ABSTRACT
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory skin disease that significantly affects the quality of life of patients. Multiple factors affect the disease's course and severity. HS is a debilitating disease and often recalcitrant to treatment, resulting in a deterioration of quality of life; hence, there is a need to evaluate the factors affecting the quality of life in patients with HS. OBJECTIVES: The objective of the study was to evaluate the various demographic and disease-related factors that affect the quality of life of patients with HS. MATERIALS AND METHODS: This is a prospectively scored questionnaire-based observational study. Data from 30 patients with HS were analyzed for the association of disease-related factors like Hurley's staging, site, duration, past history, and comorbidities with the Dermatology Life Quality Index (DLQI). RESULTS: A statistically significant relationship was found between DLQI and Hurley staging (p=0.000). The most common sites involved were the axilla and inguinal regions. Among the sites involved, the neck (p=0.002), abdomen (p=0.002), back (p=0.002), thighs (p=0.042), and gluteal (p=0.000) regions have a statistically significant association with DLQI. Prior histories of rheumatoid arthritis, scarring, surgery, lymphadenitis, and pilonidal sinus showed a statistically significant association with DLQI. CONCLUSION: The disease severity significantly hampers the quality of life of patients with HS. The disease site and presence of other comorbidities also influence the outcome. Our study will help healthcare providers better understand and fulfill the needs of patients suffering from HS.
ABSTRACT
Background: Adverse drug reactions (ADRs) are important cause of morbidity and mortality. Despite its known importance, rate and quality (completeness score) of ADR reporting is not satisfactory. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years. Material and Methods: In this retrospective study, ADRs reported between 2017 to 2021 were analyzed according to year, gender, age-group, pharmacological class and department. The completeness score of ADRs was calculated. The number of sensitization programs conducted over 5 years and its impact on the completeness score was also evaluated. Results: A total of 104 ADRs were reported among 61 (58.6%) female and 43 (41.4%) male patients. Adults (18-65 years) comprised the most affected age group, accounting for 82 (79%) patients. Out of all, 35.5% ADRs were reported in 2018, whereas 27% were reported during 2021. Except during 2017, percentage of females with ADRs was more. Department of pulmonary medicine and dermatology contributed to maximum extent in ADR reporting. Antibiotics [23 (22.11%)], antitubercular drugs (AKT) [21 (20.19%)], and vaccines [13 (12.4%)] represented the most common agents with which ADRs were reported. ADR reporting was very low in 2017 (4/104). Percentage improvement in completeness score in 2021 vs. 2018 was 11.95% (P < 0.05). Positive trend in the improvement of average completeness score with number of sensitization programs was observed. Conclusion: Incidence of ADRs was more common in females. AKT and antimicrobials are commonly implicated in ADRs. Increase in awareness of ADR reporting through sensitization programs can help to improve rate and quality of reporting.
ABSTRACT
BACKGROUND: Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms. OBJECTIVES: This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women. MATERIALS AND METHODS: In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopause-specific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone. RESULTS: Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level. CONCLUSION: These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.
Subject(s)
Withania , Double-Blind Method , Female , Hot Flashes/drug therapy , Humans , Perimenopause , Plant Extracts/pharmacology , Quality of LifeABSTRACT
ETHNOPHARMACOLOGICAL RELEVANCE: Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia. MATERIAL AND METHODS: We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed. RESULTS: In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group. CONCLUSION: The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.
