The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version was approved on 18 October 2008, by the WMA General Assembly at Seoul, South Korea, replacing all previous versions. This version highlights issues such as, participant safety, the need to include participants from otherwise underrepresented groups, clinical trial registration, post-study access, usage of data and human tissues, compensating participants with research-related injury, and usage of placebo. In this article, we discuss the major aspects of the 2008 version, including the impact of this version on all stakeholders in research, including, investigators, ethics committee members, sponsors, authors, editors, and reviewers.

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Azathioprine is commonly used for treatment of lupus nephritis. Myelosuppression is known to occur with azathioprine, but severe pancytopenia is uncommon. A 23-year-old man with lupus nephritis was initially treated with intravenous cyclophosphamide pulses and oral prednisolone along with enalapril and frusemide. Following six months of cyclophosphamide, he was initiated on oral azathioprine as maintenance therapy. He subsequently returned with febrile neutropenia and severe bone marrow suppression. Fever responded to broad spectrum antibiotics and his counts gradually improved following granulocyte-macrophage colony stimulating factor. When last seen in October, he was symptom free and disease activity in control. We suggest that physicians remain sensitive to possibility of azathioprine induced severe bone marrow suppression. Frequent monitoring of blood counts is probably the best way to avoid this complication specially, where testing for thiopurine methyltransferase is not available.

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Background: Reports from India on the prevalence and determinants of female sexual dysfunction (FSD) are scant. Aims: To determine the prevalence and risk factors for FSD. Settings and Design: A cross-sectional survey in a medical outpatient clinic of a tertiary care hospital. Materials and Methods: We administered a Tamil version of the Female Sexual Function Index (FSFI) to 149 married women. We evaluated putative risk factors for FSD. We elicited participant's attributions for their sexual difficulties. Statistical Analysis: We estimated the prevalence of possible FSD and sexual difficulties from published FSFI total and domain cut-off scores. We used logistic regression to identify risk factors for possible FSD. Results: FSFI total scores suggested FSD in two-thirds of the 149 women (73.2%; 95% confidence intervals [CI] 65.5% to 79.6%). FSFI domain scores suggested difficulties with desire in 77.2%; arousal in 91.3%; lubrication in 96.6%; orgasm in 86.6%, satisfaction in 81.2%, and pain in 64.4%. Age above 40 years (odds ratios [OR] 11.7; 95% CI 3.4 to 40.1) and fewer years of education (OR 1.2; 95% CI 1.0 to 1.3) were identified by logistic regression as contributory. Women attributed FSD to physical illness in participant or partner, relationship problems, and cultural taboos but none had sought professional help. Conclusions: Sexual problems suggestive of dysfunction, as suggested by FSFI total and domain scores, are highly prevalent in the clinic setting, particularly among women above 40 and those less educated, but confirmation using locally validated cut-off scores of the FSFI is needed.

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Background: Diabetes and its related microvascular complications like diabetic retinopathy (DR) are showing increased prevalence in India. However, the magnitude of DR in rural population with diabetes needs exploration. Aim: To estimate the prevalence and risk factors for the presence and severity of diabetic retinopathy in the self-reported rural population with diabetes. Settings and Design: In a cross-sectional study, a total of 26,519 participants (age ≥ 30 years) attended 198 diabetic retinopathy screening camps conducted in three southern districts of Tamilnadu, India, between February 2004 and April 2006. Materials and Methods: All the participants underwent a dilated eye examination to detect DR by indirect ophthalmoscopy. Systemic and ocular risk factor estimation was done in a comprehensive examination. Statistical Analysis: Univariate and stepwise regression analyses were done to identify the independent risk factors associated with the presence and severity of retinopathy. Results: The prevalence of diabetic retinopathy was 17.6% among the self-reported rural population with diabetes. The prevalence of referable (sight threatening) retinopathy was 5.3%. Risk factors associated with the development of any DR were male gender (OR= 1.37), longer duration of diabetes (per year, OR= 1.07), lean body mass index (OR= 1.30), higher systolic blood pressure (per 10 mm Hg, OR= 1.18), and insulin treatment (OR= 1.34; P < 0.0001). Risk factors associated with referable retinopathy included longer duration of diabetes (per year, OR= 1.22), lean body mass index (OR= 1.25), higher systolic blood pressure (per 10 mm Hg, OR= 1.03), and insulin treatment (OR= 1.36; P < 0.0001).Conclusion: The study identified risk factors associated with DR in the rural population with diabetes. The results suggested that there was a need for formulating effective preventive strategies to minimize avoidable blindness due to diabetes, in rural areas.

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Background: Poor school performance in children causes significant stress to parents. Aims: To analyze the quality of life (QOL) of parents having a child with newly diagnosed specific learning disability (SpLD) and to evaluate the impact of clinical and socio-demographic characteristics on their QOL. Design: Cross-sectional questionnaire-based study. Setting: Learning disability clinic in tertiary care hospital. Materials and Methods: From June 2006 to February 2007, 150 parents (either mother or father) of children consecutively diagnosed as having SpLD were enrolled. Parent's QOL was measured by the WHOQOL-100 instrument which is a generic instrument containing 25 facets of QOL organized in six domains. Statistical Analysis Used: Independent samples t-test, one-way analysis of variance, and multiple regression analysis were carried out for statistical significance. Results: Mean age of parents was 42.6 years (SD 5.5); mothers to fathers ratio 1.3:1; and 19 (12.7%) were currently ill. Only four WHOQOL-100 domains (psychological > social relationships > environment > spiritual) and five WHOQOL-100 facets (leisur > pfeel > energy > esteem > sex) contributed significantly to their "overall" QOL. Female gender, being currently ill, being in paid work, and having a male child were characteristics that independently predicted a poor domain/facet QOL score. Conclusions: The present study has identified domains and facets that need to be addressed by counselors for improving overall QOL of these parents. Initiating these measures would also improve the home environment and help in the rehabilitation of children with SpLD.

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The unknown mechanisms of impaired tissue repair in diabetes mellitus are making this disease a serious clinical problem for the physicians worldwide. The lacuna in the knowledge of the etiology of diabetic wounds necessitates more focused research in order to develop new targeting tools with higher efficacy for their effective management. Gap-junction proteins, connexins, have shown some promising results in the process of diabetic wound healing. Till now the role of connexins has been implicated in peripheral neuropathy, deafness, skin disorders, cataract, germ cell development and treatment of cancer. Recent findings have revealed that gap junctions play a key role in normal as well as diabetic wound healing. The purpose of this review is to provide the information related to etiology, epidemiology, clinical presentation of diabetic wounds and to analyze the role of connexin 43 (Cx43) in the diabetic wound healing process. The current control strategies and the future research challenges have also been discussed briefly in this review.

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A 46-year-old male with uncontrolled asthma on inhaled albuterol and formoterol with budesonide was commenced on montelukast. He developed abdominal pain and jaundice 48 days after initiating montelukast therapy. His liver tests showed an increase in serum total bilirubin, conjugated bilirubin, aspartate aminotranferase, alanine aminotranferase, and alkaline phosphatase. The patient was evaluated for possible non-drug related liver injury. Montelukast was discontinued suspecting montelukast induced hepatocellular liver injury. Liver tests began to improve and returned to normal 55 days after drug cessation. Causality of this adverse drug reaction by the Council for International Organizations of Medical Sciences or Roussel Uclaf Causality Assessment Method (CIOMS or RUCAM) and Naranjo's algorithm was 'probable'. Liver tests should be monitored in patients receiving montelukast and any early signs of liver injury should be investigated with a high index of suspicion for drug induced liver injury.

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Background: It is widely recognized that accurate and reliable product information is essential for the safe and effective use of medications. Pharmaceutical companies are the primary source of most drug information, including package inserts. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies. Studies on package inserts in India, in 1996, had shown that crucial information was often missing and they lacked uniformity. Aim: To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Materials and Methods: Package inserts accompanying allopathic drug products marketed by pharmaceutical companies in India were collected. These package inserts were analyzed for the content of clinically important information in various sections. Statistical Analysis: The results were expressed as absolute numbers and percentages. Results: Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The findings indicated considerable improvement in package inserts since 1996. However, on critical evaluation it was revealed that clinically important information was not well presented and was often incomplete. Information with regard to pediatric and geriatric use was present in only 44% and 13% of the package inserts, respectively. Only five of the inserts had information on the most frequent adverse drug reactions associated with the drug. Also, information on interactions and overdosage was often missing. Conclusion: Although the package inserts appear to have improved over the past decade there is still a definite need to further refine the clinical information contained, to minimize the risks to patients. This could be brought about by self-regulation on the part of the industry as well as by updating the relevant guidelines in line with those of developed countries.

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Background: There is hardly any structured study reporting the perspective of medical students, with regard to the medical education system in Maharashtra, which is facing challenges. Aim: A perception study of students was conducted to explore the situation, challenges, and consequent solutions of medical education in Maharashtra. Settings and Design: A descriptive perception study. Materials and Methods: A structured questionnaire was e-mailed to 92 students, and interviews with seven key-informants comprising of faculty, administrators, and policy makers were conducted, to gather qualitative insights. Results: Thirty-seven student replies were received and analyzed. The satisfaction level of student respondents for various factors was as follows: infrastructure 18/37 (48.6%), quality of teaching 14/37 (37.8%), patient population 22/37 (59.5%), and administration 8/37 (21.6%). Ninety-two percent (34/37) of the students stated that the fundamental problem was the inability of the system to attract good, quality teachers. The reasons stated were low salaries, low level of job satisfaction, high level of bureaucracy, and high work load. Conclusions: The medical education system in Maharashtra is viewed as being stagnant. The respondents emphasized an urgent need for educational reforms, which should include better compensation for teachers, sharing of facilities between government and private medical colleges, and improved efficiency of the Medical Council of India. In the long run a public-private mix with sharing of resources may be a plausible solution.

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Childhood renal amyloidosis is a rare entity and is mostly secondary in nature. We describe two cases of renal amyloidosis in association with childhood tuberculosis. The first case was a 10-year-old girl who presented with abdominal tuberculosis and nephrotic syndrome, while the second case was a 5-year-old boy who presented with disseminated tuberculosis and nephrotic syndrome. They were found to have amyloidosis on renal biopsy. The former was treated with anti-tubercular drugs, while the latter required anti-tubercular drugs and steroids. Both the cases showed clinical improvement with remission of nephrotic syndrome. Successful treatment of tuberculosis can result in remission of nephrotic syndrome due to secondary renal amyloidosis. It is important, especially in developing countries, to be aware that tuberculosis continues to be part of the differential diagnosis of amyloidosis in children.

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Background: Patient controlled sedation (PCS) gives liberty to patients to choose the time of sedative administration to attain a desired level of comfort. Aims: The PCS use was evaluated in patients during surgery under central neuraxial blockade. Settings and Design: Prospective, cross-sectional, clinical study on consecutive patients in a tertiary care university hospital. Materials and Methods: PCS technique, using propofol (1%) 2 ml in 2 min was used in 160 adult patients undergoing urologic procedures under central neuraxial block. We observed the time to first PCS activation by patient, duration of surgery, propofol dose, sedation score, hemodynamic stability, patient's acceptability, and the factors correlating with the PCS use. Statistical analysis used: Non-parametric two-tailed Pearson's test, univariate correlation analysis for the factors favoring PCS use followed by multivariate logistic regression analysis amongst correlating factors. Results: In our cohort, the majority (83%) of the patients activated PCS during surgery under central neuraxial blocks at median time of 30 min and (17%) did not activate PCS. Female patients activated sedation earlier (median 15 min) than male patients (median 30 min). All patients were hemodynamically stable and without significant side effects. Multivariate analysis showed that sedative use significantly ( P <0.05) correlated with female gender (odds ratio-3.54 [IR-2.64 to 4.73]) and prolonged surgery (>90 min). Majority (91%) of patients rated PCS technique excellent to good. Conclusions: PCS was very well accepted by patients during central neuraxial block. Propofol regimen (2 ml in 2 min) in PCS was safe, as it caused neither apnea nor significant hypotension.

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Renal artery pseudoaneurysms caused by blunt abdominal trauma are uncommon. It requires treatment with angioembolization because of high risk of rupture. Spontaneous closure of the pseudoaneurysm is extremely unusual. We report a case of a 29-year-old male who developed a traumatic intrarenal pseudoaneurysm that later resolved spontaneously. This report provides an insight into the natural history of renal pseudoaneurysm and suggests a potential option of managing them conservatively.

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