https://restorativemedicine.org/wp-content/uploads/2017/01/4Holtorf_-Lyme-CFS.pdf (Slides Found in link)
Kent Holtorf, M.D.
Holtorf Medical Group National Academy of Hypothyroidism Kholt@holtorfmed.com
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD006095.pub4/abstract
Antibiotics can disturb gastrointestinal microbiota which may lead to reduced resistance to pathogens such as Clostridium difficile (C. difficile). Probiotics are live microbial preparations that, when administered in adequate amounts, may confer a health benefit to the host, and are a potential C. difficile prevention strategy. Recent clinical practice guidelines do not recommend probiotic prophylaxis, even though probiotics have the highest quality evidence among cited prophylactic therapies.
To assess the efficacy and safety of probiotics for preventing C.difficile‐associated diarrhea (CDAD) in adults and children.
We searched PubMed, EMBASE, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 21 March 2017. Additionally, we conducted an extensive grey literature search.
Randomized controlled (placebo, alternative prophylaxis, or no treatment control) trials investigating probiotics (any strain, any dose) for prevention of CDAD, or C. difficile infection were considered for inclusion.
Two authors (independently and in duplicate) extracted data and assessed risk of bias. The primary outcome was the incidence of CDAD. Secondary outcomes included detection of C. difficile infection in stool, adverse events, antibiotic‐associated diarrhea (AAD) and length of hospital stay. Dichotomous outcomes (e.g. incidence of CDAD) were pooled using a random‐effects model to calculate the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. Continuous outcomes (e.g. length of hospital stay) were pooled using a random‐effects model to calculate the mean difference and corresponding 95% CI. Sensitivity analyses were conducted to explore the impact of missing data on efficacy and safety outcomes. For the sensitivity analyses, we assumed that the event rate for those participants in the control group who had missing data was the same as the event rate for those participants in the control group who were successfully followed. For the probiotic group, we calculated effects using the following assumed ratios of event rates in those with missing data in comparison to those successfully followed: 1.5:1, 2:1, 3:1, and 5:1. To explore possible explanations for heterogeneity, a priori subgroup analyses were conducted on probiotic species, dose, adult versus pediatric population, and risk of bias as well as a post hoc subgroup analysis on baseline risk of CDAD (low 0% to 2%; moderate 3% to 5%; high > 5%). The overall quality of the evidence supporting each outcome was independently assessed using the GRADE criteria.
Thirty‐nine studies (9955 participants) met the eligibility requirements for our review. Overall, 27 studies were rated as either high or unclear risk of bias. A complete case analysis (i.e. participants who completed the study) among trials investigating CDAD (31 trials, 8672 participants) suggests that probiotics reduce the risk of CDAD by 60%. The incidence of CDAD was 1.5% (70/4525) in the probiotic group compared to 4.0% (164/4147) in the placebo or no treatment control group (RR 0.40, 95% CI 0.30 to 0.52; GRADE = moderate). Twenty‐two of 31 trials had missing CDAD data ranging from 2% to 45%. Our complete case CDAD results proved robust to sensitivity analyses of plausible and worst‐plausible assumptions regarding missing outcome data and results were similar whether considering subgroups of trials in adults versus children, inpatients versus outpatients, different probiotic species, lower versus higher doses of probiotics, or studies at high versus low risk of bias. However, in a post hoc analysis, we did observe a subgroup effect with respect to baseline risk of developing CDAD. Trials with a baseline CDAD risk of 0% to 2% and 3% to 5% did not show any difference in risk but trials enrolling participants with a baseline risk of > 5% for developing CDAD demonstrated a large 70% risk reduction (interaction P value = 0.01). Among studies with a baseline risk > 5%, the incidence of CDAD in the probiotic group was 3.1% (43/1370) compared to 11.6% (126/1084) in the control group (13 trials, 2454 participants; RR 0.30, 95% CI 0.21 to 0.42; GRADE = moderate). With respect to detection of C. difficile in the stool pooled complete case results from 15 trials (1214 participants) did not show a reduction in infection rates. C. difficile infection was 15.5% (98/633) in the probiotics group compared to 17.0% (99/581) in the placebo or no treatment control group (RR 0.86, 95% CI 0.67 to 1.10; GRADE = moderate). Adverse events were assessed in 32 studies (8305 participants) and our pooled complete case analysis indicates probiotics reduce the risk of adverse events by 17% (RR 0.83, 95% CI 0.71 to 0.97; GRADE = very low). In both treatment and control groups the most common adverse events included abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance.
Based on this systematic review and meta‐analysis of 31 randomized controlled trials including 8672 patients, moderate certainty evidence suggests that probiotics are effective for preventing CDAD (NNTB = 42 patients, 95% CI 32 to 58). Our post hoc subgroup analyses to explore heterogeneity indicated that probiotics are effective among trials with a CDAD baseline risk >5% (NNTB = 12; moderate certainty evidence), but not among trials with a baseline risk ≤5% (low to moderate certainty evidence). Although adverse effects were reported among 32 included trials, there were more adverse events among patients in the control groups. The short‐term use of probiotics appears to be safe and effective when used along with antibiotics in patients who are not immunocompromised or severely debilitated. Despite the need for further research, hospitalized patients, particularly those at high risk of CDAD, should be informed of the potential benefits and harms of probiotics.
What is Clostridium difficile‐associated diarrhea?
Antibiotics are among the most prescribed medications worldwide. Antibiotic treatment may disturb the balance of organisms that normally populate the gut. This can result in a range of symptoms, most notably, diarrhea. Clostridium difficile (C. difficile) is a particularly dangerous organism that may colonize the gut if the normal healthy balance has been disturbed. Clostridium difficile‐related disease varies from asymptomatic infection, diarrhea, colitis, and pseudo‐membranous colitis to toxic megacolon and death. The cost of treatment is expensive and the financial burden on the medical system is substantial.
What are probiotics?
Probiotics are live organisms (bacteria or yeast) thought to improve the balance of organisms that populate the gut, counteracting potential disturbances to the gut microbial balance that are associated with antibiotic use, and reducing the risk of colonization by pathogenic bacteria. Probiotics can be found in dietary supplements or yogurts and are becoming increasingly available as capsules sold in health food stores and supermarkets. As ‘functional food’ or ‘good bacteria’, probiotics have been suggested as a means of both preventing and treating C. difficile‐associated diarrhea (CDAD).
What did the researchers investigate?
The researchers investigated whether probiotics prevent CDAD in adults and children receiving antibiotic therapy and whether probiotics causes any harms (side effects). The researchers searched the medical literature extensively up to 21 March 2017.
What did the researchers find?
This review includes 39 randomized trials with a total of 9955 participants. Thirty‐one studies (8672 participants) assessed the effectiveness of probiotics for preventing CDAD among participants taking antibiotics. Our results suggest that when probiotics are given with antibiotics the risk of developing CDAD is reduced by 60% on average. Among trials enrolling participants at high risk of developing CDAD (> 5%), the potential benefit of probiotics is more pronounced with a 70% risk reduction on average. Side effects were assessed in 32 studies (8305 participants) and our results suggest that taking probiotics does not increase the risk of developing side effects. The most common side effects reported in these studies include abdominal cramping, nausea, fever, soft stools, flatulence, and taste disturbance. The short‐term use of probiotics appears to be safe and effective when used along with antibiotics in patients who are not immunocompromised or severely debilitated. Despite the need for further research, hospitalized patients, particularly those at high risk of CDAD, should be informed of the potential benefits and harms of probiotics.
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https://www.womensinternational.com/how-do-hormones-affect-the-heart/
“How does hormone supplementation affect the heart?” This is a question that our pharmacists hear regularly. Much like the poor, maligned egg in the cardio-healthy diet, hormones have fallen in and out of favor with regard to their effect on the cardiovascular system over the years.
Although a number of studies examine hormonal effects on the cardiovascular system, these studies rarely distinguish between bioidentical and synthetic hormones. However, one study by Dr. Ferdinand Roefsena, Rebecca J. Yang, and Dr. Johannes Veldhuis looked specifically at the bioidentical hormones, estradiol, and progesterone, publishing their results in the Journal of the Endocrine Society. Let’s see what they found!
Forty healthy postmenopausal women, ages 50-80, participated in the study. The women were divided into four treatment groups:
After 23 days of using these therapies, the women’s blood was drawn and the researchers measured various markers.
Because the study was only 23 days long, Dr. Roefsena et al. were unable to evaluate primary endpoints,such as heart attacks or strokes. Instead, they looked at various markers in the blood that have been associated with physical outcomes such as heart disease, stroke, and diabetes. The researchers looked at many significant markers, including:
With the exception of HDL-C and adiponectin, for which higher levels appear beneficial, decreased levels of the other markers listed above are generally considered favorable, according to the American Heart Association.
When compared to women who weren’t using any hormone therapies:
As the researchers expected, the women using bioidentical estradiol exhibited improved cholesterol levels (including decreased LDL-C and increased HDL-C). Even though the bioidentical progesterone was associated with reduced HDL-C levels, it allowed the positive effects of bioidentical estradiol on the other cholesterol levels to remain. Synthetic progestins have been seen to reduce the positive effects of bioidentical estradiol on cholesterol levels, as evidenced by the studies discussed in Holtorf’s article. These findings suggest that bioidentical hormones may be preferable to synthetic.
This study is not without its flaws, such as its short length and small group size. Its short length made it necessary to evaluate markers rather than primary endpoints, and the data was further limited by comparing the groups to each rather than evaluating the differences between the beginning and ending measurements. The patients in the bioidentical estradiol groups were treated with injectable bioidentical estradiol—a form which is rarely used in clinical practice—and used two doses ten days apart as opposed to the usual two- to four-week intervals.
Despite this study’s shortcomings, when we combine its results with information obtained in other studies, we see that bioidentical progesterone doesn’t appear to interfere with the positive effects estrogen has on cholesterol levels. By contrast, other studies have suggested that synthetic progestins do negate these effects. And this makes perfect sense! Why would we assume that a molecule that is similar, but not identical to what the body makes, should have the same effect in the body as a molecule that is identical to what the body makes?
Due to our differences as individuals, no study is perfect. Therefore, the question of whether hormones are good for your heart may never be answered definitively because the answer may differ from person to person. Through studies like that by Dr. Roefsena et al. and others, however, one thing is becoming clear: the difference between bioidentical and synthetic hormones may prove a significant factor in whether hormones are beneficial to the heart.
Women’s International Pharmacy has several other articles focused on how hormones affect heart health. Check them out at our Heart Health Resources page!
© 2019 Women’s International Pharmacy
Reviewed by Carol Petersen, RPh, CNP; Women’s International Pharmacy
Madison Area Lyme Support Group 