A randomized comparative clinical study to evaluate the efficacy of ‘Vyoshadi Guggulu’ and ‘Shadushana Churna’ in the management of Dhatvagnimandya w.s.r. to subclinical hypothyroidism

Sub Clinical Hypothyroidism (SCH) is defined as mildly reduced function of thyroid gland with either minimal symptoms or no symptoms of hypothyroidism having an elevated serum TSH level and normal concentrations of free T3 (FT3), free T4 (FT4), T3 and T41,2. Although this definition is based solely on biochemical criteria, it is well recognized that some individual patients may present with symptoms and signs of hypothyroidism3,4,5,6. A large cross-sectional study confirmed that participants with subclinical hypothyroidism reported more symptoms than euthyroid individuals, but fewer symptoms than overtly hypothyroid participants and did not distinguish between untreated subclinical hypothyroidism and undertreated overt hypothyroidism7. Edema, generalized pain, anorexia, constipation, dry/ coarse skin, excessive sleep, menstrual irregularities, fatigue, are among the most common symptoms. It is confirmed by laboratory diagnosis of serum picture of elevated thyroid stimulating hormone (TSH) and normal serum concentration of free thyroxin (FT4) and total Triiodothyronine (T3)8.Antithyroid antibodies can be detected in 80% of patients with Subclinical hypothyroidism, and 80% of patients with Subclinical hypothyroidism have a serum TSH of less than 10 mIU/L. The risk of subclinical hypothyroidism turning into overt hypothyroidism is higher if any of the following persists i.e. symptoms, enlarged thyroid, thyroid antibodies detected in a blood test and female patient.

There is no direct mention of Thyroid gland and Hypothyroidism in Ayurveda. However, a disease named galaganda, characterized by neck swelling is well known. Acharya charaka has included it under 20 shleshma vikara9. Thyroid hormone functions are similar to the functions of agni (jatharagni, dhatvagni and bhootagni) in our body causing transformations / tissue metabolism at various levels and thus maintaining the BMR. Agnimandya at any level due to kaphakara nidana results in increased dhatugata mala sanchaya, resulting in srotorodha causing compromised dhatu - sara leading to both physical and mental features in subclinical hypothyroidim. as swelling, anemia, constipation, cold intolerance etc This agnimandya results in formation of abnormal rasa dhatu (apachita rasa dhatu) i.e. ama10. Ama lakshana and the symptoms seen in subclinical hypothyroidism are similar.

The line of treatment of ama dosha revolves around pachana (digestion of ama) then *deepana (*igniting digestive fire) and lastly shodhana after snehana & swedana karma. The shodhana karma is strictly contraindicated in first place since ama dosha is not localised. shodhana without ama pachana results in further complication as ama dosha is amalgamated with body tissues. The therapy focuses on pachana (digestion of existing Aamadosha), deepana (increasing digestive power), anulomana (purge) and shamana (medicine) to avoid further formation of Ama11. Vyoshadi guggulu (Brihat Nighantu Ratanakar) and Shadushana churna (Bhavaprakash) have been selected to manage subclinical hypothyroidism. It is indicated in arochaka (tastelessness), agnimandya (digestive impairment), ama dosha (products of impaired digestion and metabolism / consequences of ama), galaroga (diseases of throat, sthaulya (obesity). Therefore it helps in alleviating the associated features of subclinical hypothyroidism.

PREVALENCE

Subclinical Hypothyroidism (SCH) or mild thyroid failure is more prevalent in recent years and is causing major controversies concerning management and treatment. The Wickham study, an extensive population-based survey, the prevalence of Sub Clinical Hypothyroidism is 7.5% in women and 2.8% in men12. The highest prevalence (upto16%) was found in elderly women over 60 years of age13. It is more prominent in females rather than males14.

IMPORTANCE OF PRESENT STUDY

As far as modern medicine is concerned, benefits of treatment need to be weighed against any potential risks. The clinical importance of and therapy for mild elevation of serum TSH (<10 mIU/L)15 and the exact upper limit of normal for the serum TSH level remain subjects of debate16. When the TSH level is above 10 mIU/L levothyroxine therapy is generally agreed to be appropriate17. However, management of patients with a serum TSH level of less than 10 mIU/L is controversial. The arguments against treatment are its expense and the likelihood that some patients will not benefit. There is also a danger of over-treatment, which could cause iatrogenic hyperthyroidism. Management of hypothyroidism with the modern drugs may bring the value of TSH and T4 to normal range but the increased dosage and continuous medication make the patient drug dependent till the end of mortal life. Although Levothyroxine is a mostly used in Hypothyroidism but it has some limitations and side effects as extreme fatigue, fever, irregular breathing etc. 30% of the subclinical cases will progress to overt hypothyroidism, 30% revert back to euthyroidism, 40% remains in subclinical hypothyroidism. So, vyoshadi guggulu and shadushana churna having its effect on agni (a root cause of sub clinical hypothyroidism) are expected to prevent overt hypothyroidism and will revert back subclinical stage to euthyroid. So, a better, safer and long lasting therapy is needed for the present society and now it is a demand of time to search the management for this type of ailment through the heritage of Ayurveda. Keeping this fact in mind, the clinical trial is proposed after compiling all available references from classical authentic texts.

SELECTION OF DRUG

The main factor responsible for the manifestations of hypothyroidism is the agnimandya, hence drugs acting on agni, having deepana, pachana, srotoshodhaka, medohara, lekhana properties are likely to check the basic pathogenesis of hypothyroidism. Among the wide varieties of drugs mentioned in Ayurveda text books vyoshadi guggulu and shadushana churna has been chosen for the study so as to establish its efficacy in successful treatment of hypothyroidism. Contents of vyoshadi guggulu and shadushana churna having deepana and pachana properties, administration of these drugs checks control agnimandya. The contents of this drug are easily available and very effective.