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1 Komplementärmedizin Warum wir Couchepin überleben Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 1

2 Jörg Fritschi Geburtsdatum Staatsexamen 1981 FMH Innere Medizin 1989 Praxis: Im Noll 38, 4148 Pfeffingen seit 1989 ASA-TCM 1999 Vize-Präsident SGIM FACP Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 2

3 Zur Zeit gehaltene Ämter und Aufgaben Präsident der UNION der komplementärmedizinischen Ärztegesellschaften Vizepräsident der Assoziation der schweizerischen Ärztegesellschaften für Akupunktur und TCM (ASA) Vorstandsmitglied AG TCM Mitglied des Lenkungsausschusses der Initiative Ja zur Komplementärmedizin Experte für TCM beim Schweizerischen Heilmittelinstitut Swissmedic Vorstandsmitglied der Schweizerischen Gesellschaft für Innere Medizin SGIM CEO China Medical GmbH Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 3

4 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 4

5 Ärztliche Methoden der UNION Anthroposophische Medizin Akupunktur und TCM Neuraltherapie Phytotherapie SAGEM mit 11 Gesellschaften: AKS, GAMM, SABIT, SSDM,AEAP, SAGLÜ, SAGOS, SAHUM, SANTH, SART, SGZM UND Weitere, nicht ärztliche Therapeuten: EMR mit ca. 200 Methoden Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 5

6 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 6

7 Verbreitung UNION: 1700 Mitglieder, Millionen Umsatz pro Jahr innerhalb der Grundversorgung Ca Grundversorger Praxen: 2/5 mit komplementärmedizinischen Methoden EMR: ca. 12'000 angemeldete TherapeutInnen; geschätzter Umsatz 1 Milliarde CHF (1/50 der gesamten Gesundheitsausgaben, 150 Franken /P/a) Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 7

8 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 8

9 PEK: Bausteine der Evidence HTA (Health Technology Assessment) Feldstudie in allg. und CAM Praxen Oekonomiedaten der Santesuisse Literaturstudien vom BAG zitierte weitere Daten (nicht spezifiziert) Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 9

10 PEK: Evidenz-Resultate HTA: alle 5 positiv Feldstudie und Oekonomiedaten: max. gleiche Kosten, bessere Patientenzufriedenheit Literaturstudien: 3 von 5 positiv Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 10

11 PEK: Abschlussbericht Prov. Abschlussbericht : 3 von 5 positiv : Homöopathie, Anthroposophie, Phytotherapie Def. Abschlussbericht : 0 von 5 Unsere Beurteilung Beschlussfassung nicht auf wissenschaftlicher, sondern politischer Basis Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 11

12 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 12

13 Levels of Evidence and... I. Evidence is obtained from meta-analysis of multiple, welldesigned, controlled sutides. Randomized trials with low falsepositive and low false-negative errors (high power). II. Evidence is obtained from at least one well-designed experimental study. Randomized trials with high false-positive and/or negative errors (low power). III. Evidence is obtained from well-designed, quasi-experimental studies such as non-randomized, controlled single-group, prepost, cohort, time, or matched case-control series IV. Evidence is from well-designed, nonexperimental studies such as comparative and correlational descriptive and case studies V. Evidence from case reports and clinical examples Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 13

14 Grades of Recommendation A There is evidence of type I or consistent findings from multiple studies of types II, III, or IV B There is evidence of type II, III, or IV and findings are generally consistent C. There is evidence of types II, III, or IV but findings are inconsistent D. There is little or no systematic empirical evidence Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 14

15 Erkenntnisgrad wissenschaftlicher Aussagen gemäss American Heart Association (AHA) Level 1 bis 8 mit feinerer Differenzierung Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 15

16 Level of Evidence gemäss Scottish Intercollege Recommendations 1++ High quality meta analysis, systemic review of RCTs or RCTs with a very low risk of bias 1+ Well conducted meta analysis, systemic review of RCTs, or RCTs with a low risk of bias 1- Meta analysis, systemic reviews of RCTs, or RCTs with a high risk of bias 2++ High quality systemic reviews of case-control or cohort studies. High quality case-control or cohort studies with a very low risk of confounding bias, or chance and a high probability that the relationship is casual. 2+ Well conducted case control or cohort study with a low risk of confounding bias, or chance and a moderate probability that the relationship is casual. 2- Case control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not casual. 3 Non-analytical studies, e.g. case report, case series 4 Expert opinion Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 16

17 What is EBM? Evidence-Based Medicine (EBM) is the integration of best research evidence with clinical expertise and patient values. David L. Sackett, Evidence-Based Medicine Page 1, 2nd Edition, Churchill Livingstone Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 17

18 How do we actually practice EBM? Step 1 converting the need for information (about prevention, diagnosis, prognosis, therapy, causation, etc.) into an answerable question Step 2 tracking down the best evidence with which to answer that question Step 3 critically appraising that evidence for its validity (closeness to the truth), impact (size of the effect) and applicability (usefulnuess in our clinical practice) Step 4 integrating the critical appraisal with our clinical expertise and with our patient s unique biology, values and circumstances Step 5 evaluating our effectiveness and efficiency in executing steps 1-4 and seeking ways to improve them both for next time Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 18

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20 Cervical Radiculopathy (Simon Carette, M.D.) A 37-year-old woman presents with a two-week history of severe neck pain radiating to her left shoulder girdle and extending to the arm, forearm, and dorsum of the hand. She reports having had no fever, weight loss, leg weakness, or urinary or bowel dysfunction. Physical examination reveals weakness of her left triceps, finger extensors, and wrist flexors, as well as hypoesthesia of the third digit and a diminished triceps reflex. How should her case be managed? Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 20

21 Cervical Radiculopathy (Simon Carette, M.D.) TREATMENT Nonsurgical Management The main objectives of treatment are to relieve pain, improve neurologic function, and prevent recurrences. None of the commonly recommended nonsurgical therapies for cervical radiculopathy has been tested in randomized, placebo-controlled trials. Thus, recommendations derive largely from case series and anecdotal experience. The preferences of patients should be taken into account in decision making Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 21

22 Cervical Radiculopathy (Simon Carette, M.D.) SURGICAL VS. NONSURGICAL MANAGEMENT As summarized in a recent Cochrane review, there are few good-quality studies comparing surgical and nonsurgical treatments for cervical radiculopathy However, at one year, there was no difference among the treatment groups in any of the outcomes measured, including pain, function, and mood Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 22

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24 Evidenz In der Praxis In der allgemeinärztlichen Praxis sind nur ca. 20% - 30% aller Interventionen evidenzbasiert Die Methodologie für Praxis und für CAM wird differenzierter und flexibler Evidenz isolierter Interventionen als alleiniges Kriterium für die Praxis zunehmend umstritten (komplexe Syteme) Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 24

25 Evidenzsituation 2005 Verzerrung (Interpretation) der Datenlage durch... die Schulmedizin Medizinische Fakultäten: Bewahrung des Status Quo Pharmazeutische Industrie: Wirtschaftsinteressen... und bei der CAM Dogmatik: Einseitigkeit der Betrachtungsweise, Pauschalurteile Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 25

26 Onkologie Pädiatrie Chirurgie Infekte (viral) Funktionelle Störungen Psychiatrie (ambulant) Neurologie Synopsis: eine mögliche Sicht Fachgebiete Entzündliche Erkrankungen des Bewegungsapparates Behandlung während der Schwangerschaft Infekte (bakteriell) Psychiatrie (gravierend) Allgemeine Innere Medizin Schulmedizin * * * * * * CAM * * * * * * * Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 26

27 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 27

28 PEK: Arztkosten der CAM Durchschnittlicher Umsatz eines CAM Arztes/a 400'000.-, COM Arzt/a 800'000.- Zu beachten ist, dass CAM-Ärzte ein Drittel weniger Patienten pro Jahr behandeln, mehr Frauen, Jüngere Patienten Insgesamt besteht eine Kostendifferenz von 24% zu Gunsten der CAM-Ärzte (944 : 701 CHF /P/a); nach statistischer Korrektur im extremsten Fall gleiche patientenbezogenen Kosten/a Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 28

29 PEK: weitere Parameter der CAM Höhere Patientenzufriedenheit beim CAM- Arzt Im Durchschnitt mehr chronisch erkrankte Patienten Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 29

30 PEK: Gesamtkosten der CAM 200 Millionen zu ca. 53 Milliarden = ca. 0,5% der gesamten Gesundheitskosten CH und 200 Millionen zu 23 Milliarden Gesamtkosten in der Sozialversicherung= ca. 0,9% Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 30

31 Kosten der CAM Gretchenfrage Wie viel kosten bei gleicher langfristiger Qualität inkl. dem Management allfälliger unerwünschter Wirkungen und Integration aller Kosten (stationär, ambulant, AUF, Invalidität...) und mindestens gleicher Patientenzufriedenheit eine schulmedizinische und eine CAM Behandlung? Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 31

32 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 32

33 PEK Kosten: Summary CAM ist patientenbezogen günstiger, nach Korrektur maximal gleich teuer wie konventionelle Medizin. Innerhalb der Grundversicherung ist ein additives Verhalten der Ärzte und Patienten nicht zu belegen und unwahrscheinlich. Die Frage nach der freien Wahl insbesondere durch den Patienten ist aufgrund ökonomischer Daten i.s. einer liberalen und marktöffnenden Haltung zu bejahen Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 33

34 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 34

35 These 1 Das Gesundheitswesen wird teurer werden so oder so. Die Frage ist und wie viel? zu wessen Nutzen? Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 35

36 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 36

37 Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects (O Connor PW et al.) AIM Natalizumab (TYSABRI ) is a monoclonal antibody that inhibits the trafficking of leukocytes across the endothelium from the bloodstream to the central nervous system in relapsing-remitting multiple sclerosis (MS). METHODS Natalizumab is being evaluated in two ongoing randomized, double-blind, placebo-controlled trials. Study 1 enrolled patients who had not received other disease-modifying agents in the prior 6 months. Study 2 enrolled patients on interferon beta-1a (AVONEX). Natalizumab was administered intravenously 300 mg every 4 weeks for up to 28 months Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 37

38 Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects (O Connor PW et al.) RESULTS Study 1 Study 2 Natalizumab Placebo Natalizumab plus AVONEX Placebo plus AVONEX Clinical Endpoints Annualized relapse rate MRI Endpoints Patients with 0 new or newly enlarging MRI lesions, % 60% 22% 67% 40% Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 38

39 Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects (O Connor PW et al.) CONCLUSIONS Based on the above clinical trial data, natalizumab was approved by the FDA on November 23, 2004 for the treatment of patients with relapsing forms of MS. IMPACT ON INTERNAL MEDICINE Approximately 350,000 individuals have been diagnosed with MS in the US, with 10,000 new cases annually. Most patients with relapsing MS will be eligible for treatment. The annual cost of the drug will likely be in the range of $ 10, Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 39

40 Cost-effectiveness of cardiac resynchronization therapy in patients with symptomatic heart failure (Nichol G et al.) BACKGROUND Heart failure is a common, costly, and debilitating illness. Resynchronization of ventricular contraction in patients with heart failure improves ejection fraction. OBJECTIVE To assess the incremental cost-effectiveness of cardiac resynchronization therapy. INTERVENTIONS Cardiac resynchronization therapy versus medical therapy. OUTCOME MEASURES Quality-adjusted life-years (QALIs), costs, and incremental costeffectiveness Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 40

41 Cost-effectiveness of cardiac resynchronization therapy in patients with symptomatic heart failure (Nichol G et al.) RESULTS OF BASE-CASE ANALYSIS Medical therapy yielded a median of 2.64 (interquartile range, 2.47 to 2.82) discounted QALYs and a median discounted lifetime cost of $ 34,400 (interquartile range, $ 79,800 to $ 156,500) per additional QALY. CONCLUSIONS The incremental cost per QALY for cardiac resynchronization is similar to that of other commonly used interventions but is sensitive to changes in several key variable. Resynchronization therapy should not be considered in patients with comorbid illness that shortens life expectancy Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 41

42 Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population (Imperial TF, et al.) BACKGROUND/AIM If stool testing is to be done for purposes of colon cancer screening, we already know that hemoccult is both insensitive and not specific (since not all cancers bleed, but other lesions do). Recently it has become possible to test stool for cancer DNA. This study was designed to compare hemoccult to fecal DNA testing as a screening modality for colon cancer. RESULTS 5486 subjects were enrolled, but only 4404 had data available for both stool tests. 31 had colon cancer; 16 (51.6%) were positive for fecal DNA but only 4 (12.9%) for hemoccult Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 42

43 Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population (Imperial TF, et al.) IMPACT ON INTERNAL MEDICINE This is the largest study to date assessing the utility of fecal DNA testing. It was less sensitive than earlier and smaller reports had claimed, but it does appear to be a more sensitive test than hemoccult. Furthermore, the cost of the test ($ ) may limit its applicability Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 43

44 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 44

45 These 2 Der akademisch-pharmazeutische Komplex steuert im Wesentlichen den Fluss der Geldmittel im Gesundheitswesen. Diese Steuerung optimiert dabei ihre eigene Rentabilität, ohne Rücksicht auf den Gesamtnutzen, die soziale Verträglichkeit und nicht selten den individuellen Nutzen. Die ungehinderte Fortführung dieses Verhaltens ist auch durch die entsprechende Stützung der verantwortlichen Behörden möglich Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 45

46 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 46

47 Trends in antimicrobial drug development: Implications for the future (Spielberg B, et al.) AIM To review the paucity of new antibacterial agents: is there actually a paucity, and, if so, why? RESULTS 1.FDA approvals for new antibacterials : 30 (3/yr) : 10 (2/yr) : 9 (1.5/yr) 2.Analysis of 15 largest pharmaceutical companies which account for 53 of last 57 new molecular entities: 5/315 (1.6%) are antibacterials Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 47

48 Trends in antimicrobial drug development: Implications for the future (Spielberg B, et al.) RESULTS 3.Finances: 3 total withdrawals; most of the rest were downsized. 4.Rationale - Cost of new drug: $ million and 8 years. - Antibiotics are taken 7-14 days; statin is lifetime (hence rash of new HIV, HBV and HCV drugs). - Public health: We (ACP, CDC, IDSA) urge physicians to reduce abx use, especially new antibiotics. - Financial reality: Potential recovery on new antibiotic for resistant GPC is $100,000/yr compared to $1,100,00/yr for a good neuromuscular drug Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 48

49 Trends in antimicrobial drug development: Implications for the future (Spielberg B, et al.) IMPACT Year ABX Target Daptomycin Telithromycin (None) Tigecycline Resistant GPC including MRSA and VRE; not pneumonia Respiratory pathogens all S. pneumoniae Broad spectrum Proposed solutions include: 1. Economic incentives such as patent extensions and tax 2. Reduction in regulatory demands (FDA issues) Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 49

50 Dementia: Long-term donepezil treatment in 565 patients with Alzheimer s disease (AD2000): randomised double-blind trial (AD2000 Collaborative Group) AIM To determine whether donepezil produces worthwhile improvements in disability, dependency, behavioural and psychological symptoms, caregivers psychological wellbeing, or delay in institutionalization. RESULTS Over 2 years of follow-up, cognition averaged 0.8 MMSE points better (P ) and functionality 1.0 BADLS points better (P ) with donepezil. Donepezil had no effect on institutionalization, progression of disability, behavioural or psychological symptoms, caregiver psychological status, care costs, adverse events, or deaths. Donepezil 5 mg and 10 mg were equivalent Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 50

51 Dementia: Long-term donepezil treatment in 565 patients with Alzhiemr s disease (AD2000): randomised double-blind trial (AD2000 Collaborative Group) IMPACT ON INTERNAL MEDICINE Anticholinesterase inhibitors may produce modest symptomatic improvements but probably do not alter the disease course. The decision to begin treatment with a cholinesterase inhibitor should be individualized with careful attention paid to clinical response and tolerability Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 51

52 Survival after Initial Diagnosis of Alzheimer Disease (Larson E et al.) AIM Examine correlates of survival after initial diagnosis of Alzheimer s disease (AD). RESULTS Patients with AD had significantly decreased survival compared with life expectancy of US population. Median survival for men was 4.2 years; 5.7 years for women Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 52

53 Review: High-dose vitamin E supplementation is associated with increased all-cause mortality (Miller ER III et al.) QUESTION Does vitamin E supplementation increase all-cause mortality? Does a dose-response relation exist between vitamin E and all-cause mortality? METHODS Data sources: MEDLINE (1966 to August 2004), Cochrane Central Register of Controlled Trials, bibliographies of relevant studies and reviews, and personal files of the investigators. CONCLUSIONS High-dose ( 400 IU/d) vitamin E supplementation is associated with increased risk for all-cause mortality. A dose-response relation exists between mortality and vitamin E doses 150 IU/d Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 53

54 Review: Somatostatin and its analogues do not reduce mortality in acute bleeding oesophageal varices (Gotzsche PC et al.) QUESTION In patients with suspected acute bleeding from oesophageal varices, are somatostatin or its analogues more effective than placebo or no treatment? METHODS Data sources: MEDLINE (1966 to February 2004), the Cochrane Library, abstracts from conference proceedings, reference lists of trials, and contact with authors. CONCLUSIONS In patients with suspected acute bleeding from oesophageal varices, somatostatin or its analogues do not reduce mortality. Patients who receive somatostatin require fewer units of blood products and have a lower failure rate of haemostasis Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 54

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56 Mediterranean diet, lifestyle factors and 10-year mortality in elderly European men and women: the HALE project (Knoops KT et al.) CONTEXT Dietary patterns and lifestyle factors are associated with mortality from all causes, coronary hear disease, cardiovascular diseases, and cancer, but few studies have investigated these factors in combination. OBJECTIVE To investigate the single and combined effect of Mediterranean diet, being physically active, moderate alcohol use, and nonsmoking on all-cause and cause-specific mortality in European elderly individuals. MAIN OUTCOME MEASURES Ten-year mortality from all causes, coronary heart disease, cardiovascular diseases, and cancer Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 56

57 Mediterranean diet, lifestyle factors and 10-year mortality in elderly European men and women: the HALE project (Knoops KT et al.) RESULTS The combination of 4 low-risk factors lowered the all-cause mortality rate to 0.35 (95% CI, ). In total, lack of adherence to this low-risk pattern was associated with a population-attributable risk of 60% of all deaths, 64% of deaths from coronary heart disease, 61% from cardiovascular diseases, and 60% from cancer. CONCLUSION Among individuals aged 70 to 90 years, adherence to a Mediterranean diet and healthful lifestyle is associated with a more than 50% lower rate of all-cause and cause-specific mortality Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 57

58 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 58

59 These 3 Komplementärmedizinische Methoden zeichnen sich durch eine kritische Distanz zum pharmazeutisch-akademischen Komplex aus; sie sind in der Grundversorgung aber gut integriert. Zusammen mit geringen Nebenwirkungen und dem eigenverantwortlichen Umgang kann die Komplementärmedizin bereits heute zu geringerem und gleichzeitig sinnvollem Wachstum der Gesundheitskosten führen Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 59

60 Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 60

61 Is there evidence to suggest that glucosamine and chondroitin should be part of the standard treatment for osteoarthritis? (McAlindon TE et al.) Glucosamine sulphate and chondroitin sulphate are two of a number of supplements and medications referred to as SYSADOA, slow-acting drugs for OA, or DMOADs. Chondroitin-treated subjects had a slower onset of action and symptomatic response, which lasted for up to 3 months after end of the study; another RCT found a similar increased duration of response (2). Two RCTs comparing glucosamine sulphate with ibuprofen found over an 8-week period that ibuprofen was faster in reducing pain by 2 weeks but that at 8 weeks glucosamine sulphate was better. Similar results were found in a 4-week study Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 61

62 Is there evidence to suggest that glucosamine and chondroitin should be part of the standard treatment for osteoarthritis? (McAlindon TE et al.) At the time of this writing, it appears that glucosamine and chondroitin are effective in reducing knee joint pain and in improving joint function; show symptomatic efficacy in individuals with mild to moderate knee OA; and are probably equivalent in efficacy to standard NSAIDs and other analgesics. However, individuals with more severe knee OA do not appear to benefit from these medications Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 62

63 Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multicentre trial (Madisch A et al.) BACKGROUND/AIM This study was undertaken to assess the utility of a commercially available herbal preparation (STW 5), a related preparation (STW 5-II), and a bitter candytuft monoextract in treating irritable bowel syndrome Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 63

64 Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multicentre trial (Madisch A et al.) METHODS 208 patients with irritable bowel syndrome ( 3 months of abdominal discomfort associated with disturbed bowel habits) were randomized into one of four groups. Twenty drops of the medication was taken three times/day for 4 weeks. The primary outcomes were 2 symptom scores (irritable bowel and pain). RESULTS Patients receiving either STW 5 or STW 5-II had significantly better scores on both scales than did those receiving the monoextract or placebo. All of the agents were well tolerated and no serious side effects were observed. AUTHORS CONCLUSION STW 5 and STW 5-II were both effective in alleviating the symptoms of irritable bowel syndrome Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 64

65 Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multicentre trial (Madisch A et al.) IMPACT ON INTERNAL MEDICINE This was a high quality study; there was an adequate randomization scheme employed and concealment of allocation did occur. A power calculation was performed. Care was taken to blind the study to both patients and investigators. It should be noted that both STW 5 and STW 5-II contain peppermint leaves and caraway fruit. These agents have appeared to be useful in RCTs of patients with non-ulcer dyspepsia. Furthermore, the commercial preparation costs about $15-20 for a month s supply. It would seem reasonable for practitioners to consider adding it to their therapeutic armamentarium Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 65

66 Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee. A Randomized Controlled Trial (Berman B et al.) AIM Examine the efficacy of acupuncture as a complementary therapy to pharmacologic therapy for osteoarthritis (OA) of the knee. METHODS Two TCTs comparing true to sham acupuncture in patients with knee osteoarthritis. Berman study also included an education control. Major methodological points. CONCLUSION Acupuncture appears to be a useful adjuctive therapy in improving pain and function in patients with knee osteoarthritis Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 66

67 Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee. A Randomized Controlled Trial (Berman B et al.) Study Design Participants Baseline Meds Intervention: Pharm Acupuncture Primary Outcome Follow-up Analysis Vas et al (BMJ) RCT 97 (mean age ~67;40% female); Spain All NSAID stopped for one wk before trial Diclofenac 50 mg tid prn for all True acupuncture (N=48); Sham (N=49) to 9 acupuncture points with electrostimulation to all local points in pairs. One treatment/wk x 12. Treatment averaged 29.4 min. VAS Pain intensity, WOMAC pain, stiffness, and function subscales; diclofenac dosage; QOL scale at baseline and 1wk after 12wks 91% ITT and per protocol Berman et al (Annals) RCT 570 (mean age 65.5, 64% female, 69% white) in US 11% simple analgesics, 31% nonselective NSAIDS, 28% COX-2 inhibitors; 6% were receiving an opioid. Continued meds and permitted to seek usual care True acupuncture (N=190); Sham (N=191) or control education (N=189). 9 points used. Tapered schedule for 26 weeks (2 treatments/wk x8; 1 treatment/wk x2; treatment every other week x4wk, 1 treatment/month x12wk). Electrical stimulation to 1 local/sham point. Treatment averaged 20 min. Education group: 6 2-hr group sessions over 12 wks Changes in the WOMAC pain and function scores at 8 and 26wks. Education group:57%; Intervention /sham: 75% each Intention to treat Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 67

68 Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee. A Randomized Controlled Trial (Berman B et al.) RESULTS Both studies found that acupuncture is an effective adjunctive therapy to pain medication when treating OA of the knee. - Pain decreased and function improved in both groups of patients. - Effects on physical capability differed between studies, probably due to the use of different measures. - In the Vas trial, where diclofenac tablet use was measured at the end of the study, a mean of 85 had been taken by the true acupuncture group compared with 139 in the sham group. IMPACT ON INTERNAL MEDICINE Acupuncture represents a relatively low risk intervention with potentially high benefits Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 68

69 Acupuncture cuts medical expenses (Journal of Chinese Medicine No. 77 Feb 05) In this innovative Japanese study, the health expenses of two companies whose employees engaged in similar physical labour were compared. In one company around half the employees received a total of eight acupuncture treatments, once a week, for neck/shoulder, knee and lumbar pain. In the second company, used as a control, none of the employees received acupuncture. After acupuncture, the pain in 83% of neck/shoulder cases, 88% of knee cases and 77% of lumbar cases was reduced by more than 50%, there was a significant decrease in tension, depression, anger, fatigue and mental confusion scores, the number of visits to conventional hospitals decreased by around 50% and average medical expenses were reduced by about 30%. (11th Annual Symposium on Complementary Health Care 2004) Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 69

70 Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial (Vickers AJ et al.) OBJECTIVE To determine the effects of a policy of use acupuncture on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of avoid acupuncture. METHODS 401 patients with chronic headache, predominantly migraine, from general practices in England and Wales were studies in a randomised, controlled trial. Patients were randomly allocated to receive up to 12 acupuncture treatments over three months or to a control intervention offering usual care. Headache score, SF-36 health status, and use of medication were assessed at baseline, 3, and 12 months Dr. med. Joerg Fritschi, CH-4148 Pfeffingen 70

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