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[Current Medical Practitioner (1962), 7, 381] Clinical Trials with Tentex Forte in Function Impotency Sahu, K.C., M.B.,B.S. (Pat.), D.P.H. (Eng.) & H. (L'pool), F.D.S. (Lond.), Reader and Head of the Department of Skin and Veneral Diseases, S.C.B. Medical College & Hospital, Cuttack, India. INTRODUCTION In the modern world many psychopathic individuals under stress and strain become sexually neurasthenic, sub-healthy and functionally impotent. Such individuals complain of impotency i.e., complete absence of erection and inability to perform the sexual act or diminished sex desire accompanied by feeble erections. Numerous drugs have been tried for these cases but none with full satisfaction. It was therefore decided to give a careful trial to Tentex forte. This compound manufactured by the Himalaya Drug Co., Bombay contains in each tablet, Musk 6.5 mg., Saffron 7.8 mg., Yohimbine hydrochloride 3.3 mg., purified Nux vomica pulvis I.P. 16.2 mg., Makardhwaj 16.2 mg., Shilajeet 32.4 mg., Orchis mascula 16.2 mg., Anacyclus pyrethrum 16.2 mg. Withania somnifera (Ashvagandha) I.P. 64.8 mg., Sida Cordifolia 61.2 mg., Bombax malabaricum 16.2 mg., Argyria speciosa 32.4 mg., Mucuna pruriens 32.4 mg., and Swarnamakshik Bhasma 32.4 mg. MATERIAL AND METHODS In this study 26 patients of various age groups (22 to 55 years) and habits regarding diet, ganja, tobacco and opium intake have been included. This study group comprises of persons of economically differing cross-section of society. According to marital status 26 persons included in this series can be classified as follows: Bachelor but experienced 2 Married 24 Having 2 living wives 3 Having 3 living wives 1 Widower but exposing 1 Married for second time 6 Newly married first time 10 Newly married 2nd time 5 Relationship with their sex partners at the commencement of treatment: Affectionate 12 Indifferent 10 Hostile 4 Duration of the present malady: 1 - 3 months 4 4 - 6 months 6 7 - 2 months 4 More than 1 year 2 Three of the cases included in the group gave history of V.D. treated with antibiotics and heavy metals but prostatic smear test for the presence of gonococci and pus cells did not show any abnormality. All patients were carefully examined clinically as well as serologically to rule out any syphilitic or systemic or neurological causes. As control five sexually normal couples were also treated with this drug. The history of patient as given by himself as well as by his spouse was taken in detail while routine blood, urine, stool and semen investigations were carried out in all the cases. All cases were observed for at least 6 months. Five cases revealed their habit of taking at intervals either testicular hormones parenterally of their own choice or some other sex tonics advertised in the lay press. Six cases gave the history of masturbating habit in adolescent age. Two gave history of feeling dizziness after intercourse before the start of the present malady. One person disclosed homosexual feelings and acts during his early life. DOSAGE AND OBSERVATION In all the cases under study the drug was given as two tablets daily (one tablet in the evening and one on retiring) on the first day of the treatment and the same dose continued for one week. In the second week where the drug failed to give sufficient improvement specially in cases of patients having habits of alcohol or ganja or both or opium the dose was doubled (2 tablets in the evening and 2 tablets at bed time) and continued for the week. Two patients, 22 years old, having no addiction even to tobacco, who complained of giddiness and sleeplessness from the 4th day and 5th day were advised to reduce the dose to only one tablet at bed time in the second week. All other patients were advised to continue the same dose as in the first week. In the third week two heavily alcoholic patients of age 50 and 55 who reported slight improvement but no side-effects were advised 3 tablets in the evening and 3 tablets at bed time. All other patients were advised to continue the same dose as in the second week. In the fourth week, all patients were advised to continue the same dosage as in third week except for one out of the two who were taking 3 b.d. in the third week. Since he reported sufficient improvement in respect of erection, desire and duration but developed giddiness, he was advised to reduce the dose to two tablets b.d., evening and bed time, for the week. In the fifth week, treatment was discontinued in all 16 patients who revealed remarkable change in respect of desire, duration and erection. They were advised a general tonic for two weeks more and asked to come after six months for further check-up. Other nine patients who also reported sufficient improvement in respect of desire, erection and duration were advised only 1 tablet b.d. for the week. One patient 55 years of age reported no improvement but complained of giddiness and sleeplessness, was advised to continue 2 b.d. in the fifth week. In the sixth week, the same dose continued in case of all who were continuing after fourth week. In the seventh week all the nine patients, except the one of 55 years mentioned above, reported to be absolutely free from the malady. The unfortunate one who did not report satisfactory result was asked to continue the same dose for a further two weeks. At the end of the eighth week, the dissatisfied patient still complained of less desire and low erection. He was advised to discontinue the therapy and advised general tonics and a tranquilliser for two months. DISCUSSION One is aware of the difficulties of evaluating the usefulness of a drug for a complaint which is functional and for which there are no objective criteria by which improvement can be gauged. But if one is prepared to accept the patient's word that he considers himself sexually insufficient as the only evidence of his trouble, it would seem but fair to rely on his word when he considers that there has been marked improvement in his condition or when he says he is cured. In order to get corroboration of the patients' opinion, the opinion of the female partner involved was also taken and if both of them were satisfied with the results of the drug for a subjective complaint which had caused them both a great deal of distress. It was considered that the drug had performed its function. Further it is a wellknown fact that various psychological and environmental factors may be responsible for functional impotency. It would of course be ideal if those factors could be changed but in practice one finds that invariably it is not possible to change any of those factors and the physician is obliged to give the patient something that will improve his sexual function even when the same adverse psychological and environmental factors prevail. In this series, during the trials there were no marked changes in the general factors influencing the patient's lives. Whatever they were, they remained unchanged. To test the drug's effect on normal sex desire 10 normal individuals, i.e., 5 normal couples, were given the drug. Most volunteers stated that the drug improved sex desire and prolonged the duration. SUMMARY In case of partial as well as complete functional impotency and sexual neurasthenia remarkable improvement was revealed in the first week of the treatment with a dose of 1 b.d. (one tablet evening and one tablet at bed time) by patients of the younger group (21—30, 31—40). In the elderly group some improvement was noticed with dose 1 b.d. in the first week but when the dose was increased to 2 b.d. very much further improvement was apparent in the second week. In case of alcoholic and ganja addicts gratifying results were noticed a little later in the third or fourth week. The drug has brought about remarkable improvement in all but one of the cases under study. In case of two under-weight patients an increase of 4 lb. body weight was observed at the end of the treatment and 10 lb. after six months when the patient approached for check-up. General improvement in the personality of all the patients was apparent. In a peculiar case of a heavy alcoholic, 55 years of age, with normal and abnormal extraneous sex partners, the drug failed to give satisfaction to the patient but some improvement was there as revealed by his second wife when interviewed by a lady student at her place. CONCLUSIONS In the course of this trial it was found that in functional impotency and psychic sex disturbances this drug, in carefully adjusted doses, gives excellent results in both the younger and elderly age groups. The elderly age group requires a higher dosage and longer treatment. In this series of 26 cases all, but one case, were relieved of their insufficiency. Giddiness and sleeplessness were the only sideeffects observed in higher doses. No tendency to increase the normal blood pressure was noticed in any case but there was slight rise in the blood pressure of two individuals with low blood pressure. The drug improved sex desire and duration in normal persons. ACKNOWLEDGEMENTS We thank The Himalaya Drug Co., for liberal supply of the drug for trial, the assistants who helped during the course of trial and check up and the colleagues who sent selected and suitable cases for trial. We also thank the spouses of the patients who came forward to disclose the history of their sex life. Our thanks are also due to the volunteers who tried the drug at our request.