Clinical Quickies (Sept-Oct 2023)

  1. Adding Myoinositol Improves PCOS Symptoms, but Does Not Improve Pregnancy Rate Further
  2. Resveratrol + Myoinositol Combination is More Effective in Improving Metabolic Parameters than Metformin + Pioglitazone Combination
  3. Pomegranate Peel Extract May Benefit Patients with NAFLD
  4. Vitamin D Supplementation May Reduce Gingivitis Severity
  5. It May be Wise to Add Vitamin B6 to Quadruple Anti-H. Pylori  Regimen to Reduce Potential Side-Effects
  6. Reconstituted Freeze-Dried Grape Powder Appears to Prevent Metabolic Decline of the Brain in Patients with Mild Cognitive Decline
  7. Vitamin D Deficiency or Insufficiency May be Associated with and Increased Risk of Atrial Fibrillation
  8. Vitamin D Deficiency or Insufficiency May be Associated with and Increased Risk of Atrial Fibrillation
  9. Female Patients Drinking Daily Juice of Fresh Beetroot, Watermelon and Ginger Have a Higher Pregnancy Rate After ICSI Cycles
  10. Curcumin Capsules May Work as Well as Proton Pump Inhibitors in Relieving Functional Dyspepsia
  11. Patients with Chronic Conditions Unresponsive to Conventional Treatments May Benefit from Medical Cannabis Prescription
  12. Could Korean Red Ginseng Increase and Maintain COVID-19 Vaccine Response? Maybe Applicable in Other Vaccines?

1. Adding Myoinositol Improves PCOS Symptoms, but Does Not Improve Pregnancy Rate Further

OBJECTIVE: Insulin resistance and hyperinsulinemia plays an important role in pathogenesis of polycystic ovary syndrome (PCOS). Metformin, Myoinositol and d-chiro-inositol acts as insulin sensitizers and exerts beneficial effects in PCOS. The objective is to compare the effect of metformin monotherapy versus a combination of metformin with Myoinositol and d-chiro-inositol in PCOS.

DESIGN: This study is a randomized controlled trial conducted over a period of 6 months. All overweight and obese women with PCOS with the age group between 18 and 35 were included and randomized into two groups, 27 in the metformin monotherapy arm and 26 in the myoinositol combination arm.

PATIENTS AND MEASUREMENTS: The variables assessed were duration of menstrual cycle, anthropometric parameters, modified Ferriman Gallwey score, global acne score, Fasting insulin, HOMA-IR, fasting lipid profile, serum testosterone, sex hormone binding globulin, luteinizing hormone, follicle stimulating hormone, anti-Mullerian hormone, and pelvic ultrasound to assess ovarian volume, PCOS Questionnaire score. Changes in the parameters from baseline at the end of 6 months of treatment were assessed and compared between the groups.

RESULTS: Menstrual cycle regularity improved in both groups with significantly greater improvement in the group receiving myoinositol-based therapy (p < .001). Pregnancy rate was equal in both the arms. There was a significant improvement in PCOSQ score in myoinositol-based therapy group (p < .001). However, there was no statistically significant difference in other hormonal, metabolic parameters between two groups in spite of symptomatic benefits.

CONCLUSIONS: The addition of myoinositol to metformin exerts additional benefits in improving menstrual cycle regularity, and quality of life in women with PCOS.

Nazirudeen R, et al. A randomized controlled trial comparing myoinositol with metformin versus metformin monotherapy in polycystic ovary syndrome. Clin Endocrinol (Oxf). 2023 Aug;99(2):198-205. doi: 10.1111/cen.14931. Epub 2023 Jun 2.

2. Resveratrol + Myoinositol Combination is More Effective in Improving Metabolic Parameters than Metformin + Pioglitazone Combination

PURPOSE: The present study aimed to assess whether treatment with combined resveratrol and myoinositol is more effective in ameliorating the altered parameters associated with PCOS when compared to the combined metformin and pioglitazone therapy.

METHOD: One hundred and ten obese, oligo-anovulatory PCOS women, aged 20-35 years were randomly assigned into two treatment arms. Participants in arm-1 (n = 55), received combination of metformin and pioglitazone (500 mg and 15 mg, respectively), twice daily, while those in arm-2 (n = 55) received combination of resveratrol and myoinositol (1000 mg and 1000 mg, respectively) twice daily for 12 weeks. Evaluations performed at baseline were repeated after 3 months of therapy. The endocrine and metabolic derangements were assessed by measuring serum levels of testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), adiponectin and insulin using ELISA. Cohen’s perceived stress scale (PSS) was employed as a subjective measure of stress.

RESULTS: Pre-treatment PCOS women in both the arms (arm-1 and arm-2) had remarkably elevated serum testosterone and insulin concentrations, low serum adiponectin and high perceived stress response scores. The treatment reduced the altered endocrine indices in arm-2 (resveratrol and myoinositol) participants, manifested by statistically significant reduction in serum testosterone level (p = 0.001) and notably increased serum adiponectin level (p = 0.001).

Interestingly, the hormonal profile, including serum LH and FSH levels also decreased (p < 0.001) along with a marked reduction in the ovarian volume (p = 0.001) in arm-2 participants. There was a significant reduction in weight (<0.001), BMI (p < 0.001) and an improvement in waist-hip ratio (p < 0.001) in arm-2 participants compared to arm-1 group. The PSS scores of the arm-2 subjects improved significantly (p < 0.001) whereas the Ferrimen-Gallwey score was improved in both the arms (arm-1 and arm-2; p = 0.010 and 0.008 respectively) however, the change was highly significant in arm-2. Interestingly, the menstrual regularity was 81.4% in arm-2 while 18.2% in arm-1.

We conclude that the therapeutic intervention with combined resveratrol and myoinositol is more effective in ameliorating altered endocrine, metabolic indices and stress burden and could be of clinical importance in a high risk group of obese, oligo-anovulatory married PCOS affected women.

Hassen S, et al. Treatment with combined resveratrol and myoinositol ameliorates endocrine, metabolic alterations and perceived stress response in women with PCOS: a double-blind randomized clinical trial. Endocrine. 2023 Jan;79(1):208-220. doi: 10.1007/s12020-022-03198-2. Epub 2022 Sep 28.

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3. Pomegranate Peel Extract May Benefit Patients with NAFLD

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a metabolic syndrome (MS)-related liver disorder that has an increasing prevalence. Thus, the aim of our study is to evaluate the effects of pomegranate peel extract (PP) supplementation on hepatic status and metabolic syndrome risk factors.

METHODS: In phase one, the hydro-alcoholic extraction of the peel of 750 kg of pomegranate (Punica granatum L.) was performed by the soaking method. Then, in phase two, NAFLD patients received 1500 mg of placebo (n = 37) or pomegranate peel capsules (n = 39) with a 500-kcal deficit diet for 8 weeks. Gastrointestinal intolerance, dietary intake, lipid and glycemic profiles, systolic and diastolic blood pressure, body composition, insulin resistance indexes, and elastography-evaluated NAFLD changes were followed.

RESULTS: The mean age of participants was 43.1 ± 8.6 years (51.3% female). Following the intervention, the mean body weight (mean changes: -5.10 ± 2.30 kg), waist circumference (-7.57 ± 2.97 cm), body mass index (-1.82 ± 0.85 kg/m2), body fat index (-1.49 ± 0.86), and trunk fat (- 3.93 ± 3.07%), systolic (-0.63 ± 0.29 cmHg) and diastolic (-0.39 ± 0.19 cmHg) blood pressure, total cholesterol (-10.51 ± 0.77 mg/dl), triglyceride (-16.02 ± 1.7 mg/dl), low-density lipoprotein cholesterol (-9.33 ± 6.66 mg/dl; all P < 0.001), fat free mass (- 0.92 ± 0.90 kg; P < 0.003), and fasting blood sugar (-5.28 ± 1.36 mg/dl; P = 0.02) decreased significantly in PP in contrast to the placebo group in the raw model and when adjusted for confounders. Also, high-density lipoprotein cholesterol (5.10 ± 0.36 mg/dl), liver steatosis and stiffness (- 0.30 ± 0.17 and – 0.72 ± 0.35 kPa, respectively, all P < 0.001) improved in the PP group. However, fasting insulin (P = 0.81) and homeostatic model assessment for insulin resistance (HOMA-IR) (P = 0.93) were not significantly different when comparing two groups during the study in the raw and even adjusted models.

CONCLUSION: In conclusion, 1500 mg pomegranate peel extract along with a weight-loss diet improved metabolic syndrome risk factors and reduced hepatic steatosis in patients with NAFLD after 8 weeks.

Barghchi H, et al. Pomegranate (Punica granatum L.) peel extract ameliorates metabolic syndrome risk factors in patients with non-alcoholic fatty liver disease: a randomized double-blind clinical trial. Nutr J. 2023 Aug 22;22(1):40. doi: 10.1186/s12937-023-00869-2.

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4. Vitamin D Supplementation May Reduce Gingivitis Severity 

INTRODUCTION: Vitamin D deficiency increases gingivitis risk. Studies show that higher vitamin D levels reduce inflammation.

MATERIALS AND METHODS: College conducted a double-blind, randomized, controlled trial on 451 people’s vitamin D and gingival health at baseline. For three months, participants were given a placebo (group A), 1000 international units (IU) of vitamin D3 per day (group B), 500 IU per day (group C), or 2000 IU per day (group A). Gingival scores were recorded for three months to assess the anti-inflammatory effect (the first, second, and third). Vitamin D levels also affected gingivitis.

RESULTS: Vitamin D dose-dependently reduces gingivitis inflammation. Vitamin D administration negatively correlated with gingival index score. Anti-inflammatory vitamin D levels are 32–37 ng/ml.

CONCLUSIONS: Vitamin D supplementation can reduce gingivitis severity. The optimal blood vitamin D level is 30–35 ng/ml.

Srivastava R, et al. A Study to Assess Anti-Inflammatory Effect of Vitamin D on Gingivitis: A Dose Dependent Randomised Controlled Trial. J Pharm Bioallied Sci. 2023 Jul; 15(Suppl 2): S1182–S1184. Published online 2023 Jul 11. doi: 10.4103/jpbs.jpbs_169_23

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5. It May be Wise to Add Vitamin B6 to Quadruple Anti-H. Pylori Regimen to Reduce Potential Side-Effects

BACKGROUND: Vitamin B6 is an essential water-soluble vitamin for humans. It is often used to prevent a variety of neuropathies, relieve vomiting, and relieve symptoms such as hand and foot neuritis.

AIM: To evaluate whether vitamin B6 can alleviate the adverse reactions caused by the quadruple anti-Helicobacter pylori treatment regimen containing minocycline and metronidazole.

METHODS: In this randomized controlled trial, 280 patients with H. pylori infection were randomly placed into one of two treatment groups—the conventional treatment group and the vitamin B6 supplement treatment group—for 2 weeks. The primary endpoint was the total incidence of adverse reactions up to 2 weeks after treatment initiation. The study was designed according to CONSORT Medicinal Interventions. And it was registered with the Chinese Clinical Trial Registry under the name ChiCTR2100053833.

RESULTS: In terms of efficacy, vitamin B6 does not affect the efficacy of conventional regimen. In the vitamin B6 supplement treatment group, the incidence of adverse reactions was 56.92%, which was significantly lower than the 74.62% observed in the conventional treatment group. In addition, the severity of adverse reactions was also significantly reduced. The proportion of moderate to severe central nervous system symptoms decreased from 58.7 to 14.63%. And, the proportion of moderate to severe gastrointestinal reactions decreased from 33.33 to 0%. We speculate that the mechanism of vitamin B6 of reducing adverse reactions may be related to the production of GABA in the brain.

CONCLUSIONS: Vitamin B6 can alleviate adverse reactions of the quadruple anti-H. pylori regimen containing minocycline and metronidazole.

Cui, MY, et al. Can vitamin B6 alleviate the adverse reactions of quadruple anti-Helicobacter pylori regimen? : randomized controlled trial. BMC Infect Dis. 2023; 23: 590. Published online 2023 Sep 11. doi: 10.1186/s12879-023-08571-8

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6. Reconstituted Freeze-Dried Grape Powder Appears to Prevent Metabolic Decline of the Brain in Patients with Mild Cognitive Decline

INTRODUCTION: We recently reported that grape consumption over one year in a prospective, randomized, double-blind placebo-controlled study of people experiencing cognitive decline preserves metabolism in brain regions important to cognitive function (J Nucl Med. 2022;63:Supp). We now describe the long-term impact of one year of grape consumption on regional brain metabolism and associated neuropsychological status during multiple years of long-term follow-up.

METHODS: Twenty subjects (74.6±5.38 years, mean±SD; 55% male) were randomized into two groups to consume an active grape formulation (36 g reconstituted freeze-dried grape powder) or placebo formulation (matched for sweetness and appearance but free of polyphenols) twice daily for one year. Changes in brain metabolism occurring with each regimen were assessed by brain PET scans with the radiotracer [F-18] fluorodeoxyglucose (FDG) at times of initial evaluation, 1 year after initiating consumption of grape or placebo formulation, and then again 2 to 3 years after completing the one-year period of consuming the randomized regimen in half of the subjects on each arm; cognitive performance was measured through neuropsychological assessments performed at baseline, after 6, and 12 months on their randomized regimen, and at the end of follow-up, with all subjects remaining blinded to which regimen they had been assigned until after final assessments.

Activities in 47 standardized volumes of interest (sVOI) were measured for each PET scan. Voxel-based analyses using statistical parametric mapping were also conducted. Levels of activity at baseline, at the conclusion of being on regimen, and then in the years after being off regimen, were quantified for each subject in each arm.

Associations were examined between interval changes in metabolism and interval changes in neuropsychological status. Results were statistically assessed by one-tailed paired t-tests to examine regional metabolic declines within each arm, and by unpaired two-tailed t-tests to examine the significance of differences between arms, for each interval.

RESULTS: During the year while consuming the randomized regimen, subjects randomized to placebo underwent their most significant metabolic declines in right posterior medial temporal (p=0.006) and inferior frontal (p=0.004) areas, correlating with neuropsychological decline, and they also lost metabolism (p<0.05) in 25 additional sVOI’s, while no significant decline in metabolism occurred in any of the 47 sVOI’s in the active formulation group during this interval.

Voxel-based analyses corroborated this differential metabolic decline in placebo and active formulation groups, and direct difference-of-differences analyses further documented significantly more decline in the placebo than active group in these sVOI’s, bilaterally (left and right medial temporal, p=0.015 and p=0.018; left and right inferior frontal, p=0.028 and p=0.019). Moreover, a significant difference in regional metabolism persisted at the end of follow-up, after having discontinued randomized formulations for 28.1±5.7 months (40.0±5.4 after baseline), with the mean medial temporal sVOI’s demonstrating significant decline in the group that had been randomized to placebo (-4.6%, p=0.009), but not in the group that had been in the active arm (-1.5%, N.S.), a difference between arms that was again significant in direct difference-of-differences analysis.

CONCLUSIONS: In brain regions that decline in the early stages of neurodegenerative processes leading to dementia and correlating with neuropsychological decline, subjects with mild cognitive deficits who were randomized to consume reconstituted grapes twice daily enjoyed long-term protection from longitudinal loss of metabolism compared with subjects randomized to placebo, as assessed more than two years beyond the last consumed dose of either formulation.

Lu Josephine, et al. Prospective Randomized Placebo-Controlled Trial of Long-Term Durability of Effect of One Year of Grape Consumption on Stabilizing Brain Metabolism in Patients with Mild Decline in Cognition. Journal of Nuclear Medicine Jun 2023, 64 (supplement 1) P1270;

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7. Vitamin D Deficiency or Insufficiency May be Associated with and Increased Risk of Atrial Fibrillation

BACKGROUND: Since the association of vitamin D with atrial fibrillation (AF) risk is still unclear, we conducted this updated meta-analysis of prospective studies to identify the relationship between vitamin D or vitamin D supplementation and AF in the general population.

METHODS: We conducted a comprehensive search of multiple databases up to May 2023 for studies reporting vitamin D and AF. The hazard ratios (HRs) with 95% confidence intervals (CIs) were pooled by a random-effects model.

RESULTS: A total of seven studies were included in this meta-analysis. Vitamin D deficiency (<20 ng/ml) was associated with increased AF incidence (HR: 1.12, 95% CI: 1.005-1.25). The HR was not significant with vitamin D insufficiency (20-30 ng/ml; HR: 1.09, 95% CI: 0.98-1.21). Each 10 ng/ml increase in serum vitamin D was associated with a significantly decreased AF incidence (HR: 0.95, 95% CI: 0.93-0.97). Two studies reported the effect of vitamin D supplements on AF incidence but reached inconsistent results.

CONCLUSIONS: Vitamin D deficiency or insufficiency was associated with an increased risk of AF in the general population. The role of vitamin D supplementation in AF prevention needs further investigation.

Ding XL, et al. Vitamin D, vitamin D supplementation and atrial fibrillation risk in the general population: updated systematic review and meta-analysis of prospective studies. Front Nutr. 2023 Sep 21:10:1246359. doi: 10.3389/fnut.2023. 1246359. eCollection 2023. 

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8. Black Cumin Extract and Vitamin D May Improve COVID-19 Clinical Outcomes When Added to Standard Therapy

BACKGROUND: The coronavirus disease 2019 (COVID-19) is a novel coronavirus that causes severe infection in the respiratory system. Since the immune status plays an essential role in combating COVID-19, herbal medicines, which have an immunomodulatory effect, may help prevent and even treat COVID-19. Nigella sativa is one of the herbal medicines with antiviral and immunomodulatory activities, and its therapeutic effectiveness makes it a promising add-on therapy for COVID-19. In addition, vitamin D3 has an immunomodulatory role, but the effect of therapeutic vitamin D3 supplementation in SARS-CoV-2 infection is still not well-known.

Objective: This study aims to investigate the effects of Nigella sativa and vitamin D3 as single supplemental therapies and in combination on viral clearance indicated by a negative polymerase chain reaction and the alleviation of symptoms during the study follow-up duration of 14 days.

PATIENTS AND METHODS: The study design was an open-label randomized controlled clinical trial conducted at the Respiratory Hospital at the Kobry El Qobba Armed Forces Medical Complex.

In total, 120 COVID-19 patients with mild to moderate symptoms were randomly assigned to four groups, with thirty patients each as follows:

  • Group 1 received an oral dose of 900 mg Nigella sativa through 450 mg soft gelatin capsules twice daily for two weeks;
  • Group 2 received 2,000 IU of vitamin D3 through 1000-IU tablets given as two tablets, once daily;
  • Group 3 received 900 mg of Nigella sativa and 2,000 IU of vitamin D3 in the same manner of dosing as in the previous groups;
  • Group 4 was the control group. All groups received standard therapy for COVID-19 infections and clinical management of COVID-19’s clinical symptoms.

RESULTS: The Nigella sativa–vitamin D3 combination in addition to the standard therapy for COVID-19 infections significantly contributed to the alleviation of most COVID-19 symptoms: 50% of patients were free of cough after 7 days, 70% showed an absence of fatigue after 4 days, 80% had no headache after 5 days, 90% were free of rhinorrhea after 7 days, and 86.7% of the patients had no dyspnea after 7 days. Moreover, patients in the four studied groups showed a reduced median temperature after 3 days of treatment. Negative results of the polymerase chain reaction (PCR) test recorded on the 7th and 14th day of therapy were superior in the Nigella sativa and vitamin D3 combination arm compared to those of the other studied arms where the value of the odds ratio (OR) on the 7th day was 0.13 with 95% CI: 0.03–0.45 and that of the 14th day was 0.09 with 95% CI: 0.02–0.3.

CONCLUSION: The results of this study showed a promising therapeutic benefit of the administration of Nigella sativa and vitamin D3 combination in COVID-19 patients with mild to moderate symptoms. Additionally, the remarkable viral clearance in a short time interval and reduction in the severity and progression of symptoms recommended the use of this combination as an add-on therapy for the management of COVID-19 patients.

Said SA, et al. The effect of Ni gella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial. Front Pharmacol. 2022; 13: 1011522. Published online 2022 Nov 8. doi: 10.3389/fphar.

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9. Female Patients Drinking Daily Juice of Fresh Beetroot, Watermelon and Ginger Have a Higher Pregnancy Rate After ICSI Cycles

OBJECTIVE: To prove the hypothesis that beetroot, watermelon and ginger juice supplementation improves the endometrial receptivity and clinical outcomes of intracytoplasmic sperm injection (ICSI) cycles.

METHODS: This prospective randomized study enrolled 436 female patients undergoing ICSI cycles from January/2018 to June/2021, in a private university-affiliated IVF center. Female patients were randomized in a 1:3 ratio to either Control (n=109) or Supplementation Group (n=327). All patients received nutritional orientation before the beginning of the treatment.

Participants in the Supplementation Group were instructed to intake a daily dose of homemade juice, prepared with fresh beetroot, watermelon and ginger, from the day of embryo transfer until the day of pregnancy test, while patients in the Control Group did not follow the juice protocol. Generalized Linear Models, adjusted for potential confounders (female age, body mass index – BMI, endometrial thickness upon embryo transfer, and number of transferred embryos), followed by Bonferroni post hoc test for the comparison of means between groups, were used to investigate the impact of juice supplementation on the clinical outcomes of ICSI.

RESULTS: Patients and cycles characteristics were equally distributed among Supplementation and Control groups. Implantation rate (25.2% vs. 20.5%, p<0.001) and clinical pregnancy rate (41.0% vs. 22.0%, p=0.039) were significantly higher in the Supplementation compared to the Control group.

CONCLUSIONS: The use of beetroot, watermelon and ginger juice may be considered a promising strategy for improving clinical outcomes in assisted reproductive technology (ART), without any side effects.

Halpern G, et al. Beetroot, watermelon and ginger juice supplementation may increase the clinical outcomes of Intracytoplasmic Sperm Injection cycles. JBRA Assist Reprod. 2023 Sep 12;27(3):490-495. doi: 10.5935/1518-0557.20230012.

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10. Curcumin Capsules May Work as Well as Proton Pump Inhibitors in Relieving Functional Dyspepsia

OBJECTIVE: To compare the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.

DESIGN: Randomised, double blind controlled trial, with central randomisation.

SETTING: Thai traditional medicine hospital, district hospital, and university hospitals in Thailand.

PARTICIPANTS: Participants with a diagnosis of functional dyspepsia.

INTERVENTIONS: The interventions were curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.

MAIN OUTCOME MEASURES: Functional dyspepsia symptoms on days 28 and 56 were assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.

RESULTS: 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (-4.83, -5.46 and -6.22), non-pain (-2.22, -2.32 and -2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (-7.19, -8.07 and -8.85), non-pain (-4.09, -4.12 and -3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.

CONCLUSION: Curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.

Kongkam P, et al. Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial. BMJ Evid Based Med. 2023 Sep 11:bmjebm-2022-112231.doi: 10.1136/bmjebm-2022-112231. Online ahead of print.

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11. Patients with Chronic Conditions Unresponsive to Conventional Treatments May Benefit from Medical Cannabis Prescription

AIMS: Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal cannabis. We hypothesized that all patient-reported outcomes (PROs) would improve from baseline to 3-months.

METHODS: The QUEST Initiative is a large prospective multicenter study of patients with any chronic health condition newly prescribed medicinal cannabis between November 2020 and December 2021. Eligible patients were identified by 120 clinicians at medical centers across six Australian states. Consenting participants completed the EuroQol Group EQ-5D-5L health status questionnaire; European Organization for Research & Treatment of Cancer Quality of Life questionnaire (QLQ-C30); Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms in Fatigue and Sleep Disturbance, and the Depression Anxiety Stress Scale (DASS-21) before starting therapy, at 2-weeks titration, then monthly for 3-months.

RESULTS: Of the 2762 consenting participants, 2327 completed baseline and at least one follow-up questionnaire. Ages ranged between 18-97 years (mean 51y; SD = 15.4), 62.8% were female. The most commonly treated conditions were chronic pain (n = 1598/2327; 68.7%), insomnia (n = 534/2327; 22.9%), generalized anxiety (n = 508/2327; 21.5%), and mixed anxiety and depression (n = 259/2327; 11%). Across the whole cohort both EQ-5D-5L utility scores and QLQ-C30 summary scores showed clinically meaningful improvement in HRQL from baseline to mean follow-up with d = 0.54 (95%CI:0.47 to 0.59) and d = 0.64 (95%CI:0.58 to 0.70) respectively; and clinically meaningful improvement in fatigue (d = 0.54; 95%CI:0.48 to 0.59). There was clinically meaningful reduction of pain for those with chronic pain (d = 0.65; 95%CI:0.57 to 0.72); significant improvements for those with moderate to extremely severe anxiety (X2 = 383; df = 4; p<0.001) and depression (X2 = 395; df = 4; p<0.001); and no changes in sleep disturbance.

CONCLUSIONS: We observed statistically significant, clinically meaningful improvements in overall HRQL and fatigue over the first 3-months in patients with chronic health conditions accessing prescribed medical cannabis. Anxiety, depression, and pain also improved over time, particularly for those with corresponding health conditions. The study continues to follow-up patients until 12-months to determine whether improvements in PROs are maintained long-term.

Tait MA, et al. Health-related quality of life in patients accessing medicinal cannabis in Australia: The QUEST initiative results of a 3-month follow-up observational study. PLoS One. 2023 Sep 6;18(9):e0290549. doi: 10.1371/journal.pone.0290549. eCollection 2023.

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12. Could Korean Red Ginseng Increase and Maintain COVID-19 Vaccine Response? Maybe Applicable in Other Vaccines?

BACKGROUND: Despite the effectiveness and safety of COVID-19 vaccines, vaccine-induced responses decline over time; thus, booster vaccines have been approved globally. In addition, interest in natural compounds capable of improving host immunity has increased. This study aimed to examine the effect of Korean Red Ginseng (KRG) on virus-specific antibodies after COVID-19 vaccination. We conducted a 24 week clinical pilot study of 350 healthy subjects who received two doses of the COVID-19 vaccine and a booster vaccination (third dose).

These subjects were randomized 1:2 to the KRG and control groups. We evaluated antibody response five times: just before the second dose (baseline), 2 weeks, 4 weeks, 12 weeks after the second dose, and 4 weeks after the third dose. The primary endpoints were changes in COVID-19 spike antibody titers and neutralizing antibody titers. The antibody formation rate of the KRG group was sustained higher than that of the control group for 12 weeks after the second dose. This trend was prominently observed in those above 50 years old. We found that KRG can help to increase and maintain vaccine response, highlighting that KRG could potentially be used as an immunomodulator with COVID-19 vaccines.

Yoon JH, et al. Korean Red Ginseng Potentially Improves Maintaining Antibodies after COVID-19 Vaccination: A 24-Week Longitudinal Study. Nutrients. 2023 Mar 24;15(7):1584. doi: 10.3390/nu15071584.

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