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REFLECTION ON RESEARCH MANUSCRIPT

A major component of the DAOM program is to complete a research project of our choice, with approval, and submission of a final manuscript, ready for publication.  The process has evolved through learning paradigms of inquiry, qualitative and quantitative analyses, and in cases of human subject research, submission of IRB to assure ethical behavior when the research is performed.

My manuscript has gone through many versions, beginning with selection of the type of research – a systematic review of the use of acupuncture and Traditional Chinese Medicine (TCM) for the treatment of GERD (Gastroesophageal Reflux Disorder). My decision to select this topic comes from my personal clinical experience of so many patients who have sought acupuncture and TCM because current standard of care treatment of GERD didn’t work for them, created side effects from the medications, and wanted to avoid surgery.  Because of the large population in the United States that suffer from GERD, I thought it would be beneficial to determine if there is enough research literature to support a more active involvement and promotion of using acupuncture and TCM as a legitimate, safe, and effective modality.  The result of the review is provided in this artifact.

I began the project seeking as much information as I could acquire from as many sources as possible – databases, PubMed, journals, news articles, peer reviewed and  non-peer reviewed journals and newsletters, blogs, books – anything I could find that might address the topic. I thoroughly enjoyed the search.  I found quite a bit of research and information on the conventional allopathic standard of care and approaches to treatment, but the amount of literature on acupuncture and TCM treatment was considerably less, and ultimately only 3 articles met the  inclusion criteria listed in this artifact. Although the articles suggested support for acupuncture and TCM as an effective treatment for GERD, the volume of material available was quite disappointing and thus could not sufficiently support the use of acupuncture and TCM for the treatment of GERD. Obvious from this review is the need for more high quality peer reviewed research studies on the topic.

The process of creating this document has been a somewhat challenging journey.  I have not had the opportunity in the past to do any formal research, I am not strong in  statistical analyses, and have found the process of multiple revisions of the document somewhat disconcerting. I have recently learned that multiple revisions and suggestions from multiple sources is quite common in developing a research article, i.e., peer review.  My expectation was that my efforts would result in early acceptance; however that has not been the case and I have struggled with understanding the need for so many revisions.  I have learned through this process that it is imperative to be clear about what is being said and establishing accurate conclusions as well as understanding the recommendations from others.  One important comment I have incorporated into my primary knowledge base is that research never “proves” anything…there can be possible causation or correlation, but the “truth” may be elusive and controversial.

Although I am pleased with the results of this project, my experience with this project has reinforced my decision to remain in clinical practice and not venture into research. Perhaps my resistance to further developing research projects in the future rests with my own focused interest in direct patient care.  While I have learned the process necessary to develop a systematic review or other type of research, I realize I have neither the patience nor desire to pursue research. I enjoy teaching, and certainly in the past have utilized numerous research materials to support whatever subject I am teaching (and will continue to do so), but I believe there are others who are more inclined to enjoy research and I bow to them. I think doing research is a tedious, difficult venture, but is necessary especially as we move in to a more integrative practice.  Because we are practicing in a western culture where conventional medicine is prevalent, it is imperative that quality research  be presented through legitimate means.  Quality research coming from doctoral programs such as this one at AOMA will add legitimacy and acceptance of acupuncture and TCM in conventional medicine, and offer alternative or complementary support for patients, which is, after all, our ultimate purpose.

What might have been more helpful at the beginning of the DAOM program is a clear, specific outline of the entire research process, including timelines, and the process of peer review during and at the end of the program. Perhaps a written outline that detailed the entire process from beginning to end, instead of providing each segment separately with each semester in the form of an assignment, may help clarify how each segment fits into the end product and the timing thereof.  I do think there needs to be more emphasis placed on submitting a complete research manuscript long before the last semester. Perhaps requiring the first “final draft” at the end of the first year, or end of the first semester for the second year would be better timing for both the student and the program.  Such a process would allow students to address all issues as they arose as opposed to attempting to address everything during the last couple of semesters.

Selecting and/or assigning academic advisors who are available and willing to work with the student early in the process would also be helpful.  Perhaps once a topic is selected by the student (in the first or second semester of the first year),  an approved academic advisor could also be selected and incorporated into the development of the research project at that time, instead of waiting a later semester.

What also might be helpful is one to one meetings at least quarterly with the Program Director and Academic Advisor with each individual student.  In this manner the student would have an opportunity to discuss any concerns or issues they are encountering, as well as receive feedback on any topic that might come up that would help the student through the research process. I for one did not and still do not completely understand the entire process of creating a research project and manuscript, and struggled to understand how each piece of the puzzle actually fit together.

Recognizing that the doctoral program does have certain requirements to maintain their certification, searching for ways to make the program more effective and produce qualified doctoral practitioners will be an ongoing opportunity for growth.  I feel certain that there will continue to be refinements that will assist future doctoral students an opportunity to provide outstanding research.

 

SYSTEMATIC REVIEW OF ACUPUNCTURE AND TRADITIONAL CHINESE MEDICINE RESEARCH IN TREATMENT OF GASTROESOPHAGEAL REFLUX DISORDER

SHENGYAN ‘GRACE’ TAN, LAc, PHD, MD (CHINA), OMD (CHINA)
DEPARTMENT OF INTEGRAL STUDIES 
FACULTY ADVISOR

PATTI CAREY, LAc, MTOM, MS, DIPL. ACU/HERBS

DAOM CANDIDATE (2015)

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SYSTEMATIC REVIEW OF ACUPUNCTURE AND TRADITIONAL CHINESE MEDICINE RESEARCH IN TREATMENT OF GASTROESOPHAGEAL REFLUX DISORDER

ABSTRACT:

BACKGROUND: Gastroesophageal Reflux Disorder (GERD) is a common health condition that affects an estimated 20-30% of the U.S. general population on a daily basis. It is the most frequent diagnosis and reason for consulting with a gastroenterologist or other medical practitioner. (1,2,3) While there have been few comprehensive studies on the costs of GERD Vakil et.al, and other authors have shown, for example, that the cost of treating acid-related disorders is approximately $59 million in a managed care setting. Personal costs for medications range from $471 to several thousand dollars per person including medications annually. (4,5) Bloom et.al, reported in the American Journal of Gastroenterology that the cost of treating people with GERD is twice as much as those without GERD. (6) GERD can also be responsible for loss of productivity at work as well as time off work, and reduction in daily activities. Although these costs are difficult to establish, the International Foundation for Functional Gastrointestinal Disorders (IFFGD) estimates that GERD costs nearly $2 billion each week from missing work. (3) What has not been estimated or identified are the costs of treating side effects from drugs and surgeries for GERD. Current standard of care for GERD consists of over the counter and prescription medications such as proton pump inhibitors (PPI), H2 blockers, or prokinetic and reflux inhibitors, which are limited in their effectiveness, have serious side effects, may lack patient compliance for long-term remission or resolution, and can affect patient quality of life. (7,8,9,10,11) Acupuncture and Traditional Chinese Medicine (TCM) have been used for many centuries in Asian medicine for the treatment of GERD but is not well known as a treatment alternative or complement to current standard of care, although the NIH (National Institutes of Health), NCCIH (National Center for Complementary and Integrative Health) and WHO (World Health Organization) recognize Acupuncture and TCM as effective treatment for acid indigestion and digestive disorders (1,12, 13)

OBJECTIVE: The objective of this systematical review is to determine if there is sufficient research literature in previously published studies in relevant journals and other resources to identify the safety and effectiveness of Acupuncture and TCM for the treatment of GERD, and identify any significant gaps in research that would support the need for additional studies.

DATA SOURCES A systematic review of accessible literature was conducted on the Acupuncture and TCM treatment of GERD in databases, journals, and other sources from the last 15 years (2000-2015). Primary and secondary studies focusing on GERD treatment were compiled and reviewed using literature searches in all databases with specific keywords for this subject (see below). Inclusion and Exclusion criteria were established and 127 articles were reviewed. Of those meeting the Inclusion criteria only 3 were full text English language articles and 3 were abstracts. To be comprehensive, the 3 foreign-language translated abstracts are included in this review, but were not considered in the final assessment of the evidence.

CONCLUSION/IMPLICATIONS: Three studies of the 127 articles met all study criteria. One study used a combination of electroacupuncture and Chinese herbal medicine (Zhi Zhu Kuan Zhong capsules). (14) The second study used acupuncture versus doubling the dosage of the proton pump inhibitor (15) The third study used acupuncture alone with a control group using Omeprazole. (16) The 3 abstracts also used different techniques: acupoint drug-finger pressing compared with Omeprazole (17); acupuncture alone compared with Omeprazole (18), and electroacupuncture and Dalitong with a control group using Mosapride, Omeprazole, and Amitryptyline (19). All 6 studies suggested improvement with the use of Acupuncture and herbal medicine when compared with standard of care pharmaceuticals. However because of the limited number of articles that met the Inclusion criteria, this review does suggest that there are gaps in research on Acupuncture and TCM for the treatment of GERD, especially when compared with current standard of care. At this time there appears to be limited evidence to support the use of TCM and acupuncture in the treatment of GERD. More high-quality studies are needed to establish the safety and efficacy of these therapies in the treatment of GERD.

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INTRODUCTION:

According to a review by Toku Takahashi in the Journal of Gastroenterology gastrointestinal disorders are one of the most common complaints for which the general population seeks medical care. (1) GERD impacts 20-30% of the population in the US and can affect anyone from newborns to the elderly. Not only can such disorders affect patients physiologically, there are psychosocial, emotional, environmental and financial factors that can have a profound impact on their quality of life, work productivity, and overall morbidity. (2,20,21,22) GERD symptoms can vary and patients may present for medical care with no apparent gastrointestinal complaints. GERD should be considered when patients present with other symptoms such as a Clostridium difficile infection, asthma, chronic cough, hiatal hernia, etc., or when considering treatment such as a magnetic ring (a surgical implant around the esophagus to keep food in the stomach), or gastric bypass surgery for obesity. (23) GERD treatment by pharmacological therapies consists of antacids such as proton pump inhibitors which stop acid production, or H2 antagonists that block histamine receptors in parietal cells that make acid, both of which carry serious side effects such as immune suppression, exacerbation of atherosclerosis, hypocalcaemia, fatigue, weakness, and mood disorders. Table 1 provides a list of potential side effects for pharmacological therapies. Both prescription and non- prescription antacids have shown to be limited in effectiveness, and may require long-term usage, which increases the potential for side effects. Ament et al provided a summary of articles from 1992 through 2010 regarding the adverse effects of proton pump inhibitors and found that there was a strong correlation between PPI and hip fractures, cardiac events, iron deficiency, enteric infections, pneumonia, gastric acid rebound, and stress ulcers, especially with long term use of PPI. In 2010 relabeling was required by the FDA to include that PPI could lead to increased risk of fracture of the hip, wrist, and spine.(8) Over the counter antacid side effects include diarrhea if it contains magnesium, constipation if it contains calcium or aluminum, kidney stones if calcium is included, and, if it includes large amounts of aluminum, there is a potential risk of osteoporosis. (Table 1) (10) For patients who are unable to control their symptoms with medications, surgical treatment may become an option. The most common surgical procedure for GERD is Nissen fundoplication, which involves tightening and reinforcing the lower esophageal sphincter by wrapping the upper part of the stomach around the outside of the lower esophagus. Common side effects from this procedure include continued gas, bloating, difficulty swallowing, and the return of GERD. (24) Most recently, a newly created “incisionless” operation to stop GERD and reduce postoperative side effects was developed by Ohio State University Medical Center. The effectiveness of this procedure has not yet been forthcoming. (25) New Guidelines for GERD from the American College of Gastroenterology in 2013 included losing weight, elevating the head of the bed, advising against foods thought to provoke or aggravate GERD, and warning against long term use of antacids due to the possible increase in side effects as noted in Table 1. (26, 27)

There may be some genetic propensity for development of GERD. In two studies reviewed by Dent, et al., it was found there was a significant association in monozygotic twins or individual when there was a parental family history or immediate relative with GERD, but not in a spousal relationship. (5) There can also be a profound psychosocial emotional impact on patients who live with the pain and discomfort of GERD and the side effects of medications prescribed for GERD. Jansson et.al. noted the results of a large population based study that found depression and anxiety had a strong connection to reflux symptoms, although the connection has been largely unexplored in research. It seems the higher the level of anxiety and depression, the greater increased risk of GERD symptoms. (21) Sharma et. al, reported that when considering racial and geographic distribution of GERD, it appears that North America, and Europe have higher risks for GERD than Asian and African Americans. They noted that South America, Middle East, Africa, and the Subcontinent of India appear to have very little data provided for the study. The conclusion was that there are many questions that remain unanswered when exploring race and geographic distribution of GERD. (28)

One study from the Turkish Journal of Gastroenterology found that their general population is disappointed in the current treatment protocols of drugs, and are seeking alternative or complementary therapies to help resolve their GERD. (29) Comparison of standard of care pharmaceuticals with Chinese herbal formulas that have been used for many centuries for the treatment of GERD has shown minimal or no side effects with the herbal formulas. Examples of herbal formulas include Chai Hu Shu Gan Wan (origin: Zhang Jing-Yue, 1624), Er Chen Wan (origin: Chen Shiwen et al, 1080), Xiang Sha Yan Wei Wan (origin: Gong Tingxian, 1587) (a very popular formula for reflux/GERD/indigestion), Fu Zi Li Zhong Wan (origin: Chin Shiwen, et.al, 1080), Mu Xiang Bing Lang Wan (origin:

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Zang Congzhen 1228, Zhu Zhenheng 1481, and Wang Ang 1682), and Yi Guan Jian Wan (origin: Wei Zhixiu 1770). (30) (Table 2) In one case from current private clinical practice, acupuncture, nutritional counseling, and herbal formulae (Chai Hu Shu Gan Wan) seemed to provide better short and long term (6 months) resolution of symptoms with no side effects. Dietary counseling and removal of gluten products were also incorporated into the treatment protocol. (unpublished data)

METHODS:

A systematic review in relevant literature on Acupuncture and TCM for the treatment of GERD was conducted of English only or translated-into-English articles from databases, journals, and other sources published in the last 15 years (2000-2015), and the results are shown in Figure 1. The primary and secondary studies focusing on GERD treatment were compiled and reviewed by the authors using specific keywords as listed below. Once all available literature had been retrieved, each document was reviewed for meeting the inclusion or exclusion criteria, biases, and outcomes supporting or not supporting the use of Acupuncture and TCM for the treatment of GERD. An important element in determining the outcome was attempting to identify any bias based on culture, race, or geography using on the Cochrane risk of bias tool.

KEY WORDS: Acupuncture, TCM, Traditional Chinese Medicine, gastrointestinal disorders, Oriental Medicine, GERD, reflux, acid reflux, functional dyspepsia, acupuncture treatment, TCM treatment, stomach cancer, esophageal cancer, digestive disorders, acupuncture therapy, functional gastrointestinal disorders, electro- acupuncture, electro-stimulation, alternative treatment of GERD, complementary treatment of GERD

SEARCH STRATEGY AND STUDY SELECTION: Literature searches included Pub Med Health (NIH), Medline, Cochrane (all databases), Medscape, Escience Central, China Journal Full-Text Database, and SearchMedica, bibliographic references from selected research sources meeting inclusion criteria, unpublished data, peer reviewed literature – and non-peer reviewed articles and cases such as American Cancer Society, Wiley Online Library, International Foundation for Functional Gastrointestinal Disorders, Elsevier Journal Online Today, and cited articles in Acupuncture Today, Acupuncture.com and the California Journal of Oriental Medicine. Articles including standard of care and deviations from standard of care for the treatment of GERD were numerous; however, there appeared to be fewer evidenced based research articles in the literature using Acupuncture and TCM as a treatment strategy for GERD.

INCLUSION CRITERIA:

All studies including peer reviewed articles, indexed journals, case series, case studies, case-control, observational studies, comparative effectiveness and RCTs, with 5 or greater participants (to minimize bias and have adequate subjects to compare)

Studies done within the last 15 years (provides most current treatment information) Participants have diagnosis of GERD or acid reflux, (to assure study is

addressing this specific gastrointestinal disorder) Human adults only

One or more treatment modality of acupuncture, electro-acupuncture and/or Chinese herbal medicines (for recognition of multiple combinations that can be used in Acupuncture and TCM)

English language publications

EXCLUSION CRITERIA:

Studies focusing only on pharmaceutical medications or therapeutic modalities for GERD (the focus of this review

is Acupuncture and TCM treatment of GERD)

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Active cancer treatment of any digestive disease if, prior to cancer diagnosis and treatment, GERD was not diagnosed

Articles that were rejected fell primarily into three categories: 1) research articles older than 15 years, 2) studies on animals, and 3) articles with pharmaceutical only treatments. Three articles that would have met the Inclusion criteria were in a foreign language (3 Chinese) and no translation or copy of the full text was available.

RISK OF BIAS: The Cochrane Collaboration risk of bias tool was used for the 3 full text articles and the 3 abstracts. Table 4 shows the summary of the results of the 3 selected articles. None of the articles or abstracts indicated single and double blind selection (17,18, 19, 20, 30, 29, 31) All articles provided randomization. (21) Because there is a preponderance of articles from Asian countries in this review, and because of the long standing acceptance of Acupuncture and TCM as standard of care in Asian countries, there may be a potential for medium to high risk for bias.

RESULTS:

All data were independently reviewed for Inclusion criteria, including time point (how long the treatment protocol lasted), publication within the last 15 years, English translation if the study was conducted and published in a non- English journal, had a statistically relevant number of samples in the study (no less than 5 participants)., and assured a diagnosis of GERD or reflux. Extensive searching of relevant literature addressing the Objective resulted in 127 articles selected for review based on Inclusion criteria. Six studies initially met the criteria and were further reviewed, but only 3 proved to be available and were full text, meeting all criteria. Three Abstracts had the potential for meeting Inclusion criteria. However, these abstracts were in a foreign language (Chinese) and unavailable for translation Although included in the review, the abstracts were not included in the final assessment of the Objective.

In reviewing the 3 selected articles, a total of 570 patients were treated, and 150 were in a control group. All studies that met the Inclusion criteria had a small number of participants except the study that used electroacupuncture and the Zhi Zhu Kuan Zhong formula (480 patients) (14). The 3 studies were randomized but did not clarify if they were double or single blinded. They did provide time points between 4 and 6 weeks. The studies by Zhang CX and Dickman reported follow-up results at 4 and 54 weeks respectively, concluding that acupuncture alone (4 week) or acupuncture with combined therapy (Zhi Zhu Kuan Zhong and acupuncture (54 weeks) continued to provide reduction or alleviation in patient symptoms without adverse reactions and easy acceptance by the patient. (14, 15, 16) In summary, the 3 articles that met Inclusion criteria showed improvement in symptoms, fewer adverse reactions, lessening of pain, effective for the both long and short term results, reduction of reflux, symptom alleviation, good acceptance by patients, and improved quality of life. The results are encouraging and it appears Acupuncture and TCM may be effective and safe; however, from this review it appears that there is a gap in research on the treatment of GERD with Acupuncture and TCM, due to either lack of access to published articles, or actual lack of research on the subject. Had the 3 abstracts that showed similar results been available in full text translation there may have been more support for the Objective, but the current results of this systematic review suggests that larger double-blinded RCTs high-quality studies are needed to provide support for the safety and efficacy of Acupuncture and TCM in the treatment of GERD.

DISCUSSION:

Reflecting on the three studies that were selected for review, Dickman et al (2007) compared Acupuncture with doubling of proton pump inhibitors (PPI) dosage and concluded that acupuncture was more effective than doubling the dosage of the PPI alone, without side effects. (15) Zhang, et al., in the Journal of Traditional Chinese Medicine reported that electrostimulation of Zusanli ST36, Zhongwan CV 12, Neiguan P6, Taichong LR3, and Gongsun SP4, and the inclusion of Zhi Zhu Kuan Zhong capsules alleviated GERD symptoms and improved patient quality of life. The findings also suggested that utilizing both the herbal formula and Acupuncture provided better and longer relief of GERD symptoms than either alone. (14) Another study by Zhang using Acupuncture only to determine efficacy and safety reported that Acupuncture can alleviate symptoms of GERD safely, and is well

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accepted by patients.(16) Other studies that were reviewed for Inclusion but did not meet all inclusion criteria included a 2005 Taiwanese study reported in the American Journal of Physiology that using electrical stimulation on Neiguan (P6) had a significant positive impact on the lower esophageal sphincter.(31) Noguchi studied the gastroduodenal reflux regulation function and motility using acupuncture stimulation, and reported that the results were “mixed”.(32) With the recognition of the severity of side effects, other approaches need to be researched to find an acceptable solution. (7,8,9,10,33) Such research suggests the possibility of inclusion of Acupuncture and TCM as an alternative or adjunct to standard of care and pharmaceuticals but considerably more evidence-based research is needed to clarify the role, safety and effectiveness of Acupuncture and TCM in the treatment of GERD. (20) While the selected studies in this review did suggest that Acupuncture and TCM may be appropriate for the treatment of GERD, at this time there is lack of evidence to support it as standard of care either as a complementary or alternative treatment of GERD.

CONCLUSIONS:

The Objective of this systematic review was to determine if there was sufficient evidence in the research literature to support the use of Acupuncture and TCM in the treatment of GERD. GERD is a significant health issue that affects millions of people worldwide at considerable cost. The current standard of care suggests low to moderate success with treatment, and has the potential for serious side effects as well as a significant impact on patients’ quality of life., Novel effective, safe, lower cost treatment options are needed for the treatment of GERD. The results of this systematic review show that there is insufficient evidence to support the adoption of Acupuncture and TCM therapies as standard of care, and highlight the need for more high quality research in this field.

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TABLE 1
SIDE EFFECTS OF CURRENT STANDARD OF CARE PHARMACEUTICAL DRUGS FOR GERD

TYPE DRUG NAME SIDE EFFECTS PSYCHOEMOTIONAL REFERENCES_

PROTON PUMP INHIBITORS

Prilosec/omeprazole Prevacid/lansoprazole Aciphex/rabaprazole Nexium/esomeprazole Kapidex/dexlansoprazole Protonex/pantoprazole

Headaches, diarrhea (Clostridium difficile), abdominal pain, dry mouth, constipation, diarrhea, flatulence, weight gain, difficulty breathing, hives, difficulty swallowing, immune suppression pneumonia, hip fractures esp. postmenopausal females, interference with CA absorption, hypomagnesaemia resulting in arrhythmia, cardiac conductive defects, muscle spasms, tetany, hypocalcaemia, epileptic seizures, hypoparathyroidism, reduces Vit A absorption resulting in dry eyes, color blindness, peeling nails, dry hair, dry skin, grey spots in eyes, night blindness, impaired immunity, neutral pH of stomach creates UTI, reduced energy , mouth sores/ulcers, gas, digestive pain, inflammatory bowels, food sensitivities, infections from reduced Vit D.

Mood disorders due to reduced Vit D

Altman KW, Radosevich JA.

The challenge of protocols for reflux disease: a review and development of a critical pathway. Otolaryngology – Head and Neck Surgery 2009 Nov;141(5)546-66 American Gastroenterological Association (33)

Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. Dec27,2006;296(24):2947- 53. (7)

H2 RECEPTOR ANTATONIST AND BLOCKER

Zantac/rantidine Tagamet/cimetidine Pepcid/famotidine Axid/nizatidine

Headache, constipation, diarrhea, nausea, vomiting, abdominal pain, rash, liver problems, cardiac

irregularities, B9 malabsorption
atherosclerosis, skin megaloblastic anemia, reduced iron causing shortness of breath, chronic fatigue, paleness, heart palpitations,

dizziness, twitching, fatigue, neuropathy, symptoms

(folate) exacerbating paleness,

hair loss, muscle

blocks weakness,

B12 dementia-like

causing confusion,

Depression, agitation, hallucinations, confusion, anxiety, obsessive- compulsive behavior, dementia-like symptoms

Cohen,S. Acid Reflux Medications are Big Drug Muggers Causing Many Side Effects. Huffington Post Health Watch. Jan 28;2013. http://huffingtonpost.com/ suzy-cohen-rph/acid-reflux- medications-are-bit-drug- muggers-causing-many- side-effects.(10)

Patti,MG.

Gastroesophageal Reflux Disease Treatment & Management. Medscape Drugs, Diseases & Procedure Reference. May 6, 2013. http://emedicine.medscape .com/article/176595- treatment.(23)

PROKINETIC MEDICATIONS AND REFLUX INHIBITORS (serious complications, potentially fatal)

Clopra, Maxolon, Ocamide, Reglan/metoclopramide

Restlessness, drowsiness, diarrhea, musculoskeletal weakness/hypotonia, insomnia, rash, breast tenderness, prolactin stimulation, nausea, dry mouth, fatigue, hypertension, hypotension,

tachycardia, tardive methemoglobinemia, extrapyramidal reactions, ataxia,

dyskinesia,

Depression, agitation, irritability, anxiety, Disorientation, impaired mental alertness

Patti,MG.

Gastroesophageal Reflux Disease Treatment & Management. Medscape

Drugs, Procedure 6,

Diseases & Reference.May 2013.

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seizures, lack of physical coordination

http://emedicine.medscape .com/article/176595- treatment. (23)

TABLE 2
SIDE EFFECTS OF TRADITIONAL CHINESEE MEDICINE HERBAL FORMULAS FOR GERD

FORMULA INGREDIENTS CONTRAINDICATIONS SIDE EFFECTS REFERENCES _

Chai Hu Shu Gan Wan

Chai Hu, Chen Pi, Chuan Xiong, Zhi Ke, Bai Shao, Gan Cao, Xiang FU

Diarrhea, fever

Dry mouth, thirst

Bensky, D, Barolet, R. Chinese Herbal Medicine Formulas & Strategies. Eastland Press Inc. 1998 (30)

Er Chen Wan

Ban Xia/Rhizoma Pinelliae Ternatae
Ju Hong or Chen Pi/Pericarpium Citri Erythrocarpae

Fu Ling/Sclerotium Poriae Cocos
Zhi Gan Cao/Honey-fried Radix Clydyrrhizae Uralensis

Cough without phlegm or scant phlegm, emaciation, general debilitation from long illness, or night sweating.

Improper use can lead to excessive thirst and dry throat

Bensky D, Barolet, R. Chinese Herbal Medicine Formulas & Strategies.Eastland Press Inc. 1998 (30)

Xiang Sha Yan Wei Wan

Ren Shen/Radix Ginseng
Bai Zhu/Radix Atractylodis Marcrocephalae
Fu Ling/Sclerotium Poriae Cocos
Cang Zhu/Rhizoma Atractylodis Jiang Zhi Chao Huo Po/Ginger juice-fried Cortex Magnoliae Officinalis
Chen Pi/Pericarpium Citri Reticulatae
Chao Xiang Fu/Dry-fried Rhizoma Cyperi Rotundi
Bai Dou Kou/Fructus Amomi Kravanh
Mu Xiang/Radix Aucklandiae Lappae
Sha Ren/Fructus Amomi
Sheng Jiang/Rhizoma Zingiberis Officinalis Recens
Zhi Gan Cao/Honey-fried Radix Glycyrrhizae Uralensis
Da Zao/Fructus Zizyphi Jujubae

High fever, irritability, excessive thirst, constipation

Dry mouth, thirst, irritability

Bensky D, Barolet, R. Chinese Herbal Medicine Formulas & Strategies.Eastland Press Inc. 1998 (30)

Fu Zi Li Zhong Wan

Fu Zi/Radix Lateralis Aconiti Carmichaeli Praeparata
Gan Jiang/Rhizoma Zingiberis Officinalis

Ren Shen/Radix Genseng
Bai Zhu/Rhizoma Atractylodis Macrocephalae
Zhi Gan Cao/Honey-fried Radix Glycyrrhizae Uralensis

Externally contracted conditions with fever

Dry mouth, thirst

Bensky D, Barolet, R. Chinese Herbal Medicine Formulas & Strategies.Eastland Press Inc. 1998 (30)

Mu Xiang Bing Lang Wan

Mu Xiang/Radix Augklandiae Lappae
Bing Lang/Semen Arecae Catechu

Da Huang/Radix et Rhizoma

Weakness, frailty, recovering from illness

Increased diarrhea

Bensky D, Barolet, R. Chinese Herbal Medicine Formulas & Strategies.Eastland Press Inc. 1998 (30)

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Rhei
Qian Niu Zi/Semen Pharbitidis Qing Pi/Pericarpium Citri Reticulatae Viride
Chen Pi/Pericarpium Citri Reticulatae
Chao Xiang Fu/Dry-fried Cyperi Rotundi
E Zhu/Rhizoma Curcumae Ezhu Huang Lian/Rhizoma Coptidis Huang Bai/Cortex Phellodendri

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TABLE 3: CHARACTERISTICS OF TRIALS INCLUDED IN THIS REVIEW

STUDY COUNTRY TREATMEN CONTROL RESULTS GROUP GROUP

(1) Clinical trial: acupuncture vs. doubling the proton pump inhibitor dose in refractory heartburn. Dickman R., et al. 2007)(15)

(2)Clinical Study on the treatment of gastroesophageal reflux by acupuncture. Zhang CX., et al., (2010) (16)

(3) Clinical curative effect of electroacupunctu re combined with zhi zhu kuan zhong capsules for treating gastroesophageal reflux disease. Zhang C., et al. (2013) (14)

United States

China

China

30 0

30 30

360 120 (4 treatment groups
with different combinations

of treatment

Acupuncture more effective in controlling GERD symptoms when compared with doubling PPI dose.

Acupuncture inhibited acid and bile reflux and alleviated symptoms safely and was well accepted by patients

Electroacupuncture and zhi zhu kuan zhong together had better long term effects and improved quality of life.

.

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TABLE 4: QUALITY ASSESSMENT OF STUDIES IN REVIEW

ARTICLE/AUTHOR RANDOMIZED

Dickman et al. (2007) Y
Zhang CX et al. (2010) Y
Zhang C et al. (2012) Y _________________________________________________________________________________________

Y = Yes S = single blind D = double blind N = no U = Unknown

BLINDED TIME POINT

EFFECTIVENESS

N 5 weeks Y N 6 weeks Y N U Y

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FIGURE 1

FLOW CHART OF RESULTS OF SYSTEMATIC LITERATURE SEARCH

Records identified through database searching
(n = 131)

Additional records identified through other sources
(n = 3)

Records after duplicates removed (n = 127 )

Records screened (n = 124)

Studies included in qualitative synthesis (n = 3)

Records excluded (n =117)

Full-text articles assessed for eligibility
(n = 5)

Full-text articles excluded, with reasons
(n = 2)

Studies included in quantitative synthesis (meta-analysis) (n= 3)

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IDENTIFICATION SCREENING ELIGIBILITY INCLUDED

Included EligibilityELI ScreeningSSSC Identification

BIBLIOGRAPHY:

1. Takahashi T. Acupuncture for functional gastrointestinal disorders. J Gastroenterol 2006; 41:408-417 doi: 10.1007/s00535-006-1773-6.

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