Published August 25, 1994.
List of German Commission E Monographs (Phytotherapy)
Papainum crudum, papain.
Raw papain is latex from Carica papaya L. (pawpaw) [Fam. Caricaceae] that has been dried using various methods; where necessary it is decontaminated mechanically or by filtration.
Papain is the enzyme mixture extracted using various means from raw papain; it contains, along with papain (EC 126.96.36.199), chymopapain A and B and papaya peptidase A.
There is no extensive, satisfactory scientific experimental material available on the effects of raw papain/papain. The results on the analgesic and antiinflammatory effects are contradictory. Experiments have shown that papain has an edema-reducing effect. The fibrinogenous effect has not been sufficiently proven.
On the basis of animal experiments papain is said to demonstrate an absorption rate of 3 - 4 percent when taken orally. There is no research material available on the human pharmacokinetics of the drug. There is no extensive, satisfactory scientific experimental material available on the toxicology of papain/raw papain. Papain is not embryo-toxic or teratogenic; there are positive results in the case of raw papain.
There is no material available on the mutagenicity and carcinogenicity of papain.
Indications established through research:
None Reported indications for therapeutic use and grounds for rejection:
Infestation with ascarids, oxyurids, and trichocephalus nematodes. Papain/raw papain is used in combination in preparations for the treatment of inflammatory conditions of the mouth, throat and pharynx and of the upper respiratory tract; for influenza-type infections; loss of appetite; satiety; flatulence; Roemheld syndrome; putrefying-fermenting dyspepsias; enzyme deficiency; gastrointestinal digestion complaints; inflammations and ulcers in the gastroduodenal area; pancreas excretion insufficiency; dyskinesia of the liver and of the gallbladder ducts; chronic constipation; congestion of the liver; viral infections; anal thrombosis; concomitant therapy of malignant tumors; metastases; relapse prophylaxis; side effects of radiation treatment; lymphatic congestion following surgery and radiation treatment; palliative treatment of tumor patients; carcinomas, sarcomas, Hodgkin's disease, leukemia; circulatory complaints, arteriosclerosis, vascular disease, thrombophlebitis, thrombosis, hemorrhoids, varicose ulcers, poorly healing wounds, burns, abscesses, fistulas, traumatory edema, hematoma, acute and chronic inflammations, bronchitis, adnexitis, urethritis, rheumatic and degenerative complaints; conditions of aging, exhaustion, and exhaustion syndrome, in convalescence; vitamin, mineral and metabolic substance deficiency, metabolic illnesses, dyscrasia, neurosthenia, neuritis, physical and mental exhaustion and depression.
The efficacy of the drug in the above conditions is insufficiently proven with the exception of some effect of papain in the treatment of traumatory and postoperative edema.
There are other more effective substances available for the treatment of worm infestation.
An increase in the tendency to bleed in people with clotting disorders cannot be excluded. Allergic reactions may occur.
Due to the insufficiently proven efficacy of its use in the treatment of worm infestation and the risks associated, as well as the availability of treatment alternatives, the use of raw papain/papain cannot be recommended.
The efficacy of Papain in combination with other drugs used in the treatment of inflammations, edema and swelling following trauma and surgery needs to be specifically proven. Various experiment-based studies as well as clinical research indicate that Papain may be effective in high doses (daily dose = 1500 mg corresponding to 2520 FIP units).