We conducted twenty-two focus groups at the three study sites between March and August 2009. Group composition by patient diagnosis was as follows: 8 groups with mixed diagnoses; 8 groups with IBD; 3 groups with IBS, 2 groups with Crohn’s disease, and 1 group of patients with ulcerative colitis. Three groups included all women and 1 group all men. Demographic characteristics of patients are summarized in .
Characteristics of Patients (n=136)
Familiarity and Experience with Probiotics
Patients had varying degrees of familiarity with probiotics. Some patients had never heard the term while others had some knowledge of them. Of those who were familiar with probiotics, most associated the term with yogurt, live active cultures, good bacteria, and digestive balance. Many patients reported having first heard about probiotics in television commercials advertising yogurts and other over-the-counter probiotic products.
Patients had some knowledge of how probiotics function in the digestive tract. They understood that probiotics work by adding bacteria that may be absent and restoring good bacteria to the digestive tract.
[My disease]…it’s an overgrowth of bad bacteria. We’ve all got good bacteria in our bodies to control the bad bacterias that are naturally present in us, and so it’s just about a balance in there. And they’re talking about supplementing some good bacteria to sort of handle the bad bacteria so our immune system doesn’t feel like it has to.
Some patients had used or currently were using over-the-counter probiotic products, such as probiotic foods (yogurt, kefir) and supplements (pills), with varying results. Some reported relief from their symptoms and an improvement in how they felt after using probiotics.
I don’t have the gut cramps that I used to. I don’t have the burning, ‘Oh my God, my ileum’s going to fall out’ feeling…I don’t feel ‘ouchy’ and as sensitive if I press my own abdomen. It doesn’t hurt so much any more…
Others noticed no improvement in their symptoms while using probiotics or reported experiencing side effects from probiotics such as bloating and cramping.
Conceptualizations of Probiotics
The manner in which probiotics are ingested impacted patients’ conceptualizations of them. Patients often associated probiotics with yogurt products and viewed them as food. They noted the expansion of both the yogurt section at grocery stores as well as the number of food products containing probiotics. Patients frequently drew analogies between probiotic pills and vitamins or other nutritional supplements. They viewed probiotic pills as a supplement of good bacteria for the digestive tract which would improve its function similar to how calcium, for example, is taken as a supplement to support healthy bones.
I view probiotics as kind of benign thing. I don’t think they will harm you...But if it’s part of your body naturally, same as vitamins, if you take a vitamin and your body doesn’t need it, it just doesn’t absorb it and it passes through. If you take a probiotic and your body doesn’t need it, it just passes through.
Some patients also drew distinctions regarding the scope of impact in the body when comparing probiotics to vitamins. These patients viewed the effect of probiotics as gut-specific, whereas the impact of vitamins was viewed as systemic.
Patients tended to view probiotics as “natural” because they are living organisms that normally reside in our digestive tracts. Patients described their digestive tracts as unbalanced and expressed a desire to return to a healthier state of balance. They viewed probiotics as “natural” products that would restore the good bacteria that are depleted in their gut, without causing harmful side effects.
Evaluating the Benefits and Risks of Probiotics
Patients drew upon personal disease experiences when discussing probiotics as a therapeutic option. They often evaluated probiotics by comparing and contrasting them to pharmaceutical drugs they had used previously or were currently using to manage their disease. In this respect, pharmaceutical drugs were the primary interpretive frame of reference for patients evaluating probiotic options.
Some patients reported that pharmaceutical drugs worked well for them while others noted that medications had been ineffective in treating their disease. Patients expressed frustration about what they considered “a hit or miss” approach with pharmaceutical drugs.
So has everybody here kind of gone through, you know, a variety of medications? ‘We’ll try this and see if it works,’ and it doesn’t so you throw it [out], and then, ‘try this and see if it works,’ and, finally, you come across one that probably works. I mean, don’t you just feel like you’re just testing them all sometimes?
Many patients also expressed frustration that their medications had worked initially but became less effective over time. Uncertainty about the long-term effectiveness of pharmaceutical drugs left many patients with concerns about future treatment options. Probiotics were appealing to these patients because they were viewed as offering another potential therapeutic approach for patients who felt they may be running out of pharmaceutical options.
Patients were very concerned about the short- and long-term side effects of drugs and noted that at times the side effects of their medications were worse than the disease. They tended to view drugs as chemical, synthetic and toxic, with a high level of risk for side effects. Patients also expressed concerns about the high cost of pharmaceutical drugs and potential for adverse drug interactions. Overall, patients expressed a desire for cheaper, less burdensome, more “natural” alternatives to pharmaceutical drugs.
Despite this high level of interest in alternatives to pharmaceutical drugs, patients frequently expressed skepticism about the potential usefulness of probiotics as a viable alternative. Their skepticism about probiotics was based on the lack of recommendations by their physicians, minimal governmental regulation of probiotic products, and what many patients regarded as limited empirical evidence in support of probiotic efficacy. Typical in this regard is one participant’s comment that:
…my personal opinion is that if it worked, then the FDA, pharmaceutical companies, physicians would be recommending these and would have recommended them a long time ago and we would all know about it…there would have been clinical trials that had shown evidence and significant evidence demonstrating that these worked. And to date, there are no clinical trials demonstrating effectiveness of the probiotics in relation to medications or better effectiveness in relation to medications. And thus, I’m not willing to run out and buy yogurt, or any other capsules or whatever.
As a result, despite numerous concerns about the costs and burdens of pharmaceutical drugs, patients generally were reluctant to abandon medications with established effectiveness for probiotic alternatives where efficacy remains uncertain.
Some patients expressed similar concerns that probiotics had not been evaluated for safety in people with chronic GI diseases. Patients perceived probiotics as safe products for use by the general public but were concerned that probiotics might present higher risks for individuals with GI diseases. They also expressed concerns about potential interactions between probiotics and pharmaceutical drugs.
…For those of us who do have a clinical condition, circumstances might be different than for the general public to whom some of these over-the-counter things are marketed. In addition, if we already take some prescription medications, we have concerns about what the interplay might be of those with these.
Some patients also expressed concerns about the quality of probiotic products. For example, patients sometimes questioned whether product labels accurately described the bacterial strain(s) and amount of bacteria contained in probiotic products.
I have diffidence though as to what we are getting when we buy all this medicine, the probiotics or whatever. I somehow don’t feel like we’re getting the real thing. I somehow feel like we are being duped, perhaps because I never felt any real relief.
Perceived variability in quality across commercial products shaped perceptions of the overall benefits and risks of using probiotic products.
Making Decisions about Probiotics
Patients reported that the severity of their disease and their satisfaction with current treatments would be important considerations when making decisions about using probiotics. Patients’ willingness to try probiotics would be affected by the severity of their disease at any given time.
This is a very desperate population of patients that is just seeking an answer, you know, and I think we’re willing to reach out to anything.
Patients said they would be very hesitant to change their disease management plan when they are feeling well and would be reluctant to alter anything that could tip the scales in the direction of experiencing a flare up of their disease. Patients also spoke of considering the effectiveness and side effects of pharmaceutical drugs they are taking when making decisions about probiotics. If their drugs are effective in managing their disease, with few to no side effects, they would be less likely to consider using probiotics. If they are dissatisified with the effectiveness of their drugs, or are experiencing numerous side effects, they would be more likely to consider using probiotics.
Some patients talked about how they were running out of pharmaceutical options for their disease. For them, probiotics would be a worthwhile treatment to try in hopes of feeling better.
… it’s like a drowning person and you grab the hand. I mean, if you’re going down, there’s something wrong and if the doctor says ‘ we’re doing everything we can for your system, but unfortunately gastroenterology can only do so much – there’s only so much we know. There is a lot we don’t know.’
For these patients, probiotics would be an option when standard therapies were no longer effective.
The Need for Comprehensive Information from Reputable Sources
Patients reported having learned about probiotics from the internet, advertisements, family, friends, and health care providers. Although patients viewed the internet as a convenient source of information about their digestive diseases, they expressed concerns about the quality of medical information available on the internet.
The problem with the internet is that it can be helpful but it can also be deceitful because anyone can put anything out there and sometimes you have to kind of decide for yourself if that information is accurate or not.
Patients who had read patient blogs or had participated in chat rooms also expressed concerns about the quality of that information because they felt their personal disease experience was unique and what may have worked for other patients might not work for them.
Patients consistently expressed a desire for more information about probiotics, including their composition, how they function in the digestive tract, their risks and benefits, and how probiotics might fit into their treatment regimen. For example, patients wondered if they would have to go off of their current medications to take probiotics and expressed reluctance to abandon their current drugs altogether. While patients hoped that probiotics would be effective, many expressed doubts that probiotic products could manage their disease as well as pharmaceutical drugs. As one patient commented,
I would have to know that it is more than just like eating yogurt. Because, I think if I stopped all my medicine and just ate yogurt at every meal that I would have some problems. So I would have to know that this is not just about a quick little diet change, but it is something that would really help me just like the medicine would.
Patients drew distinctions between information about probiotics targeted to the general public, many of whom have occasional digestive problems, and information about the use of those products by people with chronic digestive diseases. Patients felt that information from popular media, such as television commercials, is incomplete and of questionable quality since the purpose is to sell products. They expressed a desire for more information about the use of probiotics in the management of GI diseases, such as safety and efficacy data from research studies.
I just don’t have access to real research to know ‘okay, is it good for keeping you in remission or making you feel better or is there a specific one for specific types of diseases?’ So I just feel like I’m flying a little bit blind with the information.
They consistently expressed a desire for comprehensive information about probiotics from scientists and medical professionals.
A Desire to Partner with Gastroenterologists
Some patients had sought information and advice about over-the-counter probiotics from their health care providers, including gastroenterologists, primary care physicians, nurses and pharmacists and reported mixed experiences. Patients typically reported that their gastroenterologists informed them that while there is not a lot of scientific evidence to support the use of probiotics for disease management, some of their patients had tried probiotics and found them to be helpful. In addition, gastroenterologists were reported to have advised patients that using probiotics probably would not hurt them, despite the uncertain evidence of benefit.
I talked it over with my physician…we decided, ‘Yeah, let’s give it a shot. Everything else is kind of up and down for you, so let’s see if some [probiotics] will work.’ So, it was kind of a decision together.
A few patients noted that their gastroenterologists advised them not to try probiotics, either because a diagnosis was not yet made or because their current treatments were effective.
Overall, patients expressed a desire to partner with their clinicians in deciding if probiotics may be appropriate for use. Many patients viewed their GI clinicians as trustworthy sources of information and guidance about probiotics and expected that their gastroenterologists would have the most up to date information on emerging treatment options. Patients also viewed their gastroenterologists as knowledgeable about their disease and in the best position to determine if probiotics were a good therapeutic option given each patient’s unique disease experience.
I trust my doctor first…I’ve read about it [probiotics] on the internet, but I wouldn’t trust what I read there so I asked him before I did anything.
While most patients expected their clinicians to have current information about new therapeutic options, some believed their doctors were not very well-informed about probiotics. These patients acknowledged that this might be due to a lack of evidence regarding the effectiveness of probiotics or greater familiarity with standard pharmaceutical therapies for treating chronic GI diseases. Other patients felt that their clinicians might be dismissive of their interest in probiotics.
My experience with doctors, when it comes to things like this, is as long as they know that it isn’t harmful to you they will kind of shrug and go, ‘Sure, go ahead and try it.’ You know, just a kind of a dissing of the idea of something that isn’t on a prescription pad. As long as they know that it won’t hurt you…that they can say in good conscience that it won’t be bad for you. That is my experience with them.
Overall, patients viewed their gastroenterologists as ideal partners in managing their disease but not always equipped to engage fully in a patient-centered dialogue about alternative therapeutic options. They expected their gastroenterologists to be knowledgeable about probiotic options and open to considering probiotics as a supplement to ongoing treatments.
Although patients viewed their physicians as ideal partners in clinical decisions, many also viewed probiotics as an attractive way to manage their disease without the involvement of a clinician. Some patients spoke of gaining a sense of control over their disease and improving their overall quality of life as a result of this self-management approach.
The way probiotics are now, it is something that your doctor is not going to prescribe so you have to actively seek [probiotics] and at least talk to your doctor about it. So, just through doing that I think you would feel more in control of what is going on and at least that would make me feel better.
Some patients felt that a self-care approach, of which probiotics might be one part, also would allow them to step outside of their identity as a sick person to some extent.