the missing samples, the difference in cure rates were statistically

tested using the Chi-Square Test. There is no sufficient evidence to prove that

there is a significant difference between the cure rates of apple cider treatment and

salicylic-lactic acid treatment (p=0.102).

Intention to Treat Analysis:



Cured

Not Cured

Missing / Lost to ff up

Cure Rates (%):

Complete Case Analysis

Assuming good outcome

Assuming poor outcome

--

--

--

0.102 (not sig. diff)



3

90 (45/50)

90.6 (48/53)

84.9 (45/53)

39

11

1

78 (39/50)

78.4 (40/51)

76.5 (39/51)

a cy c- ac c c

(n=51)

- quare es

P-value (vs 0.05)

45

5

Apple Cider (n=53)

Complete case analysis ignores all those who were not able to complete the clinical

trial. Assuming good outcome assumes those that were lost to follow up were cured,

while assuming poor outcome assumes those that were lost to follow up were not

cured. Chi-square test results in all three scenarios show that there is no sufficient

evidence to prove that the cure rates between the apple cider group and the

salicylic-lactic acid group are significantly different.

C. Decrease in Size of Warts



At Day 0 of the clinical trial, the common warts had a mean size of 0.499cm in the

apple cider group and 0.481cm in the salicylic-lactic acid group. For both T-test for

Independent Samples (p=0.296) and Mann-Whitney Test (p=0.425), there is no

sufficient evidence to prove that the mean sizes at Day 0 of the two groups are

significantly different. Therefore, a comparison between the mean size decrease of

the common warts at the end of the clinical trial can be performed.

The size of common warts in the apple cider group decreased by an average of

0.441cm, while the size of the common warts in the salicylic-lactic acid group

decreased by an average of 0.375cm. With p=0.087 resulting from the T-Test for

Independent Samples and with p=0.086 resulting from the Mann-Whitney Test,

there is no sufficient evidence to prove that the mean size decrease between the

two groups are significantly different.

D. Number of Days to Cure



Mean time to cure among apple cider group and among salicylic-lactic acid group

were 20 and 18 days, respectively. There is a significant difference between the two

group’s mean time to cure (p=0.026), with the salicylic-lactic acid group showing abetter clinical response across time.

E. Incidences of Adverse Effects



GROUP * Hypopigmentation Crosstabulation

Count

Hypopigmentation

TotalNO YES

GROUP Apple Cider Vinegar 49 1 50

Salicylic Acid + Lactic Acid 46 4 50

Total 95 5 100



Except for Maceration (p=0.006), there is no significant difference in the incidences

of adverse reaction between the two groups.

In the apple cider group, 2 patients had erythema, 1 had hypopigmentation, 1 had

blisters and another 1 experienced scarring. In the salicylic-lactic acid group, 2 had

erythema, 8 had maceration and 4 had hypopigmentation.

F. Disease Control

Among the apple cider group, 45 (84.9%) out of 53 common warts were cleared or

resolved, 1 (1.9%) common wart showed improved or evident clearance and 4

(7.5%) common warts were partially cleared.

Among the salicylic-lactic acid group, 39 (76.5%) out of 51 common warts were

cleared or resolved, 1 (2.0%) common wart showed improved or evident clearance

and 10 (19.6%) common warts were partially cleared.

Erythem a M acerationHypop igm entationHyperpigm entationBlistering Pain/ Tendern essScarring

Secondary Ba

In fe ct io n O

p le C id e r V in e ga r 2 0 1 0 1 0 1 0

cy lic-Lact ic A cid 2 8 4 0 0 0 0 0



66.7% (56/84) of cleared or resolved common warts were already soft on palpation

prior to curettage while 29.8% (25/84) were doughy. Common warts which showed

improved or evident clearance were all already soft. Of those common warts whichwere partially cleared, 71.4% (10/14) were also already soft.

apple cider vs salicylic-lactic acid v2

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