Dyspepsia - The Indian perspective: A cross sectional study on demographics and treatment patterns of Dyspepsia from across India (Power 1.0 study)

Background: Dyspepsia includes a spectrum of symptoms ranging from epigastric pain and early satiety to postprandial fullness. The worldwide prevalence of dyspepsia is 20–30%. It is slightly higher in the Western population and occurs more frequently among women. While the precise prevalence of dyspepsia in India is not available, different studies estimate that it affects 7.6–49% of the Indian population. Through our current study, we wanted to understand the demographics, clinical profile, patient presentation, and management in India. We also wanted to document the pattern of use of proton pump inhibitors (PPI) and patient satisfaction with PPIs in Indian patients with dyspepsia. Materials and methods: This pan-India, multi-centric, cross-sectional, questionnaire-based, noninterventional, observational study was conducted between February and October 2021 in patients >18 years of age with a clinical diagnosis of any form of dyspepsia. Descriptive statistics were used for categorical variables, and between-group comparisons were made using Fischer’s exact test, with p < 0.05 denoting statistical significance. Results: A total of 3,739 patients from across 29 states of India participated in the study. Most of the patients were male (70.8%) and were from urban areas (56.8%). The highest percentage of patients were aged 31–40 (33.8%), and most patients (60.2%) had dyspepsia for a duration of 6–12 months. Patients with functional dyspepsia (FD) (78.5%) were significantly higher compared to organic dyspepsia (OD) (21.5%) (p < 0.001). The most frequent presenting symptoms were epigastric pain, nausea, vomiting, and heartburn. A quarter (25.6%) of the dyspepsia patients were associated with various comorbid conditions, of which diabetes mellitus, hypertension, and irritable bowel syndrome are the most common ones. A total of 619 patients in the study were on concomitant medications, of which the most common were antidiabetic drugs (271/619, 43.8%). Rabeprazole was the most frequently used PPI (2467/3739, 66.0%) among the study participants. The patient satisfaction analysis showed that, overall, patients were satisfied with PPIs, as most patients (~80%) agreed to almost all questions. The analysis for individual PPIs showed the highest “agree” responses in the rabeprazole group for almost all questions (12 of 13). Around 86.4% of patients on rabeprazole agreed with “immediate relief from acidity,” 84.9% for “gives me complete relief,” and 85.9% for “relief from nighttime acidity symptoms.” Conclusion: Our study involving over 3,700 Indian patients with Dyspepsia adds to the growing knowledge of dyspepsia in India. Dyspepsia is more prevalent in males and in the 31–50 age group. FD is the most common form. Overall, patients were satisfied with PPIs in dyspepsia management in India. Patients on rabeprazole showed higher levels of medication adherence, satisfaction with symptom relief, convenience of therapy, and safety compared to patients on other PPIs. Against the backdrop of a paucity of reliable data about dyspepsia in India, our study results provide valuable insights into Dyspepsia and its management in an Indian setting

Evaluation of Effectiveness of Doxycycline as Empirical Therapy for Treatment in Acute Undifferentiated Febrile Illnesses in Routine Clinical Practice: A Retrospective, EMR-based, Real-world Study

Background: Tetracyclines, in particular doxycycline, are recommended for the treatment of patients with acute undifferentiated febrile illness (AUFI); however, real-world studies are scarce. Methods: This retrospective, multicenter, observational study reviewed electronic medical records (April 2018 to March 2021) of adult patients (outpatient and inpatient departments [OPD and IPD]) with AUFI, treated with doxycycline monotherapy (doxycycline group) or doxycycline in combination with other antimicrobials (combination therapy group), from 7 tertiary hospitals and clinics in India. Results: Overall, 473 patients were included; 73.8% and 26.2% patients were prescribed doxycycline alone or in combination with other antimicrobials, respectively. Defervescence was achieved in 65.6% and 57.3% patients, respectively at the second (8-14 days) follow-up visit. Clinical cure rate for symptomatic resolution varied between 89.6% and 100% in OPD settings. Time taken from treatment initiation to defervescence was 3.51 ± 3.16 days for the doxycycline group and 3.46 ± 3.07 days for the combination therapy group. Both groups showed improvements in body temperature in OPD settings (84.2% and 84.5%) as well as IPD settings (97.4% and 94.1%). Adverse events in OPD patients in both groups were nausea (7.8% and 8.7%), anorexia (1.6% and 33.0%) and dyspepsia (1.6% and 67.9%). Conclusion: Doxycycline appears to be a promising candidate for treating patients with AUFI due to its demonstrated real-world effectiveness and safety profile.

An open prospective study on postmarketing evaluation of the efficacy and tolerability of diacerein in osteo-arthritis of the knee (DOK).

According to World Health Organisation osteo-arthritis is the second commonest musculoskeletal problem in the world. Diacerein has been recently introduced in India for the treatment of osteo-arthritis. In view of the ulcerogenic potential of NSAIDs and the cardiotoxicity problems associated with COX-2 inhibitors, diacerein has the potential of being a non-ulcerogenic and non-cardiotoxic alternative respectively to NSAIDs and of COX-2 inhibitors in the treatment of osteo-arthritis. The present study was, therefore, undertaken to evaluate the efficacy and tolerability of diacerein in the treatment of osteo-arthritis. A total 7923 patients with osteo-arthritis of the knee fulfilling the selection criteria were enrolled in this open-label, multicentric postmarketing surveillance study. After a wash-out period of one week, patients were treated with 50mg diacerein tablets administered twice daily for 12 weeks. The primary efficacy variable of the present study was to assess the improvement in the visual analogue scale (VAS) scores for pain. The secondary variable was improvement in patients' and physicians' global assessment of efficacy of therapy. Results indicated that over the 12-week study period, diacerein 50mg tablets provided significant and sustained reduction the VAS pain scores. At baseline, VAS scores were 6.70 +/- 1.78. By the end of the 4th week, there was a significant reduction in the mean VAS scores by 21.8% and by the end of the study the mean VAS scores were further significantly reduced by 59.9%. As per the patients global assessment of treatment, 82.3% of the patients reported good to very good improvement at the end of 12 weeks therapy with diacerein. Similar responses were also recorded by the treating patients. Thus by the end of 12 weeks therapy, according to the physicians 85.5% of the total cases treated with diacerein were rated as having good to very good improvement. Therapy with diacerein was well tolerated and only 5.44% of the patients had an adverse event after treatment with diacerein. The most common adverse events were diarrhoea (2.3%), gastritis (0.99%), nausea (0.61%), abdominal pain or discomfort (0.44%) and vomiting (0.3%). The severity of the adverse events was mild in all the cases and disappeared with continued treatment. None of the patients dropped out of the study on account of adverse events or lack of efficacy. Thus, in conclusion, the results of the present study in a large population of Indian patients indicates that diacerein constitutes a novel approach to the treatment for the short- and long-term symptomatic management in Indian patients with osteo-arthritis of the knee.

Results of a single blind, randomized, placebo-controlled clinical trial to study the effect of intravenous L-carnitine supplementation on health-related quality of life in Indian patients on maintenance hemodialysis.

BACKGROUND: Carnitine insufficiency is responsible for various co-morbid conditions in maintenance hemodialysis (MHD) patients. L-carnitine supplementation is expected to improve the quality of life (QoL) of patients on MHD. AIMS: To study the effect of L-carnitine supplementation on QoL of Indian patients on MHD. SETTING AND DESIGN: This was a single (patient) blind, randomized, placebo-controlled clinical trial conducted on patients on MHD attending hemodialysis unit of the study center. MATERIALS AND METHODS: Twenty patients on MHD suffering from hemodialysis-related symptoms were randomly assigned to receive intravenous L-carnitine 20 mg/kg or placebo after every dialysis session for 8 weeks. SF36 (Short Form with 36 questions) score for QoL, laboratory investigations and dialysis related symptoms were recorded at baseline and after 8 weeks. Improvement in QoL, laboratory parameters and dialysis related symptoms in the two groups after 8 weeks was compared. STATISTICAL ANALYSIS USED: Depending on normality of data, unpaired T test or Mann Whitney U test was used for comparison of change (8 weeks-baseline) in SF36 scores and laboratory parameters observed in the two groups. RESULTS: L-carnitine supplementation increased total SF36 score by 18.29 +/- 12.71 (95% CI: 10.41 to 26) while placebo resulted in reduction in total SF36 score by 6.4 +/- 16.39 (95% CI: -16.59 to 3.73). L-carnitine also resulted in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo. More patients were relieved of dialysis related symptoms in L-carnitine group. CONCLUSION: Intravenous L-carnitine supplementation improves QoL in patients on MHD.