Keywords homeopathy - itching - placebo - randomized controlled trial - Skindex-29 - Tinea
corporis
Introduction
Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection affecting
mainly the keratin of the epidermis, hairs and nails after direct contact with infected
soil, animals, or the skin of other humans,[1 ]
[2 ] mainly caused by the Microsporum , Epidermophyton and Trichophyton genera of dermatophytes.[3 ]
[4 ]
Trichophyton rubrum is the causative organism in 70% of cases; and Trichophyton mentagrophytes and Microsporum audouinii are other common species.[5 ] Worldwide prevalence of superficial mycotic infection is 20% to 25%,[6 ] with lifetime risk of developing the infections estimated to be 10% to 20%.[7 ] In rural India, the prevalence of TC is 78%,[8 ] whereas in Kolkata it is 86.4%.[9 ] In south India, prevalence is 25.7%; the 21-30 years age group is the most commonly
affected (24%), predominantly males (1.94:1), laborers (30.6%), rural people (54.6%),
and those from a lower socioeconomic background (65.4%).[10 ]
[11 ] Conventional treatment suggests topical terbinafine and itraconazole and oral anti-fungal
therapies for local lesions[12 ]; but if the lesion is multiple, extensive, deep, recurrent, chronic or unresponsive
to topical anti-fungal treatment, or if the patient is immunodeficient, systemic anti-fungal
treatment is suggested.[13 ] Studies have shown that this kind of treatment produces mild adverse reactions,[14 ] such as gastrointestinal upset, headache, and taste disturbances.[15 ]
One recent observational study conducted on 65 participants with dermatophytosis revealed
promising results in favor of homeopathy.[16 ] Another observational study, using Bacillinum on 36 participants with tinea infection, produced equivocal results.[17 ] A recent case report on tinea with the medicine Sepia succus showed improvement.[18 ] One in vitro study documented positive effects of two homeopathic medicines—Thuja occidentalis and Graphites —on keratinophilic fungi.[19 ] Despite this preliminary evidence, we were unable to identify any published randomized,
placebo-controlled, trial of individualized homeopathic medicines (IHMs) in TC, and
so we aimed to rectify that deficiency in the research literature.
Methods
Trial Design
This double-blind, randomized (1:1), placebo-controlled, two-parallel arms trial was
conducted from November 2019 to June 2021 at the dermatology out-patient department
of the National Institute of Homoeopathy, Kolkata, India.
Ethical Matters
The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref.
No. 5–23/NIH/PG/Ethical Comm. 2009/Vol 6/ 49(PG); dated October 14, 2019] and was
registered prospectively in the Clinical Trials Registry—India [CTRI/2019/11/021999]
with a secondary identifier—UTN of U1111–1242–0070. The study complied with the Helsinki
Declaration for ethical conduct of clinical trials involving human participants and
adhered to the International Conference on Harmonization guideline for Good Clinical
Practice. The trial protocol and the full project report were submitted as the postgraduate
synopsis and thesis respectively of the corresponding author to the West Bengal University
of Health Sciences, Kolkata. Provision was kept in the protocol to treat intercurrent
illness, and adverse or serious adverse events, if any, as per homeopathic principles
or by referral. No new drug was experimented on in this trial. Prior to enrollment,
each patient was provided with an information sheet detailing the objectives, methods,
risks and benefits of participating, and addressing matters of confidentiality; written
informed consent was then obtained from each individual who agreed to participate
in the trial.
Participants
Study inclusion criteria were: suffering from TC (ICD-10-CM code B35.4) for at least
3 months; aged between 18 and 65 years, and of either sex; literate, with the ability
to read English and/or Bengali; consented to participate. A patient who was using
topical agents for tinea lesions was eligible for inclusion after a washout period
of 2 weeks. A potential participant was excluded if there was a complication such
as lichenification or eczematization, a similar looking skin condition such as seborrheic
dermatitis, pityriasis rosea or psoriasis, or if too sick for consultation, diagnosed
with unstable mental or psychiatric illness, had any uncontrolled or life-threatening
systemic illness affecting quality of life and/or any organ failure, was pregnant,
puerperal or lactating, suffered from substance abuse and/or dependence, was in a
self-reported immune-compromised state, or had been undergoing homeopathic treatment
for any chronic disease at any time within the previous 6 months.
Intervention
Both the medicines and the placebos were procured from Hahnemann Publishing Company
Private Limited—a good manufacturing practice (GMP)-certified firm.
Verum: Indicated IHMs were administered in fifty-millesimal (LM) potencies as decided appropriate
to the individual case. Homeopathic medicines are produced through sequentially agitated
(“succussed”) dilutions in decimal (D), centesimal (C) or quinquagintamillesimal (Q
or LM or 50-millesimal) potencies. In this trial, we used Q-potencies which were prepared
by grinding the raw material (C1 until C3), followed by consecutive 1:50,000 agitated
dilutions. Therefore, a Q1 corresponds to a 5 × 10−10 fraction of the raw material (Q2 = 2.5 × 10−15 , Q3 = 1.25 × 10−20 , Q4 = 6.25 × 10−24 , etc.). A single medicated cane sugar globule of poppy seed size (no.10) was dissolved
in 80 mL of distilled water with addition of two drops of 90% v/v ethanol; 16 doses
were marked on the vial. Each dose of 5 mL was instructed to be taken, after 10 uniformly
forceful downward strokes to the vial, in 45 mL of clean room-temperature water in
a clean cup; also to stir well, to take 5 mL of this liquid orally, and to discard
the rest of the liquid from the cup. Medicine selection, dosage and repetition were
decided by consensus among three qualified, experienced and affiliated homeopaths
in every case. The duration of therapy for each patient was 3 months. Follow-ups took
place in compliance with homeopathic principles.
Control : This group received placebos, identical in appearance to the verum. In LM scale,
a single non-medicated cane sugar globule of poppy seed size (no. 10) was dissolved
in 80 mL distilled water with addition of two drops of 90% v/v ethanol, and the remaining
instructions were similar to those of the verum group. The period of interventions
for each patient was also 3 months.
Concomitant care: Along with the medicines, each of the enrolled participants received advice on applying
olive oil[20 ] or coconut oil[21 ] on the affected parts, which they were requested to do twice a day, keeping the
area dry, avoiding the use of tight garments including synthetic clothes, and washing
infected clothes and bed linen separately in hot water.
Outcome Measures
Sample Size
Formal effect size calculation was not possible on account of an absence of any published
study of similar design. We expected complete disappearance of tinea lesions, in 50%
and 25% of participants in the verum and control groups respectively, within 3 months
of intervention. Calculated effect size (w ) became 0.5. To detect a significant difference between two proportions of events
over 3 months of intervention through χ
2 goodness-of-fit 2 × 2 contingency tables, a study with 2 × 31 participants would
give 95% power based on a two-tailed significance level of 5%. To achieve the 62 total,
screening and exclusion continued until the enrollment reached that number.
Randomization
A random sequence was generated by permuted block randomization maintaining 1:1 allocation,
performed by an independent third party in strict confidentiality using the StatTrek
random number generator, and was made available to the blinded pharmacist in coded
form for dispensing from the coded vials as per the prescriptions.
Blinding
The double-blinding method was ensured by masking both the participants and the investigators.
The outcome assessors, the pharmacists and the data entry operators were also kept
blinded throughout the trial. Identical looking vials were coded as “1” or “2” and
contained either medicine or placebo. Codes were assigned randomly and confidentially
by an independent third party. Both medicines and placebos were re-packed in identical
glass bottles and labeled with code, name of medicine and potency, and were dispensed
according to the random number list. The vials were destined for each patient in turn
by the random number chart. Codes were broken at the end of the trial after the dataset
was frozen.
Allocation Concealment
Blinded postgraduate trainees were involved in participant screening, enrollment and
assigning serial numbers to the enrolled participants. Subsequently, the blinded participants
were interviewed by the blinded homeopaths for prescription. Allocation concealment
was achieved by making both the recruiters and the physicians unaware of the randomization
sequence. The blinded pharmacist was provided with the coded random number chart in
strict confidentiality for dispensing of either medicines or alike placebos to the
participants sequentially.
Statistical Method
The intention-to-treat (ITT) approach was adopted; missing values were replaced by
predicted values from a linear regression model. Baseline differences between groups
were adjusted using analysis of covariance (ANCOVA) models. The intra-group changes
were examined using one-way repeated measure analysis of variance (ANOVA). Inter-group
differences were tested with Chi-square tests, unpaired t -tests and two-way repeated measures ANOVA. Effect sizes (Cohen's d : small, 0.2; medium, 0.5; large, 0.8) are also reported. Statistical Package for
Social Sciences (SPSS version 20.0 statistics for Windows; IBM Corp., Armonk, NY)
was used to analyze the data.
Reporting Guidelines
Study reporting adhered to the CONSORT extension statement for randomized trials[24 ] and the RedHot guidelines[25 ] for reporting data on homeopathic treatments ([Supplementary Tables 1 ] and [2 ], available online only).
Results
Participant Flow
Out of the 98 participants screened, 36 were excluded because of various reasons;
62 were enrolled as per the eligibility criteria and subsequently randomized. Five
participants dropped out (verum, 3; control, 2); 57 completed the trial ([Fig. 1 ]).
Fig. 1 Study flow diagram. IHMs, individualized homeopathic medicines, COVID-19, coronavirus
disease 2019; ITT, intention-to-treat.
Recruitment
The enrollment period spanned 17 months, from November 2019 until March 2021 inclusive.
Follow-up of the last enrolled patient was completed in June 2021. Total study duration
was 20 months.
Baseline Data
There were no statistical differences between the groups at baseline (all p >0.05) except Skindex-29 degree of symptoms (p = 0.004) and psychological functioning (p = 0.019) sub-scales ([Tables 1 ], [3 ], [4 ]).
Table 1
Comparison of the socio-demographic characteristics between groups at baseline (N = 62)
Features
IHMs group (n = 31)
Placebo group (n = 31)
p -Value
Age
35.7 ± 10.7
33.9 ± 13.9
0.509
Body mass index
19.4 ± 2.2
19.7 ± 2.5
0.705
Blood pressure
• Systolic
121.6 ± 9.0
121.7 ± 7.4
0.926
• Diastolic
77.8 ± 5.7
79.0 ± 5.7
0.481
Sex[a ]
0.891
• Male
15 (48.4)
14 (45.2)
• Female
16 (51.6)
17 (54.8)
Residence[a ]
0.822
• Rural
20 (64.5)
18 (58.1)
• Semi-urban
7 (22.6)
8 (25.8)
• Urban
4 (12.9)
5 (16.1)
Education[a ]
0.554
• 8th std. or less
7 (22.6)
10 (32.3)
• 9th to 12th std.
10 (32.3)
11 (35.5)
• Higher than 12th std.
14 (45.2)
10 (32.3)
Marital status[a ]
0.501
• Single
6 (19.4)
8 (25.8)
• Married
25 (80.6)
23 (74.2)
Employment status[a ]
0.916
• Employed
5 (16.1)
6 (19.4)
• Business
6 (19.4)
6 (19.4)
• Dependent
20 (64.5)
19 (61.3)
Income status[a ]
0.212
• Poor
18 (58.1)
12 (38.7)
• Middle
6 (19.4)
11 (35.5)
• Affluent
7 (22.6)
8 (25.8)
Abbreviation: IHMs, individualized homeopathic medicines.
a Continuous data presented as mean ± standard deviation and unpaired t -tests applied.
Note: Categorical data presented as absolute value (%) and Chi-square tests (Yates
corrected) applied; p less than 0.05 (two-tailed) considered as statistically significant.
Table 2
Intra- and inter-group comparison of presence or absence of lesion at different time
points between groups (N = 62)
Baseline; n (%)
After 1 month; n (%)
After 2 months; n (%)
After 3 months; n (%)
χ
2
p- Value
IHMs group (n = 31)
31 (100)
31 (100)
31 (100)
31 (100)
0.012
0.999
Placebo group (n = 31)
31 (100)
31 (100)
31 (100)
30 (96.8)
Abbreviation: IHMs, individualized homeopathic medicines.
Table 3
Intra- and inter-group comparison of pruritus intensity scores (0-10) at different
time points between groups (N = 62) (baseline differences adjusted using ANCOVA model)
Baseline
mean ± SD
After 1 month; mean ± SD
After 2 months;
mean ± SD
After 3 months;
mean ± SD
Wilks' lambda
Partial eta-square
F
3, 27
p
[c ]
• IHMs group (n = 31)
8.3 ± 0.7
8.2 ± 0.7
6.9 ± 0.6
3.9 ± 0.8
0.043
0.957
206.984
<0.001***
• Placebo group (n = 31)
8.2 ± 1.1
7.0 ± 0.7
5.8 ± 0.6
4.7 ± 0.7
0.076
0.924
113.352
<0.001***
Mean inter-group difference ± SE
0.2 ± 0.2
1.1 ± 0.2
1.2 ± 0.2
−0.7 ± 0.2
95% CI
−0.3, 0.6
0.8, 1.5
0.8, 1.5
−1.1, −0.4
t
60
0.689
6.607
7.338
−4.087
p
[a ]
0.493
<0.001***
<0.001***
<0.001***
Effect size (Cohen's d )
–
1.714
1.833
1.064
Two-way repeated measures ANOVA
• F
1, 60
12.574
• Partial eta-square
0.173
• p
[b ]
0.001**
CI, confidence interval; IHMs, Individualized homeopathic medicines; NRS, Numeric
rating scale; SD, standard deviation; SE, standard error.
a Unpaired t -tests; t
60 : t score at 60 degrees of freedom; p : inter-group differences detected by unpaired t -tests.
b
p : inter-group differences detected by two-way repeated measures ANOVA models.
c
p : intra-group changes detected by one-way repeated measures ANOVA.
*p < 0.05.
**p < 0.01.
***p < 0.001.
Table 4
Intra- and inter-group comparison of Skindex-29 scores at different time points between
groups (N = 62) (baseline differences adjusted using ANCOVA model)
Baseline;
mean ± SD
After 1 month; mean ± SD
After 2 months;
mean ± SD
After 3 months; mean ± SD
Wilks' lambda
Partial eta-square
F
3, 28
p
[c ]
Degree of symptoms (0–100)
IHMs group (n = 31)
26.2 ± 1.5
21.3 ± 1.2
17.9 ± 1.6
15.7 ± 1.9
0.031
0.969
287.368
<0.001***
Placebo group (n = 31)
24.6 ± 2.7
20.8 ± 2.5
16.7 ± 1.9
14.8 ± 2.2
0.088
0.912
96.970
<0.001***
Mean inter-group difference ± SE
1.6 ± 0.5
0.5 ± 0.5
1.2 ± 0.5
0.9 ± 0.5
95% CI
0.5, 2.7
−0.5, 1.5
0.3, 2.1
−0.2, 1.9
t
60
2.935
0.971
2.716
1.701
p
[a ]
0.004**
0.335
0.009**
0.094
Effect size (Cohen's d )
–
0.255
0.683
0.438
Two-way repeated measures ANOVA
• F
1, 60
7.908
• Partial eta-square
0.116
• p
[b ]
0.007**
Psychological functioning (0–100)
IHMs group (n = 31)
40.3 ± 3.1
33.2 ± 2.7
29.8 ± 3.0
26.9 ± 2.8
0.040
0.960
225.993
<0.001***
Placebo group (n = 31)
37.3 ± 6.2
31.3 ± 3.7
26.4 ± 3.9
25.2 ± 3.8
0.192
0.808
39.328
<0.001***
Mean inter-group difference ± SE
3.0 ± 1.2
1.9 ± 0.8
3.4 ± 0.9
1.7 ± 0.8
95% CI
0.5, 5.5
0.3, 3.6
1.6, 5.2
0, 3.4
t
60
2.410
2.305
3.806
2.027
p
[a ]
0.019*
0.025*
< 0.001***
0.047*
Effect size (Cohen's d )
–
0.587
0.977
0.509
Two-way repeated measures ANOVA
• F
1, 60
10.328
• Partial eta squared
0.147
• p
[b ]
0.002**
Emotional status (0–100)
IHMs group (n = 31)
35.3 ± 3.2
29.9 ± 2.2
25.9 ± 2.3
23.0 ± 1.9
0.068
0.932
128.661
<0.001***
Placebo group (n = 31)
36.2 ± 4.3
27.6 ± 2.6
24.1 ± 3.1
22.6 ± 3.4
0.067
0.933
129.721
<0.001***
Mean inter-group difference ± SE
−0.9 ± 0.9
2.3 ± 0.6
1.8 ± 0.7
0.4 ± 0.7
95% CI
−2.8, 0.9
1.1, 3.5
0.5, 3.2
−0.9, 1.8
t
60
−0.983
3.728
2.665
0.593
p
[a ]
0.330
< 0.001***
0.010*
0.556
Effect size (Cohen's d )
–
0.955
0.659
0.145
Two-way repeated measures ANOVA
• F
1, 60
2.312
• Partial eta-square
0.037
• p
[b ]
0.134
Overall (0–100)
IHMs group (n = 31)
101.4 ± 6.3
87.3 ± 5.3
76.2 ± 6.6
67.9 ± 6.1
0.036
0.964
248.305
<0.001***
Placebo group (n = 31)
100.4 ± 11.2
81.7 ± 6.5
69.1 ± 7.9
64.6 ± 8.6
0.083
0.917
103.689
<0.001***
Mean inter-group difference ± SE
0.9 ± 2.3
5.5 ± 1.5
7.1 ± 1.8
3.2 ± 1.9
95% CI
−3.7, 5.5
2.5, 8.5
3.4, 10.7
−0.6, 7.0
t
60
0.406
3.661
3.838
1.702
p
[a ]
0.686
0.001**
< 0.001***
0.094
Effect size (Cohen's d )
–
0.944
0.975
0.443
Two-way repeated measures ANOVA
• F
1, 60
7.231
• Partial eta-square
0.108
• p
[b ]
0.009**
Abbreviations: CI, confidence interval; IHMs, individualized homeopathic medicines;
sd, standard deviation; SE, standard error.
a Unpaired t -tests; t
60 : t score at 60 degrees of freedom; p , inter-group differences detected by unpaired t -tests.
b
p : inter-group differences detected by two-way repeated measures ANOVA models.
c
p : intra-group changes detected by one-way repeated measures ANOVA.
*p <0.05.
**p <0.01.
***p <0.001.
Numbers Analyzed
Out of the 31 enrolled in each group, outcome data were complete for 28 and 29 participants
in the IHMs and placebo groups respectively. ITT analysis included all the randomized
participants (n = 62).
Outcomes and Estimation
Primary: After 3 months of intervention, complete disappearance of the skin lesions
was observed in one patient only (in the placebo group); thus, no significant group
difference could be detected (χ
2 = 0.012, p = 0.999) ([Table 2 ]).
Secondary:
○ Itching NRS : Intra-group improvement over time was significant in both the IHMs (F
3, 27 = 206.984, p <0.001) and placebo groups (F
3, 27 = 113.352, p <0.001). Inter-group differences were significant, with large effect sizes, after
the first (mean difference: 1.1; 95% CI, 0.8 to 1.5; p <0.001; d = 1.714), the second (mean difference: 1.2; 95% CI, 0.8 to 1.5; p <0.001; d = 1.833) and the third month (mean difference: −0.7; 95% CI, −1.1 to −0.4; p <0.001; d = 1.064). Placebos were significantly superior to IMHs for the first and second months
of the study in reducing the intensity of pruritus; however, the situation was reversed
after the third month. Overall analysis favored homeopathy against placebo (F
1, 60 = 12.574, p = 0.001) ([Table 3 ]).
○ Skindex-29 questionnaire : Intra-group changes at different points in time of the overall score and the sub-scales
were statistically significant in both the groups (all p <0.001). Inter-group differences in overall score and two sub-scales after 3 months
of intervention favored IHMs significantly against placebo: Skindex-29 overall scores
(mean group difference after 1 month, 5.5 [2.5 to 8.5]; after 2 months, 7.1 [3.4 to
10.7]; after 3 months: 3.2 [−0.6 to 7.0]; F
1, 60 = 7.231, p = 0.009); Skindex-29 degree of symptoms sub-scale scores (mean group difference after
1 month, 0.5 [−0.5 to 1.5]; after 2 months, 1.2 (0.3 to 2.1); after 3 months, 0.9
(−0.2 to 1.9); F
1, 60 = 7.908, p = 0.007); and Skindex-29 psychological functioning sub-scale scores (mean group difference
after 1 month, 1.9 [0.3 to 3.6]; after 2 months, 3.4 (1.6 to 5.2); after 3 months,
1.7 (0 to 3.4); F
1, 60 = 10.328, p = 0.002). No significant inter-group difference was observed for the Skindex-29 emotional
status sub-scale scores: mean group difference after 1 month, 2.3 (1.1 to 3.5); after
2 months, 1.8 (0.5 to 3.2); after 3 months, 0.4 (−0.9 to 1.8); F
1, 60 = 2.312, p = 0.134. Inter-group differences at individual time points were mostly statistically
significant, except the Skindex-29 degree of symptoms sub-scale score after 1 month
(p = 0.335) and 3 months (p = 0.094), the Skindex-29 emotional status sub-scale scores after 3 months (p = 0.556), and the Skindex-29 overall score after 3 months (p = 0.094) ([Table 4 ]).
Medicines Used
The most frequently prescribed medicines were Sulphur (n = 8; 12.9%), Bacillinum (n = 7; 11.3%), Thuja occidentalis (n = 7; 11.3%), and Kali arsenicum and Tellurium (n = 6 each; 9.7%). The baseline prescription invariably started with the LM1 potency.
Potencies were increased during follow-up after consensus agreement among the physicians.
The highest potency used in this study was LM8 ([Table 5 ]) ([Supplementary Table 3 ], available online only).
Table 5
List of the most frequently prescribed medicines at baseline between groups (N = 62)
Medicines
Total (n = 62); n (%)
IHMs group (n = 31); n (%)
Placebo group (n = 31); n (%)
p
1. Sulphur
8 (12.9)
4 (12.9)
4 (12.9)
1.000
2. Bacillinum
7 (11.3)
4 (12.9)
3 (9.7)
0.688
3. Thuja occidentalis
7 (11.3)
2 (6.5)
5 (16.1)
0.229
4. Kali arsenicum
6 (9.7)
4 (12.9)
2 (6.5)
0.390
5. Tellurium
6 (9.7)
3 (9.7)
3 (9.7)
1.000
6. Lycopodium clavatum
5 (8.1)
3 (9.7)
2 (6.5)
0.641
7. Natrum muriaticum
5 (8.1)
2 (6.5)
3 (9.7)
0.641
8. Pulsatilla nigricans
5 (8.1)
1 (3.2)
4 (12.9)
0.162
9. Lachesis mutus
4 (6.5)
3 (9.7)
1 (3.2)
0.301
10. Sepia succus
4 (6.5)
3 (9.7)
1 (3.2)
0.301
11. Arsenicum album
2 (3.2)
1 (3.2)
1 (3.2)
1.000
12. Arsenicum iodatum
2 (3.2)
0 (0.0)
2 (6.5)
–
13. Psorinum
1 (1.6)
1 (3.2)
0 (0.0)
–
Abbreviation: IHMs, individualized homeopathic medicines;
Note: Chi-square (Yates corrected) applied; p less than 0.05 (two-tailed) considered as significant.
Adverse Events
No serious adverse events occurred that could be attributed causally either to the
intervention or to the comparator.
Discussion
In this randomized double-blind clinical trial conducted on 62 participants suffering
from TC, no inter-group differences could be detected for complete disappearance of
the skin lesions, the primary outcome. However, the secondary outcomes revealed some
statistically significant improvements in the IHMs group in comparison with placebos.
Placebos were superior to IMHs for the first and the second months of the study in
reducing the intensity of pruritus, but the situation was the opposite for the third
month, in which pruritus was significantly less intense for patients taking IHMs compared
with those receiving placebos. These contradictory results preclude any definitive
conclusion, but several observations can be made. The apparent discrepancy might be
due to the lack of effect of the highly diluted IHMs on the selected primary outcome
measure, or a different set of remedies or different potencies/dosage might have been
required to produce detectable effects in the defined timeframe of 3 months. However,
some improvement in itching severity and Skindex-29 scores with homeopathy is consistent
with the premise that homeopathy treats the whole person rather than acting on specific
symptoms of disease: that is, a curative response after administration of homeopathic
medicines follows Hering's law of cure – from above downward, from within outward,
from more vital to less vital organs, and in reverse order of the appearance of symptoms.[26 ]
The strengths of the current study include enrollment of persons who may need a wide
range of different individualized remedies rather than only one, thus reflecting classical
homeopathy practice, which in our trial required the agreement of three homeopaths
on each remedy selection to ensure high confidence in the prescription. Moreover,
we used daily, flexibly dosed LM potencies to obviate homeopathic methodological concerns
such as remedy anti-doting or aggravations, and included both categorical and continuous
variables as trial outcome measures. LM potencies were used mainly because of their
low dose, ensuring minimal chances of homeopathic aggravations, with provision for
repetition on a regular basis. The most marked divergence between active and placebo
treated groups occurred in the intensity of itching and quality of life. The findings
are consistent with homeopathic theories of healing.[27 ] Within homeopathic thinking, the remedy is not chosen for the diagnosis of TC, but
for the unique person who has TC. Consequently, IHMs are expected clinically to cause
gradual improvements in different aspects of health before eventual disappearance
of lesions.[28 ]
An intervention period of 3 months, while choosing a strict dichotomous variable as
the primary outcome measure and adhering to LM potencies only, may be considered as
important study limitations. However, extending the intervention period in a placebo-controlled
trial would have raised ethical concerns. The superiority of placebos against IHMs
in reducing the intensity of pruritus in the first 2 months may be explained by the
fact that IHMs can take some time to initiate their action in a chronic disease like
TC. It probably necessitates observations for a longer period of time. Choice of the
dichotomous outcome was based on prior assumptions and the experience of the investigators;
however, that approach did not seem to work optimally. Time to disappearance of TC
lesions after administering IHMs in centesimal potencies would be worth pursuing in
future studies.
The trial's secondary outcome findings were similar to those of the observational
study by Gupta et al[16 ]: both revealed promising effects of IHMs in TC, though the latter did not apply
any validated outcome measures or randomized design. Another observational study used
only Bacillinum ,[17 ] which is contrary to the practice of classical homeopathy, and the outcome measures
were subjective only. A case report on tinea using Sepia showed improvement,[18 ] but again validated outcomes were not used. In our trial, Thuja occidentalis was one of the most frequently prescribed homeopathic medicines, supported by an
in vitro study using Thuja occidentalis on keratinophilic fungi.[19 ]
Experts have held different “miasms” responsible for tinea infection—“sycosis” by
Allen,[29 ] “tubercular” by Burnett,[30 ] and “psora” and “latent psora” by Hahnemann[31 ]; but all concurred that treating tinea lesions with external applications gives
rise to several unfavorable consequences, citing many instances. Burnett tagged the
condition as “sub-tuberculosis” and recommended its treatment with the “pathologic
similimum” Bacillinum in high potency and administered infrequently. While analyzing miasmatic dominance
in the enrolled cases in our trial, the findings were as follows: predominantly psoric
(61.3%), tubercular (23.2%), sycotic (13.4%) and syphilitic (2.1%). Douglass suggested
“lymphatic temperament” as a predisposing condition of tinea.[32 ] Lilienthal advocated Calcarea carbonicum , Sepia officinalis and Tellurium as the most frequently indicated remedies for tinea infections.[33 ] Raue suggested several remedies—Calcarea carbonica , Hydrastis canadensis , Natrum carbonicum , Natrum muriaticum , Sepia succus , Tellurium and Chrysophanic acid
[34 ]; several of these remedies were prescribed in our trial as well. Different authors
like Kippax,[35 ] Dearborn,[36 ] Bernstein[37 ] and Morrison[38 ] have suggested different groups of remedies in treatment of TC. Homeopathic repertories
represent the condition under different rubrics, such as “ringworm”,[39 ] “herpes circinatus”,[40 ]
[41 ]
[42 ]
[43 ] “trichophytosis”[40 ] and “tetters”,[44 ] with a very similar group of medicines as were used in our trial.
Thus, robust trials on larger samples and for longer periods of time are now indicated,
especially in view of emerging basic scientific evidence that homeopathic remedies
have physical–chemical properties that differ from those of placebos.[45 ]
[46 ] We recommend that a confirmatory diagnosis of dermatophytosis, from skin scrapings
examined microscopically on a 10–20% potassium hydroxide mount, should be incorporated
in future trials.[47 ]
Conclusion
In this randomized double-blind clinical trial, conducted on 62 individuals suffering
from TC, inter-group differences could not be detected on the primary outcome after
3 months of homeopathic intervention; however, secondary outcomes included some statistically
significant improvement in the IHMs group in comparison with placebos. Independent,
more robust, trials are warranted to inform more rigorous conclusions about the clinical
effect of IHMs on TC.
Highlights
A double-blind, randomized, placebo-controlled trial of individualized homeopathic
medicines in LM potencies was conducted on 62 patients suffering from TC.
Though no inter-group differences could be detected on the primary outcome measure,
the secondary outcomes revealed some significantly better effects of homeopathic medicines
than placebo.
Sulphur , Bacillinum and Thuja occidentalis were the most frequently prescribed medicines.
