 |
       |
|
|
ORIGINAL / RESEARCH
Effectiveness of Indigenous Oral Contraceptive
HS Palep, SR Jukar
End of this century is fraught with enormous population explosion in the developing world.
Population control is the most urgent job. For this purpose, many methods of contraception are in force.
Of all, the simplest should be the oral contraceptive agents. Steroid contraceptives have been in use for over 3 decades and generations of new agents only show the ideal agent is not yet available. Even the latest year book has published the various papers supporting and opposing the complications of the various steroid formulae. Complications of concern are the damage to the liver, disturbance of blood, coagulation factors, disturbances of oral glucose tolerance, functional ovarian cysts, congenital abnormalities in the offspring of women using oral contraceptive pills. It is also conceded that smoking and oral conceptive pill combination could be dangerous.
With this present status of the steroid oral contraceptive pills, need was felt to try some Ayurvedic formulation. Standard Ayurvedic Texts have described drugs having deleterious effects on zygote at the time of implantation. For this purpose, a coded drug AC-4 prepared by Central Council for Research in Ayurveda and Siddha has been studied for its effectiveness as an oral contraceptive on 834 subjects from May, 1978 to 31st June, 1987.
Formula
ASHOKA (Saraca Indica)
VIDANGA (Embelia Ribes)
LAKSHA (lac)
KRAMUK (Areca Nut)
Dose : 2 Tablets of 500 gms each.
MATERIAL AND METHODS
Young healthy patients in active reproductive age below 40 years are selected from Indoor and Outdoor attendance of MA Podar Hospital. This drug was given from 5th day of LMP for a period of 15 days in a daily dose schedule of 1 gm (2 tablets) at bed time with milk. In all 834 patients were taken on trial, after doing a thorough clinical checkup including a history, general examination, BP check, weight, systemic examination, PV examination, routine laboratory investigations viz. CBC, ESR, blood sugar, urea, SGOT, SGPT, serum cholesterol, urine and stool are done before starting the trial.
Following is the chart of the follow-up:
Age1) Upto 30 years 589 ladies
2) 31 to 40 years 245 ladies
Parity1) Upto II para 408 ladies
2) More than II para 426 ladies
Good efficacy of the drug after 5 cycle exposure shows that the drug is having effective cumulative action.
Failure rate after exposure for 5 cycles - 1.19% (Hundred WY)
Drug is well accepted by the patients, barring minor side effects like heartburn, nausea. If it is taken with milk, these side effects do not occur. No patient had any severe side effects or complications. After the stoppage of the drug, the patients conceived without any difficulty.
RESULTS
Months of the exposure to drug Total no. of women
Total cycle No. Total drug failure Failure due to drug omission 54 1 54 - - 42 2 84 - - 40 2 80 - - 39 1 39 - - 36 1 36 - - 35 1 35 - - 33 3 99 - - 32 1 32 - - 31 1 33 - - 30 2 60 - - 28 2 56 - - 27 3 81 - - 26 2 52 - - 25 1 25 - - 24 1 24 - - 22 3 66 - - 21 1 21 - - 20 8 160 - - 18 3 54 1 - 17 10 170 - - 16 5 80 - - 15 5 75 - - 14 11 154 - 1 13 8 104 1 - 12 17 204 - - 11 14 154 - - 10 21 210 - - 9 20 180 - 2 8 26 208 - 2 7 30 210 1 1 6 31 186 - 1 1 to 5 597 1155 28 18 Total 834 4179 31 27
Five hundred ninety seven patients who had taken the drug for 1-5 months were studied for 1155 cycles. There were 28 failures. Failure rate in this group is 29/HWY.
Two hundred one women had taken the drug for 6-18 months were studied for 1989 cycles. There were three failures. Failure rate in this group is 1.8/HWY.
Thirty six patients continued the drug, from 18-54 months were studied for 1035 cycles. There was not a single case of failure.
Five months period of treatment was high failure rate. But if the patients took for six months and beyond as can be seen from the study of 3024 cycles comprising of 237 patients failure rate comes down to almost 1.19/HWY.
Prof. Dr. TK Chandy also presented his data on AC-W tablets of his work done at Trivandrum Medical College. In his series of 601 cycles when patients were treated with the drug for 7-12 cycles, there was no failure. But in 482 cycles where the drug was used for only 1-6 months, there were 20 cases of failure.
Prof. Dr. (Mrs.) MB Shah from Ahmedabad with a little different drug (Pippalyadivati) also has shown similar results. With failure rate 0.5 HWY.
Mechanism of action of the drug
Main ingredient is bidanga (Embelia Ribes). It is luteolytic, anti-oestrogenic there by interferes in the process of implantation of blastocyst.
This drug is described as a best remedy in worm infestation in Ayurveda. By acting on the gonads of the worms it prevents their multiplication and thereby remedies the worm infestation.
Ashoka (Saraca Indica). Contains Pure phenolic glycoside- P2. It is a very strong oxytocic. 10 mcg of glycoside P2 is equipotent to 0.0001 Units of oxytocin or 5 mcg of Ergometrine.
Laksha (lac) Experimental studies have shown that it reduces alkaline phosphatase, sugar level and uterine weights. It causes changes in endometrial fluid milleu which are not conducive for implementation of blastocyst.
Kramuk (Areca nut). Probably high Cu+2 content may play role in anti implantation process.
DISCUSSION
Failure rate 1.19/HWY is comparable to both steroidal OC Pills and Intrauterine device. Even with Steroidal OC Pills the failure rate is high for first two months. Hence we always advocate additional barrier method for this period. In case of AC-4 barrier method can be suggested for five months to improve the success rates. Since it is non hormonal it does not affect the hypothalamo-pituitary axis and as well as the other adverse side effects. e.g. abnormal increase in weight, thromboembolic episodes or hepatic damage. There is also no effect on lactation. Hence in lactating women it can be a good alternative. It is cheap, indigenous, well tolerated. No other side effects like intermittent or intermenstrual spotting or bleeding.
 |
