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Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? G reenspan 2003 F AIR - Yes Yes Yes Yes Yes U nclear order 25 mg promethazine with amex, U nclear 25mg promethazine sale, Yes (A) G O O D reportedas reported doubleblind asdouble blind G reenspan 2005 F AIR Yes M ethodnot Yes Yes Yes Yes Yes U nclear discount 25 mg promethazine otc, (B) described reported asdouble blind G reenwald 2005 F AIR - M ethodnot M ethodnot Yes Yes Yes U nclear, U nclear, Yes PO O R described described reportedas reported doubleblind asdouble blind Heikkinen 2004 PO O R Yes Yes Yes Yes Yes N o N o N o Heinrich 2005 PO O R N otrandom iz ed N ot N R G roups Yes Yes U nclear, U nclear, U nclear, random iz ed balancedfor reportedas reported reported age,BM I doubleblind asdouble asdouble andverbal blind blind IQ Hormone therapy Page 99 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding G reenspan Yes Yes N o N o Yes N o N IH,M erck, (A) andW y eth G reenspan Yes N o N o N o Yes Yes 3ex cluded N IH;W y eth (B) form edical andM erck contraindica provided tion study m edication G reenwald Yes N o N o N o Yes L O CF U nableto N ovo determ ine N ordisk Heikkinen Yes N o N o U nableto N o 316/464 Yes 52wom en Schering determ ine analy z ed ex cluded AG (68. Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? J offe 2006 F AIR M ethodnot M ethodnot Yes Yes Yes Yes Yes Yes described described L evine 2005 F AIR M ethodnot M ethodnot N R Yes Yes U nclear, U nclear, Yes described described reportedas reported doubleblind asdouble blind L iu 2005 F AIR M ethodnot Yes Yes Yes Yes U nclear, U nclear, Yes described reportedas reported doubleblind asdouble blind N ewton 2006 F AIR Yes Yes Yes Yes Yes U nclear, U nclear, Yes reportedas reported doubleblind asdouble blind O dm ark 2004 F AIR Yes M ethodnot Yes lowerD BP Yes Yes U nclear, U nclear, Yes described andhigher reportedas reported BM I in doubleblind asdouble startersvs blind switchers Hormone therapy Page 101 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding J offe Yes N o N o N o Yes N o Pfiz er; Berlex provided study m edication L evine Yes N o N o U nableto U nableto U nclear U nableto N ot determ ine determ ine how m any determ ine reported patients analy z ed L iu Yes Yes N o U nableto Yes U nableto N IH determ ine determ ine (N ational Instituteof Aging) N ewton Yes Yes N o N o Yes 95% N o N IH analy z edat 3m ,92% at 12m O dm ark Yes N o N o N o N o sy m ptom Yes 1ex cluded W y eth scoreson duetoloss 208/249 of diary card (83. Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? Pornel 2005 PO O R M ethodnot M ethodnot N R R eported Yes Yes U nclear, U nclear, U nclear, described described forefficacy reportedas reported reported evaluable doubleblind asdouble asdouble population blind blind only R eddy 2006 F AIR Yes M ethodnot Yes Yes Yes U nclear, U nclear, Yes described reportedas reported doubleblind asdouble blind Hormone therapy Page 103 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding Pornel Yes Yes N o U nableto N o R eport U nableto N ot determ ine m ain determ ine reported outcom eon 476/1143 patients only. N um berin ITT population notreported R eddy Yes Yes N o N o Yes Yes 2/60for N IH;Pfiz er noncom plia provided nce gabapentin; oneauthor haspatent on gabapentin forhot flushes Hormone therapy Page 104 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? R eid 2004 F AIR M ethodnot M ethodnot Yes Yes Yes Yes U nclear, U nclear, described described reported reported asdouble asdouble blind blind Schiff 2005 F AIR - Yes Yes N R Yes Yes N R N R N R PO O R Schurm ann 2004 F AIR M ethodnot M ethodnot N R Yes Yes U nclear, U nclear, U nclear, described described reportedas reported reported doubleblind asdouble asdouble blind blind Serrano 2006 F AIR Yes Yes Yes Yes Yes N o N o N o Speroff (A) 2006 F AIR Yes M ethodnot Yes Yes Yes U nclear, U nclear, Yes described reportedas reported doubleblind asdouble blind Hormone therapy Page 105 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding R eid Yes Yes N o N o 28/619 Yes Yes 6/619 L illy (4. Schiff Yes Yes N o N o N o 19/24 Yes 2/24 M erck analy z ed ex cludedfor (79. Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? Speroff (B) 2000 F AIR M ethodnot M ethodnot Yes Yes Yes U nclear, U nclear, U nclear, described described reportedas reported reported doubleblind asdouble asdouble blind blind U tian 2005 F AIR Yes Yes N o fewer Yes Yes U nclear, U nclear, Yes wom enin reportedas reported E A group doubleblind asdouble had blind dy spareunia (27. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding Speroff (B) Yes N o N o N o U nableto U nclear U nableto determ ine how m any determ ine analy z ed U tian Yes Yes N o N o Yes Yes 1wom an W arner whonever Chilcott tookstudy drug W arm ing (A) Yes N o N o N o N o Appears N o N ot thatonly reported; com pleters oneauthor analy z ed from W y eth (180/240) (statesITT) W arm ing (B) Yes N o N o N o Yes U nableto 4% other N ot determ ine Table4 reported W eisberg Yes Yes N o U nableto N o 155/185 U nableto Pharm acia determ ine analy z ed determ ine U pjohn (83. Q uality assessm entoftrials added forU pdate #3 A llocation R andom iz ation concealm ent G roups Inclusion Exclusion O utcom e C are Q uality m eth od m eth od sim ilarat criteria criteria assessors provider Patients A uth or Y ear rating adequate? Yaffe 2006 F AIR M ethodnot M ethodnot Yes Yes Yes Yes Yes Yes described described Hormone therapy Page 109 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix G. Q uality assessm entoftrials added forU pdate #3 Post- L oss to random iz ation followup Intention orpost- A ttrition A dh erence C ontam ination differential to treat enrollm ent A uth or reported? C om m ents F unding Yaffe Yes Yes N o N o Yes 417 N o Berlex and analy z ed, N ational butnot Instituteon clearhow Aging m issing data handled Hormone therapy Page 110 of 110 . The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Lee, PharmD, BCPS Susan Severance, MPH Sujata Thakurta, MPA, HA Benjamin Chan, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. Final Report Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.......................................................................................................................... For children and adults with type 1 or type 2 diabetes, does pramlintide differ in efficacy, effectiveness, and in harms for achieving glycemic control when added to prandial insulin compared to conventional insulin therapy? For children and adults with type 1 diabetes, does pramlintide differ in efficacy, effectiveness, or harms in achieving glycemic control when added to prandial insulin compared with conventional insulin therapy? Are there subgroups of patients with type 1 diabetes for which pramlintide is more or less suitable than other hypoglycemic agents?................................................................ For children and adults with type 2 diabetes, does pramlintide differ in efficacy, effectiveness, or harms in achieving glycemic control when added to prandial insulin compared with conventional insulin therapy? Are there subgroups of patients with type 2 diabetes for which pramlintide is more or less suitable than other hypoglycemic agents?................................................................
MGCD0103 safe 25mg promethazine, a novel in patients with relapsed and refractory Hodgkin’s lym- isotype-selective histone deacetylase inhibitor buy promethazine 25 mg without a prescription, has broad spec- phoma: results of ENGAGE-501 multicenter phase 2 study purchase promethazine 25mg free shipping. A phase 2 multicenter classical Hodgkin’s lymphoma: an open-label, single-arm, study of lenalidomide in relapsed or refractory classical Hodg- phase 2 trial. Who benefits from allogeneic transplantation for myelodysplastic syndromes? The increasingly complex heterogeneity of this disease entity is mirrored by life expectancy rates ranging from almost a decade for very low-risk disease down to several months in higher-risk patients, even with conventional treatments. Intensive treatment approaches are hampered by the older age of most of the patients, potentially leading to an unacceptable adverse event rate. This is especially true for allogeneic hematopoietic stem cell transplantation (HCT), which, albeit of curative intent, can lead to considerable morbidity and mortality mostly as a result of organ toxicity, infectious complications, and GVHD. Furthermore, innovative drug developments, including hypomethylating agents, have broadened the therapeutic armamentarium and, although not curative, can lead to durable responses in subgroups of patients with higher-risk MDS. In fact, there is still no prospective randomized trial available that formally demonstrates the benefit of allogeneic HCT compared with standard treatments in MDS patients. In the absence of randomized data, when considering allogeneic HCT, emphasis should be put on patient selection and optimization of the pre- and posttransplantation treatment period. In these patients, a thorough comorbidity evaluation is mandatory and stratification according to age, cytogenetics, cytopenias, disease-related quality of life, and available alternative treatments should be performed in deciding whether, when, and how to perform allogeneic HCT. Introduction (MAC) was the standard treatment for higher-risk patients younger Almost every review on myelodysplastic syndromes (MDS) starts than 60 years of age1 with a compatible donor. Meanwhile, with the important and very true premise that this term summarizes hypomethylating agents (HMAs) such as azacitidine (AZA) and a group of heterogeneous and complex hematologic disorders decitabine have become the standard approach for older patients primarily found within the older population, because the majority of with higher-risk MDS, although they are also active in lower-risk patients are older than 60 years at diagnosis. Based on a randomized study2 comparing AZA with challenging, not only in terms of diagnostics, but also in clinical conventional care (excluding allogeneic HCT), the drug was decision making. In patients above the age of 70 years, the incidence approved across the world and has become the standard therapy for is estimated at up to 60/100 000 per year. Decitabine has also been approved for this disease is constantly rising as a result of increasing longevity MDS (according to French-American-British classification) in the of the overall population. Many of these patients are in need of United States, whereas in Europe, the label covers acute myeloid disease-specific therapies because MDS causes severe cytopenia leukemia (AML) patients with 20% or more BM blasts. As yet, no that often manifests as RBC transfusion dependency (RBC-TD). Nevertheless, with the introduction This article reviews the current evidence for allogeneic hematopoi- of reduced-intensity conditioning (RIC) and the consecutive perspec- etic cell transplantation (HCT) as a therapeutic option in the context tive of reducing early transplantation-related mortality, the numbers of disease-specific characteristics and current available alternative of transplantations mainly in higher-risk MDS patients have consis- treatments. General concepts of treating patients with MDS: The search for a donor: always successful and which where is the position of allogeneic HCT? Patients with MDS are clinically subdivided into “lower-risk” Although it may seem trivial, it is important to note that the main (low/int-1) and “higher-risk” (int-2/high) disease according to the prerequisite for performing an allogeneic HCT is to identify a International Prognostic Scoring System (IPSS) risk score. Due to the social development and decline in the birth rate in the so called “developed countries,” matched related Traditionally, erythropoiesis-stimulating factors are mainly used for donors (RDs) cannot always be identified. Currently, there are more eligible patients in need of RBCs according to their transfusion than 14 million volunteer donors registered in internationally requirement and endogenous erythropoietin level. As a result, in 50% to 70% of all best supportive care was considered the primary standard treatment eligible patients, a matched unrelated donor (MUD) can be identi- for higher-risk older MDS patients, whereas, supported by retrospec- fied. When using high-resolution typing, the results with RDs and tive analyses, allogeneic HCT after myeloablative conditioning MUDs can be considered comparable with respect to overall and 522 American Society of Hematology event-free survival, although the rate of chronic GVHD seems to be What about disease risk? We prefer a younger MUD over a RD Even though the IPSS was developed mainly to determine the only in case of donor age of 65 years, also because of recent prognostic risk in newly diagnosed MDS patients, its predictive retrospective data suggesting an improved survival with younger value concerning posttransplantation outcome has been confirmed unrelated donors (age 30 years) compared with older matched in several studies. According to a decision model published a RDs or MUDs,3 which, however, is not supported by another study. However, this analysis BM grafts instead of PBSCs might be associated with comparable was restricted to MDS patients below the age of 60 years undergo- long-term results after conventional MAC but may lead to less ing HLA-matched sibling BM transplantation after MAC and chronic GVHD. Since then, new therapeutic options, mainly with HMAs, have been introduced into the clinical setting and are able to alter the natural course of the disease. In cases with no identifiable “conventional” donor, allogeneic HCT In addition to these patient groups, those with IPSS intermediate-1 with BM from haploidentical family donors using posttransplanta- harboring adverse-risk attributes including poor-risk cytogenetics, tion cyclophosphamide may represent a valuable alternative solu- 12 severe thrombocytopenia, or severe RBC-TD might also be tion for patients who are in need of transplantation. This technique considered for allogeneic HCT on an individual basis. The IPSS has has revolutionized transplantation modalities and potentially allows been revised recently to include new cytogenetic subgroups. Therefore, treatment decisions have become challenging, further supporting the inclusion of MDS patients into clinical trials. Risks and benefits of the procedure: what to tell the patient? First, the patient needs to know that allogeneic HCT can, but does An important question to be raised is whether the patient is in not necessarily, result in cure. In fact, the risk of relapse is mainly principle eligible for this procedure given his or her age and determined by disease stage and cytogenetics at the time of potential comorbidities. Recent large retrospective analyses of the transplantation.
A very good away from the uterus and you will find the description on how to perform an ovarian cystectomy infundibulopelvic ligament containing the can be found at: http://www generic promethazine 25 mg fast delivery. Dissect the liga- Postmenopausal women Every postmenopausal ment in between the forceps and double tie the woman with an ovarian cyst or mass should be part in the posterior forceps cheap 25 mg promethazine amex. Use tube and the ovarian branch of the uterine artery: put the RMI described above as a basis for your treat- a straight forceps on the tube and suspensory ment strategy order 25 mg promethazine with mastercard. If Ca-125 is not available, as in most ligament and make a hole in the mesosalpinx primary or secondary health facilities in low- underneath where you do not see any blood resource settings use the IOTA rules. Place a second forceps so that refer for specialist care to a higher level, or if you the tip is reaching the hole in the mesosalpinx are an experienced surgeon remove the ovarian and re-set the first forceps alike. A woman with tube and the suspensory ligament and ligate with a simple cyst of <5cm and a low RMI (<25) or a Heaney stitch (see Chapter 19 on how to do a B-rules can be treated conservatively provided she Heaney stitch). Most of the time the ovarian agrees to regular check up every 2 or 3 months. If branch of the uterine artery will be included in she doesn’t, it is better to remove the mass and this suture. In postmenopausal women • Dissection of the mesosalpinx: place two curved this is best done through bilateral adnexectomy. If the tube and the adja- adnexectomy for benign ovarian disease: cent mesosalpinx are larger you might need • Open the abdomen using a vertical midline more than two forceps as otherwise the tissue incision or a Pfannenstiel incision depending will slip from your forceps. Remove the adnexa on size and sonographic features of the mass. Surgical bleeding and carry out hemostasis where neces- staging in patients with ovarian tumors of low malignant potential. Ovarian serous borderline tumors: a critical review of the literature with emphasis REFERENCES on prognostic indicators. Transvaginal sonographic contraceptives for functional ovarian cysts. Cochrane ovarian findings in a random sample of women 25–40 Database Syst Rev 2011;9:CD006134 years old. Natural history of Management of suspected ovarian masses in premeno- sonographically detected simple unilocular adnexal cysts pausal women. Benign and Further reading malignant gynaecological conditions. Clinical effects of the Oxford Handbook of Obstetrics and Gynaecology, 2nd edn. Evaluation of a risk of malignancy Sheng J, Zhang WY, Zhang JP, Lu D. Br J Obstet Gynaecol 1993;100:927–31 on adenomyosis: a 3-year follow-up study on the efficacy 6. Risk of and side effects of the use of levonorgestrel intrauterine malignancy index (RMI) used as a diagnostic tool in a system for the treatment of dysmenorrhea associated with tertiary centre for patients with a pelvic mass. Contraception 2009;79:189–93 Gynecol Scand 2012;91:496–502 7. Simple ultrasound-based rules for the diagnosis of ovarian cancer. F P Executive Summary The time needed to learn a foreign language is impressive: hundreds of hours to transfer 5000+ words into a human brain and then hundreds more hours to understand people speaking at ‘3+ words/second’. In addition, language learning seems to be immune to the accelerating and streamlining effects of modern technology – today, like 50 years ago, it takes over 1000 hours to start being fluent in another language. No technology has been shown to be able to compress this time frame. Here we present a method of double exposure to a new language through intense listening plus reading. The rationale for simultaneous ear/eye exposure is that incoming signals from the ear are processed in different brain areas than signals coming in from the eyes and both areas need to be trained simultaneously. Our free smartphone app 2 Ear Memory (Google Play™: www. Supplementary audio files that you acquire (examples: page 18) 2 If you dedicate at least 30 minutes to daily Ear Memory exercises, you will rapidly learn more than 1000 words, have excellent spelling skills, develop an intuitive comprehension of important grammar rules and acquire a fairly genuine accent. You’ll use 2 Ear Memory primarily to learn languages. Other applications include the rehearsal of oral presentations (poems at school, shows at colleges, scientific demonstrations at conferences, etc. We also anticipate Ear Memory to become an instrument in the rehabilitation of stroke patients with memory deficits.
The actual mean value and 95% confidence interval was not provided for almotriptan but it was described as being higher than for the conventional tablet form of sumatriptan 100 mg discount promethazine 25 mg line. However promethazine 25mg generic, this comparison did not assess or adjust for potential clinical or methodological heterogeneity across trials discount promethazine 25mg otc. Therefore, we suggest that this finding be interpreted with caution. Triptans Page 34 of 80 Final Report Update 4 Drug Effectiveness Review Project Consistency. We found 1 fair-quality, placebo-controlled trial that examined the use of 71 almotriptan 12. The results of this trial demonstrated that a significantly greater number of patients achieved 2-hour pain-free outcomes in 3 of 3 headaches with almotriptan 12. The ‘AwM’ trial was designed to compare early and non-early intervention and involved 4 treatment groups. For the purposes of this review, our interest was in the 2 treatment groups in which patients were randomized to administer treatment with almotriptan or placebo when pain was still mild and within 1 hour of onset. Results from the other 2 treatment groups, in which patients were randomized to administer treatment with almotriptan or placebo when pain was moderate to ® severe, were reported separately and will not be discussed here. In the Axert Early Migraine Intervention Study, patients were allowed to treat pain of any intensity, as long as it was within 1 hour of onset, but outcomes for mild and moderate-to-severe headaches were reported separately. In both trials, almotriptan was superior to placebo in rates of 2-hour pain-free and 24-hour sustained pain-free. Rate of 2-hour pain-free in ‘AwM’ was 49% for almotriptan and 25% for placebo (odds ratio 2. Rate of 24-hour sustained pain-free was 46% for almotriptan and 16% for placebo in ‘AwM’, and in the ‘AEGIS’ trial was 25% and 16%, respectively (P=0. Based on our independent random-effects meta-analysis (Appendix D), these findings correspond to a pooled relative risk of 1. For 24-hour sustained pain-free rates, we calculated a pooled relative risk of 2. Functional disability and quality-of-life outcomes were also reported in a secondary publication of the 72 ‘AEGIS’ trial. At 2 hours, mean functional disability scores showed that significantly more patients functioned normally with almotriptan than placebo (54% compared with 38%; P=0. At 24 hours, scores in all 5 domains of the Migraine Quality-of-life Questionnaire were consistently better for almotriptan than placebo. Naratriptan Direct comparisons We included 2 head-to-head trials comparing naratriptan 2. No statistical analyses were performed on 24-hour outcome data, but naratriptan 2. The fair-quality trial did not report pain outcomes at 2 hours, but rates of 4-hour pain relief (76% compared with 84%) and 24-hour sustained relief (39% compared with 34%) were reported as similar for naratriptan 2. Neither trial reported on pain-free, workplace productivity, or quality of life. Both trials looked at treatment of only 1 headache per patient and thus did not provide data on consistency of response across multiple headaches. Triptans Page 35 of 80 Final Report Update 4 Drug Effectiveness Review Project Placebo-controlled trials: Naratriptan We found no placebo-controlled trials of naratriptan that reported quality of life, workplace productivity, or 2-hour or 24-hour pain-free outcomes. We also found no placebo-controlled trials that evaluated consistency of naratriptan across multiple headaches. Reformulated (rapid-release) oral sumatriptan Direct comparisons We found no head-to-head trial directly comparing reformulated (rapid-release) oral sumatriptan tablet with any other triptan. Placebo-controlled trials: Reformulated oral sumatriptan We included placebo-controlled trials of reformulated oral sumatriptan that looked at early 78, 79 treatment of migraine while pain is still mild. We also used data from placebo-controlled trials of reformulated sumatriptan 100 mg and the conventional tablet form of sumatriptan to explore indirect comparisons between the 2 formulations on 2-hour pain-free rates. The efficacy of reformulated sumatriptan 100 mg administered early in a migraine, while pain is mild, was demonstrated in a fair-quality trial of 432 adults who were 78, 79 instructed to administer treatment when pain was still mild and within 1 hour of onset. Rate of 2-hour pain-free was 66% for reformulated sumatriptan 100 mg and 20% for placebo (P<0. At 24 hours, rate of sustained pain-free also was significantly greater for reformulated sumatriptan 100 mg than placebo (40% compared with 10%; P<0. From these data, we calculated a relative risk of 3. Compared with placebo, rate of normal function was significantly greater for reformulated sumatriptan 100 mg at 45 minutes (29% compared with 18%; P<0. At 24 hours, significantly less time was lost on activities other than paid work for reformulated sumatriptan 100 mg (2. However, lost time in paid work was similar for reformulated sumatriptan 100 mg and placebo (2. Indirect comparison of reformulated with the conventional tablet form of sumatriptan. In the absence of head-to-head trials that directly compared reformulated and the conventional tablet form of sumatriptan, we explored indirect comparisons between formulations using data 80 from placebo-controlled trials.