Benno Brinkhaus

Use of complementary and alternative medicine in Germany – a survey of patients with inflammatory bowel disease

BackgroundPrevious studies have suggested an increasing use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). The aim of our study was to evaluate the use of CAM in German patients with IBD.MethodsA questionnaire was offered to IBD patients participating in patient workshops which were organized by a self-help association, the German Crohns and Colitis Association. The self-administered questionnaire included demographic and disease-related data as well as items analysing the extent of CAM use and satisfaction with CAM treatment. Seven commonly used CAM methods were predetermined on the questionnaire.Results413 questionnaires were completed and included in the analysis (n = 153 male, n = 260 female; n = 246 Crohns disease, n = 164 ulcerative colitis). 52 % of the patients reported CAM use in the present or past. In detail, homeopathy (55%), probiotics (43%), classical naturopathy (38%), Boswellia serrata extracts (36%) and acupuncture/Traditional Chinese Medicine (TCM) (33%) were the most frequently used CAM methods. Patients using probiotics, acupuncture and Boswellia serrata extracts (incense) reported more positive therapeutic effects than others. Within the statistical analysis no significant predictors for CAM use were found. 77% of the patients felt insufficiently informed about CAM.ConclusionThe use of CAM in IBD patients is very common in Germany, although a large proportion of patients felt that information about CAM is not sufficient. However, to provide an evidence-based approach more research in this field is desperately needed. Therefore, physicians should increasingly inform IBD patients about benefits and limitations of CAM treatment.

Systemic Availability and Pharmacokinetics of Thymol in Humans

Essential oil compounds such as found in thyme extract are established for the therapy of chronic and acute bronchitis. Various pharmacodynamic activities for thyme extract and the essential thyme oil, respectively, have been demonstrated in vitro, but availability of these compounds in the respective target organs has not been proven. Thus, investigation of absorption, distribution, metabolism, and excretion are necessary to provide the link between in vitro effects and in vivo studies. To determine the systemic availability and the pharmacokinetics of thymol after oral application to humans, a clinical trial was carried out in 12 healthy volunteers. Each subject received a single dose of a Bronchipret® TP tablet, which is equivalent to 1.08 mg thymol. No thymol could be detected in plasma or urine. However, the metabolites thymol sulfate and thymol glucuronide were found in urine and identified by LC‐MS/MS. Plasma and urine samples were analyzed after enzymatic hydrolysis of the metabolites by headspace solid‐phase microextraction prior to GC analysis and flame ionization detection. Thymol sulfate, but not thymol glucuronide, was detectable in plasma. Peak plasma concentrations were 93.1 ± 24.5 ng ml−1 and were reached after 2.0 ± 0.8 hours. The mean terminal elimination half‐life was 10.2 hours. Thymol sulfate was detectable up to 41 hours after administration. Urinary excretion could be followed over 24 hours. The amount of both thymol sulfate and glucuronide excreted in 24‐hour urine was 16.2% ± 4.5% of the dose.

Acupuncture and Moxibustion in the Treatment of Active Crohn’s Disease: A Randomized Controlled Study

Background: Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly being applied in Western countries. The purpose of this study was to investigate the efficacy of acupuncture in the treatment of active Crohn’s disease (CD). Methods: A prospective, randomized, controlled, single-blind clinical trial was carried out to analyze the change in the CD activity index (CDAI) after treatment as a main outcome measure, and the changes in quality of life and general well-being, serum markers of inflammation (α1-acid glycoprotein, C-reactive protein) as secondary outcome measures. 51 patients with mild to moderately active CD were treated in a single center for complementary medicine by three trained acupuncturists and randomly assigned to receive either traditional acupuncture (TCM group, n = 27) or control treatment at non-acupuncture points (control group, n = 24). Patients were treated in 10 sessions over a period of 4 weeks and followed up for 12 weeks. Results: In the TCM group the CDAI decreased from 250 ± 51 to 163 ± 56 points as compared with a mean decrease from 220 ± 42 to 181 ± 46 points in the control group (TCM vs. control group: p = 0.003). In both groups these changes were associated with improvements in general well-being and quality of life. With regard to general well-being, traditional acupuncture was superior to control treatment (p = 0.045). α1-acid glycoprotein concentration fell significantly only in the TCM group (p = 0.046). Conclusions: Apart from a marked placebo effect, traditional acupuncture offers an additional therapeutic benefit in patients with mild to moderately active CD.

Acupuncture and moxibustion in the treatment of ulcerative colitis: A randomized controlled study

Objective. Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly applied in Western countries. The objective of this study was to investigate the efficacy of acupuncture and moxibustion in the treatment of active ulcerative colitis (UC). Material and methods. In a prospective, randomized, controlled clinical trial 29 patients with mild to moderately active UC (mean age 37.8±12.0 years) were randomly assigned to receive either traditional acupuncture and moxa (TCM group, n=15), or sham acupuncture consisting of superficial needling at non-acupuncture points (control group, CG, nu200a=u200a14). All patients were treated in 10 sessions over a period of 5 weeks and followed-up for 16 weeks. The main outcome measure was the change in the Colitis Activity Index (CAI) after treatment; secondary outcome measures were changes in quality of life, general well-being and serum markers of inflammation. Results. In the TCM group, the CAI decreased from 8.0 (±3.7) to 4.2 (±2.4) points and in the control group from 6.5 (±3.4) to 4.8 (±3.9) points (TCM versus CG: p=0.048). In both groups these changes were associated with significant improvements in general well-being (TCM group: from 3.0 (±1.8) to 1.8 (±1.0); CG: from 3.2 (±1.9) to 2.2 (±1.7)) and quality of life (TCM group: from 146 (±23) to 182 (±18); CG: from 157 (±20) to 183 (±23)). No significant differences between the TCM and CG were found regarding these secondary outcome measures. Conclusions. Differences in efficacy between traditional acupuncture and sham acupuncture were small and significant only for CAI as the main outcome measure. Both traditional and sham acupuncture seem to offer an additional therapeutic benefit in patients with mild to moderately active UC.

Urinary Excretion and Metabolism of Arbutin after Oral Administration of Arctostaphylos uvae ursi Extract as Film‐Coated Tablets and Aqueous Solution in Healthy Humans

Bearberry leaves and preparations made from them are traditionally used for urinary tract infections. The urinary excretion of arbutin metabolites was examined in a randomized crossover design in 16 healthy volunteers after the application of a single oral dose of bearberry leaves dry extract (BLDE). There were two groups of application using either film‐coated tablets (FCT) or aqueous solution (AS). The urine sample analysis was performed by a validated HPLC cool‐array method (hydroquinone) and a validated capillary electrophoresis method (hydroquinone‐glucuronide, hydroquinone‐sulfate). The total amounts of hydroquinone equivalents excreted in the urine from BLDE were similar in both groups. With FCT, 64.8% of the arbutin dose administered was excreted; with AS, 66.7% was excreted (p = 0.61). The maximum mean urinary concentration of hydroquinone equivalents was a little higher and peaked earlier in the AS group versus the FCT group, although this did not reach statistical significance (Cur max = 1.6893 μmol/ml vs. 1.1250 μmol/ml, p = 0.13; tmax (t midpoint) = 360 h vs. 440 h P = 038). The relative bioavailability of FCT compared to AS was 103.3% for total hydroquinone equivalents. There was substantial intersubject variability. No significant differences between the two groups were found in the metabolite patterns detected (hydroquinone, hydroquinone‐glucuronide, and hydroquinone‐sulfate).

Herbal medicine with curcuma and fumitory in the treatment of irritable bowel syndrome: A randomized, placebo-controlled, double-blind clinical trial

Objective. Irritable bowel syndrome (IBS) is a common functional disorder for which there is no reliable medical treatment. The aim of this study was to determine the efficacy of two herbal remedies used in the treatment of IBS. Material and methods. In a randomized, double-blind, placebo-controlled trial, IBS patients were randomly assigned to one of three treatment groups: 1) Curcuma xanthorriza 60 mg daily (curcuma group) (n=24), 2) Fumaria officinalis 1500u2009mgu2009daily (fumitory group) (n=24) and 3) placebo (n=58). The study treatment was applied three times a day for 18 weeks. The main outcome parameters were changes in global patient ratings of IBS-related pain and distension on a visual analogue scale (0–50u2009mm) between baseline and at the end of treatment. Additional outcome parameters included global assessments of changes in IBS symptoms and psychosocial stress caused by IBS. Results. A total of 106u2009patients (mean age 48±12u2009years, 63% F) were included in the intention-to-treat group. IBS-related pain decreased by −0.9±11.5 (mm±SD) in the fumitory group, −0.3±9.9 in the placebo group and increased by 2.0±9.5 in the curcuma group (p=0.81). IBS-related distension decreased by −1.4±12.5 in the curcuma group, −2.1±9.2 in the placebo group and increased by 0.3±9.3 in the fumitory group (p=0.48). Additionally, the global assessment of changes in IBS symptoms and psychological stress due to IBS did not differ significantly among the three treatment groups. Conclusions. Neither fumitory nor curcuma showed any therapeutic benefit over placebo in patients with IBS. Therefore, the use of these herbs for the treatment of IBS cannot be recommended.

Akupunktur und Moxibustion als ergänzende Therapie bei M. Crohn

ZusammenfassungEinleitung: Im Rahmen von Behandlungsansätzen mit Traditioneller Chinesischer Medizin (TCM) findet Akupunktur zunehmend Anwendung bei Patienten mit chronisch entzündlichen Darmerkrankungen. In der vorliegenden randomisierten, kontrollierten, einfach-blinden Studie wird die Wirksamkeit von Akupunktur als zusätzliche Behandlung bei Patienten mit M. Crohn untersucht.Methodik: 51 Patienten mit leicht bis mäßig aktivem Morbus Crohn wurden über 4 Wochen zusätzlich zu ihrer medikamentösen Therapie mit Akupunktur behandelt (10 Sitzungen). 27 Patienten erhielten eine semi-standardisierte Behandlung gemäß den Regeln der TCM (TCM-Gruppe), 24 Patienten erhielgroups ten eine oberflächliche Akupunktur an Nicht-Akupunkturpunkten (Kontrollgruppe). Als Hauptzielparameter diente die Veränderung der Krankheitsaktivität, erhoben mittels eines etablierten Fragebogens, dem Crohn´s Disease Activity Index (CDAI). Als Nebenzielparameter wurden Lebensqualität, subjektive Befindlichkeit und Entzündungsmarker im Blut (saures α1-Glykoprotein, C-reaktives Protein) untersucht. Alle Patienten wurden über 12 Wochen nachbeobachtet.Ergebnisse: In der TCM Gruppe fiel der CDAI nach 4-wöchiger Akupunkturbehandlung deutlich von 250 (± 51) auf 163 (± 56), in der Kontrollgruppe von 220 (± 42) auf 181 (± 46) Punkte ab (TCM- vs. Kontrollgruppe: p = 0,003). In beiden Gruppen waren diese Veränderungen mit Verbesserungen der subjektiven Befindlichkeit sowie der Lebensqualität assoziiert. In der TCM-Gruppe fiel außerdem das saure α1-Glykoprotein signifikant ab (p = 0,046).Schlussfolgerung: Die Crohn-Patienten profitieren hinsichtlich fast aller untersuchten Parameter von einer zusätzlich zur medikamentösen Therapie durchgeführten Akupunktur. Die nachgewiesene signifikante Überlegenheit der TCMAkupunktur weist dabei auf eine spezifische Wirkung der Akupunktur hin.AbstractBackground: Acupuncture has traditionally been used in the treatment of inflammatory bowel disease in China and is increasingly applied in Western countries. The aim of the study was to investigate the efficacy of acupuncture in the treatment of active Crohn’s disease.Methods: Prospective, randomized, controlled, single-blind clinical trial. Change in Crohn’s Disease Activity Index (CDAI) was used after treatment as main outcome measure, changes in quality of life and general well-being, serum markers of inflammation (α1-acid glycoprotein, C-reactive protein) as secondary outcome measures. 51 patients with mild to moderately active Crohn’s disease were treated in a single center for complementary medicine by three trained acupuncterists and randomly assigned to receive either traditional acupuncture (TCM group, n = 27) or control treatment at nonacupuncture points (control group, n = 24). Patients were treated in 10 sessions over a period of 4 weeks and followed up for 12 weeks.Results: In the TCM group CDAI decreased from 250 (± 51) to 163 (± 56) points as compared with a mean decrease from 220 (± 42) to 181 (± 46) points in the control group (TCM vs. control group: p = 0.003). In both groups these changes were associated with improvements in general well-being and quality of life. α1-acid glycoprotein concentration fell significantly only in the TCM group (p = 0.046)Conclusions: Apart from a marked placebo-effect traditional acupuncture offers an additional therapeutic benefit in patients with mild to moderately active Crohn’s disease.