Melatonin for Insomnia

sleep, sleeping, girl, young woman
Dr. Emily Deans says if you need an alarm clock to wake up, you’re probably not getting enough sleep

I often get pages from hospital nurses regarding a patient’s request for a sleeping pill. (Or is the request really from the nurse because a sleeping patient is less hassle? LOL.) My hospital’s formulary limits me to ambien, restoril, trazodone, benadryl, and melatonin. Of those, melatonin seems to be the safest. But does it work?

Dr Harriet Hall over at SBM writes this:

The evidence is mixed and weak. There is some positive evidence for melatonin, and side effects are mild. I wouldn’t discourage anyone who wants to give it a try, but I think good sleep hygiene measures would be a better first step for treating insomnia.

Furthermore…

The optimum dosage has not been established. In studies, the doses have ranged from 1 to 12 mg. Supplements typically contain 1-3 mg. Dosages between 1 and 10 mg can raise melatonin levels to 3-60 times the levels normally found in the body.

Caution is advisable, since quality control is a documented problem. 71% of products did not contain within 10% of the labelled amount of melatonin, with variations ranging from -83% to +478%, lot-to-lot variability was as high as 465%, and the discrepancies were not correlated to any manufacturer or product type. To make matters worse, 8 out of 31 products were contaminated with the neurotransmitter serotonin.

If melatonin works by placebo effect alone, it will help ~10% of users, almost always without adverse effects. I dose it at 1.5 mg, with a repeat dose an hour later if needed.

Steve Parker, M.D.

Snapshot of the Swiss Healthcare System

Switzerland?
<p class="has-drop-cap" value="<amp-fit-text layout="fixed-height" min-font-size="6" max-font-size="72" height="80"><span class="has-inline-color has-black-color">The Swiss have the U.S. beat in terms of longevity and percentage of gross domestic product devoted to healthcare. Their healthcare system may or may not have something to do with it.</span> Switzerland, which has twice as many square miles as New Jersy, only has 8,700,000 people compared to the 331,000,000 in the U.S. The Swiss have the U.S. beat in terms of longevity and percentage of gross domestic product devoted to healthcare. Their healthcare system may or may not have something to do with it. Switzerland, which has twice as many square miles as New Jersy, only has 8,700,000 people compared to the 331,000,000 in the U.S.

From Health Systems in Transition:

Abstract

This analysis of the Swiss health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. The Swiss health system is highly complex, combining aspects of managed competition and corporatism (the integration of interest groups in the policy process) in a decentralized regulatory framework shaped by the influences of direct democracy. The health system performs very well with regard to a broad range of indicators. Life expectancy in Switzerland (82.8 years) is the highest in Europe after Iceland, and healthy life expectancy is several years above the European Union (EU) average. Coverage is ensured through mandatory health insurance (MHI), with subsidies for people on low incomes. The system offers a high degree of choice and direct access to all levels of care with virtually no waiting times, though managed care type insurance plans that include gatekeeping restrictions are becoming increasingly important. Public satisfaction with the system is high and quality is generally viewed to be good or very good. Reforms since the year 2000 have improved the MHI system, changed the financing of hospitals, strengthened regulations in the area of pharmaceuticals and the control of epidemics, and harmonized regulation of human resources across the country. In addition, there has been a slow (and not always linear) process towards more centralization of national health policy-making. Nevertheless, a number of challenges remain. The costs of the health care system are well above the EU average, in particular in absolute terms but also as a percentage of gross domestic product (GDP) (11.5%). MHI premiums have increased more quickly than incomes since 2003. By European standards, the share of out-of-pocket payments is exceptionally high at 26% of total health expenditure (compared to the EU average of 16%). Low and middle-income households contribute a greater share of their income to the financing of the health system than higher-income households. Flawed financial incentives exist at different levels of the health system, potentially distorting the allocation of resources to different providers. Furthermore, the system remains highly fragmented as regards both organization and planning as well as health care provision.

I wonder if we should adopt some of their system’s attributes.

Steve Parker, M.D.

Does Remdesivir Help Fight COVID-19?

intubation, mechanical ventilation, ventilator
Intubated to prevent death

Remdesivir and hydroxychloroquine don’t do much good for hospitalized COVID-19 patients, according to this abstract of the SOLIDARITY trial:

BACKGROUND

World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19).

METHODS

We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.

RESULTS

At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.

CONCLUSIONS

These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.

Steve Parker, M.D.

From the UK: More COVID-19 Vaccine Skepticism

face mask, elderly, worried
Very few, if any, vaccine trial participants were elderly and carrying major co-morbidities

UK Medical Freedom Alliance has published a white paper on the new vaccines:

The morbidity and mortality impact on public health from SARS-CoV-2 must be balanced with the risks and costs of a vaccine roll-out. We have shown that the mortality and morbidity from SARS-CoV-2 is no longer an existential threat to society.

It is a huge responsibility to roll out a vaccine manufactured with novel technology. To do so with the intention that all 60+ million people in the UK should receive the vaccine as soon as possible, without full transparency as to potential risks, may be viewed as irresponsible, potentially even negligent, from a legal standpoint. We urge you to heed the wisdom in the Hippocratic Oath: “First, do no harm“.

The only alliance team member I’ve heard of is Dr Malcolm Kendrick. I’m sure none of them have ever heard of me.

I haven’t decided what I’ll tell my my mother if she asks me if she should take the vaccine soon. She’s 89 years old and readily admits she’s ready to go to Heaven. What has she got to lose? I’ll back her choice either way.

Steve Parker, M.D.

Feds Blame Walmart for Contributing to Opioid Crisis

Photo by freestocks.org on Pexels.com

From New4Nashville:

The Justice Department alleges Walmart violated federal law by selling thousands of prescriptions for controlled substances that its pharmacists “knew were invalid,” said Jeffrey Clark, the acting assistant attorney general in charge of the Justice Department’s civil division.

Federal law required Walmart to spot suspicious orders for controlled substances and report those to the Drug Enforcement Administration, but prosecutors charge the company didn’t do that. 

This could get interesting. Questions immediately arise:

  • Are the Feds trying to deflect blame from themselves?
  • Did Walmart fail to make adequate political contributions and/or bribes?
  • Pharmacists, not pharmacies, are supposed to be on the lookout for illegitimate prescriptions. Where do they stand in this?
  • Will the customers or “patients” be let off the hook?
  • Is this just a bold career move by a stagnant Justice Department bureaucrat?
  • Are the Feds trying to extort Walmart to help reduce the federal deficit?

Are you addicted to opioids and want to tape off and quit? Click for one method.

Steve Parker, M.D.

h/t Knuckledraggin My Life Away

h/t Knuckledraggin My Life Away

Blood Pressure Lowering Barely Lowered the Incidence of Dementia in New Meta-Analysis

dementia, memory loss, Mediterranean diet, low-carb diet, glycemic index, dementia memory loss
“C’mon now! Let’s go Mediterranean before it’s too late.”

I haven’t read the entire article below and probably won’t ever. It will be used to promote treatment of mild to moderate hypertension in order to prevent dementia, despite cost and drug side effects. Results are distinctly unimpressive. Four years of drug therapy reduced the incidence of dementia and cognitive decline by less than 1%.

I was expecting and hoping for a much more significant reduction. Nevertheless, anti-hypertensive drug therapy is pretty well established as an effective preventative for cardiovascular disease, including stroke.

From JAMA Network:

Fourteen randomized clinical trials were eligible for inclusion (96 158 participants), of which 12 reported the incidence of dementia (or composite of dementia and cognitive impairment [3 trials]) on follow-up and were included in the primary meta-analysis, 8 reported cognitive decline, and 8 reported changes in cognitive test scores. The mean (SD) age of trial participants was 69 (5.4) years and 40 617 (42.2%) were women. The mean systolic baseline blood pressure was 154 (14.9) mm Hg and the mean diastolic blood pressure was 83.3 (9.9) mm Hg. The mean duration of follow-up was 49.2 months. Blood pressure lowering with antihypertensive agents compared with control was significantly associated with a reduced risk of dementia or cognitive impairment (12 trials; 92 135 participants) (7.0% vs 7.5% of patients over a mean trial follow-up of 4.1 years; odds ratio [OR], 0.93 [95% CI, 0.88-0.98]; absolute risk reduction, 0.39% [95% CI, 0.09%-0.68%]; I2 = 0.0%) and cognitive decline (8 trials) (20.2% vs 21.1% of participants over a mean trial follow-up of 4.1 years; OR, 0.93 [95% CI, 0.88-0.99]; absolute risk reduction, 0.71% [95% CI, 0.19%-1.2%]; I2 = 36.1%). Blood pressure lowering was not significantly associated with a change in cognitive test scores.

Conclusions and Relevance

In this meta-analysis of randomized clinical trials, blood pressure lowering with antihypertensive agents compared with control was significantly associated with a lower risk of incident dementia or cognitive impairment.

Source: Association of Blood Pressure Lowering With Incident Dementia or Cognitive Impairment: A Systematic Review and Meta-analysis | Dementia and Cognitive Impairment | JAMA | JAMA Network

Steve Parker, M.D.

PS: You know what has been proven to reduce the risk of dementia? The Mediterranean diet!

Should You Consider a “Dry January”?

Goodbye to you. Maybe see you in February.

I’ve run across a number of people who slowly increased their alcohol consumption over months or years, not realizing it was causing or would cause problems for them. Alcohol is dangerous, lethal at times.

From a health standpoint, the generally accepted safe levels of consumption are:

  • no more than one standard drink per day for women
  • no more than two standard drinks per day for men

One drink is 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof distilled spirits (e.g., vodka, whiskey, gin).

Dry January was conceived in the UK in 2012 or 2014. The idea is simply to abstain from all alcohol for the month of January. The Alcohol Change UK website can help you git ‘er done. Many folks notice that they sleep better, have more energy, lose weight, and save money. There are other potential benefits.

If you think you may have an unhealthy relationship with alcohol, check your CAGE score. It’s quick and easy.

Alternatively, if you make a commitment to a Dry January but can’t do it, you may well have a problem.

Steve Parker, M.D.

PS: I did the Dry January in January 2020. The only definite change I saw was that I was more productive. E.g., I blogged more regularly, worked out a bit more. The lesson for me is that alcohol makes me a little lazy. At three weeks in, I started thinking maybe I was able to fall asleep sooner but still woke up often, as usual. I also lost three pounds of body weight fat, but had consciously cut back on food intake.

front cover of Conquer Diabetes and Prediabetes

Click to purchase at Amazon.com. E-book also available at Smashwords.com.

front cover of paleobetic diet

Click to purchase at Amazon.com. E-book also available at Smashwords. com.

Elderly Hospitalized Patients Benefit From Mediterranean Diet

…at least in Greece, where the study was done.

Santorini, Greek seaside

In an observational study of folks over 65 admitted to a hospital, the Mediterranean diet was linked to:

  • Shorter duration of hospitalization
  • Reduced healthcare cost
  • Improved longevity

The study at hand lasted two years.

Click for details of the traditional Mediterranean diet.

Objective:

Mediterranean diet (MD) has been related to reduced overall mortality and improved diseases’ outcome. Purpose of our study was to estimate the impact of MD on duration of admission, financial cost and mortality (from hospitalization up to 24 months afterwards) in elderly, hospitalized patients.

Research Methods & Procedures:

One hundred eighty three elderly patients (aged >65 years), urgently admitted for any cause in the Internal Medicine department of our hospital, participated in this observational study. Duration of admission and its financial cost, mortality (during hospitalization, 6 and 24 months after discharge), physical activity, medical and anthropometric data were recorded and they were correlated with the level of adherence to MD (MedDiet score).

Results:

In multivariate analyses, duration of admission decreased 0.3 days for each unit increase of MedDiet score (p<0.0001), 2.1 days for each 1g/dL increase of albumin (p=0.001) and increased 0.1 days for each day of previous admissions (p<0.0001). Extended hospitalization (p<0.0001) and its interaction with MedDiet score (p=0.01) remained the significant associated variables for financial cost. Mortality risk increased 3% per each year increase of age (HR=1.03, p=0.02), 6% for each previous admission (HR=1.06, p=0.04) whereas it decreased 13% per each unit increase of MedDiet score (HR=0.87, p<0.0001).

Conclusion:

Adoption of MD decreases duration of admission and long-term mortality in elderly hospitalized patients with parallel reduction of relevant financial cost.

Source: The impact of Mediterranean Diet on duration of admission, medical expenses and mortality in elderly, hospitalized patients: A 2-year observational study – ScienceDirect

I haven’t read the entire article. Didn’t see any need, based on my prior knowledge of the Mediterranean diet. The findings are not unexpected.

Steve Parker, M.D.

Ivermectin for COVID-19?

face mask, young woman
Probably at little risk of serious illness if she’s generally healthy

From Diabetes Metab Syndr in Sept 2020:

The clinical efficacy and utility of ivermectin in SARS CoV-2 infected patients are unpredictable at this stage, as we are dealing with a completely novel virus. However, repurposing existing drugs as possible COVID-19 treatment is astute usage of existing resources, and we await results of well-designed large scale randomized controlled clinical trials exploring treatment efficacy of ivermectin to treat SARS-CoV-2.

The authors of this letter mention current clinical trials (~38) with a dose [presumably by mouth] ranging from 200 to 1200 mcg/kg body weight, for a duration of 3–7 days, which is showing promising results both in terms of symptoms as well as viral load reduction. Another article mentioned the usual treatment dose is 0.2mg/kg on day 1 and day 3 followed by Days 6 and 8 if not recovered.

The authors cite the Broward Health hospital system study from South Florida. In this small pilot study, hospitalized patients treated with ivermectin had a better survival rate compared with “standard care,” whatever that was back in Spring 2020. The ivermectin-treated patients received “at least one dose” of the drug at 200 mcg/kg, by mouth. Has this report been peer-reviewed and published yet? If not, why not?

Moving on…

One small study (probably 60 each in the treatment and placebo groups) found that 12 mg ivermectin by mouth once a month impressively protected healthcare workers against COVID-19.

Another study: “Two-dose ivermectin prophylaxis at a dose of 300 μg/kg with a gap of 72 hours was associated 73% reduction of COVID-19 infection among [hospital] healthcare workers for the following one-month. Further research is required before its large scale use.”

After hydroxychloroquine, azithromycin, and ivermectin, will nitazoxanide be the next panacea? You heard it first here!

A small study in Barcelona found no benefit from a single standard dose (200 mcg/kg) of ivermectin in patients hospitalized with severe disease. They suggest that a higher dose might be useful.

I’ve spent about 90 minutes on my day off trying to figure out if I should prescribe ivermectin to my hospitalized patients. My conclusion is that we need more and better data before it’s ready for prime time. I agree with Dr Ananda Swaminathan, who probably spent many hours more on the subject:

Evidence for the use of Ivermectin is based on in vitro [lab studies, not living animals], prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…

Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few

Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format

Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect

Ivermectin is interesting, there is certainly signal to evaluate further, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine

Like they say, “more studies are needed.”

Steve Parker, M.D.

PS: Something you can do to help prevent and survive COVID-19 is to get and stay as healthy as possible. Let me help:

Where Do You Go For Satisfaction After Injury by the New COVID-19 Vaccine?

No, you won’t have to inject the vaccine yourself

I know it’s a little early to be asking that question. Within a year, an unknown number of you will be asking. Where do you go for satisfaction? The “National Vaccine Injury Compensation Program.” Forget about suing the vaccine manufacturer, distributor, or medical practitioner who jabbed you. They got the federal government to absolve them of liability in most cases.

As far as I know, this program only applies to U.S. residents. Perhaps only U.S. citizens.

The following is verbatim from the NVICP web page, not my words:

Vaccines save lives by preventing disease.

Most people who get vaccines have no serious problems. Vaccines, like any medicines, can cause side effects, but most are very rare and very mild. Some health problems that follow vaccinations are not caused by vaccines.

In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction.  

In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement. 

How does the VICP work?

The National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.

It was created in the 1980s, after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which could have caused a resurgence of vaccine preventable diseases.

Any individual, of any age, who received a covered vaccine and believes he or she was injured as a result, can file a petition. Parents, legal guardians and legal representatives can file on behalf of children, disabled adults, and individuals who are deceased.

What is the process?

  1. An individual files a petition with the U.S. Court of Federal Claims.
  2. The U.S. Department of Health and Human Services medical staff reviews the petition, determines if it meets the medical criteria for compensation and makes a preliminary recommendation.
  3. The U.S. Department of Justice develops a report that includes the medical recommendation and legal analysis and submits it to the Court.
  4. The report is presented to a court-appointed special master, who decides whether the petitioner should be compensated, often after holding a hearing in which both parties can present evidence. If compensation is awarded, the special master determines the amount and type of compensation.
  5. The Court orders the U.S. Department of Health and Human Services to award compensation. Even if the petition is dismissed, if certain requirements are met, the Court may order the Department to pay attorneys’ fees and costs. 

The special master’s decision may be appealed and petitioners who reject the decision of the court (or withdraw their petitions within certain timelines) may file a claim in civil court against the vaccine company and/or the health care provider who administered the vaccine.

Parker here again. I’d never heard of a “special master” before. Makes me think you’re a slave when you enter the system. I searched the “covered vaccines” but didn’t see the COVID-19 vaccines. But I bet they’re covered.

Don’t label me as anti-vaccine in general. I am not. As a child I got the vaccines for polio, measles, mumps, rubella, tetanus, and probably diphtheria, maybe others. I took the hepatitis B vaccine as an adult because I’m exposed to blood from my patients. I’m due for another tetanus booster and will take it without reservation.

I’ve got risk factors for more serious COVID-19 disease: age 66 and hypertension. After reviewing what little data are available from the Warp Speed vaccine trials, I’m not convinced the vaccines are safe enough for me. I’ll take my chances with the virus rather than the vaccine. I’m not afraid of dying from COVID-19; if that happens I’ll be in heaven with Jesus. I’ve lived a full and lucky life, blessed by a wonderful wife, fantastic children, good health, missed Viet Nam by a few years, no major economic upheaval. My biggest concern about catching the virus is the burden it would lay on my co-workers if I’m off-duty for 1 to 3 weeks.

That said, if I were older and had other co-morbidities, I might take the vaccine now. When we have more long-term data on vaccine safety, I might take the vaccine. It could take up to a couple years before we have that data.

Steve Parker, M.D.

PS: I’m doing everything I can to optimize my health and immune system, including weight management and regular exercise.

Update on Dec 11, 2020:

Pharmacist Scott Gavura at Science Based Medicine provides a table comparing vaccination vs catching the virus vs hydroxychloroquine treatment. He implies my odds of death from COVID-19 infection are two out of a hundred (2%). I don’t think it’s nearly that high.

Update on Dec 17, 2020:

I’m wrong about the NVICP compensating you financially if injured but the current COVID-19 vaccines. The correct program seems to be the CICP: Countermeasures Injury Compensation Program. File your claim within a year of vaccination.

Click for an interesting article on CICP at the Centre for Research on Globalization. I have no idea of its accuracy.