Total Drug Effect Research Articles

A Clinical Evaluation of Haritaki Kashaya and Madhu as Kawala in the Management of Post Operative Sore Throat due to Tracheal Intubation Under General Anaesthesia

A sore throat is pain or irritation in the throat. It is usually caused by acute pharyngitis (inflammation of the pharynx). Although it can also appear as a result of trauma, diphtheria or other conditions. Post (Post Operative Sore Throat) is a common complaint in patients undergoing general anaesthesia following orotracheal intubation, with reported incidence of 21-65%. POST ranks among the most frequent subjective complaint after tracheal intubation under general anaesthesia. Post operative sore throat, cough and hoarseness of voice though minor sequel, but they may cause significant post operative morbidity and patient dissatisfaction. Various pharmacological and non-pharmacological trials have been used for attenuating POST with no single proven modality in modern medicine. Keeping this in mind, a thorough study was planned to search out for an ideal Ayurvedic preparation for the management of Post Operative Sore Throat due to tracheal intubation under general anaesthesia. As Haritaki has anti-inflammatory and anti-septic properties and Madhu has anti microbial and wound healing properties, A planned study was done on “Haritaki Kashaya and Madhu as Kawala” to evaluate its importance in treating post operative sore throat caused by tracheal intubation and the results were compared with the patients receiving normal saline gargles. Total effect of drug was evaluated on the basis of signs and symptoms relieved after completion of the trial. The data obtained in clinical study before and after the trial was expressed in terms of Mean, Standard Deviation (SD±) and Standard Error (SE±). Group-II (trial group) revealed better results than Group-I (control group) over total criteria of assessment. The trial drug was found to be efficient to relieve the symptoms like coughing, pain in throat and post operative sore throat in the patients who undergo orotracheal intubation after general anaesthesia

A Clinical Study to Evaluate the Efficacy of Asthapana Basti and Uttar Basti in Asrigdara w.s.r to Abnormal Uterine Bleeding

Regular periods are necessary to maintain good health of women. Any abnormality in Rituchakra leads to excessive and irregular uterine bleeding which is known as Asrigdara which can be correlated to Abnormal Uterine bleeding. In Ayurvedic text, many preparations are described to treat Asrigdara. Samshodhan therapy is mainstay in the management of Artava related disorders of which Basti is supreme to manage Asrigdara. In conventional science, Hormonal therapy is given but chances of recurrence of the disease are high. This study was planned to provide simple, safe, non- hormonal drug for the patients of Asrigdara. Total 40 patients fulfilling the inclusion criteria were selected randomly from Dept. of Stree roga and Prasuti tantra O.P.D.and I.P.D. The total effect of drug was evaluated on the basis of signs and symptoms after completion of therapy. Overall effect of therapy shows in group-I 6 (60%) patients were markedly improved, 11 (61.11%) were partially improved and 1 (5.6%) was not improved and group II- 6 (33.33%) patients were cured, 9 (50%) were markedly improved, 2 (11.1%) were partially improved, and 1 (5.6%) was unimproved. Thus, Basti Chikitsa manifested promising results for the management of Asrigdara, although hormonal pill manifested better cycle but for shorter duration.

Prophylactic effects or withdrawal reactions? An analysis of time-to-event data from antidepressant relapse prevention trials submitted to the FDA.

Background:Relapse prevention trials build the scientific foundation for recommendation of antidepressant continuation and maintenance therapy. However, the validity of the evidence is disputed and may be biased due to withdrawal confounding.Methods:We analysed survival curves from all antidepressant relapse prevention trials submitted to the United States (US) Food and Drug Administration (FDA) between 1987 and 2012 for 13 approved drugs. The main outcome was the percent of the drug effect (placebo-antidepressant difference in relapse events) at any week of the maintenance phase in relation to the total drug effect at the endpoint of the randomised maintenance phase.Results:Altogether, 14 studies with a mean observation period of 38.9 weeks (Kaplan–Meier estimators) were analysed. At week 3, a mean of 20.6% [95% confidence interval (CI) = 10.9–30.3%] of the total drug effect was achieved. At weeks 6 and 12, the corresponding figures were 50.3% (37.3–63.3%) and 69.0% (55.1–82.8%). No further antidepressant–placebo separation was observed as of week 24 [101.0% of total drug effect (94.6–107.3%)]. This means that censoring relapse events that occurred in the first 3, 6, 12 and 24 weeks would reduce the total drug effect at study endpoint by 20.6%, 50.3%, 69.0% and 101.0%, respectively. Assuming antidepressants had a constant prophylactic effect over 38.9 weeks, we further showed that, around week 6, the antidepressant–placebo separation was about three times larger than expected.Conclusion:The placebo–antidepressant separation was disproportionally large between weeks 3 and 6 of the randomised maintenance phase. The benefits of continuing antidepressants relative to abrupt/rapid discontinuation declined sharply after week 6. This indicates an excess of relapse events in the placebo arms during the early maintenance phase that may be due to withdrawal reactions caused by abrupt/rapid discontinuation of active treatment. If these early relapse events are due to a direct pharmacological effect, then antidepressants’ true prophylactic long-term effects are substantially overestimated.

Effect Of Palasha Kshara With Palasha Ghrita In The Management Of Cervical Erosion

Karnini Yonivyapada (Cervical Erosion) is one of the very common gynecological conditions seen in gynecology OPD’s. About 80% of women in her reproductive age group suffer from this problem. Cervical erosion is a benign condition but if left untreated may leads up to infertility. A cardinal symptom of this disease is white discharge per vaginum which is very common in women. Electric Cauterization is known treatment for cervical erosion but chances of recurrence of the disease are high. But the Ayurvedic management seems to be more practical, cost effective and showing better result with negligible side effects. Keeping this fact in mind the present clinical study has been undertaken. Material and method: Total 50 patients of cervical erosion and fulfilling the inclusion criteria were selected for this study, from Deptt. Of Stree roga and Prasuti tantra. O.P.D. Result: The total effect of drug was evaluated on the basis of signs and symptoms after completion of therapy. Overall effect of therapy shows 89.13% patients had cured and 10.86% patients had marked improvement in sign and symptoms. Group –I revealed better results than group –II over total criteria of assessment Conclusion: The therapy proved to be effective measure in the management of cervical erosion.

Memo to the FDA and ICH: appeal for in vivo drug target identification and target pharmacokinetics: Recommendations for improved procedures and requirements

This memorandum is addressed to members of regulatory agencies, as well as managers of pharmaceutical companies. Pharmacokineticists and toxicologists may consider this proposal, weigh its merits, and provide input for implementation. Experience from academic research and ADME experiments during drug development has prompted this appeal for improved drug target recognition. Similar demands have been made repeatedly in the literature. Such efforts are not new, but a renewed urgency has come from comparing results obtained with methods of different resolution and sensitivity, namely high-resolution receptor microscopic autoradiography compared and viewed in parallel to conventional low-resolution 'cut-and-count' radioassays and whole body autoradiography. Conflicting results reveal astounding deficiencies of current ADME approaches. False negatives and false positives of favored 'expedient' procedures allow drugs to reach the market with misleading and inaccurate information about the total drug effect.

A Note on the Invention, Invisibility and Dissolution of the Placebo Effect

In the 1950s an increasing number of articles about the subject were published2. Especially one of these articles became well known and is often mentioned today: it is Henry K. Beecher’s article from 1955 entitled The Powerful Placebo3. Beecher claimed in this article that in 1,082 patients in 15 studies on 9 different diseases or symptoms 35% of the patients were satisfactorily relieved by a placebo. He defined the total drug effect as equal to its active effect plus its placebo effect. This was a common understanding of the placebo effect in the 1950s. In 1956 the Danish physician Jacob KjaerLarsen wrote that placebo reactions could be caused by spontaneous changes in the disease, accidental coinciding factors, conditioned reflexes or suggestion4. These definitions were later criticised, especially in the 1990s, where the total drug effect was not seen as an addition of the active effect of the treatment and the placebo effect. The placebo effect was instead singled out as one out of many effects besides the active effect of the treatment. These

An approach to the modeling of the tolerance mechanism in the drug effect. I: The drug effect as a disturbance of regulations

In this paper the disturbing effect of drugs upon regulation in the organism is argued to be an important factor in the total drug effect. It is made plausible that the decrease of the drug effect after prolonged or repeated administration of the drug is caused by the adaptation of the involved regulations to the presence of the drug, the adaptive process being selective for the drug in question. A model based on these assumptions is developed taking into account the specific behaviour of regulated processes. The functioning of the model is investigated by means of computer simulations. The behaviour of the model appears to be well in accordance with the phenomenon of drug tolerance as described in literature.