Use of Phytodolor®
PPhytodolor® (manufacturer’s internal abbreviation: STW1) is a tincture made from 3 ingredients: ash bark (Fraxinus excelsior), aspen bark and leaves (Populus tremula), and goldenrod (Solidago virgaurea) in a fixed mixing ratio of 1:3:1 (1).
Solidago virgaurea is traditionally used to increase urine output (9, 12), while Fraxinus excelsior and Populus tremula are used to relieve mild joint discomfort and to increase urine output (9, 13).
Phytodolor® is a herbal medicine intended for use in adults for muscle and joint pain, with the indications “painful symptoms associated with degenerative and inflammatory rheumatic diseases” (10, 11). The dosage for internal use is specified as 3 times daily, 30–40 drops (10, 11). The recommended duration of use for Solidago virgaurea is 2–4 weeks (12). Long-term use of Phytodolor® (>4 weeks) is not recommended (10). Phytodolor® is available over the counter at pharmacies.
Chemical and pharmacological composition:
Phytodolor® is a tincture. This is defined as a thin, usually alcoholic extract of raw materials, which may be of plant or animal origin. The main components of ash bark are reported to be coumarin and iridoid bitter compounds (9); for aspen, salicin/salicortin; and for goldenrod, flavonoids, triterpene saponins (virgaurea saponins), and phenolic glycosides (9).
In vitro and in vivo effects/in animal models
For STW1, reduced TNF-alpha gene expression and inhibition of COX-2 synthesis in activated human monocytes were demonstrated in human cell cultures following lipopolysaccharide stimulation (2). A reduction in inflammation-induced apoptosis was also described, as well as inhibition of prostaglandin synthesis (with a similar effect to indomethacin) and of the inflammatory mediators histamine and leukotriene (3). In animal experimental models, anti-inflammatory, analgesic, anti-exudative, antioxidant, antipyretic, and antiproliferative effects have been described for Phytodolor® (2, 6, 14). Merzenich et al. report changes in the cytokine profile for IL-1α, IL-8, IL-10, and IL-15 in in vitro models with fibroblast cultures under Phytodolor® starting at an STW1 concentration of 0.1% (2). In studies of LPS-activated monocytes and differentiated macrophages, Bonaterra et al. provided evidence of anti-inflammatory and pro-apoptotic effects with Phytodolor in vitro (1). The inhibition of prostaglandin endoperoxidase synthase 2 is likely due to the presence of salicin/salicylic alcohol in the aspen (1).
A PubMed search was conducted using the terms: “Phytodolor” or “STW1” and “rheuma” or “pain” or “arthritis,” in English and German, retrieved on April 29, 2024. Nine usable articles were identified. Of these articles, four were review articles and one was identified as a meta-analysis.
Use of Phytodolor in Rheumatoid Arthritis
In 2009 and 2011, Cameron et al. conducted Cochrane analyses of the unpublished study results provided by the manufacturer from randomized trials by Meier (1987) over 2 weeks and Eberl et al. (1988) over 12 months (4, 8). These initially showed higher diclofenac use in the active treatment group than in the placebo group. In months 2–11, NSAID use during treatment with Phytodolor® was lower than in the placebo group. Both studies were conducted with support from the manufacturing company (4).
Use of Phytodolor® for Osteoarthritis
In a 2009 Cochrane review (7), Cameron et al. examined three comparative studies conducted by the manufacturer (Steigerwald Pharmaceuticals). In these studies, Phytodolor® was compared to placebo or piroxicam. The studies, involving a total of 176 participants, showed a reduction in NSAID use (diclofenac) and, as the sole outcome measure, an improvement in finger-to-floor distance (Schadler 1988; Bernhardt et al. 1991; Huber 1991) (7). The choice of the “finger-to-floor distance” as an outcome measure for a patient cohort with osteoarthritis was also viewed critically by the authors of the Cochrane Report. Schadler used a crossover design with intervention periods of seven days and administered a dose of Phytodolor that was 33% higher than in the other two studies. The other two studies employed a parallel-group design and lasted three and four weeks, respectively. The data could not be pooled for meta-analyses.
Use of Phytodolor® for Various Musculoskeletal Conditions
Uehleke et al. conducted a meta-analysis of 11 randomized studies, most of which had not been published and were provided by the manufacturer. The analysis evaluated global patient assessments of efficacy and, as a secondary outcome measure, pain assessment at rest and during movement in patients with musculoskeletal symptoms and conditions (back pain, epicondylitis, rheumatoid arthritis, spondylitis, and knee osteoarthritis). The aforementioned studies on osteoarthritis were included in the analysis; the duration of the studies ranged from 7 days to 12 months. The subgroup of patients with knee osteoarthritis showed a tendency toward inferiority compared to NSAIDs, while the group of all other patients (combined) showed a tendency toward superiority (though not statistically significant) (5). Mild adverse events were reported (8.1% in the placebo group, 14.2% in the STW1 group, and 18.9% in the NSAID group) (5).
In 2020, Gundermann, together with a co-author from the manufacturer, reported once again on the same (often unpublished) clinical studies and in vitro results, concluding that Phytodolor® had what he termed “multifaceted” effects on various rheumatic and degenerative diseases without substantiating this claim with his own data (6).
Even though the use of Phytodolor® for the treatment of joint pain may be perceived as helpful in individual cases, its use for the “treatment of painful symptoms in degenerative and inflammatory rheumatic diseases” (manufacturer’s label) cannot be considered proven effective due to the limited data available for rheumatological conditions. Long-term effects have not been studied, and the manufacturer recommends use for a maximum of 4 weeks.
Phytodolor® should not be used in cases of allergy to any of the ingredients or in cases of acute gastrointestinal ulcers. Use during pregnancy and breastfeeding is not recommended (11,12,13). “A health risk exists, among others, for people with liver disease, alcoholics, epileptics, patients with organic brain disorders, pregnant women, breastfeeding women, and children. The effects of other medications may be impaired or enhanced” (10).
The high alcohol content of 46.5% (0.7 g per 40 drops) poses a health risk to children and patients with liver disease, epilepsy, and brain damage (4, 7). Children and adolescents under 18 years of age should not take this product (according to Reference 11).
The manufacturer’s information includes the following notes:
“Common side effects of Phytodolor® include gastrointestinal complaints such as stomach pain, nausea, and vomiting. Headaches may occur occasionally. It may lead to an increase in blood sugar, hypersensitivity reactions (skin reactions), fluid retention (edema), and frequent urination” (10).
Hypersensitivity reactions and gastrointestinal complaints have been reported for Solidago virgaurea; concomitant use of diuretics should be avoided (12). Use during pregnancy and breastfeeding is not recommended (12). A contraindication exists for conditions involving restricted fluid intake, such as severe cardiac and nephrological diseases, as well as in cases of hypersensitivity to phytotherapeutics of the Asteraceae family (e.g., arnica).
For Fraxinus excelsior, there is also a contraindication in cases of conditions with restricted fluid intake, such as severe cardiac and nephrological diseases (13). Use during pregnancy and breastfeeding is not recommended (13).
No reports of serious side effects have been received to date (6).
There is insufficient clinical and scientific evidence to support the prescription of Phytodolor® tincture for defined inflammatory rheumatic diseases. The study data date from the 1980s and 1990s, feature variable study designs, and have largely not been published or have only been published in abstracts. Furthermore, no data are available on long-term use or on the impact on the long-term course of rheumatic diseases. A limiting factor is therefore the recommended use for a maximum of 4 weeks in the context of chronic diseases.
In cases of mild to moderate pain associated with degenerative joint and spinal disorders, short-term use need not necessarily be ruled out, particularly when NSAIDs or other pharmacological interventions are contraindicated or not indicated for other reasons, and when patients express a desire for phytotherapeutic treatment.
1 Bonaterra GA, Schwarzbach H, Kelber O, Weiser D, Kinscherf R Anti-inflammatory effects of Phytodolor® (STW 1) and components (poplar, ash, and goldenrod) on human monocytes/macrophages. Phytomedicine 2019; 58 (2019) 152868
2 Ulrich-Merzenich G, Hartbrod F, Kelber O, Müller J, Koptina A, Zeitler H. Salicylate-based phytopharmaceuticals induce adaptive cytokine and chemokine network responses in human fibroblast cultures. Phytomedicine. 2017 Oct 15;34:202-211. doi: 10.1016/j.phymed.2017.08.002. Epub 2017 Aug 9. PMID: 28899503.
3 Gundermann KJ, Müller J. Phytodolor—effects and efficacy of a herbal medicine. Wien Med Wochenschr. 2007;157(13-14):343-7. doi: 10.1007/s10354-007-0436-4. PMID: 17704984.
4 Cameron M, Gagnier JJ, Chrubasik S. Herbal therapy for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD002948. doi: 10.1002/14651858.CD002948.pub2. PMID: 21328257.
5 Uehleke B, Brignoli R, Rostock M, Saller R, Melzer J Phytodolor® in musculoskeletal disorders: re-analysis and meta-analysis. Forschende Komplementärmedizin, 2011; 18(5):249-256.
6 Gundermann KJ, Müller J, Kraft K. STW1 and Its Versatile Pharmacological and Clinical Effects in Rheumatic Disorders: A Comprehensive Report. Evid Based Complement Alternat Med. 2020 Jul 14;2020:7841748. doi: 10.1155/2020/7841748. PMID: 32733586; PMCID: PMC7376409.
7 Cameron M, Gagnier JJ, Little CV, Parsons TJ, Blümle A, Chrubasik S. Evidence of effectiveness of herbal medicinal products in the treatment of arthritis. Part I: Osteoarthritis. Phytother Res. 2009 Nov;23(11):1497-515. doi: 10.1002/ptr.3007. PMID: 19856319.
8 Cameron M, Gagnier JJ, Little CV, Parsons TJ, Blümle A, Chrubasik S. Evidence of effectiveness of herbal medicinal products in the treatment of arthritis. Part 2: Rheumatoid arthritis. Phytother Res. 2009 Dec;23(12):1647-62. doi: 10.1002/ptr.3006. PMID: 19941324.
9 www.arzneipflanzenlexikon.info
10 www.phytodolor.de
11 www.apotheken-umschau.de/medikamente/beipackzettel/phytodolor-tinktur-7153853.html ABDATA Pharma Data Service 04/19
12 www.ema.europa.eu/en/medicines/herbal/solidaginis-virgaureae-herba
13 www.ema.europa.eu/en/medicines/herbal/fraxini-folium
14 el-Ghazaly, M T Khayyal, S N Okpanyi, M Arens-Corell Study of the anti-inflammatory activity of Populus tremula, Solidago virgaurea, and Fraxinus excelsior Arzneimittelforschung 1992 Mar;42(3):333-6.
Last updated: March 10, 2024