As a naturopath, patients often ask me questions like “Do you think I should I take this treatment I heard about?”
Here are some of the things I consider when I try to answer such questions for an individual patients:
When a patient comes to me and asks me about an experimental, FDA approved conventional or alternative medicine treatment I do my best to research the answers to the questions listed below. And after the research, I do my best to give a thorough and thoroughly understandable explanation of the risks and benefits of any treatment. Then I ask the patient what their gut tells them about the treatment. This is very important information and should never be ignored when deciding on a new treatment. Understanding is key to tapping into the internal wisdom that is so important for deciding whether or not to take a treatment.
- How many other treatments exist for that condition?
a. How effective are those treatments?
b. What is the potential for harm with those other treatments?
- How impairing is that condition? Is it life threatening, extremely painful, debilitating, or only embarrassing or inconvenient?
- Are there potential for harms?
a. Has anyone been harmed?
b. What is the likelihood for harm? How long has this drug or new treatment been out on the market?
c. Is the treatment expensive or difficult?
- What it that treatment’s mechanism of action?
- Is this mechanism plausible? How likely is it that it could occur?
- What is known about the treatment from its use in traditional cultures or indigenous cultural practices of consuming or taking the food or remedy?
a. Has the food or treatment been used for thousands of years without noticeably negative consequences?
b. Is it a new substance or process that has no historical track record of use?
- Is there any scientific evidence of benefit or harm?
- Is the only evidence anecdotal?
- Have any studies been done? And who founded those studies?
- What type(s) of studies have been performed using this treatment or modality? What is the level of evidence?
a. Case reports (anecdotal)
b. Cohort, population (correlational) studies- how generalizable are the results used in cohort to that patient? And all the below items.
c. RCTs or randomized controlled trials
i. How many patients or persons used in the study? This speaks to statistical power (ability of the study to find a reliable result)
ii. Was there any blinding or a placebo used?
iii. End-points and surrogate markers used-Were the study’s end-points reliable predictors of the practical outcomes in question?
iv. How well did the study control confounders?
v. What do the numbers look like?
What do the confidence intervals look like? What is the magnitude of effect?
What are the numbers needed to treat?
Are the results clinically meaningful?
Is there a dose-response or any trends with increasing exposure to the intervention or treatment?
Do the confidence intervals include the results?
Are the confidence intervals wide or narrow?
What is the level of statistical significance?
Where any statistical tricks used to make the results look clinically relevant when they are not that impressive?
Do the researcher’s conclusions match the numbers seen in the results?
vi. Potential conflicts of interest- who funded the study? Do they have any interest in the outcome in the sense that they could stand to benefit financially from a favorable outcome.
- Is the study a review, a systematic review, a meta-analysis or a combined study?
a. What types of studies were used in the review or meta-analysis
i. Correlational studies
b. What is the combined or “N” number of study participants (total number of persons from all the studies included in the review or meta-analysis)
- If it is a drug treatment, has the drug been out on the market long enough to know its safety record? Rare side-effects cannot be known from clinical trials of 1-3,000 people which typically are done over a relatively short period of time. Studies can be designed in such a way as to exclude common side-effects by for example, stopping the study before side-effects would show up and excluding certain study subjects who would be more likely to get the side-effects. Even when side-effects are known they may be omitted at publication. The Health Research Group, an independent consumer watch-dog organization with a 30 year history of reporting on drug safety issues, recommends waiting 7 years before taking a new drug if a substitute is unavailable.
Often, any available answers to these questions are not in a language that anyone can understand. And without an understanding of both the questions and the answers a person does not have an adequate basis for evaluating the relative desirability of a treatment he or she is considering.
This list can be printed and taken to your own physician or healthcare provider. You could then ask your healthcare provider to give you answers to these questions. You can ask the sources of their information so you can determine if there are any conflicts of interest in those sources including sources from a drug manufacturer. You can find out if they are using the above criteria upon which to evaluate new treatments, and if not using these criteria, you could ask them upon what basis is it that they are providing you with treatment recommendations. Their answers may be revealing to you.