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Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial

Park et al. Trials 2010, 11:83 Banha-sasim-tang as an herbal formula for thetreatment of functional dyspepsia: a randomized,double-blind, placebo-controlled, two-center trial Jae-Woo Park1, Bongha Ryu1, Inkwon Yeo2, Ui-Min Jerng1, Gajin Han1, Sunghwan Oh1, Jinsoo Lee1, Jinsung Kim1* Background: Functional dyspepsia (FD) is characterized by a high prevalence rate and no standard conventionaltreatments. Alternative therapies, such as herbal formulas, are widely used to treat FD. However, there areinadequate evidences regarding the safety and efficacy of these formulas. Moreover, the mechanisms by whichherbal formulas act in the gastrointestinal tract are controversial. In traditional Korean medicine, Banha-sasim-tanghas long been one of the most frequently prescribed herbal formulas for treating dyspepsia. The current study isdesigned to evaluate the efficacy and safety of Banha-sasim-tang for FD patients and to examine whether therewill be a significant correlation between cutaneous electrogastrography recordings and dyspeptic symptoms in FDpatients, and between changes in gastric myoelectrical activity and improvement in dyspeptic symptoms duringBanha-sasim-tang administration.
Methods: This randomized, double-blind, placebo-controlled trial will be performed at two centers and will includea Banha-sasim-tang group and placebo group. Each group will consist of 50 FD patients. Six weeks ofadministration of Banha-sasim-tang or placebo will be conducted. During the subsequent 2 months, follow-upobservations of primary and secondary outcomes will be performed. The primary outcomes are differences asmeasured on the gastrointestinal symptom scale, and the secondary outcomes are differences as measured on thevisual analogue scale for dyspepsia and on the questionnaire for FD-related quality of life. All outcomes will bemeasured at baseline, at 2, 4, and 6 weeks of treatment, and at the 1 and 2 month follow-up. Cutaneouselectrogastrography will be performed and assessed at baseline and at 6 weeks.
Discussion: This trial will provide evidence of the safety and efficacy of Banha-sasim-tang for the treatment for FD.
Furthermore, based on the assessment of the relationship between cutaneous electrogastrography recordings anddyspeptic symptoms in this trial, the possibility of clinical applications of cutaneous electrogastrography in thetreatment of FD will be elucidated.
Trial Registration: Current Controlled Trials (ISRCTN 51910678); Clinical Identifier: NCT00987805 epidemiologic survey conducted in South Korea Functional dyspepsia (FD) is characterized by chronic or reported that 25% of the population suffers from FD relapsing dyspeptic symptoms in the absence of struc- Although the pathogenic causes of FD remain unclear, tural lesions that can be identified with clinically avail- delayed gastric emptying has been found in up to 50% able tests [In developed countries, 15-20% of the of FD patients Delayed gastric emptying may be general population experiences dyspeptic symptoms at attributed to gastric hypomotility and to uncoordinated some point over the course of any given year An antral duodenal contractions Normal gastric slowwaves originating in the gastric pacemaker lead to nor-mal frequency and peristaltic gastric contractions [Abnormal gastric myoelectrical dysrhythmias has been * Correspondence: 1 observed in FD patients who have shown delayed gastric Department of Gastroenterology, College of Oriental Medicine, Kyung Hee University, Seoul, Korea emptying . Cutaneous electrogastrography (EGG) is a 2010 Park et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License ), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.
Park et al. Trials 2010, 11:83 non-invasive diagnostic technique that detects gastric myoelectrical activity (GMA). Many researchers have (1) Six weeks of oral administration of BST improves used cutaneous EGG, which suggests that this technique dyspeptic symptoms and quality of life in patients with may be useful in the evaluation of gastric motor func- tion in FD patients [. However, the relationship (2) In patients with FD or FD subtypes according to between dyspeptic symptoms and cutaneous EGG the Rome III criteria, there will be a significant correla- recordings remains a controversial topic in FD.
tion between the degree of dyspeptic symptoms and Current treatments for FD target putative underlying cutaneous EGG recordings and 6 weeks of oral adminis- tration of BST can improve the abnormal frequency and impaired gastric emptying, and acid hypersensitivity .
power parameters on cutaneous EGG.
The symptoms of FD are diverse, thus mechanism-focused therapies, such as acid secretion inhibitors, pro- kinetics, and H. pylori eradication, have been used with This study will be carried out as a randomized, placebo- limited effects [Therefore, many patients use controlled, double-blind, two-center trial at the Oriental alternative therapies, including herbal formulas, acu- Hospital at Kyung Hee University Medical Center and puncture treatments, and natural products, to treat FD at the Oriental Hospital at the East-West Neo Medical Centre of Kyung Hee University in Seoul, Korea.
Banha-sasim-tang (BST; Hange-shashin-to in Kampo This clinical trial will consist of a 6-week oral admin- Medicine; Banxia-xiexin-tang in Traditional Chinese istration of BST and a 2-month follow-up period. Before Medicine) is one of the herbal formulas described in screening, all participants will go through a 7-day wash- "Treatise on Cold Damage and Miscellaneous Diseases out phase. During 6 weeks' administration of experi- (Shan-han-za-bing-lin)" the Chinese authoritative mental drugs, patients will be prohibited from taking monographs. This formula is composed of seven herbs.
any kind of dyspepsia-relieving drugs. After randomiza- In traditional Korean medicine, this formula has been tion, 3 g TID of BST or placebos will be provided for 6 applied for treating the symptom "gastric stuffiness" weeks. Outcomes will be measured at baseline, at 2 , which is similar to dyspepsia. Recently, several stu- weeks, at 4 weeks and at 6 weeks after randomization.
dies have elucidated the gastric function and related Outcomes will also be measured at 1 month and 2 mechanisms of BST months after completion of BST administration. During Moreover, BST can be obtained as an over-the-coun- 2-month follow-up period, conventional treatments for ter herbal formula in Korea or prescribed for dyspeptic dyspepsia will be permitted if the dyspeptic symptoms symptoms by the Traditional Korean Medicine doctors.
are exacerbated or recur. Any treatment received by the For that reason, reliable clinical evidence regarding BST patient during the follow-up period will be reported by as treatment for FD is needed. However, there are no them or documented in their diary (Figure relevant randomized controlled clinical trials regarding This study will be performed in accordance with the FD as far as we know.
standards of the International Committee on Harmoniza- The current study is designed to investigate the tion on Good Clinical Practice and the revised version of effect of BST on FD and related quality of life. We will the Declaration of Helsinki. The protocol of the trial has also examine the relationship between the frequency or been approved by two ethics committees: the institu- power variables in cutaneous EGG and dyspeptic tional review boards of both the Oriental Hospital at symptoms of FD patients in this trial and determine Kyung Hee University Medical Center and the Oriental whether the changes in GMA recorded by cutaneous Hospital at East West Neo Medical Center of Kyung Hee EGG before and after the oral administration of University. The permission numbers are KOMC IRB BST can reflect the clinical efficacy of BST in the 2009-05 for the Oriental Hospital at Kyung Hee Univer- treatment of FD.
sity Medical Centre and KHNMC-OH-IRB 2009-001 forthe Oriental Hospital at East-West Neo Medical Centre of Kyung Hee University. Written informed consent will be obtained from all participants prior to enrollment, and The aims of this study are to: patients will be given enough time to decide if they wish (1) To determine whether BST can improve dyspeptic to participate before signing the consent form.
symptoms in patients with FD.
(2) To examine the relationship between dyspeptic symptoms and cutaneous EGG recordings and a possi- Inclusion criteria ble biological evidence of BST's efficacy via cutaneous Patients 19-75 years old who complain of dyspepsia for EGG recordings.
the previous 3 months, and who have an onset of Park et al. Trials 2010, 11:83 . The presence of "moderate" as the degree of sever-ity for at least three GIS scale symptoms will be a basiccriterion for trial inclusion Exclusion criteriaPatients who report the following conditions will beexcluded: History of peptic ulcer, gastroesophageal reflux disease (GERD), gastrointestinal surgery or mental disorders,marked current symptoms of irritable bowel disease, thepresence of the alarm symptoms such as severe weightloss, black or tar stool, dysphagia, the presence ofuncontrolled severe organ diseases including cancer,ingestion of aspirin or nonsteroidal anti-inflammatorydrugs (NSAIDs), and women who are pregnant orlactating.
At the screening phase, patients who are using any antibiotic, proton-pump inhibitor, bismuth salt, proki-netic agents such as itopride, herbal formulas, or whoare participating in any other clinical trial, will beexcluded from this study.
RecruitmentRecruitment will be done through hospitals and withnewspaper advertisements. Patients who have severedyspeptic symptoms are likely to receive conservativetherapies. Thus, interested patients with severe symp-toms of functional dyspepsia may be recruited throughhospitals. However, patients with mild to moderatesymptoms of functional dyspepsia seldom receive regu-lar hospital treatment. Recruitment advertisements in Figure 1 Flow chart of the trial.
newspapers can attract those patients with less severesymptoms.
symptoms at least 6 months prior, meet the definition ofthe Rome III criteria for FD [. Patients with one or more of the following symptoms: postprandial fullness, Randomization will be controlled by an independent early satiety, epigastric pain or burning, will be also con- clinical research coordinator (CRC). First, the randomi- sidered as meeting the study definition of FD. Then, all zation form with the basic information of the participant the participants will undergo endogastroduodenoscopy who has passed the screening phase will be transmitted (EGD) before enrollment and be examined by gastroen- in facsimile to the independent statistician. The rando- terologists to determine whether the EGD observations mization number in the randomization form will be left are related to the present dyspeptic symptoms. On the blank before arrival to the statistician. The statistician other hand, the Helicobacter pylori status of the patients will then decide the randomization number based on and history of H. pylori eradication therapy will be the allocation sequence which has been generated by a assessed before enrollment by non-invasive tests (urea random number creation program in advance and the breath test) or the rapid urease test.
statistician will return the randomization form filled in Patients who are diagnosed with FD can be categor- with the established number (specific ID number) to the ized as having either 1) meal-induced dyspeptic symp- CRC. The ratio of randomization allocation to the sites toms (postprandial distress syndrome; PDS) or 2) will be 1:1. The CRC will inform the investigators of the epigastric pain syndrome (EPS) and, in this trial, all FD specific ID number. This procedure will be guaranteed patients will be classified into one of the abovemen- by the authorized contract research organization (CRO).
tioned subtypes (PDS and EPS) []. The dyspepsiaseverity of patients who meet the Rome III criteria will be assessed by a validated Gastrointestinal Symptom In this trial, investigators will not be in contact with the (GIS) scale, which measures the severity of 10 symptoms CRC, the clinical pharmacist, or the statistician. The Park et al. Trials 2010, 11:83 CRC will be separated from all researchers, thus the Bansasin granule® administration in this trial. Therefore, researchers will not have any influence on enrollment or mimicking the original color and taste of the Bansasin randomization. The statistician will receive the randomi- granule® without adding any active components was zation form in facsimile, fill in the blank and return it in quite a difficult procedure. The company that makes the order, thus any contact with other researchers cannot Bansasin granule® was experienced in making placebos be made. The blinding procedure will also be verified by of herbal extracts and they succeeded in making a Ban- the authorized CRO.
sasin granule® placebo through the development ofseveral test samples. The placebo is a starch and lactose Experimental drugs mixture which has a color and taste similar to the Ban- Banha-sasim-tang (BST) sasin granule®. Retention samples of placebo used in the BST has long been used in traditional Korean medicine current study will be kept at the Hanpoong Pharm & to treat gastrointestinal diseases. According to recent Food Company. At the end of the study, the question to experimental researches, BST has been known to reduce participants whether the drugs that they have taken is inflammation in inflammatory bowel diseases and diar- real or not will be answered by themselves for evalua- rhea, to regulate gastrointestinal functional in FD, and tion of success in blinding.
to protect against the side effects of chemotherapy ingastrointestinal cancers Although many experimental studies suggest that BST can be used to treat FD, there are no randomized stu- The primary outcome is the proof of BST's superiority dies of BST as a treatment for FD as far as we know.
compared with placebo in treating FD. For this purpose, BST used in this trial is a brown, bitter herbal extract the GIS scale is chosen as the primary variable []. The granule (Bansasin granule®, Hanpoong Pharm & Food primary efficacy parameter is the change in the sum Co., Ltd., Jeonju, Korea) produced according to Korean totals of the GIS scales. The GIS scale is composed of Good Manufacturing Practice. Bansasin granule® is per- the following 10 dyspeptic symptoms: epigastric pain/ mitted and regulated by the Korean Food & Drug upper abdominal pain, abdominal cramps, fullness, early Administration. Each 3 g Bansasin granule® (water- satiety, loss of appetite, malaise, nausea, vomiting, retro- extracted BST mixed with starch and lactose) is com- sternal discomfort, and acidic regurgitation/heartburn.
posed of seven herbs: Pinelliae Tuber (the rhizome of Symptom severity per each item will be assessed by a 5- Pinellia ternata (Thunb.) Breit., family Araceae) 1.67 g, point Likert scale: none - 0, slight - 1, moderate - 2, Scutellariae Radix (the root of Scutellaria baicalensis severe - 3, and very severe - 4. The GIS scale is very Georgi, family Labiatae) 1.00 g, Ginseng Radix (the root easy for participants to understand and to complete.
of Panax ginseng C.A. Meyer, family Araliaceae) 1.00 g, The GIS scale will be assessed at baseline, 2 weeks, Glycyrrhizae Radix (the root of Glycyrrhiza uralensis 4 weeks and 6 weeks during oral administration of BST, Fisch., family Leguminosae) 1.00 g, Zizyphi Fructus (the and at 1 month and 2 months after completion of BST fruit of Zizyphus jujuba Mill. var. inermis Rehder, family Rhamnaceae) 1.00 g, Zingiberis Rhizoma (the rhizome of Secondary outcomes Zingiberis officinale Roscoe, family Zingiberaceae) 0.83 A visual analogue scale (VAS) will be used to determine g, and Coptidis Rhizoma (the rhizome of Coptis chinen- the patient's global judgment of intensity of discomfort sis Franch., family Ranunculceae) 0.33 g. As standard due to dyspepsia (ranging from 0 mm as no discomfort chemical components in each 3 g Bansasin granule®, to 100 mm as the most intense discomfort). The VAS 11.6 mg of berberin, 25.0 mg of glycyrrhzin acid and measurements will be performed with the same 100.0 mg of baicalin are included. Voucher specimens frequency as the GIS scale measurements.
will be retained at the research laboratory of Hanpoong The validated Functional Dyspepsia related Quality of Pharm & Food Company. Regular dosage is 3 g TID for Life (FD-QoL) questionnaire assesses FD's influence on adults while dyspeptic symptoms, nausea, vomiting, diar- quality of life and consists of four categories: diet (5 rhea, abdominal pain, and anorexia continue.
items), daily activity (4 items), emotion (6 items), and social functioning (6 items) [FD-QoL will also be At present, there is no standard treatment in FD. Thus, performed with the same frequency as the GIS scale the placebo for this trial requires no active components.
Although Bansasin granule® is not a chemical drug andrelevant drug packagings may be needed for succeeding Measurement of GMA blinding, drug packaging, such as starch capsules, will Gastric hypomotility and uncoordinated antral duodenal not be used for reproducing the real situation of contractions in FD patients are closely associated with Park et al. Trials 2010, 11:83 gastric myoelectrical dysrhythmias. These dysrhythmias During the trial, all adverse events will be observed in arise from dysregulation of gastric slow waves, which detail and documented in case report forms (CRFs).
normally occur at a frequency of 3 cycles per minute(cpm) Electrogastrogram records GMA acquired from cuta- Before starting the trial, investigators who assess the neous abdominal electrodes [. Although some EGG will receive thorough training in taking EGG researchers have suggested that some cutaneously acquired dysrhythmias may be artifactual in nature , To maintain the accuracy and quality of the clinical other experiments have suggested a positive correlation trial, audit and monitoring will be conducted by the between the frequencies found with cutaneous EGG Marinet Corporation, a CRO located in Seoul, Korea.
recordings and myoelectrical signals acquired from gas- The sites' CRF completion and compliance with stan- tric serosal leads dard operation procedures will be audited. Clinical In this study, the GMAs of the participants will be research associates will, at regular periods, monitor the measured using surface multichannel EGG (Polygraf ID®, clinical trial procedures such as compliance with BST Medtronic A/S, Denmark) at baseline and at 6 weeks.
administration and voluntary withdrawal of participants.
This method of EGG measurement will be conducted as In particular, reasons for withdrawal will be fully docu- described previously [First, the epigastric skin to be mented in CRFs.
attached to the electrodes will be shaved and abradedwith a sandy skin preparation jelly to reduce impedence.
Statistical analysis Four active surface electrodes will be positioned at the The primary hypothesis is that oral administration of sites: the corpus of stomach as channel 1, proximal BST is more effective than placebo for treating FD. We antrum as channel 2, distal antrum as channel 3, and hope to prove this hypothesis by means of a 2-sided test pylorus region as channel 4. A ground electrode and a yielding a 5% significance level. Because there is no rele- reference electrode will also be placed. EGG measure- vant previous study using BST for calculating sample ments will be performed in a quiet room and patients size, we referred to a similar herbal trial for FD treat- will fast over night for ≥ 8 hours. Participants will be ment which used the GIS scale The formula for esti- asked not to talk and to remain as still as possible during mating the sample size is as follows: the EGG assessment to avoid motion artifacts. Patients will undergo a 20 minute fasting (preprandial) EGG mea- n = n = {(Za 2 + Z ) surement in the supine position, then they will eat twoscrambled medium eggs and two pieces of toasted bread The previous trial demonstrated 3.5 points of with 500 ml of water as the standard solid test meal (500 improvement (μc - μt = Δ) in the GIS scale over treat- Kcal). Then, postprandial EGG measurement will be con- ment with placebo during 4 weeks of herbal treatments ducted for 40 minutes. The percentage of slow wave cou- The same study indicated a mean standard deviation pling, the EGG dominant frequency and power, the (SD = s) of 5.37. In our study, the ratio (l) of experi- percentage of normal gastric slow waves, the percentage mental group to placebo group will be 1:1. With a of gastric dysrhythmia, and the postprandial to prepran- power of 80% (1 - b) and significance level of 5% (a), dial power ratio will be assessed.
assuming Δ = 3.5 and s = 5.37, a sample size of nt =nc = 37 patients per treatment group will be required.
(nt, number of BST group; nc, number of placebo Before randomization and after completion of BST group). Considering an assumed dropout rate of 25%, a administration, we will perform the following tests on total of 100 patients will be needed.
all participants: complete blood cell count, AST/ALT, The analysis strategy in this study is as follows: gGT, BUN, creatinine, erythrocyte sedimentation rate as As a first step, the baseline characteristics of both well as electrocardiogram. The above tests will serve to groups, sex, age, duration of dyspeptic periods, and exclude participants who have serious illnesses and smoking, will be compared. As a second step, we will abnormal heart, liver, kidney, or other organ function- compare the efficacy of BST and placebo, as the change ing. Throughout the study, we will also assess whether 6 in GIS totals from the beginning (0 day) to the end (6 weeks of BST administration in FD patients is safe by weeks) of the study period. As a third step, we will ana- above tests or CRF documentations.
lyze the secondary variables (VAS and FD-QoL) in the The guide for taking BST which are verified by the same manner as we did the GIS scale. Finally, various Korean Food & Drug Administration lists several parameters in the EGG measurement, such as frequency adverse events: pseudoaldosteronism, myopathy, skin and power-related variables will be compared before disorders, liver malfunction, pneumonia, or dry mouth.
and after treatment in both groups. Correlations Park et al. Trials 2010, 11:83 between changes in GIS scale results and EGG para- in these parameters can evaluate the possibility of clini- meter findings will also be analyzed.
cal applications of cutaneous EGG in the treatment of All analyses in this study will be based on the inten- FD, and a detailed guide, based on biological evidences, tion-to-treat principle. If data distribution is skewed for treatment in FD patients.
owing to insufficient sample size, relevant transforma-tion by a statistician prior to analysis will be made. The baseline characteristics will be compared by either c2- FD: functional dyspepsia; EGG: electrogastrography; EGD: test or the Student t-test. Primary and secondary endogastroduodenoscopy; H. pylori: Helicobacter pylori; PDS: postprandial outcomes will be presented as means and SDs, and ana- distress syndrome; EPS: epigastric pain syndrome; GMA: gastric myoelectricalactivity; BST: Banha-sasim-tang; GIS: gastrointestinal symptom; GERD: lyzed by independent t-tests, Mann-Whitney tests, or gastroesophageal reflux disease; NSAIDs: nonsteroidal anti-inflammatory Wilcoxon singed-rank tests. Correlations between the drugs; CRC: clinical research coordinator; CRO: contract research organization; GIS scale and EGG parameters will be analyzed by Pear- VAS: visual analogue scale; FD-QoL: functional dyspepsia related quality oflife; CRF: case report form.
son's correlation coefficients or by Spearman's Rho.
Adverse events will be calculated and compared using c2-test or Fisher's exact test.
This study was supported by a grant of the Traditional Korean Medicine R&DProject, Ministry for Health & Welfare & Family Affairs, Republic of Korea Statistical analyses will be conducted in a blind man- ner by an independent statistician and performed usingSPSS 16.0 (SPSS inc., Chicago, Illinois, USA).
Author details1Department of Gastroenterology, College of Oriental Medicine, Kyung HeeUniversity, Seoul, Korea. 2Department of Statistics, College of Sookmyung Women's University, Seoul, Korea.
The current clinical study is a randomized, double-blind, Authors' contributions placebo-controlled trial investigating the safety and effi- JSK, JWP, and BHR contributed to the securing of funding for the project cacy of frequently used herbal formulas as part of the and to the study design. UMJ, GJH, SHO and JSL participated in the design national project for studying the traditional herbal medi- of the trial. JSK and JWP drafted the protocol and wrote the finalmanuscript. JWP and IKY were responsible for the statistical design of the cines of South Korea. This clinical trial belongs to the trial. All authors read and approved the final manuscript.
2009 Traditional Korean Medicine R&D projects fundedby the Ministry for Health & Welfare & Family Affairs, Competing interestsThe authors declare that they have no competing interests.
Republic of Korea. BST is one of the most frequentlyprescribed herbal formulas in Korea, BST is thought to Received: 27 January 2010 Accepted: 30 July 2010 be safe, and experimental evidences support BST's effec- Published: 30 July 2010 tiveness for dyspepsia However, there have not been any randomized controlled trials showing the effec- Madisch A, Holtmann G, Mayr G, Vinson B, Hotz J tiveness of BST for the treatment of FD. Through the current study, we expect to gain objective clinical evi- Digestion 2004, 69:45-52.
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