Benefits
Traditional use for fullness, slow digestion and flatulence
The European Medicines Agency accepts fumitory tea, powder, extracts, tincture and fresh juice as a traditional herbal medicine for digestive disturbances such as fullness, slow digestion and flatulence, taken before meals. This rests on long-standing use; the agency says efficacy is plausible but not proven by clinical data.
Symptom ratings in older studies of bile-duct complaints
Studies from the 1960s and 1970s gave water extracts, mainly 1,500 mg a day, to about 700 patients with bile-duct complaints and reported favorable ratings, mostly for fullness and flatulence, with good tolerance. Most had no control group and few details; the abstract of one study of 85 patients reports success in 70% and a significant difference from placebo.
Abdominal pain and bloating scores over 18 weeks
In a randomized, double-blind trial in 106 adults with irritable bowel syndrome, 1,500 mg a day of powdered fumitory for 18 weeks did not change pain or bloating ratings more than placebo, and global symptom and stress ratings did not differ between groups. This is the only modern controlled trial of fumitory alone.
Bile flow regulation in animal studies
In rats, water extracts of fumitory did not change normal bile flow but slowed bile flow that had been raised experimentally and increased flow that had been lowered, with a light antispasmodic effect. In mice, an extract was reported to inhibit experimental gallstone formation. These are older animal findings; bile flow has not been measured in people.
Anti-inflammatory activity of fumitory alkaloids in lab and mouse tests
An alkaloid extract of fumitory, rich in jatrorrhizine and protopine, protected a protein (albumin) from denaturation in a lab test and reduced chemically induced paw swelling in mice by up to 77% at 200 mg/kg. No human study has tested an anti-inflammatory effect of fumitory.
Mechanism of action
Isoquinoline alkaloids led by protopine
Fumitory contains about 0.3 to 1% isoquinoline alkaloids. Protopine is the main one, which is why the European Pharmacopoeia sets a minimum alkaloid content expressed as protopine. One lab analysis isolated 20 alkaloids from the aerial parts, two of them new. EU regulators do not recognize any single constituent as the active one.
Two-way effect on bile flow (amphocholeretic action)
Fumitory is described as amphocholeretic: in older rat studies it brought abnormally high or low bile flow back toward normal without changing normal flow. Protopine made the sphincter muscle at the bile duct outlet contract in animals. EU regulators cite possible stimulation of bile secretion as the reason to avoid fumitory with bile-duct disease.
How the body handles protopine
In a horse study that included one human volunteer, protopine from fumitory was broken down into several related alkaloids that appeared in urine, with a similar pattern in horse and human. EU regulators found no pharmacokinetic data on fumitory extracts themselves, so how much alkaloid reaches the blood from tea or tablets is unknown.
Clinical trials
Randomized, double-blind, placebo-controlled, three-arm trial: Fumaria officinalis 1,500 mg/day or Curcuma xanthorrhiza 60 mg/day or placebo, taken three times a day for 18 weeks (Brinkhaus et al. 2005, Scand J Gastroenterol)
106 adults with irritable bowel syndrome in the intention-to-treat analysis (mean age 48, 63% women): 24 on fumitory, 24 on curcuma, 58 on placebo.
Pain ratings fell by 0.9 mm on fumitory and 0.3 mm on placebo on a 0 to 50 mm scale (p=0.81 across groups); bloating rose by 0.3 mm on fumitory and fell by 2.1 mm on placebo (p=0.48). Global symptom and stress ratings did not differ. The authors concluded fumitory showed no benefit over placebo. The EMA assessment table lists the duration as 16 days, but the trial's own abstract reports 18 weeks.
Clinical study of the Fumaria extract product Oddibil, indexed as a randomized controlled trial; article in German with a short English abstract (Zacharewicz et al. 1979, Wien Med Wochenschr)
85 patients with gallbladder and bile-duct complaints (cholecystopathies), including biliary dyskinesia.
The abstract reports success in 70% overall and in more than 80% of those with biliary dyskinesia, best results after about 10 days on average, a statistically significant difference from placebo and no side effects. Dose, randomization and outcome measures are not given in the abstract. The EMA assessment describes this paper as an open study of 45 patients at 3 tablets of 250 mg a day for 16 days, so the design is unclear.
Analytical metabolism study in horses and one human volunteer given Fumaria officinalis or purified protopine, with urine analyzed by gas chromatography and mass spectrometry (Wynne et al. 2004, J Chromatogr B Analyt Technol Biomed Life Sci)
Horses and a single human volunteer.
Several urinary metabolites of protopine were identified, including tetrahydroprotoberberine alkaloids; protopine-like metabolites built up only when the main route was overloaded. Metabolism was qualitatively similar in horse and human. The study measured metabolites only, not effects or safety.
Single case report of suspected herb-induced liver injury, published as a letter in French with no abstract (Bonnet et al. 2007, Gastroenterol Clin Biol)
One patient; the EMA assessment describes a 56-year-old woman who took a multi-herb product for about 7 months.
The title reports acute hepatitis judged probably induced by Fumaria and Vitis vinifera tinctoria (red vine) herbal products. In its safety section the EMA assessment describes a combination product that also contained dandelion, boldo, artichoke (Cynara cardunculus) and horsetail; its overall conclusions instead name Fumaria and red vine products. One case cannot prove that fumitory caused the injury.