You need to ask 3 main questions about unconventional therapies (UTs), and indeed any therapy:
- Is it safe?
- Is it effective?
- Do the possible benefits outweigh the possible harms?
IS IT SAFE?
Establishing whether the UT you are considering is safe is most important. This is sometimes a difficult question to answer. Look for information about side effects and any effects on existing health problems. Find out how common these effects are and whether they are likely to be mild or severe, temporary or permanent. Look for information about adverse interactions with foods, drugs and alcohol. Try to use products that are manufactured by established companies, since good manufacturing practices will minimize the risk of contamination.
The safety of a conventional therapy is usually established by systematic animal and human research before it is released to the public. However, a UT is often assumed to be safe if it has been in widespread use without reported harm. Unexpected harms from conventional therapies have to be reported to Health Canada, but regulations governing the reporting of such harms from UTs do not yet exist.
All products intended to be ingested are regulated by Health Canada as a "drug" or a "food". A drug is a substance that will restore, correct or modify a body function or one that is sold or represented for sale as a treatment, prevention or cure of a disease, disorder or abnormal state. A food is something that is normally expected to be consumed for its nutrient value. Most UTs intended to be ingested do not carry health claims on their labels and fall in the "food" category. For those that make a "drug" claim on the label, there should be a drug identification number (DIN) or a general public (GP) number on the label as well. The presence of this number is helpful because it indicates that the Health Protection Branch of Health Canada has reviewed and approved the product’s formulation, labeling and instructions for use.
IS IT EFFECTIVE?
The effectiveness of a therapy is a measure of its ability to improve health and well-being. It is usually assessed in relation to specific health outcomes such as improved survival, reduced pain or discomfort, reduced tumor size or spread (in the case of cancer), improved appetite or weight gain, or other measures of improved quality of life.
Although the desired or expected health outcomes of different treatments will vary, how evidence of the effectiveness of each treatment is gathered is basically the same. The strength of the evidence that a therapy "works" depends on the design of the study – how the subjects were selected, how systematically the treatment was provided, how well other factors that could affect the outcome were controlled and how completely the results were reported. The same rules apply to both UTs and conventional therapies. Evidence of effectiveness may come from anecdotal reports, studies of a series of cases treated at a particular clinic or institution, and randomized controlled trials.
Anecdotal Reports
Frequently, testimonials from individuals who have used the therapy are presented as the main evidence of the effectiveness of UTs. This type of evidence is of interest and can help to identify promising new treatments; however, a therapy may be effective in one person but not in another. Collections of anecdotal reports are sometimes available, but look at these critically. Testimonials from people in whom the treatment had no effect are usually not reported. Key information that might influence outcomes (eg. the person’s diagnosis and previous treatments) may be neither provided nor considered.
Case Series From a Particular Clinic or Institution
These studies have more value than individual testimonials, but they can also be misleading. Good case series ensure that each patient enrolled has an established diagnosis and has followed a prescribed treatment. All cases are included regardless of whether the outcome was good or bad. The studies usually compare the results in the group that received the treatment (study group) with those in a group of patients who are matched to the study patients, for example by age, diagnosis and prior treatment, but who are not given the treatment being tested (control group). If the control group is not carefully matched, any positive results reported in the study group might reflect their better general health, less severe disease or better prior treatment.
Randomized Controlled Trials
A randomized controlled trial gives the strongest evidence for the effectiveness of a therapy. In such trials, informed, consenting patients who meet preset criteria for inclusion in the study (eg. age, sex, a confirmed specific diagnosis, known stage of illness, known prior treatment) are randomly assigned to receive either the therapy being tested or the usual treatment, or sometimes a placebo. (A placebo is a treatment that is known to have no biological effect but that may affect outcomes in other ways. The placebo effect may be good, but the treatment being studied must do better to be considered effective.) All outcomes are measured and reported in a preset manner. Wherever possible, steps are taken to reduce the chance that prejudices and expectations of the patients or the providers will influence the results.
For some therapies (both unconventional and conventional) it is not possible to do a randomized controlled trial. In these cases, carefully designed controlled case series together with expert review and opinion will guide treatment recommendations.
DO THE BENEFITS OUTWEIGH THE HARMS?
Once you have gathered all the information you can find on your chosen UT, it is most important to review the possible benefits and harms carefully and objectively as they apply to your situation. Seek help if necessary. Don’t let a fear of conventional treatment or personal prejudices cloud your judgement.
You will probably find that the information available to you is incomplete. There is a serious shortage of good research studies on which to base decisions. Nonetheless, your knowledge of your own health situation, the pros and cons of all the treatments open to you (conventional and unconventional) and your own health preferences and values will help you reach the best decision possible.
