Comparison of Probiotics, Metformin & Their Combination Therapy in the Treatment of PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is a common gynecological state worldwide characterized by
      numerous small cysts in the ovaries mainly due to the imbalance of endocrine hormones in
      premenopausal women. Metformin is long being used for different symptoms of PCOS along with
      other medication. This study involves the assessment of different parameters of PCOS.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive
      age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing
      age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple
      folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually
      represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries.
      The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most
      common cause.

      Metformin has been considered as the first line agent for the treatment of non-insulin
      dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS.
      Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients
      usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like
      for ovulation clomiphene citrate must be given etc. So there is a need of novel and
      comprehensive agent that can prove to be effective in improving maximum symptoms of this
      disease. Probiotics have received renewed attention in the 21st century through research
      studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms
      that, when administered in adequate amounts, confer a health benefit on the host. In recent
      year it has shown tremendous promising effect in treatment of different diseases like
      diarrhea, gingivitis and obesity etc with negligible side effects.

      In this context the investigators are going to evaluate and compare the effects of
      probiotics, metformin and their combination therapy in treatment of various symptoms of
      PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical
      trial. As mentioned above patients will be divided into three groups with 20 patients each.
      In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the
      second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics
      B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care
      Hospital
    

Intervention name(s): Probiotic Agent; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host.
Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases.
Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug; Metformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis.
It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS
Other intervention name(s): Ecotec; glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment