Usefulness of homoeopathic treatment in the management of melasma – A prospective study

INTRODUCTION

Melasma is a hyperpigmentation disorder among Indians.^[1] It is characterised by the presence of well-demarcated bilateral symmetrical tan to brown hyperpigmented macular patches on the skin. The most commonly affected areas are the cheeks, upper lip, chin, and forehead; however, melasma can also occur in other sun-exposed areas, such as the forearms. Globally, melasma occurs in 8–10% of people.^[2] It is most commonly found in darker-skinned women, typically Asian or Hispanic women with Fitzpatrick skin types III-VI; men account for 10% of the cases.^[3,4] It is common during pregnancy; approximately 8% cases show remission post-pregnancy.^[5] Melasma is classified into facial (centrofacial-63%, malar-21% and mandibular-16%) or extrafacial according to lesion distribution; mild, moderate or severe according to the severity of pigmentation; epidermal, dermal or mixed according to the depth of pigmentation and transient (disappears within 1 year of withdrawal of hormonal stimulation) or persistent (that persists >1 year of withdrawal of hormonal stimulation and is maintained by other factors) according to the disease history.^[6-9]

The exact underlying cause of melasma is unclear; etiopathogenetic factors are postulated, including pregnancy, oral contraceptives, genetics, sun exposure, cosmetics and race.^[10] Despite having no systemic consequences, melasma can cause significant psychological stress to the affected individual. A study of 156 patients with melasma used the melasma quality of life scale (MELASQOL) questionnaire and determined that patients with melasma felt dejected, ashamed and frustrated. In addition, it demonstrated how melasma affects interpersonal relationships.^[11]

Melasma is assessed using the modified melasma area and severity index (mMASI).^[12] The mMASI enables clinicians to assess the amount and degree of pigmentation, systematically assess and measure the severity of melasma and the response to treatment. The mMASI uses the variables area of involvement (A) and darkness (D). The calculation of the area of involvement encompasses the forehead (f), left malar region (lm), right malar region (rm), and chin (c), which account for 30%, 30%, 10%, and 30% of the entire face, respectively. The four sections are assigned a number between 0 and 6, 0 = No involvement, 1 = <10%, 2 = 10%–29%, 3 = 30%–49%, 4 =50%–69%, 5 = 70%–89% and 6 = 90%–100%. The darkness (D) of the melasma is rated as follows: 0, 1, 2, 3, and 4 indicate no, minimal, mild, moderate, and severe hyperpigmentation, respectively. The sum of the darkness severity ratings multiplied by the area of involvement value for each of the four face areas yields the final mMASI score that ranges from 0 to 24, where 24 is the most severe.

The MELASQOL is a disease-specific questionnaire that highlights the quality of life concerns unique to melasma.^[13] It assesses ten items: three questions on skin discolouration and seven questions from the Skindex-16, which are more concerned with the psychological and emotional elements of melasma than the physical manifestations. A Likert scale with a range of 1 (not bothered at all) to 7 (bothered all the time) is used to score each item. The MELASQOL score runs from 7 to 70, where a higher number denotes lower quality.

Various methods have been explored in conventional treatments for melasma, including sunscreens, bleaching creams (e.g. hydroquinone), acne creams (e.g. azelaic acid), topical retinoids (e.g. tretinoin) and facial peels (e.g. glycolic acid peels), a combination approach such as triple-combination cream (hydroquinone, tretinoin and steroid).^[14] Irrespective of various treatment methods that have been utilised for melasma, there is no gold standard treatment for melasma to date.^[15]

Research shows that homoeopathic remedies can be used to treat individual cases of melasma. A case report demonstrated successful treatment of melasma using Lycopodium. The case was found to be in remission even a year after stopping treatment.^[16] Another case of hyperpigmentation of skin in a 62-year-old woman was successfully treated with Chininum sulphuricum.^[17]

Thus, we see some evidence that homoeopathy is promising for treating of melasma. However, currently available evidence comprises a few case reports and no clinical research. Therefore, this study aimed to understand the role of homoeopathy in the treatment of melasma and to assess the quality of life in patients with melasma after homoeopathic treatment.

MATERIAL AND METHODS

Sample size and enrolment

Keeping the above factors in mind, the study was conducted with the aim of enrolling a minimum of 30 patients for assessment. Among patients attending the peripheral outpatient department of Bakson Homoeopathic Medical College and Hospital, Greater Noida, Uttar Pradesh, 54 were screened and 40 were enrolled on the basis of the inclusion and exclusion criteria [Figure 1]. The patients were assessed and diagnosed using clinical examination. The patients were assessed for Fitzpatrick skin type and melasma severity using the Melasma Severity Scale at baseline. Among the patients enrolled (n = 40), data of the patients who completed 6 months of follow-up were included in the statistical analysis (n = 35).

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Figure 1:

Study flowchart.

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RESULTS

Outcome

The result was a significant P < 0.0001 for both mMASI and MELASQOL scores. For mMASI, three cases (8.57%) showed <10% improvement, 13 cases (37.14 %) >10% improvement, and 7 cases (20%) >30% improvement, while 8 cases (22.85%) showed no improvement in pigmentation [Figure 2]. For MELASQOL scores, 8 cases (22.85%) showed improvement of up to 10%, 16 cases (45.71%) showed improvement of more than 10%, and 3 cases (8.57%) showed improvement of more than 30%. In contrast, 8 cases (22.85%) showed no improvement [Figure 3]. A detailed statistical analysis for mMASI is mentioned in Table 2.

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Figure 2:

Pre- and post-treatment modified melasma area and severity index scores (mMASI).

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Figure 3:

Pre- and post-treatment melasma quality of life scale scores (MELASQOL).

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Table 2: Outcome measures of the study (primary and secondary).

Outcome measure	Baseline µ±SD	After 6 months µ±SD	Difference MD±SE	t-value	P-value
Primary outcome
mMASI	5.13±3.33	4.37±3.15	0.75±0.13	5.80	0.0001*
Secondary outcome
MELASQOL	41.34±10.32	35.28±5.95	6.05±1.06	5.68	0.0001*

*P<0.05 was considered as significant. µ: Mean, SD: Standard deviation, MD: Mean difference, SE: Standard error, mMASI: Melasma area and severity, MELASQOL: Melasma quality of life scale

Medicines used

The most common medicines indicated in the study were Phosphorus , Pulsatilla, Sepia, Lachesis, Lycopodium, Natrium muriaticum and Kalium carbonicum. Phosphorus was used in 4 cases (12%), of which 3 showed improvement. Lachesis and Natrum muriaticum were administered in 3 cases (9%), all of which showed improvement. Pulsatilla, Sepia and Lycopodium were each prescribed in 3 cases (9%), of which two improved. Kalium carbonicum was used in 2 cases (6%); both showed improvement. The details of other medicines used are given in [Figure 4]. However, maximum reduction in mMASI and MELASQOL scores was seen in the patients prescribed Sepia and Lachesis.

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Figure 4:

Medicines indicated in melasma cases.

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DISCUSSION

The present study was conducted with the aim of determining the role of homoeopathic treatment in melasma through two main objectives: Primary, to study the usefulness of homoeopathic treatment in melasma using the mMASI, and secondary, to assess the quality of life in melasma after homoeopathic treatment using the MELASQOL. As melasma is a common disorder of pigmentation with a multifactorial aetiology, the need for a long and safe treatment plan has become a challenge due to its increasing prevalence.^[15]

As the homoeopathic approach is holistic, the patient’s physical and mental symptoms are assessed. This study majorly highlights the scope of homoeopathic treatment in melasma. The principal finding of the study was a statistically significant reduction in the mMASI score after administration of homoeopathic medicines for 6 months. Further, correlation between the mental and physical spheres can be seen through the statistically significant reduction in MELASQOL score, with improvement in pigmentation.

The major limitation of the study was its small sample size and the reduced study duration due to the COVID-19 pandemic. This resulted in some subjects being lost to follow-up. Only women were included in the study due to evidence of a greater number of incidences in epidemiological studies, whereas during enrolment, several male patients were seen seeking medical attention for melasma. Since the number of subjects was small, a larger sample size and an increase in treatment period are required for better generalisations and conclusions.

We need more observational studies and randomised controlled trials in the future, including both sexes, to explore the factors responsible for the development of melasma, the effect of homoeopathic treatment on melasma in both genders and to explore the exact way of prescribing for melasma. Attempts can be made to see other contributing factors for the development of melasma. We also need studies that investigate the use of different scales and potencies of homoeopathic medicine in the context of treating melasma.

CONCLUSION

The results of the study suggest that individualised homoeopathic medicines can be used as a promising approach in cases of melasma, as seen by the improvement in the mMASI score. The relation between the physical and mental spheres is also seen through improvement in the MELASQOL score in patients with a reduction in pigmentation. Thus, the findings of this study can pave the way for future research studies in the area.