ABSTRACT
BACKGROUND AND PURPOSE: Osteoarthritis (OA) is a joint disease characterized by pain, inflammation, and physical disability. Boswellia serrata (BS) is widely studied for its effectiveness in OA condition. Our systematic review and meta-analysis study was aimed to evaluate BS extract efficacy in OA. A sub-group analysis was performed to compare the efficacy of a standardized BS extract (Aflapinâ) with other BS extracts. METHODS: Randomized controlled trials, identified from three online databases, evaluating the effect of BS extracts in OA were included. Quality of studies was assessed using PEDro scale and risk of bias was assessed using Cochrane Risk of Bias tool. Pooled effect was reported as mean difference (MD) and 95% confidence interval. Study was conducted as per the Cochrane guidelines (PROSPERO registration ID: CRD42023411356). RESULTS: Nine RCTs with 712 participants were included. All studies (except one) were good quality studies. BS supplementation significantly reduced VAS (MD: -10.71; p<0.00001), LFI (MD: -2.99; p<0.00001), WOMAC-pain (MD: -10.69; p<0.0001), WOMAC-stiffness (MD: -5.49; p<0.00001), and WOMAC-function (MD: -10.69; p<0.00001) scores compared to control therapy. By sub-group analysis, Aflapinâ supplementation showed greater reduction in VAS (MD: -16.09 vs -4.68), LFI (MD: -3.81 vs -2.01), WOMAC-pain (MD: -18.68 vs -7.07), WOMAC-stiffness (MD: -14.25 vs -3.78), and WOMAC-function (MD: -14.99 vs -8.41) scores as compared to other BS therapies. CONCLUSIONS: BS supplementation is effective OA symptomatic management. Sub-group analysis revealed that Aflapinâ supplementation may be better in improving the symptoms of OA which needs to be confirmed by more comparative clinical studies.
ABSTRACT
Menopause is characterized by various physical, mental and emotional symptoms. ERr 731 ® is a standardized extract from Rheum rhaponticum root and has been clinically studied for its role in reducing menopausal symptoms. The current systematic review and meta-analysis aimed to evaluate the efficacy of ERr 731 ® supplementation in alleviating the severity of menopausal symptoms. In this review, we searched across three online databases up to March 2023, evaluated the quality of the included studies by the Physiotherapy Evidence Database scale, and assessed the risk of bias by the Cochrane Risk of Bias tool. We then performed a meta-analysis using RevMan software to estimate the pooled mean difference (MD). The study protocol was registered in the Prospective Register of Systematic Reviews (CRD42023416808). After screening and evaluation, we included four high-quality studies (a total of 390 participants; the ERr 731 ® group: 193 participants; the control group: 197 participants) in the meta-analysis. The results showed that ERr 731 ® supplementation significantly reduced the Menopause Rating Scale score (MD: -15.12; P < 0.001), compared with control therapy. Sensitivity analysis revealed no effect of individual studies on the overall pooled estimate or overall observed heterogeneity. The current review provides evidence that ERr 731 ® supplementation is effective in reducing menopause symptoms. Potential bias and high heterogeneity in the results warrant further clinical studies.
ABSTRACT
Background Pre-menstrual syndrome (PMS) is a condition associated with altered hormone levels during the menstrual phase of females and is characterised by physical, emotional, and behavioural symptoms that have a negative impact on the quality of life of females. The symptoms of PMS may vary between individuals, but the major complication is pain, especially during menstrual days. The current treatment strategy involves the use of hormonal therapies and analgesics for symptomatic relief, but these therapies have a risk of potential side effects. The use of herbal and nutraceutical supplements in PMS conditions is increasing due to their long-term safety and proven efficacy. The current real-world study aimed to evaluate the efficacy and tolerability of Ezedayz® tablets containing Vitex agnus-castus extract (EVX40™), vitamin B6, and magnesium in PMS subjects. Methodology A real-world, open-label study was conducted involving 64 participants with varied severity of PMS symptoms. Participants were categorised into Group A (N=23) receiving standard therapies, Group B (N=20) receiving Ezedayz® tablets, or Group C (N=21) receiving standard and Ezedayz® therapy. Standard therapies were provided as per physician supervision, and Ezedayz® tablets were given for 90 days. All subjects were evaluated on core symptoms of PMS like menstrual backache, menstrual cramps, joint or muscle pain, and headache using the numerical rating scale (NRS), and quality-of-life (QoL) was evaluated using a QoL questionnaire. A spontaneous reporting methodology was used to evaluate the tolerability of the therapies provided. Statistical analysis was performed as per the statistical plan. A p-value of <0.05 was considered statistically significant. Results Out of 64 participants, five were lost to follow-up, and the data of 59 participants were included in the final analysis. All groups showed improvement in all evaluated parameters, but Group B and Group C showed greater improvement at the end of the study in all evaluated parameters. The quality-of-life assessment revealed greater improvement in Group B and Group C participants compared to Group C in all evaluated QoL parameters. No serious side effects were observed in any subjects. Conclusion The results of the current study conclude that the nutraceutical composition of Vitex agnus-castus extract, vitamin B6, and magnesium is effective in reducing the severity of PMS symptoms and improving the quality of life of PMS subjects. The nutraceutical therapy provided greater relief from PMS symptoms compared to standard therapy alone, and this effect was augmented when the nutraceutical therapy was provided in combination with standard therapies. Similarly, the improvement in quality-of-life parameters was greater in subjects treated with nutraceuticals alone or in combination therapy. Despite the limitations of the study, the results of the current study are promising, and the nutraceutical composition (Ezedayz®) can be effectively used in clinical settings to control symptoms and improve the quality of life of PMS patients.
ABSTRACT
Background: Chronic low back pain (LBP) is the most common musculoskeletal condition affecting a person's quality of life. Over the past decades, a lot of work was done in an attempt to reduce the negative impact of LBP, and help patients recover and maintain a better quality of life. Nevertheless, there is still a lot to be done to fully understand the problem of underlying chronic LBP and a wide gap that exist between basic science and applied rehabilitation research on LBP. Objectives: This was an open label, multicentric, observational, post-marketing surveillance study in a real-world setup designed to evaluate the efficacy and safety of MyrliMax® capsules containing standardised Commiphora myrrha gum resin extract in Indian subjects with chronic LBP varying in intensity. Materials and methods:This study included 204 subjects diagnosed with chronic LBP at the outpatient department of 20 centres under the supervision of a medical doctor. All subjects took MyrliMax® capsules twice daily for 20 days. Visual Analogue Scale (VAS) pain score, rescue medicine requirement, therapy satisfaction scores and safety parameters were assessed as per the schedule. Outcomes:Treatment with MyrliMax® capsules significantly (p<0.01) and progressively reduced the VAS score throughout treatment. A significant pain reduction was observed from the second visit. The mean VAS score was 6.58, 4.66, 2.99 and 1.88 on Day 0, Day 7, Day 14 and Day 20, respectively. A similar trend was also observed in subgroups based on gender and severity score. The need of rescue analgesics/NSAIDs was significantly reduced from the second week, indicating a potential of MyrliMax® capsules to increase the pain threshold. All physicians and patients were satisfied with the efficacy of MyrliMax® capsules assessed by physician's satisfaction score and patient's satisfaction score. There were no significant serious adverse events due to treatment during the study, which indicated that the treatment with MyrliMax® was well tolerated by subjects. Conclusion:MyrliMax® capsule is a potentially effective and safe therapy for pain reduction in patients suffering from chronic LBP. MyrliMax® capsules can be used to reduce pain in NSAIDs intolerant subjects suffering from chronic LBP.
ABSTRACT
AIM: This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children. METHODS: A total of 100 infants and children 3-36 months of age with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints. RESULTS: The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated. CONCLUSION: S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.