Disclaimer: The information contained within the Grand Rounds Archive is intended for use by doctors and other health care professionals. These documents were prepared by resident physicians for presentation and discussion at a conference held at Baylor College of Medicine in Houston, Texas. No guarantees are made with respect to accuracy or timeliness of this material. This material should not be used as a basis for treatment decisions, and is not a substitute for professional consultation and/or peer-reviewed medical literature. Complementary and Alternative Medicine in Otolaryngology Patient is a 55-year-old male who presented to the VA Medical Center Otolaryngology Clinic with the chief complaint of worsening dysphagia, odynophagia, and hoarseness for several months. His past medical history is significant for COPD and also greater than 100-pack year of tobacco use. He is taking aspirin, albuterol inhaler, and also the herbal medication red clover. The exam is notable for an ulcerative epiglottic lesion that extends now bilaterally to both AE folds and on to the vallecula. The base of the tongue and other parts of head and neck exam were clear. There were no palpable lymph nodes, and bilateral true vocal cords are mobile. The CT imaging of the neck shows that there was a pre-epiglottic space mass with no lymphadenopathy. The patient was taken to the operating room in April 2003 for a direct laryngoscopy and biopsy, which confirmed the diagnosis of moderately differentiated squamous cell carcinoma by specimen taken from the vallecula and the epiglottis. The patient could not tolerate chemo and XRT at that time, and he expressed desire for surgery. However, on the day he was scheduled for total laryngectomy, he canceled his scheduled surgery, believing that red clover and spiritual healing was going to cure him of the cancer. We obtained ethics and psychiatry consults. Both services deemed that the patient was competent to make his own medical decisions. Follow-up appointments were set up for both Medical Oncology and with our service; however, the patient did not keep his follow-up appointment. A brief note on red clover. The active ingredients in this herbal medication are isoflavones, and it is most commonly used as a phytoestrogen compound to treat symptoms of menopause. It is also used for bronchitis and, in some cases, cancer—most commonly breast and prostate—and is also used to treat sore throat and eczema as well. There is limited in vitro evidence showing that it has an inhibition activity of carcinogen activation in cancer cell culture. However, there have been no in vivo trials to confirm this finding. Our patient returned to the clinic about a year later with intermittent respiratory difficulty and also evidence of pulmonary metastases. Shown here is a CT of the neck showing the supraglottic mass and, also here, metastatic squamous cell carcinoma confirmed by needle biopsy in the right upper lobe. Our service performed a tracheostomy, and the patient was then transferred to the palliative care service. The National Center for Complementary and Alternative Medicine, a branch of the NIH, defines complementary and alternative medicine into four broad categories. The fist is biologically-based practices, things such as herbs and vitamins. Second is energy medicine, including acupuncture, qi kong, and homeopathy. Third is mind-body medicine including meditation and yoga. And finally, the fourth category is manipulative and body-based practices such as massage and chiropractors. There has been a trend for increased complementary alternative medicine use during the past half century. It is estimated that 36% of adults in the United States have used complementary alternative medicine in some form during the past 12 months, if we exclude prayer as a form of therapy. The expenditure on the complementary alternative medicine methods in the US was estimated to be between 36 to 47 billion dollars in 1997; and there has been increased interest in developing CAM centers and departments. According to a recent survey in 2002, some of the most commonly used forms of therapy, excluding prayer, are natural products, deep breathing exercises, meditation, and chiropractor. The number of visits to complementary and alternative medicine practitioners outnumbered the total number of visits to primary care physicians by 240 million, according to a survey in 1997. It is estimated that approximately 38% of people who use this type of therapy disclose their information to physicians. The most common reason for using complementary and alternative medicine according to a recent survey was that the patient thought it would help when combined with the conventional treatments (55%); and patients believing that this would be interesting to try (50%). Only about 27% of the patients use CAM because they believe that conventional medicine was not helpful. The use of complementary and alternative medicine in otology and neurootology include the practice of ear candles, which is said to have originated more than 3000 years ago, starting with Native American Hopi tribes, which reportedly taught the practice to visiting Europeans in pre-colonial times. The practice involves lighting a hollow candle and placing it into the external auditory canal. It’s believed that a lighted candle can create a vacuum that drawscerumen and other impurities from the external auditory canal and deposit them in the candle as it burns. Some of the claimed benefits of ear candles include: relieving sinus pressure and pain; purifying the mind; curing swimmer’s ears and other ear infections; sharpening the sense of smell, taste, and color perception; and, stopping tinnitus and vertigo. It has also has been claimed that it strengthens the brain as well. In the scientific literature, the use of ear candles has been called a "triumph of ignorance over science," according to a recent article published in 2004. Seely and others have done a scientific trial where they burned the ear candle and measured the pressure that is generated - of course, there was none. Mass spectrometry of the dark deposited substance, which is probably no surprise, was found to be candle wax, not earwax. The use of ear candles, however, can result in significant and frequent complications. A survey of 122 otolaryngologists, in 1996, showed that greater than a third was aware that ear candles were used by their patients. About 10% of the otolaryngologists surveyed have treated patients with complications from ear candle use. These include auricular and external auditory canal thermal burn and also occlusion of the ear canal with candle wax, otitis externa, and sometimes a TM perforation, as well. Therefore, the use of the ear candles should be discouraged. Ginkgo biloba, more commonly known as Ginkgo, is an extract of Ginkgo biloba leaves that have been used for more than 5000 years in China for medicinal purposes. It is actually registered as a drug in Europe, and the active ingredients in the compound include flavonoids and terpenoids. It has been shown to have some vasoregulatory effects and promotes increased blood flow and skin perfusion in laboratory trials. It has been used for treatment of peripheral vascular disease. The terpenoid components of the compound have also been shown to have antagonistic effect of platelet activating factor and, in laboratory trials, it has been shown to protect against hypoxic brain injury in animals. It is claimed to have some therapeutic benefit of symptoms with cerebral insufficiency, such as a stroke. In vitro, it has been shown to prevent cell membranes damaged by free radical salvage. Some of the most common side effects from this medication include GI upset and also potentiation of the anticoagulation effects because of the terpenoid component of these compounds. There have been small and non-controlled reports in literature suggesting effectiveness of Ginkgo in the treatment of tinnitus. However, the limited evidence that we have from randomized controlled trials shows that Ginkgo is not effective in the treatment of tinnitus. Morgenstern, in 1997, conducted a double-blinded placebo controlled trial of 99 subjects. The experimental group received 120 mg of Ginkgo for a total of 12 weeks. They showed a very small and non-statistically significant improvement in the loudness of tinnitus in the experimental group. This study was further expanded in 2001. Drew conducted a similar trial involving 1,000 subjects, and the experimental group similarly received 150 mg of Ginkgo for a total of 12 weeks. Again, there was no statistically significant difference in the amount ofimprovement between the two groups, showing that there was a significant placebo effect with the use of medication. Acupuncture is a traditional Chinese medicine technique that has been practiced since 200 B.C., which is based on the premise that systemic homeostasis can be restored by activity of needles on acupuncture points, shown here in this model. In the western nations, this is most frequently used for pain relief. Based on the available evidence, the efficacy of acupuncture treatment of tinnitus has not been convincing. Six randomized controlled trials have been reviewed in the literature. Two of the unblinded studies showed a positive benefit, but the four blinded studies did not show any benefit. Therefore, well-designed and larger clinical trials are needed before we can really conclude as to the benefit of using acupuncture in tinnitus. Tai Chi is an exercise discipline that was derived from Chinese martial arts and is practiced in a preset sequence of movement modules lasting approximately 30 minutes in total duration. The standard set has 108 movements. Shown in the figure is one of the basic Tai Chi movements called "Turning the Wheel." It has been noted that the static and dynamic tasks and the progressive nature of this exercise is similar to the balance training exercise that we offer to patients. Hain and others conducted a clinical trial involving 22 subjects who underwent eight one-hour weekly Tai Chi exercises and showed a significant improvement in both objective and subjective measures of dizziness. However, this trial did not have an internal control group and, therefore, it is hard for us to conclude whether or not the placebo effect is present. Therefore, further studies are needed to compare the efficacy of Tai Chi to conventional balance training. Betahistine or Serc® was approved by FDA about 30 years ago, but was subsequently withdrawn about four or five years later because of lack of evidence for the efficacy of this medication. Interestingly, it is used by 94% of the otolaryngologists in the United Kingdom for Ménière’s treatment, while only 63% of the otolaryngologists in the UK routinely use diuretics for treatment of Ménière's, and only 71% routinely prescribed salt restriction, according to a recent survey. The mechanism of its action is not clearly understood; however, it is shown to be a potent H3 receptor antagonist, therefore, increasing the histamine release. It has also been shown as a weak H1 receptor agonist as well. It has been shown to cause vasal dilation within the vertebral basilar and the vestibular arterial system with an increase up to 54% of the blood flow within these systems. Betahistine has been suggested to reduce the frequency and the severity of the vertigo episodes as well as tinnitus and also, there are suggestions that it arrests the progression of hearing loss in Ménière’s disease. There are some theories as to why betahistine might work. One of these is that it reduces the lymphatic pressure through improved microvascular circulation in the stria vascularis. It’s also been suggested that betahistine inhibits neuronal activities centrally in the vestibular nuclei and also decreases sensory input on the more peripheral level by inhibiting the electric discharge of the vestibular-afferent neurons. So far, in the literature, we have insufficient evidence about the effects of betahistine on Ménière’s disease. A Cochrane review was done in 2001, where 6 randomized controlled trials of betahistine versus placebo in 162 patients were reviewed. None of these trials met the highest quality standard. The highest graded trial was a grade B. The number of patients in these trials ranged as low as from 10 to 36. The Betahistine dose ranged from 16 to 72 mg total per day, and the treatment duration ranged from a total of 2 to 40 weeks. The vertigo was improved in 5/6 trials, tinnitus in 2/5, and hearing loss had no difference in all four of the trials that examined it as an outcome measure. Aural fullness was improved in 1/3 of the trials that examined aural fullness as an outcome measure. Since the publication of the Cochrane database review, Mira and others, in 2003, conducted the largest randomized controlled trial looking at betahistine in vertigo with 144 patients. Seventy-five patients were treated with Betahistine with 16 mg p.o. b.i.d. for 3 months versus 69 patients on placebo. They saw a statistically significant reduction in the frequency, intensity, and duration of vertigo attacks in the experimental group. They also saw significant quality of life and symptomatic improvement in patients with Ménière’s disease. The use of complementary and alternative medicine by head and neck patients has been looked at in three studies from the UK, Canada, and Israel. There are none that I am aware of in the US. The number of subjects ranged from 75 to 200, and the prevalent use has been ranged from 16% to 22%, which is lower than that used by average cancer patients, estimated at about 31%. Herbal medicine was the most commonly used complementary alternative measure by head and neck patients at about 50%. Some of the characteristics of the head and neck cancer patients who used complementary alternative medicine include younger age, higher educational level, and also Indo-Asian descent. There has been an increased use noted among patients with tumors of nasopharynx, nonsquamous cell carcinoma pathology, and also recurring disease. The most common reason for use is relief from symptoms resulting from the treatment of cancer. The most common source of information on CAM noted by patients was from family and friends; however, interestingly, the most knowledgeable source on complementary alternative medicine perceived by all patients was physicians. The use of acupuncture point stimulation for reducing the incidence of chemotherapy-related acute vomiting has been studied in a recent Cochrane database review published this year. They looked at 11 randomized controlled trials comparing antiemetics plus acupuncture in the experimental group versus antiemetics alone or, in some cases, with a sham control in 7/11 trials. In this review, acupuncture stimulation is defined as stimulation involving needles, electrical stimulation, or acupressure. They saw a reduction in proportions of acute vomiting in needle acupuncture and also in electrical acupuncture. And I emphasize “acute” because there was no relief for delayed symptoms seen in the studies. There were minimal side effects from the use of acupuncture. Aroma therapy massage has been also noted to be commonly used in cancer palliativecare to improve quality of life and is reported to be the mostly commonly used complementary medicine therapy in the United Kingdom. It has been shown to have some short-term benefit in psychological well being, particularly anxiety. Eight randomized controlled trials of the aromatherapy massage show that a reduction in anxiety was the most commonly found benefit. There was no clear benefit demonstrated for relief of depression, pain, nausea, and vomiting. The use of herbal remedies can often affect the absorption distribution, metabolism, and also excretion of anticancer drugs. Most commonly, it is secondary to the altered expression or functionality of the cytochrome P450 isoenzyme. CYP3A4 is responsible for oxidation of the majority of anticancer drugs, and the use of herbal remedies can often increase the CYP activity causing induction to enzymes resulting in a decreased plasma drug concentration and also therapeutic defect. It often can also cause a decrease in the cytochrome P450 activity resulting in inhibition and in increased plasma drug concentration and toxicity. It can also affect anticancer drug absorption through the effect on ATP binding cassette transport protein in the intestinal epithelium as well. Some of the commonly known herbal remedies that have been shown to inhibit CYP3A4 enzyme include Ginkgo and ginseng. Some of the inducers include echinacea, St. John’s Wort, and also kava, which is known to have some possible hepatotoxicity. Particularly, caution should be exercised when herbal medicines are used in conjunction with cyclophosphamide and also taxanes, such as Paclitaxel, and vinca alkaloids, such as Vincristine Complementary and alternative medicines are commonly employed by patients to alleviate symptoms of sinusitis, according to a recent study by Krause and others in 1999. They surveyed 120 patients who were referred to a community otolaryngology clinic with a chief complaint of sinusitis. Among these patients, 45% had used, prior to their visit, dietary supplements; 35% chiropractors, 29% herbs; 26% biofeedback therapies; and 19% acupuncture. The use of homeopathy has been called by the advocates as the art and science of healing the sick by using substances capable of inducing the same symptoms. By opponents, it has been called the ultimate fake. The practice actually involves a serial dilution of the extract. The extract is diluted, usually in an alcohol-base solution, and then poured off and then mixed again. The process is repeated up to 200 times. As a result, the resulting dilution usually does not contain even a single molecule of the active ingredient. However, interestingly, the FDA moved a number of homeopathic remedies from over-the-counter status to a prescription status in 1990. So, the question to physicians and scientists is, "How does the medicine actually work if the active ingredient is actually not present in the dilution?" However, interestingly, homeopathic remedy has been shown to relieve symptoms of allergic rhinitis by improving nasal airflow. Taylor and others from BMJ, in 2000, did a randomized double-blinded placebo control trial of 50 subjects with allergic rhinitis. The intervention was an aural homeopathic allergen preparation of 1:10 60 dilutions—obviously, there is no molecule of the allergen left whatsoever—versus a placebo control group. Interestingly, they actually saw that the homeopathic group had some objective improvement in the nasal airflow versus the placebo group, as shown here in the square boxes. There was actually no significant difference in the subjective symptoms. The main caveat of this study was that it was a small sample size of 50 patients. Oscillococcinum is a homeopathic regimen for treatment of influenza, which is touted to be the nature’s number one flu medicine. It is a patented homeopathic remedy available over the counters and is very popular in UK, France, and Germany. It is actually manufactured from wild duck hearts and liver extracts, which are said to be reservoirs for influenza virus. The Cochrane review, done in 2004, by Vickers and Smith reviewed a series of randomized controlled trials involving over 3000 subjects. They show that there is no evidence that oscillococcinum prevents influenza-like symptoms. However, they did see that this medication can reduce the length of the influenza illness by about 0.28 days. The conclusion was that, although promising, the data is not strong enough to make general recommendation of this medication as a first line treatment. There have been controversies regarding the positive effect of homeopathy. A meta-analysis done, which was published in Lancet in 1997, looked at 89 double-blinded placebo controlled studies of homeopathy in various disorders involving over 10,000 subjects. They show that there was an overall odds ratio of 2.45 favoring homeopathy over placebo, but there was insufficient evidence showing efficacy for any single clinical condition involving homeopathy in different types of illnesses. An updated meta-analysis published just last year, in Lancet again, includes 110 placebo-controlled homeopathic trials and 110 conventional medicine placebo-controlled trials matched for disorders and outcome. And this time, they did not see any convincing evidence that homeopathy was superior to placebo. The odds ratio was 0.88 with a confidence interval crossing 1.0, but effect did remain, fortunately for us, for conventional medicine, after adjustments. The conclusion was that clinical effects of homeopathy are placebo effects. Capsaicin peptide compound has been used to treat rhinitis. It is a component of the hot pepper. Intranasal capsaicin stimulates the afferent nerve endings mostly on myelinated C fibers and to a certain extent myelinated A delta fibers as well, causing release of substance P and calcitonin gene-related peptide. Repeated stimulation has shown to result in depletion of these fibers resulting in nerve destruction and desensitization. It has been shown to improve the nasal symptoms in nonallergic rhinitis in some randomized placebo-controlled trials. These studies are all small in sample size. There was questionable effect in allergic rhinitis where they show subjective improvement, but not objective improvement. Complementary and alternative medicine use in surgical patients is reported to be about 22% in a recent study. Fifty-one percent of the patients in the same study used vitamins. It is most common among females in age 40 to 60. There is a strong association between use of over-the-counter medication and herbal medication. The most common herbs noted were echinacea, Ginkgo, St. John’s Wort, garlic, and ginseng. There is higher incidence of use among a certain subset of surgical patients, particularly cosmetic surgery patients. According to that same study, the top 10 herbal medicines used by preoperative patients—note that these are cosmetic surgery patients—are: 10. Garlic, used for infection, hypertension, and cancer prevention 9. Kava, anxiolytic and muscle relaxant 8. Ginseng, used for antioxidant and hyperglycemia 7. Milk thistle used as anti-inflammatory agent 6. Golden seal, similarly an anti-inflammatory effect 5. Ginkgo biloba used for dementia, vascular disease, and tinnitus as well as asthma 4. Glucosamine, for osteoarthritis 3. Echinacea used for infection and common cold 2. Ephedra used for energy boost and also weight loss 1. Chondroitin, used for osteoarthritis Garlic, whose active ingredients include ajoene and other thiosulfinates, has been shown to inhibit platelet aggregation, although not platelet adhesion, by inhibiting incorporation of arachidonic acid into the platelets. It is recommended that garlic be stopped at least one week prior to surgery. Ginkgo, as we mentioned earlier, inhibits platelet-activating factor, therefore resulting in increased bleeding risk. It is recommended that ginkgo be discontinued at least 36 hours prior to surgery. Long-term use of Echinacea for greater than eight weeks has been shown to cause potential immunosuppression and, therefore, theoretically increases the risk of poor wound healing, and opportunistic infections. Therefore, we may recommend discontinued use of echinacea as far in advance as possible prior to the scheduled surgery, although there is no evidence to support this at this time. Ginseng, with the active ingredient ginsenosides, is primarily used in Western nations to lower postprandial blood glucose. It has been shown to inhibit platelet aggregation in vitro and also possibly may have other antiplatelet activities as well. It is recommended that this be discontinued at least 7 days prior to surgery. St. John’s Wort has been shown to inhibit serotonin, norepinephrine, and dopamine uptake by neurons. It is used for mild to moderate depression, and it is also a CYP3A4 inducer. It has been show experimentally to double the hepatic metabolic activity. The median half-life of this compound is about 43 hours, and is recommended that this should be discontinued at least 5 days prior to surgery because of drug interactions. Ephedra, known as Ma Huang in Chinese, is commonly used for weight loss, energy boost, and treatment of URI symptoms. The active ingredient is ephedrine, which is a noncatecholamine sympathomimetic agent. It has both direct and indirect effects on adrenergic receptors, and can also cause indirect release of endogenous norepinephrine. Its use carries with it a significant risk of vasal spasm and intraoperative ventricular arrhythmias, and its use was banned by FDA in April 2004. Kava is derived from the dry roots of the pepper plant, Piper methysticum. It is commonly used by the public as an anxiolytic. The active ingredient is kavalactones, which potentiate GABA inhibitory neurotransmission and also can increase barbiturate-induced sleep time in animals. It has the potential to increase the sedative effect in anesthetics and, therefore, it should be discontinued for at least 5 days prior to surgery. In summary, it is important for us, as physicians, to elicit information regarding patients who use complementary alternative medicine. For the interested patient, proven conventional therapeutic options can be discussed with viable complementary alternative medicine treatment modalities. It is also important for us as physicians to emphasize to the patients that natural does not equal safe, as we discuss the evidence on the available complementary alternative medicine treatment options. And, as we show in this presentation, larger, high quality clinical trials are needed to determine the efficacy of most of the available CAM treatment modalities. It is important for us to be aware of the different therapies that are available so that we can advise patients appropriately regarding the use of these treatment modalities. Case Presentation: J.T. is a 55-year-old male veteran who presented to the Houston Michael E. DeBakey Veterans Affairs Medical Center Otolaryngology Clinic in February 2003 for evaluation of worsening dysphagia, odynophagia, and hoarseness for the past several months. His past medical history was significant for COPD and a >100 pack year smoking history. He was taking an albuterol/atrovent inhaler as well as the herbal compound red clover. On exam he was noted to have an ulcerative epiglottic lesion extending into the vallecula and onto both AE folds. The BOT was clear and bilateral TVCs were mobile. CT evaluation showed pre-epiglottic space mass with no lymphadenopathy. J.T. was taken to the OR in April 2003 for DL&B. Biopsy specimen from the epiglottis and vallecula confirmed the diagnosis of moderately-differentiated squamous cell carcinoma. He was tentatively staged as T3N0M0. The patient could not tolerate lying down flat for radiation therapy and expressed desire for surgery. He was scheduled for total laryngectomy but declined the procedure on the day of surgery. He had decided that he will continue to seek spiritual care and red clover for his cancer. Ethics and psychiatry consults were obtained and deemed patient competent to make his own medical decisions. He failed to keep his medical oncology appointments despite multiple attempts to contact him. J.T. returned to the otolaryngology clinic 1 year later with progressive respiratory distress. Workup at that time revealed progression of disease as well as new pulmonary metastasis. He was clinically staged as T4N2bM1. Tracheostomy was performed to secure the airway and patient tolerated the procedure well. He refused further treatments and was transferred to the palliative care service. Bibliography: Ang-Lee MK, Moss J, Yuan CS. Herbal medicines and perioperative care. JAMA 2001;286:208-216. Asher BF, Seidman M, Snyderman C. Complementary and alternative medicine in otolaryngology. Laryngoscope 2001;111:1383-1389. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Adv Data 2004:1-19. Cassady JM, Zennie TM, Chae YH, Ferin MA, Portuondo NE, Baird WM. 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