Effect of shatapushpa taila matra basti and pathadi kwatha on poly cystic ovarian disease.

Poly Cystic Ovarian Disease (PCOD) is a complex disorder affecting 5-15% women in their reproductive age and related to ovarian dysfunction, characterized by menstrual irregularities, hyperandrogonism, obesity, and infertility. In Ayurveda, these symptoms are found under various conditions, caused by vitiated Vata and Kapha. Pathadi Kwatha and Shatapushpa Taila Matra Basti were studied in the current attempt to evaluate their comparative efficacy in cases of PCOD. Total 34 patients of PCOD were registered among which, 32 had completed the treatment of 2 months. They were randomly divided in to three groups. In group A Pathadi Kwatha (10 g, bid) and Shatapushpa Taila Matra Basti (60 ml for 7 days after cessation of menses for 2 consecutive cycles) were administered. In group B only Basti, whereas in group C capsules of roosted wheat flour were administered. Better results were obtained in group A especially in menstrual irregularities, achieving follicular growth and in weight reduction.

RCT Entities:   Population Interventions Outcomes

Introduction

Poly Cystic Ovarian Disease (PCOD) is a common cause of infrequent and irregular periods and affects as many as 5-15% of woman in their reproductive age. [1] This disease is characterized by menstrual irregularities, clinical, and/or bio-chemical hyperandrogonism and hyperinsulinemia, which ultimately leads to infertility. Apart from infertility, some of the other symptoms associated with Poly Cystic Ovarian Syndrome (like hirsutism, obesity, and android fat patterning) [1] may interfere with female self perception and are in contradiction to culture-dependent beauty ideals.

Symptoms of PCOD direct the way of involvement of Kapha and Vata Dushti causing Avarodha or Avarana in Artavavaha Srotas. Thus for the treatment, Pathadi Kwatha mentioned by Sushruta in Vatakaphaja Artavadushti[2] was selected. This drug contains Patha (Cissampelos pareira Linn.), Shunthi (Zingibar officinalis Roxb.), Maricha (Piper nigrum Linn.), Pippali (Piper longum Linn.), and Kutaja (Holarrhena antidysenterica Roxb.ex. Fleming) in equal proporation. Shatapushpa (Anethum sowa Kurz.) is the drug of choice in any disease related to Artava[3] in any form so Shatapushpa Taila Matra Basti (STMB) was selected.

Materials and Methods

Patients

Patients attending the OPD of Stree Roga and Prasooti Tantra, I. P. G. T. and R. A., Jamnagar, fulfilling the criteria for the selection were selected into the study irrespective of their religion, caste, etc.

Inclusion criteria

Patients, fulfilling at least two of the following three criteria [4] (ESHRE/ASRM – Rotterdam revised criteria for PCOD, 2003):

Oligomenorrhea and/or anovulation.

Hyperandrogonism (clinical and/or bio-chemical).

PCO-diagnosed by Trans Vaginal Sonography (TVS).

Patients having any other disease causing oligomenorrhea and anovulation excluding PCOD on the above criteria.

Any organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities, or any other pelvic pathology.

Patients suffering from adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushing’s syndrome, cardiac diseases will be excluded.

Drugs

The drug Patha was collected from Sanjivani Pharmaceuticals, Baroda in raw form. Shatapushpa was purchased from the market of Jamnagar. Other drugs, (Trikatu, Kutaja, and Tila Taila) were obtained from the Pharmacy of Gujarat Ayurved University, Jamnagar. All drugs were identified in the Pharmacognosy laboratory, IPGT and RA. Pathadi Kwatha, Shatapushpa Taila, and roasted wheat flour capsules as placebo drug were prepared in the Pharmacy of Gujarat Ayurved University, Jamnagar.

Investigations

Hematological investigations like Hb%, TC, DC, ESR, and routine urine investigations were done. serum Lutinizing Hormone (LH), serum Follicular Stimulating Hormone (FSH) were done on 2nd or 3rd day of menses. USG was done on 2nd or 3rd day of menses for diagnosis of PCO and it was also done in between 12th to 20th day of menses for follicular growth and ovulation.

Study design

Placebo controlled randomized clinical study was carried out. Informed consent was taken from the patient before including them in the clinical trial.

Management of the Patients

Drug dosage, duration, and method of administration

Grouping

Selected patients were randomly divided into three groups.

Group A

Patients were given 10 g of Pathadi Kwatha Churna, 2 times/day. They were advised to make decoction from it. Along with the oral drug, patients were also given STMB in the dose of 60 ml for 7 days after cessation of menses in two consecutive cycles. In this group, 14 patients completed the treatment and 1 discontinued.

Group B

Patients of this group were treated with only STMB in the dose of 60 ml for 7 days after cessation of menses in two consecutive cycles. In this group, 12 patients completed the treatment and 1 discontinued.

Group C

Patients were given Placebo capsules in the dose of 2 capsules of 500 mg each 2 times/day. In total, six patients were registered and have completed the treatment in Group C.

Duration

2 months.

Pathya-Apathya

Patients were advised to take less amount of diet than required, correct their dietary habits, and avoid unhygienic and junk food. Mild to moderate exercise especially inclusion of Suryanamaskara as per their capacity was suggested. They were also advised for intercourse during rutukala (from 12th to 20th day of menses) and not to take much of stress.

Follow up

Follow-up was carried out for one month.

Criteria for assessment

Assessment was made on change in clinical features before and after treatment. Special scoring pattern was given to each symptom ranging from 0 to 3. Total effect of therapy in each patient was evaluated after completion of the treatment.

The obtained results were measured according to the grades given below:

Completely cured: 100% relief

Marked improvement: b75% to `100% relief

Moderate improvement: b50–75% relief

Mild improvement: b25–50% relief

Unchanged: up to 25% relief

Statistical analysis

The obtained data on the basis of observations was subjected to statistical analysis. P ` 0.001 is considered as highly significant, P ` 0.01 as significant, and P ` 0.05 as insignificant.

Observations and Results

In the present study, majority (55.88%) of patients belonged to age group of 25-35 years, 94.12% were married, 76.47% were housewives, 50% had taken allopathic medicines, 38.24% had chronicity of b5 years, 94.11% were having the dietetic habits of Vishamasana, 20.59% had dyspareunia, 79.41% were suffering from Chinta (worry), 67.65% had Vatakapha Prakriti, 73.53% had Mandagni. Maximum (64.71%) patients had irregular delayed menses (oligomenorrhoea), 29.41% had painful menses, 61.76% had primary infertility, 52.94% had Ferriman Gellway score[5] ≥8, 23.52% were obese, 100% patients were having Artavavaha Srotodushti, 88.24% had bilateral PCO on USG finding, 90.63% had the follicular size between 0-b12 mm and LH:FSH ratio b2 in 32.35% of the patients.

In group A, statistically significant results were found in delayed menses (32.43%), painful menses (62.50%), and achieving follicular growth (100%). In this group statistically highly significant results were found in reduction of body weight (4.31%). In group B, statistically significant results were found in delayed menses (50%), painful menses (100%), and achieving follicular growth (66.67%). No change was found in any symptoms in group C. Though weight reduction was found in group A but, no change was found in the BMI score, whereas in groups B and C, there was increase in weight instead of decrease [Tables 1-3]. At the same time no improvement was found in hirsutism and LH:FSH ratio in any group. Changes in hematological parameters were within normal limits.

Table 1

Effect of therapy in Group A

Table 3

Effect of therapy in Group C

On overall assessment in group A, 7.14% patients showed complete remission, 14.29% showed marked improvement, 28.57% showed mild improvement, whereas 50% remained unchanged. In group B, 33.33% patients showed complete remission, 8.33% showed moderate improvement, 16.67% showed mild improvement, whereas 41.68% remained unchanged. In group C, only 16.67% patients showed mild improvement, whereas 83.33% remained unchanged [Figure 1].

Figure 1

Overall effect of therapy

Discussion

Effect on menstrual irregularities

Amapachana, Srotoshodhana, and Vatakaphashamaka properties of both Pathadi Kwatha and STMB may be responsible for the efficacy.[6] Ushna, Tikshna, Lekhana, Pachana, etc., properties of contents of Pathadi Kwatha are similar to Pitta increases Agneya Guna of Pitta, which is responsible for decreasing interval. This effect is also supported by Vatanulomana property of Matra Basti. Looking to the result, it can be said that the combination of Kwatha and Matra Basti may decrease the level of androgen, which allows estrogen to work on endometrium.

Effect on follicular growth and ovulation

Group A shows significant (P ` 0.01) result on follicular growth, group B shows insignificant (P ` 0.05) result, whereas no change was found in group C. Follicular size increased after treatment in maximum patients in group A. Patients with no follicular growth reported increase in follicular size after therapy. This may because of removal of Sanga by Kapha-Vata Shamaka Srotoshodhana, Aama Pachana, etc. properties of both the drugs. After removal of Sanga created by vitiated Kapha and Ama in Artavavaha Srotas, Apana Vata functions well leading to normal Rajah Pravritti and Beeja Nirmana. It may be hypothesized that both the treatment modalities may decreases LH level thus preventing premature lutinization. Thus normal FSH level stimulates growth and development of follicle.

Effect on other symptoms

Group A shows highly significant (P ` 0.001) result in reduction of weight, whereas group B and group C show statistically insignificant (P ` 0.05) result. In groups B and C, weight increased instead of decrease. In group A, additional properties like Lekhana, Rruksha, Tikshana, Deepana, Pachana, etc., of Pathadi Kwatha adds this effect of reduction in body weight[7] by regulating Jatharagni. Thus, it checks the excessive growth and accumulation of Medodhatu and thereby causing Lakshana Upashamana of disease PCOD. These properties are lacking in groups B and C although strict Pathya Palana was administered in all three groups. Overall, Group A shows 62.50% result, whereas group B shows 100% result in pain associated with menses. Group C shows insignificant result. Effect of therapy on LH:FSH ratio shows statistically insignificant (P ` 0.05) in all groups.

Comparing the total effect of therapy with the placebo group, group A and B shows statistically significant (P ` 0.01) results [Tables 1 and 2] whereas there is insignificant difference in group A compared with group B [Table 3]. Hence, it can be said that both trial drugs have similar effect.

Table 2

Effect of therapy in Group B

Probable Mode of Action of Drugs

Basti works on whole body after entering into Pakvashaya or Guda. Guda is said as Sharira Mula having Shiras and Dhamanies, which spreads all over the body.[8] It exerts local as well as systemic effect. Basti Dravyas normalize Apana Vata making it to function normal. It also enhances the function of Purisha.[9] One of the function of Purisha is ‘Anila Anala Dharana’, thus Basti leads to correction of Agni Dushti. At the end, Basti normalize the function of Apana Vata leading to normal Rajah Pravritti and normal Beeja Nirmana. Here, Shatapushpa Taila was used for the Basti and the Gunas of Shatapushpa are Balya, Deepan, Pachan, Yonivishodhana, Artavajanana, and Beejotsarga.

As per modern appraise, any drug given via rectal route absorbs through mucosal layer of rectum and enters into systemic circulation. Entering into Gastro Intestinal Tract (GIT), Basti stimulates Enteric Nervous System (ENS) and generates the stimulatory signals for Central Nervous System (CNS) as ENS resembles CNS.[10, 11] These signals stimulate endogenous opioids present in GIT, mainly β-endorphin, which exerts the inhibition of gonadotropin releasing hormone release.[12] Thus, Basti given in the patient of PCOD regulates Hypothalamic-Pitutary-Ovary axis, which results into normalization of ovarian cycle and menstrual cycle too. Parasympathetic activity may be responsible for the function of Apana Vata. Basti introducing through rectum and may stimulate the parasympathetic nerve supply, which in turn helps for development of follicles and release of ovum from the ovary.

Conclusion

Treatment with the combination of both Pathadi Kwatha and STMB has additional effect on the symptoms of PCOD. It is proved statistically to be effective in regularizing menstruation, achieving considerable reduction in body weight, substantial growth of follicles, and thus ovulation. The final outcome of the study is very positive. This treatment protocol may be helpful for management of PCOD in future definitely.