Efficacy of Munzij Mushil and Zimaad Therapy in Sala E Sadi (Fibroadenoma of Breast) – A Randomized Single-Blind Study
The breast or mammary gland is the most important structure present in the pectoral region [1]. Breast
shape and size depend upon the genetic, racial, and dietary factors and the age, parity, and menopausal
status of the individual. Breasts may be hemi-spherical, conical, variably pendulous, pyriform, or thin and
flattened [2]. The Breast is one of the target organs for various hormones, particularly estrogens,
progesterone, and Prolactin. As such, many breast-related complaints or diseases are associated with
endocrine dysfunction 3 . The ductal epithelium of the mature female breast has some secretory activity,
and the secretion is normally reabsorbed [4,5,6]. The diseases of the breasts are usually referred to the
gynecologist as the breasts are organs related to reproduction. Changes in the breasts are directly related
to the interplay of ovarian hormones. Examination of breasts is mandatory and should be included as a
routine in obstetric and gynecological examination [7]. The common benign breast conditions in women
are mastalgia, fibroadenosis, fibroadenoma, cyst of the breast, breast abscess, and discharge from the
nipple 7 . The female breast is in the unique position of being a gland that is non-functional except during lactation 4 .
Fibro-adenoma presents as a lobulated firm rubbery lump. It moves about very freely in the breast substance, even
after the breast has been rendered immobile by traction on the nipple 8 . For this reason, it is called ‘Breast mouse
[8,9,10,11]’ or ‘a Floating tumor 12 ’. It does not contain fluid on aspiration 10 . It is not considered to be a true tumor,
but a disorder of development. The reason is that fibro-adenoma arises from a lobule rather than from a single cell
[13,14].
Fibro–Fibr-(L.fibra, fiber)–Fibrous tissue, adeno–from the Greek aden meaning originally “an acorn”
and later “a gland” in the form of an acorn, oma–A tumor or other abnormal growths.
Fibroadenoma is the most common benign tumor of the female breast [9,12,15,16]. Occurs at any
age within the reproductive period of life [3,4,10,15,17]. Fibroadenomas are somewhat more common
before age 30 13 . They are frequently multiple and bilateral. Young women usually present with a palpable
mass and older women with a mammographic density or mammographic calcifications [18]. Unopposed
high levels of estrogen and androgens may have a role in both fibrocystic disease of the breast and breast cancer 19 .
During pregnancy, fibro-adenomata often enlarge but involute together with the rest of the breast
after lactation. This feature is a demonstration of the influence of hormones on neoplasms 8 . A lump may
have been detected by the patient herself (usually by chance, e.g. in the shower, although occasionally during self-
examination) [10,20,21].
Though malignant change in fibro-adenoma is extremely rare (it changes to a sarcoma rather than to a
carcinoma), excision biopsy is always advisable as mistakes in diagnosis could happen. The operative
incision should be cosmetic, curvilinear and parallel to the areola, and the tumor is shelled out from within its
capsule. Satellite modules should be carefully looked for and excised [18].
In allopathic Medicine the only way to cure the fibroadenoma is through surgery. But for the first
time in unani system of medicine an attempt has made to manage the fibroadenoma of breast in non-
invasive way by using unani herbs. As it is a tumor, it can be treated by using the unani herbs which can
relieve the symptoms as well as the tumor.
Aim and Objectives
To evaluate the Efficacy of munzij wa mushil therapy & zimaad in sala’-e-sadi (fibroadenoma of the
breast), to minimize the surgical hazards and to avoid scarring and deformity of the breast.
UNANILITERATURE
According to Unani Physicians Sala is a type of benign tumor which is formed by the accumulation of
putrefied Balgham. According to Janab Abdul Hakeem Khan Saheb (Jamiul Uloom Tibbi), Ibn Hubal
Baghdadi (Kitab Al Muqtarat E Fit Tibb) & Majoosi has described in detail about all types of Sala. They
also mentioned that sala is formed from viscid phlegm, which is derived from the organ itself. They also
stated about the types & sizes of sala & encapsulation. Ismail Jurjani (Zakheera Khwarzam Shahi),
Samarqandi (SharahAsbaab) has described in detail about sala, its etiology, types & treatment. They also
stated that sala may also be hereditary [22-26].
SALAE SADI
Unani Physicians termed Sala e Sadi for Fibroadenoma of breast. According to ancient Unani
physicians, Sala e sadi is an inflammation-like swelling. It is formed due to accumulation of viscid
Phlegm beneath the skin of the breast. The tumor has a characteristic that it is differentiated from flesh but
it is attached to the skin superiorly. On palpation it is movable on all sides. It is firm in consistency.
Generally, it is small in size starting from the size of a pea nut but sometimes it may also increase in size
and shows its pressure effects on breast [27,28].
Hakeem Waseem Ahmed Aazmi in his book Amraz e Niswan described that “in breast after so
many changes the tumor will occur.” First they form a nodule in the breast, later it is converted into
tumor. Generally these tumors are benign in nature but sometimes it may also converted to malignant
tumor, which may be very fatal 29 . According to Samarqandi Sala e sadi is a fatty or fat like tumors. The
color &consistency of sala is like fat & it is formed by viscous Balgham. Which is cold in nature. This is
the firm tumor & encapsulated. There is no pain [26].
CLASSIFICATION OF SALA E SADI
Sala e Saalim (Benign Tumors): The structure of these sala are similar to the organ in which they
develop. Most of the sala are encapsulated & they do not have liquid in them. They are fleshy or fatty.
Recurrence of sala e sadi is common. Usually no pain is present but when they become large, they may
cause pressure effect due to which pain & swelling may be present 26 .
Saale khabeesa (Malignant Tumours): These are fatal tumors. They may also cause death 26 .
ETIOPATHOLOGY OF SALA E SADI: According to ancient unani physicians 3 types of diseases occur in breast.
- Due to Sue Mizaaj, 2. Due to Sue Tarkeeb, 3. Due to Tafarruqe ittesaal
Najeebuddin Samarqandi in his book ‘Sharah Asbaab’ stated that there is a relation between,
reproductive organs & breast through circulating channels. The matter reaches to breast through these
channels. Sometimes this matter becomes liquid & viscid. The liquid matter gets dissolved & the
remaining morbid matter will accumulate in breast itself & forms a tumour 26 .
Abul Hasan Ali Ibn Abbas Majoosi in his book ‘Kaamilus Sana’ mentioned that “among all the
diseases of breast, some are common & some are specific”. Common diseases are like all other diseases
but specific diseases are caused due to derangement in the temperament of breast. He also mentioned that
there is a close relation between the diseases of other reproductive organs with breast 24 . Jurjani in his book
‘Zakheera Qhwarzam Shaahi’ mentioned that proper food in proper time and required quantity, produces
pure & excess blood. When the food we ingest is abnormal & in excess, then it produces impure & less
amount of blood & it also changes the temperament of breast. Hence, the tumor occurs due to
derangement in the normal temperament of breast. So here the cause of the tumor is sue mizaaj [25].
Hasanul Samarqandi in his book ‘Gina Mina’ stated that “sometimes the breast may undergo several
changes to form a tumor.” If the morbid matter is cold in temperament the breast is also cold in touch &
white in colour [30].
Material and Methods
RESEARCH DESIGN: Clinical Research designed as a randomized single blind study with sample size of
30 was conducted from 2017-2019 in post graduate Dept of Ilmul Qabalat Wa Amraz-e-Niswan, Govt
Nizamia Tibbi College and Hospital, Charminar, Hyderabad. Single group is planned for study. Method
selected for Statistical analysis is “Chi-Square test”. Ethical clearance is issued by an institutional ethical
committee. Single group of 30patients is planned for study. Duration of Study: 18 Months
INCLUSION CRITERIA: Unmarried and married women of reproductive age i.e; 15-50yrs. women with
Symptomatic and asymptomatic fibroadenomas. Mammography reports with fibroadenoma lump size
<5cms. Bilateral fibroadenomas. Non pregnant state.
EXCLUSION CRITERIA: Menopausal women and women above 50 years. Pregnant women. Women
with serious medical illnesses such as cardio vascular diseases, respiratory distress and other systemic
diseases. Carcinoma of the breast. Fast-growing and Giant fibroadenomas were excluded
PHARMACOGNOSY: Drugs that are cost effective, easily available in the market, and with the least side
effects were selected. Drugs were coded and given in the form of Munzij (concoction), Mushil
(purgative), and Zimaad (Local application). A Single group was planned for the study.
MUNZIJ THERAPY: Afthimoon Vilaithi, Gul e Banafsha, Maweez Munaqqha, Beekh e Kasini, Tukhm e
Baadiyan, Barg e Gaozabaan, Aslessos Mukhasshar, Gul e Gaozabaan, Tukhm e Katan (Alsi), Gul e
Surkh, Gul e Mundi, Sapistan, Shaahatra, Tukhm e Kasoos. Soak the above medicine over-night in 400ml
of water, and boil it in the morning till it becomes half. Filter it and give 100ml decoction 2 times i.e
morning on an empty stomach and night before going to sleep for 21days.
MUSHIL THERAPY: Turbud, Barg e Sana Maki, Turanjabeen, Anjeer. Soak the above medicine along with
the medicines of munzij over night in 200ml of water, and boil it till it becomes half. Filter it and give 100ml
joshanda in the morning on an empty stomach for 3 alternative days.
Tabreed: Khameera Gav Zubaan Saada is used as Tabreed. 5gms of halwa Morning and night for
3alternative days in between mushil.
Zimaad: Aaride Jao, Aarid e Hulba, Gul e Banafsha, Charbi e Bataq, Charbi e Murg. Both the fats are
melted separately. All other medicines are powdered, cleaned, and mixed separately. Now all these
medicines are mixed with previously melted fats and a 5gms of wax is added to it as a binding material.
Now this zimaad is applied locally on breast for 5 alternative days after Munzij Therapy.
Follow-up: Patients are instructed to start munzij therapy followed by mushil & zimaad for 3 months.
Before starting the treatment all the Patients are investigated by Mammography & FNAC to rule out
carcinoma. Patients were also enquired about any adverse effects of test drug during the trial.
SUBJECTIVE PARAMETERS: During the first cycle of treatment, the nature and size of the lump is
palpated and History of pain and swelling is also assessed.
OBJECTIVEPARAMETERS: Routine Investigations: CBP (Complete Blood Picture), RBS (Random
Blood Sugar), BGT (Blood Grouping & Rh Typing), HIV, HBs Ag, VDRL, LFT,RFT, CUE(Complete
Urine Examination)
Special Investigations: Sono-Mammography, FNAC (Fine Needle Aspiration Cytology). Before
starting the treatment all the Patients are investigated by Mammography & FNAC to rule out
carcinoma. Carcinoma of the breast is assessed by BIRRDS score. If any patient is diagnosed with
carcinoma, those patients are excluded from the study.
DISCUSSION
The present dissertation is carried out with the title “Efficacy of Munzij wa mushil therapy and Zimaad
in “Sala e sadi” – A Randomised single Blind Study, to scientifically evaluate the efficacy of Unani
medicine in sala’e sadi. From the current studies it is confirmed that this disease is more common in
younger age group (2 nd and 3 rd decade) 31 . A fibroadenoma can be confused with: Breast Cyst, Breast
Carcinoma, Phyllodes tumour, Breast lymphoma, Metastasis to the breast from another Primary site 32 .
The only way to treat fibroadenoma in alternative medicine is through surgery. Unani medicine is the
famous branch of alternative & complementary medicine that tries to treat the cause with a change in
lifestyle & using medicinal plants.
The present study is carried out for the first time in unani system of medicine to evaluate the efficacy
and management of sala e sadi by using unani medicinal plants. In the present study the medicinal
plants having the properties of muhallilat, musakkinat, mulattif, carminative, astringent, anti-cancerous
properties, purgative, laxative, have been used to treat fibroadenoma. Based on current study, the
selected group medicines were proven to be effective in the management of fibroadenoma. The
medicinal group have- Aftimoon Vilaithi, Gul E banafsha, Maweez Munaqqha, Beekh e Kasini,
Tukhme Baadiyan, Barg e Gaozabaan, Gul e Gaozabaan, Aslessoos Mukhasshar, Tukhm e Katan, Gul e
Surkh, Gul e Mundi, Sapistan, Shahatra, Tukhm e Kasoos. These medicines were found to be more
effective in current medicinal references. These medicines did not have any side effects &
complications in proper dosage with proper duration according to reviewed ancient unani literatures in
the present study. Phytochemical studies have shown that flavonoids, alkaloids, phyto sterols,
phenolics, glycosides, albuminoids, mono saturated fats, poly unsaturated fats, saturated fats are the
main components in the medicinal plants which are responsible for resolving the tumor as well as some
of the medicines also have anti cancerous action [33-44].
Fibroadenoma of ectopic breast tissue in the vulva: a case report
Glands located out of the anatomical breast and mimicking breast tissue are ectopic breast tissue with reported incidence
of 1-6%. Supernumerary breasts are a known entity. Ectopic breast tissue can occur anywhere along the primitive
embryonic milk lines, extending from axilla to groin. Accessory breast tissue is subject to the same benign and / or
malignant pathologic processes characteristic of thoracic breast tissue. Vulvar fibroadenoma is rare entity. It has been
proposed that the tissue of origin is either ectopic breast tissue or vulvar mammary like glands. Most of the cases in the
literature involve malignancies arising from ectopic breast tissues located in the vulva. There are few reports about the
benign pathologies of the vulvar mammary glands 45 .
Rehana begum et al in her article mentioned that 70-90% of fibroadenomas remain simple, occurrence of giant
fibroadenomas is just about 0.5%-2% of all fibroadenomas 46 .
Animal-origin medicine like duck fat & hen fat were used in the study. These medicines were used as external
application as they have the properties of resolvent, demulcent & astringent, which were helped in resolving the
morbid matter from the breast. The resolving; antioxidant, demulcent, anti-inflammatory & anti-cancerous
properties of the plants have been proposed to play a key role in regulating oestrogen level, preventing from
cancer as well as helped in dissolving the tumors 25,39-44 .
Patient Assessment: A total of 40 patients were screened for the study, out of which 3 patients denied
participation and 37 were evaluated through investigations. 2 patients were excluded as they doesn’t comes
under inclusion criteria, and 35 patients were enrolled in the study. Among these 35 patients, 5 patients were
dropped out.
In the present study; it was observed that among 30 patients, 14 patients had less response to the medicine & 16
patients have shown good response to the study medicine. The less responsive patients had <30% decrease in
lump size after treatment. Good responsive patients have shown >30% decrease in lump size. Among all 30
patients only 1 patient had 70% decrease in lump size. 2 patients out of 30 shown 60% decrease, 3 patients out
of 30 showed 50% decrease, 6 patients out of 30 shown 40% decrease, 4 patients out of 30 showed 30%
decrease, 4 patients out of 30 showed 20% decrease, 3 patients out of 30 showed 10% decrease. 7 patients had
no response to the study drug.
In fig.3 the distribution of patients is purely based on the temperament. In this analysis, majority of patients
50% i.e 15patients with sala e sadi are of Balghami (phlegmatic) Mizaj followed by Safravi 23% i.e 7 patients
& Damawi &saudawi are 13.3% in each i.e 4 patients were in damavi & 4patients were in saudavi mizaj. It
proves the literature mentioned by Ancient Unani Physicians in pathophysiology of sala e sadi, that it is caused
by derangement in temperament of balgham 33 & accumulation of putrified balgham beneath the skin of the
breast 27 . It is described in “Kamil us Sana” that sala is formed by the organ in which it is developed 24 . In
‘Zakheera e qhwarzamShaahi’ also it is mentioned that sala e sadi is a cold swelling that is formed from
Phlegm 25 . Ismail Jurjani also described sala as a type of tumor that is formed by viscid Phlegm & the
consistency of which is Lahmi. So, the above analysis proves that sala e sadi is more prevalent i.e common
among balghami mizaj women 25 .
STRENGTH OF RESEARCH: The efficacy of coded Unani medicine has been proved & for the first time an
attempt has made to treat sala‟ e sadi without any surgical hazards. The patients who received treatment have
shown gradual relief from symptoms. The main strength of this study was that the patient can over-come their
disease without a surgical incision. The Patient is satisfied by the coded medicine and patients have shown more
interest in unani medicine comparatively than surgery.
WEAKNESS OF RESEARCH: Late diagnosis, Patients were not willing to undergo Investigations. Some of the
patient refused to take unani medicine. Some patients have undergone surgery even after counselling, because
they had a fear of breast cancer. Most of the Patients have complained about the sour taste and coarse texture of
test drugs. As the Munzij therapy is of 21 days patients don’t want to be admitted in the hospital for a longer
duration.
LIMITATIONS OF THE STUDY: Small sample size (30 patients), Limited duration for research work (18
months). Less prevalence in the Study.
FURTHER RECOMMENDATIONS: Further attempts can be made to treat Sala e sadi with unani medicines on
large sample size. Further work can be done by using fewer medicines (can check the efficacy of the single drug
in sala‟e sadi).
CONCLUSION
From the present study carried out, it is observed that the patients had good responses to group medicine. Most
of the patients were from low socio-economic groups. A good response to study drugs is observed
comparatively than modern medicine. A marked decrease was observed after treatment, in patients who had the
lump size of 1-2 cm. No side effects of the unani medicines were observed in patients. The selected unani drugs
can be used further to treat fibroadenoma of breast (Sala’esadi). Finally, it is concluded that the unani medicines
can be used to treat sala’e sadi (fibroadenoma of the breast) rather than the surgical incision.
ACKNOWLEDGEMENT
I am thankful to all my patients for their cooperation, who trusted me & took part in my research work. I Would
like to express my deep & sincere gratitude to my Guide & advisor Dr.Q.N.Qhuddsia Madam, Rtd HOD, Dept.
of QON, for the continuous support of my study & related research, I would also like to express my sincere
thanks to my Professor as well as our principal madam & Superintendent, RMO, to all my teachers, DMO’s &
all teaching staff for their help during my research work. I extend my profound thanks to the statistician,
CCRUM, Hyderabad, for helping me during my statistical analysis & all the sisters, library in-charge, librarian,
pharmacist, and staff of the pathology laboratory for timely help throughout the trials. Finally, I extend my
thanks to each & every person who supported me directly & indirectly during my research work.
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