ADDYZOA In The Management Of Male Infertility

Summary

l   The efficacy and safety of the Ayurvedic preparation ADDYZOA in improving seminal parameters has been investigated in a 3-month, randomised, placebo-controlled trial of 50 men with idiopathic oligo-astheno-teratospermia (OST).

l   At the end of the treatment period there was a statistically significant improvement in sperm density, motility, and morphology in patients receiving ADDYZOA, but not in those receiving placebo.

l   ADDYZOA can be recommended for the empirical treatment of idiopathic male infertility, although a large-scale (cross-over) trial documenting conception and pregnancy rates is needed to confirm whether the beneficial effects of the drug on seminal parameters results in increased fertility.

 

Introduction

      Significant medical effort should be directed towards the diagnosis and treatment of infertility, as approximately 15% of all couples worldwide suffer from this perplexing problem. It is estimated that in approximately 30% of infertile couples, the ‘fault’ lies with the male; in another 20%, both male and female factors are responsible. Thus, in around half of all infertile couples, male-factor infertility plays a part in the inability to conceive a child.

      Abnormalities in seminal parameters are important causes of male-factor infertility. However, there is a large group of men for whom no cause can be identified. As yet, there is no satisfactory treatment available for these idiopathic cases, and the choice lies between a trial of non-specific drug therapy or artificial inseminations with husband’s washed sperm (AIH).

      The list of conventional medicines for non-specific therapy is long and includes clomiphene, tamoxifen, and mesterolone. Success rates varying from 10-50% have been reported with these agents although, overall, results remain poor. Human chorionic gonadotrophin has also been used with varying claims of success. Besides their oftentimes prohibitive cost, side effects associated with these empirical conventional medicines are disadvantageous.

      In such a scenario, the judicious use of indigenous medicines adds a new dimension to the management of male infertility. Besides being easy to administer, Ayurvedic medicines are cost effective and have an excellent tolerability profile : they are relatively free of side effects and are without any absolute contraindication or special precautions.

      ADDYZOA is one such Ayurvedic medicine which, despite being widely used for the empirical treatment of male infertility for more than 3 decades, has only been sporadically evaluated in this condition.^1-3 According to Thakre and Thakre,² this herbo-mineral preparation improved the quality and quantity of semen by increasing sperm count and motility.

      Against this background, an attempt was made to scientifically document the effect of ADDYZOA on various seminal parameters in cases of idiopathic male infertility.

 

Materials and Methods

      A total of 50 patients with male-factor infertility of no known cause attending the Malhotra Test Tube Baby Centre and Agra Andrology Centre were recruited in the present study. On the basis of routine clinical examination, semen analysis, and, where necessary, further investigations (including sperm function tests, anti-sperm antibody tests, blood hormone profile, and scrotal ultrasound scan to rule out varicocele), all were diagnosed with idiopathic OST.

      Pre-treatment semen analysis parameters were recorded. The patients were then randomly assigned in a double-blind fashion to treatment with ADDYZOA or placebo (oral administration of two capsules twice daily for 3 months). The two groups were equally sized, each containing 25 patients.

      Repeat semen analysis was conducted at monthly intervals, with sperm density, motility, and morphology being evaluated. In order to classify the effect of treatment, the subjective criteria shown in table 1 were adopted.

      Within each group, pre-treatment parameters were compared with post-treatment parameters (after 3 months). Post-treatment parameters between the two groups were also compared. The results were expressed as mean ± standard deviation.

 

Table 1. Classification of treatment response

                                          Improvement                            Unchanged                Deterioration

Semen parameter

Sperm quantity                    > 7 ´ 10⁶ increase in                  —                              > 7 ´ 10⁶ decrease in

                                          Sperms/ml                                                                 sperms/ml

Sperm quality                      > 25% increase in                      —                              > 25% decrease in

                                          motile sperms and in                                                  motile sperms and in

                                          normal sperm forms                                                   normal sperm forms

 

Table 2. ADDYZOA on semen parameters pre-and post treatment values

                                                   ADDYZOA (n = 25)                                   Placebo (n = 25)

Semen parameter                     Pre                         Post                       Pre                         Post

Density                                     11.92 ± 4.99            35.14 ± 24.10*         7.44 ± 2.08              11.92 ± 4.99

( ´ 106 sperms/ml)

Motility (%)                               50.64 ± 5.33            60.24 ± 3.62**          51.64 ± 4.17            45.28 ± 4.07

Normal morphology (%)             49.84 ± 3.96            54.48 ± 2.91**          52.32 ± 3.34            49.00 ± 3.06

Symbols : * p < 0.05, ** p < 0.01 vs pre-treatment baseline

 

Results

      Absolute (objective) values for semen parameters are summarised in table 2, while subjective assessments of sperm density, motility, and morphology are illustrated in figures 1, 2 and 3, respectively.

      According to the subjective criteria :

l    There was an improvement in sperm density in 84% of patients on ADDYZOA compared with 52% of patients on placebo (figure 1).

By Dr. Arun Tewari*, Dr. Narendra Malhotra**, Dr. Jaideep Malhotra**