Should I take this treatment ?

By reading further, you agree to accept Moodchangemedicine.com website’s terms of use, which can be viewed here.

By Joie Meissner ND, BCB

As a naturopath, patients often ask me questions like “Do you think I should I take this treatment I heard about?”

What patients need to know is what are the risks and what are the benefits. But what they might not know is how doctors should be assessing those risk and benefits. The list of questions below provides insight into how a qualified health care provider should be evaluating risk and benefits.

The more patients know about how medical science works, the more they can benefit from the information that their doctors give them about risks versus benefits of various treatments.

These 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. Once they have had a chance to ask me questions and really understand the information, 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. Getting a sense of the science behind a treatment optimizes this process.

Here are a few questions that can help people get a feel for how medical science works:

1. 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?
2. How impairing is that condition? Is it life threatening, extremely painful, debilitating, or only embarrassing or inconvenient?
3. 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?
4. What it that treatment’s mechanism of action?
5. Is this mechanism plausible? How likely is it that it could occur?
6. 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?
7. Is there any scientific evidence of benefit or harm?
8. Is the only evidence anecdotal?
9. Have any studies been done? Have the studies been done on the treatment for the specific condition that I have or were they tested on another condition? This speaks to off-label use of medications which are a common practice in medicine.
10. 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? Are the people like me? And all the below items:
    c. RCTs or randomized controlled trials? Or Meta-analyses or reviews of RCTs?
    i.     How many patients or persons used in the study, the ‘N’ number? This speaks to statistical power (ability of the study to find a result)
    ii.     Was there any blinding or a placebo used? Did the study participants and researchers know who was given the treatment and who was given the placebo?
    iii.    What were the 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- the other factors that could account for the results?
    v.     How large is the effect/What is the magnitude of effect (effect size)? Are the results clinically meaningful?
    vi.    What do the confidence intervals look like?  Are the confidence intervals wide or narrow?
    vii.   Do the confidence intervals include the results? Are the results statistical significance?
    viii.  What are the numbers needed to treat? (Also speaks to clinical significance of the findings.)
    ix.    Is there a dose-response? Or only trends with increasing exposure to the intervention or treatment?
    x.     Who were the study participants? Are the results generalizable to a general population or only to certain people?
    xi.    Where any statistical tricks used to make the results look clinically relevant when they are not that impressive?
    xii.   Where any statistical tricks used to make the results look clinically relevant when they are not that impressive?
    xiii.  Do the researcher’s conclusions match the numbers seen in the results?
    xiv.  Potential conflicts of interest- who funded the study? Do researchers or funders have any interest in the outcome in the sense that they could stand to benefit financially from a particular outcome.
11. 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 (find correlations not causes)
    ii.   RCTs
    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)
12.  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.
13. What do professional organizations say about the treatment? (For treatments that have been around for a while, especially FDA-approved medications, professional organizations in the various areas of medicine often put together teams of physicians to review the evidence. These teams put forth consensus statements on where the specialty comes down on a medication or a class of medications.)

Any available answers to these questions often are not in a language that most people 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. That’s why it’s important to get the advice of a physician or qualified healthcare provider, especially one who understands you and your health conditions before making these decisions.

The list of questions above stands in sharp contrast to what you might see in an internet chat room where people might say things like “I took this treatment and now I’m cured” or “I took this treatment and now I have this distressing symptom.” While it might seem that such testimonials are good enough to tell if a treatment is helpful or harmful, they are far short of the rigor that is needed. Such statements provide very little information about whether a treatment is harmful or helpful.

What it comes down to is that we need to do studies that have a control group of study participants not taking the treatment and which is similar to the group in the study taking the treatment. That’s because there are a lot of possible reasons people can get better and get worse and we need to know if it is really the treatment that causes any health improvements or harms.

Patients have a right to demand from their physicians an explanation of risks and benefits that is based on answering the questions listed above. We have a choice to take or not to take a treatment. A mark of a good provider is one who gives their patients information on the risk and benefits of every treatment they recommend. Patients can then use this information to weigh the benefits against the risk and make an informed decision.

The above list of 13 questions 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 for 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 they are not using these criteria, you could ask them upon what basis they are providing you with treatment recommendations. Their answers may be revealing to you.

We want treatments with only benefits and no risks. If your provider provides you with the scientific evidence of the risk and benefits of a treatment, you will see that there are risks associated with taking pills and natural supplements. Surgery, medications, most procedures and most “natural” nutritional and herbal supplements all come with risk. But one thing that may surprise you is that lifestyle changes that have little to no risk can be as effective or even more effective than oral treatments like medications and supplements. 

Our culture conditions us to see pills as “real” medicine and things like exercise, dietary changes, stress management, emotional wellness interventions and getting better sleep as secondary supports. But that is often not what the evidence actually tells us. I believe that an objective look at the evidence would motivate patients to seek to optimize the lifestyle factors that are under our control before they look into pills and procedures. That includes things like limiting processed foods, optimizing exercise, sleep and stress management using techniques like meditation, cognitive behavioral therapies and mindfulness-based interventions. There are, of course, times when medication and surgery are needed. But many people ignore lifestyle as a power source of health.

Care informed by the understanding that emotional and physical wellbeing are deeply connected

By using MoodChangeMedicine.com, you agree to accept this website’s terms of use, which can be viewed here.