STW1 and Its Versatile Pharmacological and Clinical Effects in Rheumatic Disorders: A Comprehensive Report.

AIM: To review the published and unpublished experimental and clinical studies about the efficacy and tolerability of STW1 and to compare the results to the efficacy and tolerability of investigated NSAIDs in parallel. Content. STW1 (Phytodolor®) contains a fixed combination of extracts from aspen leaves and bark (Populus tremula), common ash bark (Fraxinus excelsior), and goldenrod herb (Solidago virgaurea). It belongs to the group of anti-inflammatory and antirheumatic drugs, and it is authorized for the treatment of painful disorders of degenerative and inflammatory rheumatic diseases. The individual components have complementary effects. Its multifocal mode of action includes antiphlogistic, analgesic, antiexudative, antioxidative, antipyretic, and antiproliferative properties. The effects of both STW1 and its components have been verified in comprehensive pharmacological investigations. Open and randomized, placebo- and verum-controlled, and single-blind (sb) or double-blind (db) clinical trials, performed in different subtypes of rheumatic diseases confirm the pharmacological evidence. Its efficacy is comparable to a range of standard nonsteroidal anti-inflammatory drugs (NSAIDs) studied in parallel, but it has a superior safety profile. CONCLUSION: STW1 is a reasonable alternative to NSAIDs with comparable efficacy and a superior safety profile. It is also suitable to reduce the intake of NSAIDs.

Essential phospholipids in fatty liver: a scientific update.

AIM: Although essential phospholipids (EPL) from soybean are often used in membrane-associated disorders and diseases, their high quality of purification and effects on prevalent liver diseases, especially on fatty liver diseases (FLDs) of different origin, are still widely unknown and a matter of continuous active research. The aim of this article is to review, discuss, and summarize the available results of EPL in the treatment of FLD. METHODS: Database research was carried out on Medline, Embase, Cochrane Library, country-specific journals, and follow-up literature citations for relevant hepatogastroenterological articles published between 1988 and 2014. We searched for and reviewed only those papers that indicated minimum extraction amount of 72% (3-sn-phosphatidyl)choline from soybean as being necessary to treat patients with a considerable amount of 1,2-dilinoleoylphosphatidylcholine as a key component in EPL. RESULTS: EPL has a well-established mode of action, therapeutic effectiveness, and lack of toxicity, which ensures clinically relevant efficacy-to-safety ratio. It influences membrane- dependent cellular functions and shows anti-inflammatory, antioxidant, antifibrogenic, anti apoptotic, membrane-protective, and lipid-regulating effects. Due to its positive effects on membrane composition and functions, it accelerates the improvement or normalization of subjective symptoms; pathological, clinical, and biochemical findings; hepatic imaging; and liver histology. It is justified to administer EPL together with other therapeutic measurements in the liver. CONCLUSION: Pharmacological and clinical results confirm the efficacy of EPL in the treatment of FLD.

Activity of essential phospholipids (EPL) from soybean in liver diseases.

Essential phospholipids (EPL) contain a highly purified extract of polyenylphosphatidylcholine (PPC) molecules from soybean. The main active ingredient is 1,2-dilinoleoylphosphatidylcholine (DLPC), which differentiates it from other phospholipids, lecithins, or extracts from other sources. Although EPLis widely used in liver diseases of various origins, its mode of action and pharmacological and clinical evidence of its efficacy have not yet been concisely reviewed. This paper critically summarizes experimental and clinical results. With regard to in-vitro and animal tests, EPL influenced membrane-dependent cellular functions and showed anti-oxidant, anti-inflammatory, anti-fibrotic, apoptosis-modulating, regenerative, membrane-repairing and -protective, cell-signaling and receptor-influencing, as well as lipid-regulating effects in intoxication models with chemicals or drugs. Clinical studies, primarily from European and Asian countries, have shown improvement in subjective symptoms; clinical, biochemical and imaging findings; and histology in liver indications such as fatty liver of different origin, drug hepatotoxicity, and adjuvant in chronic viral hepatitis and hepatic coma. The available studies characterize EPL as evidence-based medicine, although further long-term controlled clinical trials are required to precisely determine its benefit for alleviating symptoms, improving well-being, inducing histological changes and slowing the progression of liver disease. EPL-related relevant side effects were not observed.

Phytodolor--effects and efficacy of a herbal medicine.

UNLABELLED: Herbal antirheumatics are successfully used in painful inflammatory or degenerative rheumatic diseases. One of these herbal medicines is Phytodolor (STW 1), a fixed combination of extracts from aspen leaves and bark (Populus tremula), common ash bark (Fraxinus excelsior), and golden rod herb (Solidago virgaurea). Its effects as well as those of its components have been verified in experimental and human pharmacological investigations. The mode of action of STW 1 includes antiinflammatory, antioedematous, antioxidative and analgesic properties, and it is considered to be broader than that of synthetic antirheumatics. Open clinical studies and randomised, placebo- or verum-controlled double-blind trials, performed in different subtypes of rheumatic diseases, confirm the pharmacological evidence of efficacy, such as by reducing the intake of non-steroidal antiinflammatory drugs (NSAIDs). STW 1 has a high drug safety. CONCLUSION: Phytodolor (STW 1) is a reasonable alternative to NSAIDs and to cyclooxygenase(COX)-2-inhibitors such as rofecoxib.

STW 5, a phytopharmacon for patients with functional dyspepsia: results of a multicenter, placebo-controlled double-blind study.

BACKGROUND: Functional dyspepsia (FD) constitutes a complex picture with a variety of epigastric symptoms. No standard therapy is currently available for FD. OBJECTIVE: This multicenter, placebo-controlled, double-blind study evaluated the efficacy and tolerability of the herbal drug STW 5, mainly comprising a fresh plant extract from Iberis amara. METHODS: Patients with FD were included. Gastrointestinal endoscopy, H. pylori-status, and a 7-day run-in phase were required. A total of 315 patients were treated with 3 x 20 drops/day of either STW 5 or placebo. Symptom assessment: day 0, 2, 4, and 8 wk of treatment. The principal outcome criterion was the change in a validated Gastrointestinal Symptom Score (GIS). Symptom severity was rated using the Likert scale. RESULTS: A total of 315 patients remained in the safety population. Of them, 158 were treated with STW 5 and 157 with placebo. The intention-to-treat population comprised 308 patients. Dropout number was similar in both groups. GIS showed improvement during the treatment period. The STW 5 group improved 6.9+/-4.8 points up to day 56, placebo group by 5.9+/-4.3 (P<0.05). H. pylori did not influence the results. Drug tolerability and safety were similar in both groups. CONCLUSION: This placebo-controlled study with an 8-wk treatment period documents the efficacy of STW 5 in FD.

Efficacy of a herbal preparation in patients with functional dyspepsia: a meta-analysis of double-blind, randomized, clinical trials.

A meta-analysis was performed of double-blind, randomized clinical studies that evaluated the efficacy of the herbal preparation Iberogast in patients with functional dyspepsia. All studies had the same duration and used the same dosage of active treatment and the same primary outcome measure, a dyspepsia-specific gastrointestinal symptom score. Of the 592 trial participants, 196 were treated with Iberogast and 192 with placebo or cisapride (positive control). The individual studies all showed a substantial improvement of symptoms with Iberogast but varying results regarding its statistically significant superiority to placebo. The meta-analysis of all studies, however, demonstrated a clear, highly significant overall therapeutic effect of Iberogast in the treatment of functional dyspepsia. Tolerability of the preparation was excellent.