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- A Study on Drug Safety Monitoring Program in India. [REVIEW]
- Indian J Pharm Sci 2014 9; 76(5):379-386.
Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.
- Interventions for the management of taste disturbances. [JOURNAL ARTICLE]
- Cochrane Database Syst Rev 2014 Nov 26.:CD010470.
The sense of taste is very much essential to the overall health of the individual. It is a necessary component to enjoying one's food, which in turn provides nutrition to an individual. Any disturbance in taste perception can hamper the quality of life in such patients by influencing their appetite, body weight and psychological well-being. Taste disorders have been treated using different modalities of treatment and there is no consensus for the best intervention. Hence this Cochrane systematic review was undertaken.To assess the effects of interventions for the management of patients with taste disturbances.We searched the Cochrane Oral Health Group Trials Register (to 5 March 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2014), MEDLINE via OVID (1948 to 5 March 2014), EMBASE via OVID (1980 to 5 March 2014), CINAHL via EBSCO (1980 to 5 March 2014) and AMED via OVID (1985 to 5 March 2014). We also searched the relevant clinical trial registries and conference proceedings from the International Association of Dental Research/American Association of Dental Research (to 5 March 2014), Association for Research in Otolaryngology (to 5 March 2014), the US National Institutes of Health Trials Register (to 5 March 2014), metaRegister of Controlled Trials (mRCT) (to 5 March 2014), World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) (to 5 March 2014) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal (to 5 March 2014).We included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.Two authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted study authors for additional information. We collected adverse events information from the trials.We included nine trials (seven parallel and two cross-over RCTs) with 566 participants. We assessed three trials (33.3%) as having a low risk of bias, four trials (44.5%) at high risk of bias and two trials (22.2%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.Of these, eight trials with 529 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other six trials had adult participants. Out of these eight, two trials assessed the patient reported outcome for improvement in taste acuity using zinc supplements (RR 1.45, 95% CI 1.0 to 2.1; very low quality evidence). We included three trials in the meta-analysis for overall taste improvement (effect size 0.44, 95% CI 0.23 to 0.65; moderate quality evidence). Two other trials described the results as taste acuity improvement and we conducted subgroup analyses due to clinical heterogeneity. One trial described the results as taste recognition improvement for each taste sensation and we analysed this separately. We also analysed one cross-over trial separately using the first half of the results. None of the zinc trials tested taste discrimination. Only one trial tested taste discrimination using acupuncture (effect size 2.80, 95% CI -1.18 to 6.78; low quality evidence).Out of the eight trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides. No adverse events were reported in the acupuncture trial.None of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.We found very low quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste perception by patients, however we found moderate quality evidence that zinc supplements improve overall taste improvement in patients with zinc deficiency/idiopathic taste disorders. We also found low quality evidence that zinc supplements improve taste acuity in zinc deficient/idiopathic taste disorders and very low quality evidence for taste recognition improvement in children with taste disorders secondary to chronic renal failure. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.We found low quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.
- Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study. [Journal Article]
- Hum Vaccin Immunother 2014 Aug; 10(8):2276-83.
Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.
- Hydrogen breath test in patients with severe constipation: the interference of the mixing of intestinal content. [Journal Article]
- Neurogastroenterol Motil 2014 Dec; 26(12):1754-60.
The diagnostic accuracy of the hydrogen (H2 ) breath test might be reduced by the release of preformed H2 , trapped in hard stools. Test solution ingestion might induce the mixing of colonic content and a false positive result. We studied severely constipated patients, at diagnosis and after the normalization of bowel function, to clarify whether this mechanism affects test results.Twenty functional constipated patients, 10 consecutive patients with functional diarrhea and 10 healthy volunteers underwent (i) a H2 breath test after lactulose, to exclude differences among the groups in fermenting capacity; (ii) breath H2 excretion monitoring after non-absorbable, non-fermentable PEG-electrolyte solution, to exclude the role of the delivery to the colon of preexisting fermentable substrates or of the release of preformed H2 entrapped in the feces; (iii) H2 measurement during a 7-h fasting period, to exclude the role of spontaneous variations of breath gas excretion; and (iv) breath H2 excretion monitoring after PEG, after normalization of bowel function.All the subjects excreted similar amounts of H2 after lactulose. After PEG, only severely constipated patients showed significant breath H2 excretion, theoretically able to induce a false positivity of the lactose breath test in 70% of patients and a false positivity of glucose breath tests in 50% of patients. Breath H2 excretion after PEG disappeared if fecal consistency improved after therapy.Severely constipated patients may harbor preformed gas in hard stools which can be released when mixing of the intestinal content is induced. This mechanism may interfere with breath test results.
- [Clinical and economical evaluation of new analgesics for the management of chronic pain]. [English Abstract, Journal Article]
- Recenti Prog Med 2014 Nov; 105(11):415-9.
The management of chronic pain still represent a challenge for physicians. Opioids are the main stem in the treatment of chronic severe pain, not only for their potency, but as they act as central drugs. The main limit to their utilization in clinical practice is the prevalence of side effects, in particular in the gastrointestinal tract, whose constipation represents the most common. Two new formulations are nowadays available on the market: tapentadol PR (TAP PR) and oxycodone/naloxone (OXN). A recent meta-analysis showed that both drugs have a better tolerability profile than a tradizional opioid, such as oxycodone CR (OXY CR), but TAP PR reduces by 47% (RR=0.53) the percentage of patients discontinuing treatment because of side effects, compared to 24% (RR=0.76) of OXN. A similar advantage has been reported in the reduction of the risk of developing nausea and/or vomiting: TAP PR reduces the risk by 47% (RR=0.53), while OXN reduces the risk by only by 10% (RR=0.90). Both drugs reduced by about 40% the risk of constipation (RR=0.61 for TAP PR and for OXN). These results have been recently confirmed by a direct comparison of the two formulations (TAP PR vs OXN) in patients with chronic low back pain with neuropathic component. Both drugs were reported to be effective in reducing pain intensity and neuropathic symptoms, however TAP PR resulted superior to OXN in terms of analgesic efficacy, quality of life, and tolerability, in particular regarding constipation and adherence to treatment. A pharmacoeconomic analysis can be useful to understand the costs of these clinical advantages, and can be done by using a probabilistic analisys and by populating a Markov model that simulates the transition in time of 100 patients through 4 different possible health states: 1) still on treatment; 2) presence of adverse events; 3) discontinuation; 4) death. Both treatments (TAP PR and OXN) have been shown to have an excellent cost-effectiveness profile. In the case of OXN, in one year, 0.29 QALYs were gained compared to the use of OXY CR at an additional cost of € 138 resulting in a cost per QALY gained of € 475 (€ 138/0.29). In the case of TAP PR, instead, 0.31 QALYs were gained with additional savings due to the reduction of drug side effects, hospitalizations and emergency department access. Therefore, the use of TAP PR implies an average saving of € 31.6 per patient. These data are the results of a pharmacoeconomic model and require a further validation in clinical practice.
- North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes. [JOURNAL ARTICLE]
- Menopause 2014 Nov 24.
Hot flashes are a common symptom in breast cancer survivors that can negatively impact quality of life. Preliminary data suggested that magnesium might be used as an effective low-cost treatment of hot flashes with minimal adverse effects.A four-arm, double-blind, placebo-controlled, randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome hot flashes were randomized into treatment groups of magnesium oxide 800 or 1,200 mg daily or corresponding placebo groups at a 2:2:(1:1) ratio. Hot flash frequency and hot flash score (number × mean severity) were measured using a validated hot flash diary. A 1-week baseline period preceded initiation of study medication. The primary endpoint was intrapatient difference in mean hot flash score between baseline and treatment periods, comparing each magnesium group with the combined placebo groups using a gatekeeping procedure. Results were analyzed using repeated-measures and growth curve models on weekly hot flash scores based on a modified intent-to-treat principle.Two hundred eighty-nine women enrolled between December 2011 and March 2013. Study groups were well balanced for baseline characteristics. Mean hot flash scores, mean hot flash frequencies, and associated changes during the treatment period were similar for each group. An increased incidence of diarrhea and a corresponding lower incidence of constipation were reported in magnesium arms compared with placebo. No statistically significant difference in other toxicities or quality-of-life measures was observed.The results of this trial do not support the use of magnesium oxide for hot flashes.
- [Perianal pyramidal protrusion]. [Journal Article]
- Pan Afr Med J 2014.:224.
- Diagnostic investigations of canine prostatitis incidence together with benign prostate hyperplasia, prostate malignancies, and biochemical recurrence in high-risk prostate cancer as a model for human study. [JOURNAL ARTICLE]
- Tumour Biol 2014 Nov 25.
The aim of this study was to evaluate the prevalence of acute and chronic inflammation, benign prostatic hyperplasia (BPH), and cancer of the prostate glands in the canine as a human model in prostate disorders. The study was carried out on 12 cases of different male dogs of terrier (50 %), German shepherd (25 %) breeds, and Greden (25 %), and the age of the dogs ranged from 6 to 13 years (average age 7.8 ± 3.6). The bodyweight ranged from 3.6 to 7.9 kg. Signalment, clinical signs, and diagnostic tools such as ultrasonography, urinary cytology, and histopathology are presented. Dysuria was the most common clinical sign in this study and occurred in 10/12 canine (83.3 %) included. Other clinical signs included lameness (5/12 canine, 41.6 %) and constipation (3/12 canine, 25 %). The range of duration of clinical signs was 5 days to 7 months. Moreover, in the present study, the urinary biochemical markers of different prostate lesions include blood, protein, and glucose and were detected in 11/12 cases (91.6 %), 5/12 cases (41.6 %), and 2/12 cases (16.6 %), respectively. Taken together, sonographic data were classified into four groups based on histological diagnosis. In 7/12 cases (58.4 %), the prostate appeared to have BPH lesions, and the remaining lesions included inflammation (3/12 cases, 25 %), abscess (1 case, 8.3 %), and adenocarcinoma (1 case, 8/3 %) on ultrasound. In all cases, prostate tissue had an irregular echotexture. None of the dogs had sonographic evidence of sublumbar lymph node enlargement. Histopathologically, we looked at the prevalence of inflammation (33.3 % chronic and 8.3% acute) and BPH (58.4 %) in dogs of different ages and breeds, and also, we observed chronic inflammation in >20 % of dogs, which was about 25 % in 3 cases of the 12 cases referred. More chronic inflammation was associated with more BPH. The majority of the asymptomatic inflammation that is detected in the prostate is classified as chronic inflammation (i.e., as evidenced by the presence of monocytic and/or lymphoplasmacytic inflammatory cell infiltrates); however, acute inflammation is also observed to a lesser degree. Acute inflammation, as is typically evidenced by the infiltration of neutrophils, is classically an indicator of an infectious process. Finally, the patients included seven castrated, four castrated together with antibiotic therapy, and one castrated together with chemotherapy intact male dogs, which were treated with the mentioned cases. In conclusion, chronic prostatic inflammation could be a central mechanism in BPH progression, but the pathological features of tissue inflammation were different between BPH and prostate cancer (PCa). Nevertheless, the histological examination of prostate biopsies remains the only way to diagnose prostatic disorders.
- Analysis of the Chaotic Characteristics of Human Colonic Activities and Comparison of Healthy Participants to Costive Subjects. [JOURNAL ARTICLE]
- IEEE J Biomed Health Inform 2014 Nov 20.
Constipation is a common yet distressing disease that has high rates of morbidity and impacts patients' quality of life. However, there is no perfect method to distinguish costive patients from healthy subjects. Is there chaos in human colonic activities? Are there any differences for the chaos indicators of colonic activities between healthy and costive subjects? Can these indicators distinguish patients with constipation from healthy subjects? To answer these questions, colonic pressure data from 16 healthy subjects and 48 patients with constipation were analyzed using chaos theory. Three chaotic indicators (i.e., the largest lyapunov exponent (LyE), correlation dimension (CorDim), and Kolmogorov entropy (KoEn)) were calculated and compared between groups with the Wilcoxon rank sum test. As a result, the LyE was greater than zero and the CorDim was fractioned, which showed that human colonic activities have clear chaotic characteristics. Statistically significant differences were observed between groups for CorDim (p < 0.05) whereas LyE did not show statistically significant differences between groups. The chaotic indicator of CorDim was able to differentiate between patients with constipation and healthy subjects. The chaos theory provides a new method for learning the nonlinear dynamics of human gastrointestinal activities.
- Management of Chronic Intractable Constipation in Children. [JOURNAL ARTICLE]
- J Pediatr Gastroenterol Nutr 2014 Dec; 59(6):754-757.
Chronic intractable constipation (CIC) is a debilitating disease that is challenging to manage. Treatment options in children include medications, enemas, and surgical management in selected cases.We reviewed medical records of pediatric patients diagnosed as having CIC at Tufts Medical Center from 2005 to 2012. Demographic variables, diagnostic procedures, and medical and surgical outcomes were collected. Clinical outcome was defined using the Rome III criteria.A total of 14 patients were included in the study (10 boys). The age range was 10 to 21 years. All of the patients had the diagnosis of CIC. Eleven patients had cecostomy placement. During the follow-up period, 10 patients underwent total abdominal colectomy with ileorectal anastomosis, 1 had total colectomy with ileostomy, and 1 had partial colectomy with colorectal anastomosis. Successful clinical outcome was reported in 7 patients with 3 patients reporting persistent fecal incontinence. Colonic motility studies were performed on 12 patients (colonic neuropathy in 11 patients and normal study in 1 patient). Defecography was consistent with isolated pelvic floor dysfunction in 1 patient, abnormal motility and anatomy in 1 patient, pelvic floor dysfunction and abnormal motility in 2 patients, and found abnormal motility only in 5. Defecography study was normal in 5 patients. All of the patients with abnormal colonic manometry underwent a surgical procedure.Anorectal manometry, colonic manometry, and defecography help in understanding the pathophysiology of defecation disorders in children. The majority of patients with abnormal colonic manometry underwent TAC-IRA. There was no statistical correlation between individual investigations (anorectal manometry, colonic manometry, and defecography) with surgical intervention (P > 0.35). TAC-IRA may be safe and useful intervention in a subset of patients when other treatment options have failed.