[Update chronic viral hepatitis]. / Update chronische Virushepatitis.

More than 500,000 people in Germany have chronic viral hepatitis. The interferon-based treatments formerly used in hepatitis B have been widely replaced by life-long oral medication with nucleoside or nucleotide analogues. Treatment for chronic hepatitis C has been improved substantially by the development of new and very expensive drug combinations. Up to 90% of patients can now be cured with certainty, and one to two years after successful treatment there is no relevant risk of recurrence. These individuals expect to receive insurance cover under appropriate conditions. Vaccination programmes are very efficient at decreasing the incidence of hepatitis B, but no vaccine against hepatitis C is likely to become available in the next decade.

[Biologics--the new horizon for medical therapy]. / Biologika--der aktuelle Mega-Trend in der Arzneimitteltherapie.

Biologics include a wide range of medications that are produced by means of biological processes involving recombinant DNA technology. Approximately one in four of the recently approved new therapeuticals belongs to this group. Biologics have added major therapeutic options for the treatment of many diseases with an especially profound impact on rheumatoid arthritis, chronic inflammatory bowel disease, psoriasis, multiple sclerosis and a great array of malignancies. Many more targets are already screened in clinical research. Despite their clinical promises, monoclonal antibodies are raising concern about the potential adverse effects of long-term use. Costs are dramatically higher than for conventional medications, raising severe pharmacoeconomic concerns.

[Bile acid-independent effect of hymecromone on bile secretion and common bile duct motility]. / Gallensäure-unabhängige Wirkung von Hymecromon auf die Gallesekretion und die Motilität der Gallenwege.

BACKGROUND AND OBJECTIVE: Hymecromone (4-methyl-umbiliferone) has been used for more than 20 years for the treatment of functional and obstructive spasms of the biliary tract. Its mode of action however is still largely unknown. We investigated the effect of 4-methyl-umbiliferone p. o. and i. v. on gall bladder and common bile duct motility and studied potentially indirect effects via alterations in bile acid metabolism. PATIENTS AND METHODS: Twenty healthy volunteers, aged 25 - 37, 10 males, 10 females, were included into a Placebo-controlled, randomised, cross-over double-blind study. Subjects were treated with 800 mg hymecromone p. o.; in addition a standardized meal (Biloptin, 40 gs) was given. Gall bladder volume and common bile duct diameter were determined by ultrasound. Conjugated and unconjugated bile acids were analysed by gas chromatography. Additionally, in a third open label phase hymecromone was given i. v. RESULTS: Common bile duct diameter was significantly larger after a standard meal with hymecromone given p. o. or i. v. than with placebo (each p < 0.01). However, alterations in gall bladder volume after a standard meal were not different between placebo and hymecromone (p. o. or i. v.). Unconjugated and conjugated bile acids rose after standard meal in all three groups without significant differences between hymecromone and placebo. CONCLUSIONS: Hymecromone was associated with significant dilation of the common bile duct. In contrast to previous reports an effect of hymecromone on gall bladder motility could not be observed. The unchanged values of bile acids in serum after hymecromone compared to placebo, together with the dilatation of the common bile duct after hymecromone, may indicate a bile acid-independent effect of hymecromone on bile secretion.

[Development and current status of non-specific enzyme therapy]. / Entwicklung und aktueller Stellenwert der unspezifischen Enzymtherapie.

Non-specific enzyme therapy does not intend the catalysis of definite steps of metabolism, but claims to stimulate regenerative processes in general. Initially, non-specific enzyme therapy had been considered to be a promising approach. The growing knowledge in basic research and the lack of evidence for clinical effectiveness rendered the predominantly oral application of enzyme preparations for non-specific treatment outdated by the 1960s. In Germany, however, the absence of strict legal regulations prevented the deregistration of drugs designed for non-specific enzyme therapy. Furthermore, numerous clinical studies were initiated by the leading producer of enzyme preparations in Germany in order to provide the scientific confirmation missing so far. Our critical and systemic review of the published trials shows that neither the mechanism of action could be enlightened, nor the clinical benefit of non-specific enzyme therapy proven on an acceptable level of scientific standards.

[Autologous chondrocyte transplantation--progress or misleading development in high-tech medicine?]. / Autologe Chondrozytentransplantation--Fortschritt oder Irrweg der Hightech-Medizin?

Autologous chondrocyte transplantation (ACT) is a recently developed procedure for repairing chondral defects of the knee. An analysis of the literature provides no evidence so far for regular regeneration of hyaline cartilage, and no randomized controlled studies are available showing a long-term efficacy. Therefore, controlled randomized studies are urgently needed. At present, ACT cannot be recommended for extended application in clinical practice.

[Health management in private health insurance]. / Gesundheitsmanagement in der Privaten Krankenversicherung.

German private health insurance faces new challenges. The classical tools of cost containment are no longer sufficient to keep up with ever increasing expenses for health care, and international competitors with managed care experience from their home markets are on the point of entering business in Germany. Although the American example of managed care is not fully compatible with customer demands and state regulations, some elements of this approach will gradually be introduced. First agreements were signed with networks or individual preferred providers in outpatient care and rehabilitation medicine. Insurance companies become more and more interested in supporting evidence based guidelines and programmes for disease and case management. The pros and cons of various other health management tools are discussed against the specific background of the quite unique German health care system.

[Subarachnoid hemorrhage as life-threatening complication of neural therapy. Case report]. / Subarachnoidalblutung als lebensbedrohliche Komplikation nach Neuraltherapie. Fallbericht.

In Germany, neural therapy is a frequently used method of complementary medicine. It is based on the hypothesis, that pathologically altered regions may cause symptoms in other, distant localizations and that this process can be interrupted by the local injection of anesthetic drugs. Since the pathogenetic acting regions are supposed to occur in any part of the body, neural therapy is not limited to superficial injections, but also includes injections into deep structures and internal organs. Supporters of this therapeutic approach always claim that these procedures are free of risk if carried out by an experienced therapist. We report the case of a young woman, who suffered subarachnoidal bleeding caused by an attempt to infiltrate the tonsilla pharyngea during a neural therapeutic treatment. The analysis of this incident shows that severe and even life threatening complications cannot be ruled out in all neural therapeutic injections, even if they are performed strictly according to the rules given in the textbooks of neural therapy.

[New physician reimbursement guidelines and private health insurance. I. Changes in general liquidation regulations]. / Neue GOA und private Krankenversicherung. I. Anderungen der allgemeinen Liquidationsvorschriften.

In Germany, physicians' charges for the treatment of private patients have to be based on a fee-for-service schedule that is established by law. Every few years medical progress and changes of economic and legal conditions require major amendments. The latest adjustment reduces the accounts for laboratory tests and advanced imaging techniques. Further regulations concern the better information of patients about treatment costs and a reduced upper limit of fees for in-patient procedures not performed by the head of the department himself. For private insurers it is a challenge to identify the quite frequent medical accounts which are not in accordance with the complex fee schedule.

Cisapride increases gallbladder volume in gallstone patients before and after extracorporeal shock wave lithotripsy.

We have previously shown that oral cisapride causes a dose-related increase of fasting gallbladder volume in healthy subjects. The present study investigates the effect of cisapride on gallbladder motility in 16 patients with gallbladder stones; 8 patients had no biliary symptoms, but the other 8 patients with symptomatic gallstone disease were studied before and 6 weeks after extracorporeal shock wave lithotripsy (ESWL). For each study the patients received a single oral dose of 20 mg cisapride; fasting gallbladder volume was measured by ultrasound before, and for 120 minutes after, drug administration. In the 8 asymptomatic patients a mean maximal increase of the fasting volume to 152.7 +/- 7.6% of the initial value was observed at a mean 97.5 +/- 8.3 minutes after cisapride ingestion. Similarly, in the 8 patients with biliary pain mean fasting volume after cisapride ingestion increased to 141.3 +/- 5.7% before ESWL treatment and to 145.0 +/- 5.8% after ESWL and 6 weeks of oral litholytic therapy. There were no significant differences between the results in the symptomatic and asymptomatic patients. Our results indicate that cisapride increases the gallbladder volume in gallstone patients regardless of biliary symptoms. Similar volume changes were observed before therapy and after ESWL with bile acid therapy. The therapeutic efficacy of litholytic agents could be diminished by simultaneous cisapride administration.

Induced gall-bladder contraction accelerates fragment clearance after extracorporeal shockwave lithotripsy.

At the end of extracorporeal shockwave lithotripsy (ESWL) gallstone fragments are dispersed throughout the gall-bladder. In this state they should be expelled more easily than when later sedimented to the gall-bladder fundus. Thus, a randomized study was performed to evaluate the clinical benefit of induced gall-bladder contraction after ESWL. One hundred and five patients with radiolucent gallstones (1-3 stones, diameter < or = 30 mm) were randomized to received either saline or an infusion of 0.2 micrograms/kg ceruletide. Stone clearance rates and incidence of biliary symptoms were recorded. Clearance rates at 6 weeks and 3 months after ESWL were significantly (P < 0.025) improved by the ceruletide infusion. This effect, resulting in shortened bile acid therapy, was limited to patients with small solitary stones and dependent on a good initial fragmentation. Major side effects attributable to ceruletide were not observed. These results suggest that induced gall-bladder contraction can be successfully applied as an adjuvant treatment in a subgroup of patients with small solitary gallstones.

Comparison between endoscopic laser and different surgical treatments for palliation of advanced rectal cancer.

The results of different treatment modalities in 196 patients with rectal carcinoma were analyzed. Patients were treated by palliative endoscopic laser therapy (n = 37), palliative surgery (n = 42), and curative surgery (n = 117). Laser therapy was successful for recanalization of the stenosis with 1.3 (range, one to five) sessions. Bleeding stopped always after a single session. If necessary, treatment was repeated monthly. Good results were seen in 35/37 patients (95 percent). They received an average of four sessions during their remaining lifetime, the median of which was eight months. No morbidity and no therapy-related mortality occurred. Palliative surgery (expanded and restricted resections) showed good results in 41/42 patients (98 percent). Morbidity was 3/42 (7 percent); mortality was 1/42 (2 percent). The median survival was 14 months for local surgical treatment and 6.3 months for deep anterior rectal resection and for abdominoperineal (Dixon's) resection. No significant difference (P = 0.15) in survival times between the palliatively treated patient groups could be detected. Survival prognosis was determined by tumor stage and outcome. In the curative (outcome R0) resection patients, morbidity and mortality were each 9/117 (8 percent). The three-year survival rate was 80 percent. If curative resection is impossible, laser therapy should be considered as an alternative to palliative surgery because of less hospitalization and seemingly less side effects. The decision on the kind of palliation in patients with rectal carcinoma should be made with regard to the patient's quality of life.

Successful extracorporeal lithotripsy of gallbladder stones in a 12 year-old girl.

An otherwise healthy 12-year-old girl presented with radiolucent gallstones and colicky pain. After extracorporeal shock wave lithotripsy and oral bile acid treatment she is free of stones and biliary symptoms since 18 months. The treatment options for gallstone disease in this age group are discussed.

Combined treatment of large and calcified gallstones by ESWL and laparoscopic cholecystectomy.

In order to facilitate laparoscopic cholecystectomy in the presence of large gallbladder stones seven patients underwent ESWL before operation. In six cases (83%) a fragmentation to less than or equal to 1 cm could be achieved by application of 1,605 to 2,900 (mean 2,266) shock waves with the spark-gap lithotripter Philips-Dornier MFL 5000. In these cases intraoperative stone destruction or an increase of the puncture incision size could be avoided, thus proving the efficacy of this combined treatment approach. Laparoscopic inspection was performed 2 to 48 hours after ESWL. Including two additional cases operated because of unsuccessful ESWL, hematomas of the liver and adjacent organs were observed in six of nine patients (67%). This high rate of subclinical tissue lesions warrants caution if repeated ESWL sessions are scheduled at short-term intervals.

[Traveler's diarrhea in Turkey. Prospective randomized therapeutic comparison of charcoal versus tannin albuminate/ethacridine lactate]. / Reisediarrhö in der Türkei. Prospektiv randomisierter Therapievergleich Kohle versus Tanninalbuminat/Ethacridinlactat.

In most cases traveler's diarrhea is a self-limiting disease not requiring professional assistance. As data on self-treatment are very limited, a prospective randomized trial was performed in 620 German tourists spending a two week-holiday in Turkey. 31.6% of these travelers developed diarrhea and 186 were assigned to two treatment groups, receiving either medical coal or a combination of tannalbuminate and ethacridinlactate (TA/EL). In the TA/EL group stool frequencies significantly earlier returned to normal and complaints of moderate to severe abdominal pain were recorded less frequently (50 vs. 82.2%) than in patients receiving charcoal preparations. Both medications were well tolerated and TA/EL appeared more efficient for self medication of uncomplicated traveler's diarrhea.

Senna vs. bisacodyl in addition to Golytely lavage for colonoscopy preparation--a prospective randomized trial.

Colonoscopy preparation with lavage is a clinically accepted procedure. After having shown that its results can be improved by the additional intake of Senna this randomized prospective trial was designed to evaluate the effects of different laxatives in a combined preparation regimen. The day before endoscopy either Bisacodyl or extractum Sennae was given to 120 patients. Immediately before examination all patients underwent whole gut irrigation with Golytely solution. Patient acceptance and effectiveness of the two procedures were excellent and no relevant intolerance was observed. Satisfactory cleansing results were achieved with Bisacodyl as well as with Senna (98.3 vs. 95%). There was no significant difference between the laxatives used. We conclude that both regimens are safe, generally well tolerated and effective ways of preparation for colonoscopy.

Adding more fluid to wheat bran has no significant effects on intestinal functions of healthy subjects.

To regulate intestinal transit, increased fluid intake, along with fiber is recommended. Considering the usually large volumes of intestinal secretion, this advice is questionable. To demonstrate the effects of adding fluid to fiber, 11 volunteers ingested 15 g of wheat bran twice a day, randomly given without or with 600 mL of additional fluid. Stool weight and frequency were similarly increased in the two settings. Gastric emptying was delayed by bran only when bran was given without additional fluid. Orocecal transit showed no significant changes. Whole gut transit was slightly more accelerated with added fluid (20.6 vs. 13.5%). No test showed significant differences in direct comparison of bran and bran with additional fluid. We conclude that in healthy persons, such effects of wheat bran as acceleration of transit and increase in stool weight and frequency do not depend on an additional intake of fluid.

Addition of senna improves colonoscopy preparation with lavage: a prospective randomized trial.

Attempts have been made to further improve the widely performed colonoscopy preparation with lavage. In a prospective study, 120 outpatients and inpatients scheduled for total colonoscopy were randomized to two preparatory regimens. The day before endoscopy either extractum sennae (N = 60) or a placebo solution (N = 60) was given. Just before examination all patients underwent whole gut irrigation with a polyethylene glycol electrolyte lavage solution (PEG-ELS). Adequacy of preparation, patient tolerance, and the necessary amount of PEG-ELS were assessed. Physician assessment of colon cleansing showed superiority in the group with additional laxative. The colon was free of solid debris in 66.7% of patients after PEG-ELS and in 90% after senna/PEG-ELS administration (p less than 0.01). Patient tolerance was similar in both groups with 86.7% vs. 83.3% of subjects rating the preparation as tolerable. Severe adverse events were not observed. In the senna/PEG-ELS group, significantly less (p less than 0.05) lavage fluid was needed. We conclude that the combination of senna and PEG-ELS is more effective than PEG-ELS in cleansing the colon for colonoscopy.