Brian Altonen, MPH, MS

The use of a grounded theory approach to studying herbal medicine use and toxicity is one of the better ways to document this form of preventive or integrative medicine activity that is self-motivated and typically not well researched by regular and alternative, complementary or integrative doctors.

The chief problem with herbal medicine research to date is the two major routes taken by researchers of this form of therapy. 

The first most common approach is for a research group to evaluate the use of plant medicines simply for their absence or presence. 

The second is the use of some standardized matched or pared group analysis with the goal of measuring differences or change, for example by demonstrating that group 1 had less complications than group 2. 

This first method is an ecologic study method designed to provide us with helpful insights into the use of non-allopathic practices in some sort of professional or non-professional, and allopathy-promoted, or non-promoted form of self-administered therapy. 

The second method is more directed towards producing some sort of measurement of failure versus success, such as an answer to the question – “did the use of this additional method of treatment have a statistically significant impact on patient’s outcomes?”

To date, these two types of studies tend to focus on quantitative research methods, and try to compare and contrast allopathic behaviors with non-allopathic or unoffical allopathic behaviors regarding patients in terms of nutrition therapy (I’ll include plant medicines here for the moment), exercise or sports therapy, religious or social group therapy and the various forms of “energy” therapy that are available.   During the 1990s, the publication of these studies was instrumental in helping the allopathic profession develop a way to manage patients who opted to engage in this form of self-administered therapy on their own.  The risks that might have incurred had the allopathy profession ignored this avenue that customers were taking would have been detrimental to their own profession and to the health of the patient. 

Fortunately, regular medicine has opted to enable members of their consumer population to engage in this therapeutic route more openly and freely.  Some members of the regular medical profession have even taken on some of these practices and alttached preventive screening behaviors as a part of their own health care regimens.  It is not unusual for family physicians, a significant number of gynecological patients, and even internal medicine physicians to have some background in this field of non-allopathic teachings.  Unfortunately, the avenues out there for regular physicians to take when it comes to learning about non-“traditional” forms of medicine are the same routes provided for the patient population as  a whole, and individual who wish to receive some form of certification in these health care practice methods.  The regular physician has the option of obtaining an additional degree in another field, or attend some sort of accredited or non-accredited licensure program set up to train individuals in these additional clinical skills, like obtaining some sort of certification in homeopathy or some unique form of physical or massage therapy. 

When it comes to learning more about plant medicines however, there are so many approaches out there for an MD to take, that it is unlikely an MD is going to invest much time in taking enough of these programs in order to become self-assured that he/she is clinically capable of working in this field of patient care with the right training, and the right amount of confidence. 

The following methods are out there for learning herbal medicines:

• Self-taught
• Self-taught, at home program, but directed by a business, agency, or npo
• Apprenticed, by an individual
• Self-taught with added optional schooling (classes taken to improve background and knowledge base, institutional or non-institutional)
• Schooled through a non-accredited institution, agency, npo or business, unlicensed or uncertified
• Schooled through a non-accredited institution, agency, npo or business, licensed and/or certified
• Schooled through an accredited institution, agency, npo or business, licensed and certified

In general, MDs are mostly likely to engage in the 4th approach above (in blue).   [Generally speaking, without any additional survey tools yet developed yet to back up this claim, my impressions so far are based on a survey I administered every year since I began teaching these programs back in the 1982.]   Physicians tend to want to learn about plant medicines on their own.  The reasons for this are numerous. 

First, there are no programs out there specifically designed for MDs to take, that are professional or profession (AMA)-linked.  When these forms of education do exist, they exist in the AMA-accredited continuing education setting, and can tend to be biased in their presentation and handling of this information.   There are of course exceptions to this, which are on a steady increase in recent years, if the administration of the very few that do exist are worth quantifying through such a statement.  But in general, the production of these programs has not benefited that much by the change in approaching the value of these other forms of care practice, labelling them as “evidence-based” in some non-biased fashion.   In current terms, the potential for allopathic support is out there, but limited by the retention of some old time schooling, teaching and research methods, standard old-time quantiative research methds redefined with these new names.

The other option for MDs is to partake in the numerous classes offered by the nationally accredited naturopathy schools.  But these are not easily accessible to physicians and other members of the regular medical staff.   To attend such programs, clinicians have to travel to the site in order to received this form of professional training in plant medicines.  To receive the best training at these programs requires a full year’s attendance, if not more, for each type of medicine they wish to learn from these accredited schools.  The options a physician has for engaging in these various programs is to attend programs devoted to regular herbal medicine, oriental herbal medicine, or homeopathy, each of which has more than one year’s worth of classroom instruction to engage in as students, and usually requires as well that you engage in the internship for this program.  After at least four years of medical school training, and another few years devoted to residency in their field of specialty, it is unlikely an MD is going to engage in this sort of additional training, which if taken completely will last about two and one-half to 3 years.  Therefore, this means that patients are left to deal with the intelligence of their MDs in terms of determining what medicines are best for them, be these medicines regular pharamceuticals and over-the-counters and/or plant-derived medicines and nutritional supplements available as over-the-counters and through special sales programs.

Bringing all of this research methodology and background back to the use of grounded theory approach to study plant medicines, I am kind of surprised that to date no one has really made much use of grounded theory approach to document this particular aspect of human behavior, referring of course to both the practitioner and the patient.  The individual who engages in herbal medicine use has his/her personal reasons for this self-prescribed, self-administered therapeutic practice.  The physician has his/her reasons for approaching this topic in a fairly conservative, unobtrusive manner.  Often the patient will engage in this practice without informing the regular doctor of these behaviors, although in the past ten years or so, the efforts to document these  mostly patient-defined therapeutic activities as part of a the physical exam and overall health review has become common practice. Likewise, the physician has taken some small steps to document these patient activities, but not in any useful fashion with regards to research application. 

I make this claim based on my work with the Medicare/Medicaid/CHP/Employee health HEDIS and NCQA programs over the years, in particular from 2004-2008.   During this time, information regarding alternative medicine practices was documented in the yearly visit documents.  Some physicians went through all the details of the OTC product uses; some engaged in this more as a routine, without paying much attention to the details.  Patients with a considerable history of chronic disease almost always engage in these self-administered regimens.  But there is no way to document the degree of interaction taking place on the patient’s behalf, except when on occasion a patient hands in specific papers detailing this information.  Examples of how this history has been recorded include:

• a note on the contents of a drug cabinet, including the details on the OTCs taken regular,
• dietary and nutritional supplements and plant medicine information provided as part of the dietary habits notes provided by a patient
•  inclusion of this information along with the results of daily diabetes blood glucose measures taken (now that this possibly by totally electronic means, these notes will be less)
• a note produced before a surgical process
• a note produced in relation to an ongoing study of the specific topic of herbal medicine use, or the testing of a new prescription drug (often a mood-behavior-affect directed medication)
• diary notes related to the chronic disease being managed (i.e. a seizure diary with valerian and chamomile use history)

 

Still, even though this information is sometimes documented about a patients self-defined portion of the health care process, little to no effort is made to better document these notes in the standard physical exam form.  This means that this information is not useful for engaging in any clinically based studies of patients using these products versus those who do not use these products.   To make more effective use of this portion of the patient history provided, the following process would be needed: 

• Development of a standard series of questions focused on the various forms of “nutritional” or dietary supplement practices that patients engaged in, related to diet type and plant uses (regular, oriental (with subgroups), ayurvedic, unaanic, homeopathic, african, carribean, aromatherapeutic, Bach flower, etc.).
• Development a series of questions that are placed on a special form that a patient fills out when specific questions are responded to with the ‘yes’ response.
• Produce a reporting sheet to handle these queries.  Attached this to the medical records alongside the prescription/OTC sheet normally included in a patient’s record or file.

 

These methods can be used in association with the other standard approaches taken to documenting patient health.  The results can in turn be used to evaluate the possible risks that patients may be in  whenever they are engaged in unmonitored or partially-monitored plant medicine related herbal or niutritional medicine therapies.   These risks may also be evaluated for other important health related risks.  Each of these topics regarding plant medicine use has its own specific levels of clinical importance:

• Pregnancy or planned pregnancy history
• Liver disease history
• Renal history
• Diabetes history
• Gastrointestinal history
• Autoimmune history
• Neurological history

Accompanying this review of the biological systems is a review of the chronic disease history and potential for a given individual.   The most important types of chronic disease conditions that can impact an individual’s health when that person commences a fairly long-term plan for dietary supplement/herbal medicine use are the following risk factors:

• Age
• End stage renal disease
• Renal failure
• Liver Failure or Chronic Liver diseases
• Extensive cancer history
• Diabetes that is out of control
• Autoimmune disease problems (with AIDS and AIDS-related syndromes treated separately as a distinct subclass)
• History of Gastrointestinal lining or membrane disorders, such as Gastric Ulcer, Ulcerative Colitis, Crohn’s Disease
• History of antiplatelet aggregation and clotting inhibitors

These histories do not exclude the possibility for use of plant medicines.  In fact, some of these chronic diseases may benefit from certain dietary changes related to these practices.  By documenting these particular features, the clinician provides the documentation needed for a more reliable method of analysis of these clinical methods to be engaged in at some later point in the professional career.

Finally, there is this method I developed back in 1982/3 that still has application to this type of research.  In the winter of 1982/3 (perhaps a year earlier actually), I began applying taxonomy to the toxicity of plants.  This is how I initiated all of my work in plant chemistry at the field and lab level from 1982/3 on.  Due to shared chemistries and mechanisms for toxicity, plants can be grouped generally into groups with shared chemistries and shared toxicities.   When this was first employed, we termed these toxic presentations toxic syndromes or “toxidrome,” a term invented by Howard Mofenson of the Long Island Poison Control Center.  Approximately 35 toxic syndromes were developed as a result of this work, and in 1990 applied to an alternative medicine database, IBIS/TM, marketed by AM’TRA.  {more on this list to be added later}

Additional Study Methods/Research Tools

The following methods can be employed in order to obtain more useful information related to the patient use of herbal medicines.

• Development of a survey tool on the uses, reasons for uses, patient’s professional background, patient’s information sources, patient’s non-allopathic clinical history
• Development of a series of questions pertaining to patients’ concepts regarding safety, knowledge of drug and plant toxicity and other information related to potential drug and drug-plant interactions
• Use of Pre- , Post- and Intermediate to Long-term Follow-up survey methods with standardized bimodal and scaled response questions
• Promotion of the development and upkeep of a diary by each patient, for later use in chi-squared or odds-ratio directed text analysis
• Application of either a Focus group or Case evaluation approach to analyzing study topics with exceptionally low numbers of patients applicable to engaging in this type of study.  For example, the development of a focus group study on 6-24 patients with a history of a chronic disease or condition who find it necessary to employ plant medications to their regimen (i.e. insomnia, epilepsy, MS, chronic infectious or autoimmune disease, hormone therapy, etc.).  [Focus groups are employed for larger numbers; case studies are applied to very few cases, for which more detailed data are gathered.]



Grounded Theory Applications

The more feedback a clinician obtains from patients using this approach, the more evaluations can be made using a grounded theory approach.  The use of grounded theory requires that there be ample amounts of information available for the analyst to review and begin to evaluate in order to better understand the topic at hand and the patients’ interpretation of this medical topic.  For this reason, the information that an individual provides you with allows for a more reliable research process to be developed as the amount of  information that is provided is increased.   This method of researching a patient population using herbal or nutritional supplements allows for a more detailed approach to be developed throughout the research process, based on a number of variables introduced through the use of additional information tools, such as surveys, patient’s diaries.  By standardizing the data entry process, this clinician is now able to engage in standard analyses such as chi squared, odd ratio analysis, risk analyses, and perhaps even some mann whitney form of analysis based on the format of the questions a patient is asked.  This enables a clinical researcher to produce a study project that would be fairly productive, with the options of producing several more avenues of research not normally taken as a s result of the current research processes.

With grounded theory, what a researcher is trying to do is review the documents available for research, engage in some sort of supervised (closed) or unsupervised (open) method for analyzing the documents provided for analysis.  It is also possible that two individuals could independenlty apply open and/or closed reviews of the documents, and then these results compared at some later time.   For example, a group of ten patients engaged in a diet and nutritional supplement program designed to help them with their hypertension may be asked to fill out a standardized form, with standardized questions, some with open response options, and then later this information entered into a database for subsequent text analysis review.  The text analysis review would consist of some questions that are posed by the analyst, such as:

• what major groupings of the adjunct remedies stand out?  (herbs, chinese meds, vitamins, homeopathics, etc.)
• do any of these have documentation that the patient could provide (the patient’s source for this use and claim)?
• what were the sources from which the patient originally learned about the use of these remedies?  (clinical, reading material, TV?)
• what social support system is out there for this patient’s interpretations?
• how secretive is the patient about these uses with respect to the family?
• does the patient keep a listing or other record of this history of self-therapy?

If the cases analyzed have the potential for keeping a diary, a diary can be used to further evaluate the patients’ behaviors and attitudes about these methods being employed.  For particular disease or condition types, for example insomnia, irritable bowel syndrome, GERD, fibromyalgia, uncontrolled diabetes, uncontrolled asthma, MS or seizures, this can be used to evaluated sequences of events related to particular problems that erupt in day to day life. 

Since the purpose of this example of a research project is to evaluate OTC-Integrative Medicine uses with regard to standard allopathic proactices and prescription drug regimens, the end result of the above qualitative research has to be related to the overall goal for this research project.  Does the above information tell use anything about patient coniditons, age, behaviors, social status, etc. that might help to define those patients who are most at risk for developing complications due to their integrative medical approach?  In other words, are there cases where drug-OTC interactions or exacerbations induced by drugs and/or OTCs could result in a worsening of the patient’s health status. 

These latter two questions draw this research process back into the main frame for regular medical researchers.  There are some standard methods that can be employed to document answers to the above questions, such as the monitoring of  liver enzymes, lipids, blood sugar, level sensitivity based on the use a pain scale, a standard series of quality of life questions directed at evaluating the major symptoms of complications of a given disease or condition state, etc. 

These questions might also allow for new high risk cases to be discovered that were previously missed, such as the misuse of botanicals for preventing or treating chronic asthma related events–the use of certain botanicals can actually worsen the longterm history of asthmatics if wrongly applied, resulting in bronchiectasis and onset of chronic upper respiratory tract infections–or the overtreatment of stroke, cardiovascular disease and pulmonary embolism cases due to the application of both herbal-based “blood thinners” (coumarin agents) and standard OTC half-dose aspirin therapy.

Examples of Applications

Case 1.  Herbal Medicine and Prenatal Care

I.  Research Question.  “What is the general attitude about the use of  OTC supplement use and herbal medicine use by women who are pregnant?”

II.  Related Questions:

• How adherent do these women feel they are in terms of recommendations by their PCP/Obstetrician?
• How frequency do they engage in prenatal care visits? (are they in compliance?)
• How adherent are they according to their responses to a survey on self-claimed OTC use history?
• How engaged are they in the preventive process when it comes to smoking?  drinking alcoholic beverages?  the use of street drugs?  caffeine consumption (including sodas)?  the use of OTC aspirin and tylenol? driving and the use of seat belts? 
• What are the reasons for why the these women engage in the each of the above risky behaviors when so noted?

III.  Questions for the researcher to explore: 

1. Which herbal medicines are toxic to women who are pregnant? (trick question)
2. Which herbal medicines are fetotoxic (toxic to the fetus)? (include western and chinese medicinal plants)
3. Which herbal medicines are teratotoxic (toxic to the fetus during specific fetal formation and development stages, usually, first and early second trimester)?  (include western and chinese medicinal plants)
4. Which herbal medicines are uterotoxic and capable of inducing labor?
5. Which herbal medicines are toxic to young stage solid organ tissues developing within feti?
6. Which herbal medicines are capable of causing phototoxicity in neonates and young children?
7. Which herbal medicines are capable of causing hepatotoxicity in neonates and young children due to lack of solid organ maturation?
8. Which herbal medicines or supplements effect lactation and/or the breast-feeding process?
9. Which of the following plant groups are capable of crossing the placental barrier?

• • alkaloids
  • organic acids
  • fatty acids
  • simple sugars
  • modified amino acids
  • flavonoids
  • sugar alcohols
  • phytosterols and reversed triterpenoids
  • lectins
  • mucopolysaccharides
  • iridoids
  • phenolics
  • carotenoids
  • monoterpenes and sesquiterpenes
  • alkamines
  • quinones, anthraquinones and dianthrones
  • lignans and neolignans
  • diterpenes
  • saponins
  • tannins
  • proteases

     10. Which of the above chemical groups produce well-known fetotoxins or teratotoxins? (think of cancer drugs distribution)

IV.  Research Methods and Practices

• develop a survey tool; implement
• recommend use of a diary to monitor one or more of the risky behaviors noted above
• perhaps consider a case approach to interventions or a focus group approach
• design a pre-test, post-test, follow-up methodology in order to evaluate patient learning, patient response and engagement/participation measures as part of the evaluation of some new prevention process.

V.  Analysis

• design analytic approach
  • develop survey tool
  • develop descriptive pamphlet of HO about the reason for a diary
  • develop descriptive information of focus group related topics and queries to be made
  • develop pre-post-follow-up questions (they need not be identical for follow-up, in fact shorter is better than, with open-ended text responses to some general questions)
• carry out approaches and follow-ups

VI.  Report/Final Report