Efficacy of local application of an Unani formulation in acne vulgaris.

BACKGROUND AND OBJECTIVES: Buthūr-i-Labaniyya (Acne vulgaris) is affecting up to 80% of adolescents and many adults at different stages of life. It is one of the commonest skin disorders which appears on cheeks and nose as white eruptions that seems like solidified milk drops. These eruptions are treated by drugs having properties of tajfīf wa taḥlīl (desiccant and resolving), as mentioned by Ibne Sina. Daood Antaki in his book Tazkira Oolulalbab recommends the local application of a paste of Shonīz (nigella sativa), Naushādar (ammonium chloride) and Būra Armani mixed with Sirka (vinegar) for effective treatment of Acne vulgaris.
METHODS: The study was observational self comparison before and after treatment, conducted in the OPD of the hospital which is part of the National Institute of Unani Medicine, Bangalore. The duration of study was one year. 40 Female patients with combination of comedones, papules, pustules and nodules were recruited for this purpose. The test drug, Shonīz, Būra Armani, Naushadar powder, mixed with sirka were applied locally for one month with taqlīl-i-ghidhā tadābīr (low calorie index diet). All subjects were assessed on the basis of changes in subjective and objective parameters.
RESULTS: The response of test drugs was statistically highly significant (P < 0.01) by using ANOVA repeated measure test, there was also relief in subjective parameters. Subjects reported a reduction of 82.6%, 80.9%, 66.6% in tenderness, itching and irritation respectively. INTERPRETATION AND
CONCLUSION: The present study reveals that the test drug formulation is safe and effective in treating Acne vulgaris if used along with low calorie index diet. No side effects of drugs were reported, therefore the trial formulation can be recommended to manage Acne vulgaris of mild to severe degree as a therapy.

INTRODUCTION

Buthūr-i-Labaniyya (Acne vulgaris) is one of the commonest skin conditions treated by dermatologists.[123456] The term acne is derived from a Greek word “acme” which means prime of life. It is more severe in late teenage years. Acne vulgaris is a pleomorphic disorder; it can occur at any time in life, most commonly it presents between 12-24 years of age. It is a chronic, self cured inflammatory disorder of pilocebaceous units that peak at puberty and is found to be associated with increased androgen production in this period.[7]

It has been estimated that 70% of the population have some clinically evident acne at some stage during adolescence.[8] It affects more than 80% of adolescents.[910] In 2001, the expenditure of health care on acne vulgaris was estimated to exceed one billion dollars.[11] A prerequisite for the development of acne is active sebaceous glands with the level of their sebum secretion correlating with the severity of the acne.[1213]

Acne vulgaris is characterized by the formation of open and closed comedones, papules, pustules, nodules and cysts.[1414151617]

Four factors are responsible for pathogenesis of acne vulgaris:[111218]

Increased sebum production

Abnormal follicular kerarinisation (microcomedo formation)

Proliferation of propionibacterium acnes

Inflammation.

It occurs when sebaceous glands duct becomes blocked and then infected which leads to inflammation and formation of pustule. In severe cases permanent scarring may occur. The most common sites are face, chest and upper back.[1920]

According to Ibn Sina Buthūr-i-Labaniyya are small white eruptions on the nose and cheeks, which resemble condensed drop of milk.[2122] While according to Arzani these are white eruptions which appear on nose and forehead.[2223] Due to its resemblance with milk drops, the condition is named as Muhāsa (pimples). Generally it appears in young males.[22]

Cause of these eruptions is a mādda-i-ṣadīdiya (infected matter) which comes towards skin surface due to bukharāt-i-badan (body vapours).[212425] The prevalence of acne in school children ranges from 30% -100%, depending on age, with the 16-18 age group experiencing 93.3% of acne.[26] Although it is a condition of adolescents, acne affects 8% of 25-34 year and 3% of 30-44 year age group.[16] There are some evidences which suggest that reduced academic performance and employment opportunities are associated with acne, as well as general social difficulties.[14] Between 30-50% of adolescents experience psychological difficulties along with pimples including body image concerns, social embarrassment, social impairment, apprehension, dissatisfaction, anger, depression and poor self confidence because of acne.[9]

In severe form, acne causes severe anxiety and disfiguring scars in young, and hence can cause emotional disturbances.[2] Acne vulgaris has a significant impact on the mental well being of affected individuals and has been compared to other major diseases in adverse impact on quality of life.[2728]

The patients of acne suffer reduced academic achievements and employment opportunities. Because acne affects body image, persons with severe acne and acne scarring are at risk of depression and suicide.[26] Therefore Acne vulgaris needs proper treatment and care. In Allopathy many drugs are available, but no drug is sufficiently effective. Benzoyl peroxide and topical retinoids are skin irritants and bleaching, tretinoin can cause sun burn. Systemic isotretenoin is teratogenic. So there is need of treatment of acne vulgaris which can cure the condition and its consequences without side effects.

Unani System of Medicine contains treatise of crude and compound formulations that can be administered orally and locally in the treatment of Acne vulgaris. These preparations are useful, effective and well tolerated. Ibne Sina recommended drugs with tajfīf and taḥlīl (desiccant and resolving) properties in treatment of acne vulgaris centuries ago. These drugs are easily available, economic and have no side effects.

METHODS

The study was observational self comparison before and after treatment, conducted in the OPD of the hospital which is a part of the National Institute of Unani Medicine, Bangalore. The study was started after obtaining ethical clearance from NIUM Institutional Ethical committee.

The duration of study was one year between December 2012 – December 2013 with 30 days protocol. Only 40 Female patients of 16-26 years of age with combination of comedones, papules, pustules and nodulo-cystic lesions on face were recruited for this purpose as per inclusion criteria while patients who did not co-operate, age <16 and >26 years, or patients having local wound and infection on face were excluded from study.

In this study Shonīz, Naushādar, Būra Armani and Sirka have been used. All the drugs had the desired properties.

Shonīz, Naushādar, Būra Armani in equal weight were powdered separately and sieved with 80 number filter. This powder was stored in an air tight container. At the time of use this powder was mixed with sirka in adequate quantity to form a paste. The paste was applied on face from hairline to mandible line, from one ear to another, was left on the face overnight and washed with luke warm water in morning.

Local application of the test drug was advised for one month, daily at night initially for 15 days, then on alternate days for another 15 days.

Patients were directed to avoid application of paste on eyes, ears, nostrils etc., they were also advised to avoid application of any other product on face during study protocol and were also advised to follow low calorie index diet regimen.

The drug voucher specimen number is 24/UH/Res/2014. All subjects were assessed on the basis of change in subjective parameters (itching, pain and irritation) and objective parameter (Cook's grading scale for acne vulgaris).

ANOVA repeated measure was applied for statistical analysis and the significance was seen at (P < 0.01).

RESULTS

In the present study out of 40 patients, tenderness of lesion was present in 23 (57.5%), 12 (30%) and 4 (10%) patients on 0th, 15th and 30th days respectively. Out of 40 patients 23 reported tenderness on 0th day, out of 23 patients 11 patients reported reduction in tenderness on 15th day and out of 12, 8 patients reported reduced tenderness on 30th day. So out of 23 patients 19 (82.6%) reported reduction in tenderness and 4 did not respond to treatment [Table 1].

Table 1

Distribution of patients according to reduction in subjective parameters

Out of 40 patients, itching was present in 21 (52.5%), 12 (30%) and in 4 (10%) patients on 0th, 15th and 30th days respectively. Out of 40 patients 21 reported itching on 0th day, out of 21 patients 9 patients reported reduction in itching on 15th day and out of 12, 8 patients reported reduced itching on 30th day. So out of 21 patients 17 (80.95%) reported reduction in itching while 4 (19.04%) did not respond to the treatment [Table 1].

Out of 40 patients irritation was present only in 9 (22.5%), 3 (7.5%) and in 3 (7.5%) patients on 0th, 15th and 30th days respectively. Out of 40 patients 9 reported irritation on 0th day, out of 9 patients 6 patient reported reduction in irritation on 15th day. So out of 9 patients 6 (66.6%) reported reduction in irritation while 3 (33.3%) did not respond to treatment [Table 1].

Cook's grading scale for acne is taken as an objective parameter by which acne was measured in grades (0, 2, 4, 6, 8). In the present study on 0th day 26 (65%) patients were in grade 2, 13 (32.5%) patients were in grade 4 and only 1 (2.5%) patient was in grade 6. On 15th day 11 (27.5%) patients were in grade 0, 26 (65%) patients were in grade 2 and 3 (7.5%) patients were in grade 4. On 30th day 26 (65%) patients were in grade 0, 12 (30%) patients were in grade 2 and only 2 (5%) patients were in grade 4 [Tables 2 and 3].

Table 2

Distribution of patients according to reduction in grades in objective parameter

Table 3

Effect of Unani formulation on Cook's Grading Scale in Acne vulgaris

The results were analyzed by ANOVA repeated measure, with degree of freedom df = 3.36.

DISCUSSION

It is observed from above results that this Unani drug formulation is safe and effective in treating Acne vulgaris if used along with low calorie index diet. The results are highly significant at P < 0.01. This study is in accordance with the study of Lone et al., they used a Polyherbal Unani formulation and reported improvement at P < 0.001.[16] The present study is also in accordance with study by Parveen et al., they also found role of Unani herbomineral cream significant in reducing Acne vulgaris.[29]

Due to the quwwat-i-jilā (detergent power) all drugs clean the skin and remove mawād (matter) that adhere to the skin in the form of bukhārāt (vapour) as precursor of acne. Shonīz is jāli (detergent),[303132] jāzib (absorbent),[32] antihistaminic,[33] antioxidant,[34] anti-inflammatory[313435] and antimicrobial. Due to these properties it cleans the skin surface, reduces inflammatory lesions, such as papules and pustules. Due to its anti-inflammatory, antioxidant and antimicrobial effects, it inhibits bacterial growth on skin surface. According to Jālīnūs, Kalaunji is effective where jilā (detergent action), taqtī’(disintegrating action) and yubūsat (dryness) are required.[36] According to Razi, Kalaunji dissolves waram (inflammation) especially balghami (phlegmatic) waram.[37] Locally it cleans and dries skin, so new acne lesions or comedones do not appear.

Naushādar has also jāli,[3038] mulattif-i-mawād (attenuant),[3038] muḥallil-i-awrām (anti inflammatory),[303138] jāzib-i-akhlāṭ (absorbant),[38] mujaffif[3031] properties. Due to these properties it removes mādda from deep parts of the skin, provides jilā reduces inflammatory lesions and prevents further flare-up of acne.

Būra Armanī is jail[3238] and qate’ akhlāṭ-i-ghalīẓ (incisive to viscous matter).[38] Due to its arḍiat (earthy compound) and hiddat (excessive heat) it cleans mawād from skin,[30] it also eliminates ghalīẓ khilṭ (viscous matter),[31] due to these properties it cures inflammatory lesions and reduces pimples and its flare-up.

Sirka, due to its latāfat (volatility) posseses sarīun-nufūdh (quickly infusible) property, so it was mixed mostly with ḍimadāt (paste), face packs and massage oils.[3132] Sirka is qate’ akhlāṭ-i-ghalīẓ[30] and qābiḍ (astringent). The mādda (matter) of buthūr is shaḥmī (fatty) so Sirka dissolves mādda, and produces qabiḍ (astringent) effect on masāmāt-i-jild (skin pores). Due to this the pores becomes narrow and mādda does not accumulate in these pores.

The highly significant result was also due to the low calorie index diet. Razi and Ibne Sina state that the cause of these eruptions is mādda-i-ṣadīdiya which comes towards skin surface due to bukhārāt-i-badan.[212425] Razi mentioned in Kitabul Fakhir fil Tib that if there is excess accumulation of viscous material in the body then ṭabī’at (medicatrix naturae) expells them towards skin, which leads to formation of buthūr and awrām.[24]

Due to taqlīl-i-ghidha the excess raddi mādda (morbid material) does not accumulate in the body, and body will utilize all retained material which is already deposited in body, further accumulation of raddi mādda (morbid matter) or fuḍlāt-i-ṣaleḥ (good waste) does not occur in the body, hence the material cause of buthūr becomes unavailable.

CONCLUSION

Further long term studies may be planned to determine the relapse rate and to show significant scientific evidence of usefulness. The present study reveals that the test drug formulation is safe and an effective treatment in Buthūr-i-Labaniyya (Acne vulgaris) if used along with taqlīl-i-ghidhā tadābīr. No side effects of the drugs were reported, therefore the trial formulation can be recommended to manage Buthūr-i-Labaniyya of mild to severe degree as a therapy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.