Indo American Journal of Pharmaceutical Research, 2018 ISSN NO: 2231-6876

SIDDHA THERAPEUTICS FOR THE MANAGEMENT OF PCOS - A REVIEW

A. Faridha*, Gayathri Gunalan, A. Rajendra Kumar
Siddha Regional Research Institute (CCRS), Kuyavarpalayam, Puducherry – 605013.
ARTICLE INFO ABSTRACT
Article history Siddha system of medicine is the renowned indigenous traditional system, provided for all the
Received 17/02/2018 lives of earth by the scientific sages, Siddhars. The therapeutic methodology in Siddha is
Available online based mainly on three humors viz, vatham, pittham and kabam, which are when altered from
31/03/2018 its equilibrium, results in various ailments. In Siddha, etiology of a disease is mainly depicted
with alterations in lifestyle, diet and environmental conditions. As a part of such
Keywords modifications, PCOS is a major troublesome complication among female population in recent
Karparogam, days. In Siddha literatures, Pararasasegaram, Yugimuni vaithiya kaaviyam, Gnanavettiyan -
Soothaga Katti, 1500, PCOS and its associated complications may be related to sinaipai neer kattigal,
Soothaga Thadai, soothagavaayu, soothaga kattigal, soothaga thadai, karparogam, karpa vaayu. PCOS, being
PCOS, a major restraint for healthy life, results in arising health issues such as hyperandrogenism,
Siddha Formulations, anovulatory menstrual cycle, sub-fertility, obesity, amenorrhoea and dysmenorrhoea along
Herbs. with insulin resistance. To overcome the adverse effects of available modern treatment, we
are in need of implying the better methodology for the treatment of PCOS to sustain the
growing female population of reproductive age. The objective of this review is to emphasize
various Siddha formulations and available herbal-polyherbal practices for PCOS, which are
depicted in the literatures possessing potential therapeutic values, are discussed with scientific
validations. The management protocol ensures not only the treatment but also for the
prevention and recurrence of the disease condition. The medicines practiced may be adopted
for scientific validation in future for further clinical and research purposes.

Corresponding author
Dr. A. Faridha
Senior Research Fellow (Siddha),
Siddha Regional Research Institute
(Under Central Council Research in Siddha, Ministry of AYUSH, Govt. of India),
Kuyavarpalayam, Puducherry – 605013.
fari.jas@gmail.com

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INTRODUCTION
A metabolic disorder and one of the most common hormonal disorders, affecting the female population of reproductive age
group (18-45 years) is, PCOS. It is a major troublesome ailment affecting the individual’s quality of life which may be a hindrance for
procreation in the near future. PCOS (Polycystic ovarian syndrome) is characterized by hyperandrogenism, ovulatory dysfunction with
polycystic ovaries (fluid filled clear cysts with immature eggs, when seen through ultrasonogram). The pathophysiology and etiology
of PCOS is an enigma in medical science as it is a syndrome rather than a single disease. WHO reports its prevalence as 3.4% of
women worldwide. However 30% of women with PCOS will have normal menstrual cycle. Approximately 85%–90% of women with
oligomenorrhea have PCOS while 30%–40% of women with amenorrhea will have PCOS. Its prevalence in India ranges from 2.2 to
26% with age group of 18 – 45 years. Prevalence of PCOS in South India is reported as 9.13%
A study conducted by PCOS society reports that one in every 10 women in India has polycystic ovarian syndrome and out of
every 10 women, six are teenage girls. PCOS was described as early as 1935, but this health condition is estimated to affect about 10
million women globally in recent days. Another study conducted by the department of endocrinology and metabolism, AIIMS, shows
that about 20-25% of Indian women of childbearing age are suffering from PCOS. While 60% of women with PCOS are obese, about
70% have insulin resistance, 60-70% has a high level of androgen and 40-60% has glucose intolerance.
Many aspects of the disorder are not understood properly as its symptoms and severity vary greatly. Women with PCOS are
often found to have higher than normal insulin levels. Insulin resistance can make it harder to lose weight, which is why women with
PCOS often struggle with this issue.
The treatment methodology for PCOS in modern system of medicine aims at curing mainly the symptoms with the help of
oral contraceptive pills, anti-diabetic drugs, anti-androgenic drugs, lipid lowering drugs which may produce certain complications in
the reproductive period of women. The prolonged usage of market drugs in treating PCOS may lead to abdominal bloating, flushing,
dizziness, breast tenderness, metorrhagia, multiple pregnancies due to over stimulation syndrome and so on. PCOS is an emerging
endocrinology health problem resulting in complications such as obesity, sub-fertility, hirsutism, amenorrhoea, dysmenorrhoea,
insulin resistance, cardio vascular diseases, endometrial cancer, breast cancer and miscarriage. Hence, promotion of healthy lifestyles
and early interventions are required to prevent future morbidities and we are also in need of implying a better methodology for the
treatment of PCOS, to prevent the adverse effects of modern drugs.
Siddha system of medicine, the traditional system of Tamil people teaches the way of living to attain the eternal life.
According to the Siddha system, the etiology of a disease is predominantly depicted through alterations in the three humors vatham,
pitham and kabam due to dietary and lifestyle changes. PCOS may be related to Garpavaayu, Soothagathadai, Soothagavayu,
Soothagakatti, Garpasoolai, according to the presenting complaints, in Siddha system of medicine. As per the text, Pararasasekeram,
Garpavaayu is one among the Garparogam mentioned in it. The symptoms of Garpavaayu are abdominal discomfort,
dysmenorrhoea, low back pain, constipation, amenorrhoea, and heaviness of thigh pertaining to the clinical manifestations of PCOS.
According to panchabootham and mukkutram theory, bitter taste (kaippu suvai) and astringent taste (thuvarppu suvai) influences
vatham and neutralizes pitham and kabam. In Siddha literatures, herbs possessing emmenagogue action are of mainly bitter in taste.
The major cause for PCOS may be due to deranged vatham and kabam. Hence herbs which are bitter in taste are used to normalise the
deranged humors. The management protocol is aimed at to alleviate the vatham with the help of purgative drugs initially, then to
induce the ovulation, to regulate the menstrual cycle and to increase the chances of fertility; therefore the associated symptoms like
hyperandrogenism, obesity, and insulin resistance due to impaired kabam may be managed in a better way.
The therapeutics in Siddha enunciates the treatment to the core of the ailment. This evidence based system of ancient
medicine renders various therapies including internal and external medications with herbal, mineral, metal and animal based drugs.
Also Siddha system emphasizes promising methodologies for the prevention and recurrence of the illness by adopting kaala ozhukkam
(healthy life style), yogam and aasanas for procuring a healthy life.
The aim of this review is to discuss about the available therapeutics in Siddha for the management of PCOS and its
associated conditions. This review will emphasize the Siddha therapeutics which includes individual medicinal herbs, poly-herbal, and
herbo-mineral formulations which are practically used in the treatment of PCOS. Medicinal plants possessing emmenagogue action
are discussed here. Many herbs which are indicated for PCOS in Siddha literatures with lack of practical applications may be
subjected to scientific validation for future clinical practice.

Siddha Therapeutics for PCOS and its Related Conditions.

Individual Medicinal Plants
Various medicinal plants have been indicated for the treatment of PCOS related gynaecological disorders in different Siddha
literatures of Agathiyar Siddhar and Theran Siddhar. The usage of individual medicinal herbs is of much importance due to its easy
availability and cost effectiveness. In this current review, few important medicinal plants with notable antiandrogenic activity for
PCOS and menstrual abnormalities with scientific evidences are summarised below. Also these plants possess kaippu suvai
(predominantly) and thuvarpu suvai, thereby regularize the deranged vatham and kabam, which is the major cause for irregular
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menstrual cycle and obesity in PCOS condition as discussed earlier. The inference from the classic Tamil verses is also given below:

Kalyanamurungu- Erythrina variegata Linn.

The leaf of Erythrina variegata L. possesses emmenagogue action according to Siddha pharmacology and is one of the most
commonly practised traditional medicines since long time for gynaecological disorders by Siddha medical practitioners.
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Evidence in Siddha literature:

கருப்பா சயத்திற் கறுத்துத் தடித்தத
பருத்தவுதி ரத்தினைப் பஞ்சாய்த் துரத்திதத்ரது -
பண்முருக்கு மின்பமமாழிப் பாதாய் – உலகறிய
முண்முருக்கது பூனத மமாழி .[16]

Inference:
It can be given for any tumor like abnormalities in uterus and ovaries. Also it is administered during dysmenorrhoea and thus
it helps in expelling the accumulated menstrual blood.

Uses:
The leaf juice of this plant is given for two to three months twice a day for in fertility. This leaf juice also helps in reducing
obesity. The decoction of flower helps in reducing dysmenorrhoea when applied externally [16].

Scientific evidences:
Shalini et al, studied the effect of Erythrina variegata leaves in letrozole induced polycystic ovarian disease in female wistar
albino rats in comparison with the standard drug metformin [1]. The animals treated with ethanolic extract of Erythrina variegata
leaves with 200mg/kg and 400 mg/kg body weight dose, showed a significant changes in body weight(decreased),lipid
profile(decreased, except HDL),blood glucose levels(decreased) and also reduction in ovarian and uterus weight.The histopathological
features revealed the presence of secondary follicles and corpus luteum development with ovulation. Also, the researchers studied the
antioxidant property of the plant.
The anti-inflammatory effect of Erythrina variegata, studied in rats, showed a significant reduction in granuloma formation
and inhibition of WBC migration [2]. Lahari et al, quoted the effect of antiangiogenic activity, antimicrobial activity and diuretic
property of Erythrina variegata [3].

Karunseeragam- Nigella sativa Linn.

The seeds of Nigella sativa L. are well known for its emmenagogue action in Siddha system of medicine and is most
commonly prescribed drug for the management of menstrual abnormalities.

Evidence in Siddha Literature:

கருஞ்சீ ரகத்தான் கரப்பமைார புண்ணுது

தருஞ்சிராய்ப் பீநசமு மாற்றுது ல்ருனதிைாஅ -
காய்ச்சஅ தனலதலியுங் கண்தலியுது தபாமுலகிஅ
தாய்ச்ச மருனமதைதத னத. [16]

Inference:
Nigella sativa has been indicated for skin diseases like eczema, ulcerations, chronic sinusitis, fever headache and ocular pain
in Siddha literature. Besides, as mentioned in the T.V. Sambasivampillai Maruthuva Agarathi (Siddha Medical Dictionary), Nigella
sativa when administered in small doses is effective for the management of dysmenorrhoea, which is a concerning symptom in PCOS
condition [18].

Uses:
One to three gram of seed powder is indicated for soothakakattu, soothagasoolai. [16]

Scientific evidences:
Jasim, et al, studied the effect of Nigella sativa on healthy female rats to rule out the enhancement in thyroid function and
reproductive hormones for a period of 30 days [4]. The hormonal assay revealed significant improvement in T3, T4 levels and
decrease in TSH level and also the levels of LH, GnRh were increased and hence it promoted the estrogen synthesis. Nigella sativa
also had effective antioxidant activity.
Mohammed Arif et al, (2016) validated the effect of Thymoquinone, an active component of Nigella sativa on PCO rats [5].
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They studied the anti-inflammatory effect which is one of the essential things in the treatment of PCOS in mouse granulose cell lines
KK1 (in vitro) and positively obtained the suppression of NF-kB pathway. Also the in vivo studies in female rats revealed the effect of
thymoquinone as it increased the ovulation through follicular development and leutinization.
Nigella sativa has been extensively studied for its effective pharmacological activities such as hypoglycemic activity,
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hypolipidemic effect, estrogenic effect, cytotoxic effect and antioxidant properties [6]. The effect of Nigella sativa has also been
evaluated for its potent activity in patients having Hashimoto’s thyroiditis [7].

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Sathakuppai- Anethum graveolons Linn.

Anethum graveolens is also an easily available herb possessing emmenagogue action which is mainly used as uterine tonic
especially given during postnatal period of women for removing the lochia thereby regularises the menstrual cycle after delivery.

Evidence in Siddha Literature:

தாததமார சூதிகா தாதது சிரசுதநாய்
தமாதுமசதத் தநாய்கபதநாய் மூரசுரது – ஓதுகின்ற
மூலக் கரப்பு முதிர்பத்ைசது தபாகுது
ஞாலச் சதகுப்னப நார. [16]

Inference:
It is advised for the deranged kabam and soothiga vatham (a convulsive disorder especially due to menstrual abnormalities in
young women).

Uses:
The leaf extract or leaves boiled in castor oil is used in treatment of soothagakattu and soothagasanni. Hence, it can be
administered even for mood swings and anxiety seen in PCOS [16].

Scientific evidences:
The ethanol extract of Anethum graveolens have been studied for the hormonal changes in PCO rats. The experimental
animal group treated with Anethum graveolens revealed the significant decrease in progesterone level and increase in the estrus cycle
[8].
Ali et al, mentioned the beneficial effects of Anethum graveolens as anti-hyperlipidemic, anti-inflammatory, analgesic and
antioxidant activities along with positive effect on female reproductive system [9].

Nochi - Vitex negundo Linn.

Vitex negundo L. has been used variedly for menstrual disturbances in recent days. According to Siddha pharmacology,
Nochi possesses diuretic and vermifuge properties.

Evidence in Siddha Literature:

தநாயா கலினய மநாடிக்கு ளருனதமததுனம
தயாயா மணாளு முயர்த்துதலுக் காய -
தனதமுதஅ நண்பாகி தாதத்னத தயயுறதாற்
சினதுதாரங்கைலுன தீ . [16]

Inference:
Vitex negundo when given in decoction form regularizes the imbalanced vatham so that the natural force essential for
ovulation in PCOS can be restored.

Uses:
Handful of fresh Vitex negundo leaves is boiled in 400 ml of water till it reduces to 1/4 th volume. This decoction is effectively
used for the induction of ovulation. [16]

Scientific evidences:
Diaz et al, studied the broad cytotoxicity effect of Vitex negundo leaves in human cancer cell line with Vitexcarpine,a flavone
isolated from Vitex negundo leaves [10]. The seed extract of Vitex negundo has been subjected for analysing its potential to lower the
testosterone levels in hyperandrogenic female SD rats induced with PCO, against the standard drug Finastride. The histopathological
results revealed a remarkable increase in the primordial follicles, reduction in follicular cysts and level of testosterone. There was a
decrease in mean blood sugar level, triglycerides level and body weight too. The anti-androgenic activity may be due to the presence
of beta-sitosterol and inhibition of 5α-reductase [11]. Also the leaves of Vitex negundo have been used as sitz bath for inflammatory
conditions of uterus and ovaries, amenorrhoea and oligomenorrhoea [12].
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Malai Vembu- Melia azadirach Linn.

Melia azadirach L. is well known for its fertility enhancement through purgative action and is a very potent anthelmentic. It is
widely practised among Siddha medical practitioners for infertility management.
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Evidence in Siddha Literature:

மலட்ர புழுவுது தயத்ற்றின் தலியுது
ல்லட்ரதாய்வுது தபாது ல்டக்கி தகாலட்ரது -
உலததஞ் சினைதததற்கண் ஓதிமதம தகளாய்;
மனலதததுபத்ன் தபனர தழுத்து. [16]

Inference:
Melia azadirach leaves are administered for dysmenorrhoea and abdominal flatulence, which are the premonitory symptoms
of PCOS. Also the leaves possess potential properties for infertility management.

Uses:
3-5 g of the leaf paste when given with rice soaked water during first three days of the menstrual cycle will induce fertility
and reduces the pain due to dysmenorrhea [16]. A medicated oil, Malaivembathi thailam prepared with Melia azadirach leaves as a
major ingredient, is exclusively prescribed for infertility.

Scientific evidences:
Azarnia et al., studied the serum concentrations of sex hormones in rats induced with PCO with the hydroalcoholic extract of
Melia azadirach. The results revealed its antisteroidogenic properties [13]. Serum concentrations of FSH was significantly increased
(P<0.05) and the levels of testosterone and estradiol were decreased significantly in the treatment groups when compared with PCO
rats. The anti-hyperglycemic activity of Melia azadirach leaves exhibited a significant result in allaxon induced diabetic rats [14].

Aatruthumatti- Citrullus Colocynthis Linn.

Citrullus colocynthis L. is the most frequently used herb for the management of irregular menstrual cycle. The fruits of this
plant possess enormous medicinal values for dysmenorrhoea, amenorrhoea and medicines prepared with Citrullus colocynthis are
extensively prescribed for uterine and ovarian abnormalities in Siddha medicine.

Evidence in Siddha literature:

கினடமயங்தக தசாதுபமலங்தக தகரறச்மசய் தாதக்
கனடமயங்தக யாற்றுக் கலிங்க மனடதிறக்கின் -
ல்ண்னட யனடச்சமலங்தக யாயத்னழயார் சூதகத்தின்
உண்னட யுனடச்சமலங்தக தயாது.[17]

Inference:
It is indicated for soothaga katti (abscess or tumour or suppression of menstrual discharge) which leads to dysmenorrhoea. It
also alleviates vatham and thereby regularizes the menstrual cycle.

Uses:
The fleshy part of this fruit is used for uterine disorders and constipation with a dose level of 65mg to 200 mg for a specific
period of time. [16]

Scientific evidences:
The fruit extract of Citrullus colocynthis has been studied in letrozole induced PCOS female rats for the for its hypolipidemic
activity, anti-androgenic activity. The ethanolic effect of Citrullus colocynthis drastically reduced the levels of increased testosterone
and LH levels, mean blood glucose levels and lipid profile. The histopathological studies stated that there was a presence of thick
corpus luteum indicating ovulation with the restoration of normal estrus cycle when compared with the control and untreated group.
Also it possessed antioxidant and cytotoxic properties [15].
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Effective single herbs for PCOS along with Siddha Properties- Table 1.

S.No. Tamil Name Botanical Phytochemicals Siddha Properties

Name
1. Kalyanamurungu Erythrina 3-eicosyne, Squalene, Gallic acid, Caffeic Suvai-Kaippu, Kaarppu.
variegata L. acid, Phytol, Butanoic acid. Thanmai- Veppam.
Pirivu- Kaarppu.

2. Karunjeeragam Nigella sativa Nigellinine-N-oxide,Nigellicine, Suvai- Kaippu.

L. Arenasterol-5-ene, lophenol, α-hederin and Thanmai-Veppam.
fatty acids. Pirivu-Kaarppu.

3. Sathakuppai Anethum Carvone, limonene, α-phellandrene, Suvai-Inippu,Kaarppu.

graveolens L. diterpene, cineole, myrcene, paramyrcene, Thanmai-Veppam.
dillapiole, isomyristicin, myristicin, Pirivu-Kaarppu.
myristin, apiol, dillapiol, gallic acid.

4. Nochi Vitex negundo Nishidine, Negundoside, Suvai-Kaippu, Kaarppu,

L. Hydrocotylene, Nishindaside, Essential oil Thuvarppu.
Thanmai- Veppam.
Pirivu- Kaarppu.

5. Malaivembu Melia Terpenoids and limonoids like l- Suvai- Kaippu.

azadirach L. Cinnamoyl-3-acetyl-11-hydroxy Thanmai- Veppam.
meliacarpin,l-Cinnamoyl- 3-methacrylyl- Pirivu- Kaarppu.
l1-hydroxy meliacarpin, Deacetylsalannin,
α & β-Pinene,α- Terpinene &
Terpineol,Kaempferol-3-O-β-rutinoside,
Kaempferol-3-L-rhamno-D-glucoside,
Rutin.

6. Aatru thumatti Citrullus Cucurbitacin-E,I,J,L,T, Coloside A, Suvai- Kaippu.

colocynthis L. Colocynthitin, Colocynthin, Isovitexin, Thanmai- Veppam.
Citrullol Pirivu- Kaarppu.

Polyherbal combinations
Nigella sativa L., Anethum graveolons L. and Coscinium fenestratum (Goetgh) Colebr.
35g of the above ingredients and 105g of palm jaggery are mixed well and given in kottaipakku alavu ( 3 - 4 g) in sombu
kudineer (decoction) enhances the chances of fertility by regulating the menstrual cycle [16].

Bambusa arundinacea (Retz) willd. (Moongil), Syzygium cuminum (Naaval) and Acacia nilotica willd. (Karuvel)
The above plant roots (each 17.5g) are prepared as decotion and consumed with 17.5 gm of palm jaggery and cow’s butter for
the treatment of infertility and this polyherbal combination is mentioned as Malattu karpam, one of the karpam medicines [21].

Siddha Formulations
The below table deals with the various Siddha formulations that are used for the management of PCOS and its associated
conditions.
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Table 2

S.No. Name of the Nature of the Indications Dosage and Adjuvant Reference
Formulation Formulation
1 Chithiramoola Herbomineral Yoni putru, Soolai noigal One black pepper Size SFI, Part –II, P.No.156
Kuligai

2 Kumari Lehgyam Herbal Maadhavidaai pinigal 5-10g twice a day SFI, Part- II, P.No.71

3 Arumuga Herbomineral Vedisoolai, Karbarogam 500 mg with Thirikadugu SFI, Part – I, P.No.36
Chendhuram and Soolai chooranam;
Adjuvant – Honey

4 Agasthiyar Herbomineral Soodhaga Vaayu, One kundrimani size (130 SFI, Part – I, P.No.60
Kuzhambhu Karbavadham. mg) should be taken along
with naavar pattaisaaru
and Seeragapodi.
Maladu. Should be taken along with
peepel leaves paste which
is prepared with cow’s
milk.
Soodhavayu, Should be taken with
Thiratchivali pepper and dry ginger as
adjuvant.

5 Rasagandhi Herbomineral Vedi Soolai, Thudi 500mg twice a day SFI, Part – I, P.No.
Mezhugu Soolai, Yoni Silandhi, 68,69
Yoni putru.

6 Nava Uppu Herbomineral Soolai, Soodhaga Vayu One black pepper size SFI, Part- I, P.No. 71,72
Mezhughu

7 Nandhi Mezhughu Herbomineral Sronidhanoi, Yoni putru, 500mg once or twice a SFI, Part- I, P.No.70,71
Garba azhivu noi day;
Adjuvant- Palm jaggery

8. Siddhathi Ennai Herbal Garpasoolai, 3-5 drops with sombu SFI, Part – I, P.No.104
Perumbadu, kudineer
Soothagavettai, Gunmam

9. Senkottai Nei Herbal Vatha noi kootangal 5-10 ml twice a day SFI, Part- I, P.No.132

10. Kumatti Herbal Gunmam, Mandham 4.1g once a day Siddha Vaidhiya
Chooranam Thirattu, P.No. 215

11. Vaan Kumari Herbomineral Sarva roga nivarani 2-4g with water –twice a Gnana Vettiyaan–1500,
Lehgyam day P.No. 103.

12. Nilakadambhu Herbal Soothaga Vayu, 2g with milk SKM Anubhava murai
Chooranam Soothagavali, 1998, I Edition, P.No.38
menorrhagia, Soothaga
idupuvali

13. Gunma Kudori Herbal Soothaga vayu, Vali and One sundai alavu (250mg) Siddha Vaidhiya
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Gunmam Thirattu, P.No. 200, 201

14. Pattukaruppu Herbo-mineral Soothaga soolai, 1-2 arisi alavu Siddha Vaidhiya
Soothaga sanni, (65 -100mg) Thirattu, P.No.
Soothaga vettai 163
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CONCLUSION
The above mentioned Siddha medicinal plants and various Siddha formulations are effectively used for the management of
PCOS and its related complications. Besides, many other plants and formulations that possess hypoglycemic activity (corrects the
insulin resistance), hypolipidemic activity (reduces obesity) and antiandrogenic activity may also be used for the treatment of PCOS.
Many of the above mentioned therapeutics are employed based on medical practice. These are yet to be scientifically proved by
clinical trials so that it may be adopted by the conventional medicine and thus helpful for the betterment of the mankind. The
incidence of PCOS among women and teenage girls has risen to such an extent that the Indian Council of Medical Research (ICMR)
has taken up a nationwide survey. The reason it is dangerous is that, if this condition is left unchecked or undiagnosed, it can lead to
infertility among other long-term health concerns. Non-communicable diseases such as diabetes, CVD and cancers panic the human
population in recent days. However, these diseases can be managed and prevented from getting transmitted to next generation whereas
PCOS needs to be get rid of, as this condition may be a hindrance in producing the next generation if not managed effectively. Hence,
as stated in the previous lines, it is hereby reinstated that extensive future research in several aspects is required in order to emphasize
the significance of therapeutic values of Siddha system of medicine in a much better way.

Abbreviations:
PCOS – Poly Cystic Ovarian Syndrome
PCO – Poly Cystic Ovaries
LH – Luteinizing Hormone
FSH – Follicle Stimulating Hormone
TSH – Thyroid Stimulating Hormone
CVD – Cardio Vascular Diseases
HDL – High Density Lipoprotein
SFI – Siddha Formulary of India

Conflict of Interest
The authors declare no conflict of interest.

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