Omphalia

Synopsis

Omphalia (Omphalia lapidescens Schroet.): A Comprehensive Reference

1. Identity

1.1 Botanical and Taxonomic Names

Omphalia lapidescens is the dried sclerotium of Omphalia lapidescens Schroet., a fungus of the genus Omphalia in the family Tricholomataceae. Omphalia is a macrofungus — a fungal organism that produces visible, macroscopic fruiting structures — rather than a vascular plant, and accordingly it occupies a distinctive niche in the world of traditional herbal medicine as a medicinal fungus.

Its taxonomic status has been subject to ongoing scholarly revision. Despite its long history of use, there has been a debate regarding the classification and scientific designation of O. lapidescens. The Encyclopedia of Chinese Materia Medica, the Pharmacopoeia of the People's Republic of China, and the Complete Collection of Chinese Medicine frequently categorize O. lapidescens as a member of the Tricholomataceae family, with the scientific name Omphalia lapidescens. However, the 2020 publication Chinese Medicinal Fungi reclassified it under the genus Laccocephalum, with the scientific name Laccocephalum mylittae. Recent phylogenetic analyses based on fruiting body morphology and internal transcribed spacer sequencing have indicated that O. lapidescens is more closely related to the family Marasmiaceae and the genus Gerronema.

1.2 Common Names

O. lapidescens, commonly known as "Lei Wan" or "Zhu Ling," is a medicinal fungus that is widely distributed in western China. The name "Lei Wan" (雷丸) translates roughly as "thunder ball," a reference to the roughly spherical, hard shape of the underground sclerotia. In English-language supplement literature it is also simply called "Omphalia" or "Omphalia mushroom."

1.3 Natural Source and Growth Habit

O. lapidescens forms sclerotia underground, much like black truffles, setting it apart from ordinary edible fungi. The sclerotia can be found on the roots of bamboo during the summer and autumn seasons; after winter, new fruiting bodies are produced by the sclerotium, which are generally not easy to see.

The offspring have a short life span, most commonly as sclerotia, and generally grow near the roots of bamboo, phoenix, or pine trees, and have always been wild. The sclerotia are collected in autumn, and the preferred material is described in traditional texts as large, full, firm, and heavy, with a purplish-brown exterior and a white interior, free of sand. The main producing regions are Sichuan, Guizhou, and Yunnan provinces in China. The sclerotia are collected in autumn, slightly bitter without unpleasant smell, washed, and dried in the sun; used unprocessed.

1.4 Medicinal Part and Common Preparations

The dried sclerotia of Omphalia lapidescens are ground into powder when used as medicine. In traditional and contemporary settings, preparations include raw dried powder, decoctions, tablets, capsules, and injectable extracts. The China Food and Drug Administration has approved Lei Wan Pian (tablets) and Lei Wan Jiao Nang (capsules) as antitumor auxiliary drugs.

2. Traditional and Historical Use

2.1 Traditional Chinese Medicine (TCM)

Omphalia lapidescens has long been regarded as a crucial antiparasitic herb in traditional Chinese medicine, whose importance was particularly pronounced when parasitic diseases were prevalent across China.

In TCM theory, O. lapidescens was historically linked to the large intestine and stomach meridians and used for the treatment of parasitic infestations and the promotion of digestion. Classical TCM characterizes it as slightly bitter and cold in nature, mildly toxic, and associated with the stomach and large intestine meridians.

As documented in the Compendium of Materia Medica (Bencao Gangmu), O. lapidescens is used to treat infections by Taenia, a genus of tapeworms. The same classical source, compiled by Li Shizhen in the 16th century CE, remains among the most authoritative references for the drug's traditional therapeutic profile.

It can expel various intestinal parasites such as taeniasis, ancylostomiasis, and ascariasis, and is especially recommended for taeniasis. Historically, it was used for childhood nutritional deficiencies (gan ji) caused by parasitic infections and abdominal pain.

2.2 Traditional Preparations

The dried fruiting body (sclerotium) of Omphalia was typically decocted or powdered, then administered to alleviate symptoms like abdominal pain, distention, and irregular stools associated with parasitic infections. One classical dosing approach documented in TCM sources specifies that it is ground into powder and swallowed for treating taeniasis, 20 g per dose, three times daily; tapeworm bodies are reportedly completely or partially expelled in most cases within two to three days.

2.3 Herbal Combinations

Omphalia (dried sclerotia of Omphalia lapidescens Schroet.), alongside Semen Arecae, Rhizoma Dryopteris Crassirhizomae, Pericarpium Granati, pumpkin seeds, and the extract from the radical bud of Herba Agrimoniae, was used for the treatment of taeniasis very early in China.

In multi-herb formulas, Omphalia is often synergized with botanicals such as Areca catechu (betel nut), Punica granatum (pomegranate rind), and Quisqualis indica (rangoon creeper). These polyherbals were crafted to address multiple stages of parasitic life cycles.

3. Key Constituents and Active Compounds

Omphalia lapidescens is a macrofungus that is used in traditional Chinese medicine for its insecticidal and stagnation-relieving properties. The active ingredients of this fungus — including proteins, polysaccharides, and sterols — have been demonstrated to exhibit antiparasitic, anti-inflammatory, and antitumor effects.

3.1 Proteases (Including Omphalin)

Two distinct proteases have been isolated from O. lapidescens: a thiol protease and a metalloprotease. The thiol protease isolated from O. lapidescens has a molecular weight of 16.8 kDa, constituting approximately 3% of the sclerotium. This protease exhibits the ability to hydrolyze common esters and demonstrates optimal activity at 37 °C and pH 7.48.

O. lapidescens contains omphalin (a protease), with a molecular weight of approximately 16,800 Da, considered the effective component for tapeworm expulsion; it can decompose the parasitic worm body protein in human and animal bodies, so as to achieve the purpose of repellent and insecticide.

Using polyvinylpyrrolidone (PVP) for extraction followed by molecular sieve chromatography, the proteins extracted from O. lapidescens were separated into three fractions. The fraction with the highest content was designated as pPeOp, with a molecular weight of approximately 16 kDa.

3.2 Polysaccharides

Given the extensive bioactivity of fungal polysaccharides, research on O. lapidescens has focused on the study of its polysaccharides. The content of polysaccharides in O. lapidescens is about 2.3%.

Modern pharmacological studies have found that it also contains an O. lapidescens polysaccharide whose chemical structure is a glucan with (1–3) glucoside linkage as the main chain and (1–6) glucoside linkage as the branch chain.

A key isolated polysaccharide, OL-2, has been characterized from Lei Wan. Physicochemical properties and antitumor activities of a fungal (1→3)-beta-D-glucan, OL-2, isolated from Leiwan (Omphalia lapidescens) were examined.

A further polysaccharide, LW-1, has been identified as the main anti-TMV active component. LW-1 is a glucan with β-(1,3) glucoside bonds as the main chain and β-(1,6) glucoside bonds as the branch chain, with a molecular weight in the range of 172,916–338,827 Da.

3.3 Sterols and Ergosterols

Two new steroids, leiwansterols A and B, along with three known ones, were isolated from the sclerotia of the fungus Omphalia lapidescens. Their structures were elucidated on the basis of spectral data. Additional ergosterol-type compounds have been characterized; structural formulae of new ergosterols isolated from O. lapidescens include (22E,24R)-ergosta-7,9(11),22-tetraene-3-one (Compound 2) and (22E,24R)-ergosta-7,9(11),22-triene-3β,5β,6α-triol (Compound 3).

3.4 Volatile Oil Components

Of the volatile oil components in the petroleum ether extract of O. lapidescens sclerotia, palmitic acid, ethyl palmitate, and dibutyl phthalate were found in relatively high concentrations, accounting for approximately 25% of the volatile components. These three compounds are commonly used in the manufacture of insecticides in the industrial and agricultural sectors, and their combined effects may contribute to the insecticidal activities observed with O. lapidescens.

3.5 Terpenes

The main components of O. lapidescens with antitumor properties include pPeOp protein, polysaccharides, terpenes, and ergosterol. Terpene research remains an early-stage area of investigation relative to the protease and polysaccharide constituents.

4. Mechanisms of Action

4.1 Antiparasitic Mechanism

Omphalia proteinase is the most effective ingredient in natural O. lapidescens. Its proteolysis is able to break down the proteins of the parasitic tapeworms. Experiments have shown that the proteolysis of the parasitic proteins may induce the anthelmintic activity of O. lapidescens.

Electron microscopy demonstrated that parasitic tissues treated with O. lapidescens proteases exhibited substantial damage, characterized by extensive necrosis in the cortical and parenchymal regions of the parasite.

4.2 Antitumor Mechanisms

Research has revealed that the antitumor effects of the active ingredients from O. lapidescens Schroet are associated with certain polysaccharides and proteins, with mechanisms that include the direct killing of tumor cells through induction of apoptosis, and the enhancement of immune and anti-inflammatory responses.

The pPeOp protein plays a central role. In research on the mechanism of the antitumor effects of O. lapidescens, proteases were extracted using a polyvinylpyrrolidone solution and purified by gel column chromatography, yielding an O. lapidescens protein designated pPeOp, with a molecular weight of approximately 16 kDa. pPeOp exhibited a concentration-dependent inhibition of the migration ability of MC-4 gastric cancer cells, without significant toxicity to normal gastric cells; further research revealed that the O. lapidescens pPeOp protein arrests MC-4 and SGC-7901 gastric cancer cells in the S phase of the cell cycle while having no effect on the cell cycle of MC-1 normal gastric mucosal cells.

4.3 Immunomodulatory Mechanism (Polysaccharides)

Fungal polysaccharides have been demonstrated to possess a range of beneficial properties including antitumor, antiviral, immunomodulatory, antidiabetic, anticoagulant, and antioxidant effects. With respect to OL-2 specifically, intraperitoneal administration of OL-2 to ICR mice induced a significant number of peritoneal exudate cells and white blood cells over the period of a few days. Spleen cell numbers were also increased by intraperitoneal administration of OL-2 at about a week. These changes reverted to the normal level within a month. Responses of spleen cells and bone marrow cells to colony-stimulating factors were augmented by OL-2 administration, assessed by cell proliferation assay. Sera from OL-2-administered mice contained an increased concentration of colony-stimulating activity.

4.4 Antiviral Mechanism (Plant Pathogen)

Omphalia lapidescens has significant activity against Tobacco Mosaic Virus (TMV), and its main active component is the homopolysaccharide LW-1. LW-1 activated the MAPK signaling pathway, induced overexpression of resistance genes, and activated the plant immune system. LW-1 has the potential to be developed as a new botanical-derived immune inducer. It bears noting that this antiviral activity has been studied exclusively in plant systems and should not be extrapolated to human viral diseases.

5. Scientific Evidence by Area of Use

5.1 Antiparasitic Activity

Strength of evidence: Moderate (animal/laboratory studies, limited robust clinical trials; some clinical use in China).

O. lapidescens showed good anthelmintic effects in studies involving tapeworms, Ascaris, Spirometra mansoni, and Giardia lamblia. These results largely derive from Chinese-language parasitology studies and experimental models rather than large randomized controlled trials meeting contemporary standards.

Omphalia (dried sclerotia of Omphalia lapidescens Schroet.), along with several other plants, was used for the treatment of taeniasis very early in China. The drug is listed for this indication in official Chinese pharmaceutical references. The efficacy of O. lapidescens treatment was better than that of traditional anthelmintic drugs such as albendazole and comparable to other standard comparators in cited experimental work, though such comparisons are reported from Chinese specialty literature and have not been independently replicated in large multicenter trials.

Mechanistically, the antiparasitic action is well-supported at the molecular level: Omphalia proteinase is the most effective ingredient. Its proteolysis is able to break down the proteins of the parasitic tapeworms. Experiments have shown that the proteolysis of the parasitic proteins may induce the anthelmintic activity of O. lapidescens.

5.2 Antitumor and Oncology-Adjuvant Activity

Strength of evidence: Preliminary to moderate (early animal studies, in vitro data, and limited clinical observations; no large-scale randomized controlled human trials identified in peer-reviewed literature).

The earliest documented antitumor research is from 1988: in 1988, Yao et al. conducted research on the antitumor effects of O. lapidescens and found that O. lapidescens protein extracts inhibited the growth of ascites sarcoma 180 tumors in mice.

A cell-culture study from a PMC-indexed journal investigated the pPeOp protein. The aim was to investigate the effect of purified Omphalia lapidescens protein (pPeOp) extracted by polyvinylpyrrolidone from O. lapidescens Schroet on the proliferation and cell cycle progression of MC-4 human gastric tumor cells. MC-4 cells were cultured with 30, 60, or 90 µg/ml pPeOp, with 5-fluorouracil used as a positive control. Survival rates of treated cells were significantly decreased compared with those of the untreated control group in a dose-dependent manner. Using flow cytometric analysis, cells treated with pPeOp were demonstrated to arrest in S phase and exhibit abnormal G0/G1 and G2/M phase cell cycle distribution. In addition, a wound healing assay demonstrated that pPeOp significantly inhibited the migration of MC-4 cells. This is an in vitro study only; no human clinical data are attached to these specific findings.

Regarding clinical use as an adjunct: tablets and capsules containing O. lapidescens as a principal component have since been extensively employed in clinical tumor treatments. The combination of Omphalia capsules with chemotherapy has been demonstrated to reduce the toxicity of chemotherapy drugs and stimulate hematopoiesis in the bone marrow, thereby enhancing the treatment effectiveness by 10%. Furthermore, the combination of Omphalia capsules with gemcitabine for the treatment of advanced lung cancer has been demonstrated to improve patient survival rates and quality of life. In particular, the Omphalia capsule group exhibited a 32.6% enhancement in clinical efficacy and a 20% improvement in disease control. These clinical observations are cited from Chinese clinical literature; the studies are not large, double-blind, independently replicated trials, and should be interpreted accordingly.

Chinese regulatory approval lends some institutional backing: the China Food and Drug Administration has approved Lei Wan Pian and Lei Wan Jiao Nang as antitumor auxiliary drugs.

5.3 Immunomodulatory Activity

Strength of evidence: Preliminary (animal studies and in vitro; no robust human trials identified).

Immunomodulatory properties are attributed primarily to the beta-glucan polysaccharide fractions. The OL-2 glucan study described above demonstrated hematopoietic and colony-stimulating-factor responses in a mouse model, indicating systemic immune activation. These results suggested the activation of hematopoietic responses, and were related to the incremental increases in peritoneal exudate cells, white blood cells, and spleen cell counts. These findings are animal-model data and require validation in human subjects.

5.4 Antiviral Activity (Plant Pathogen Systems)

Strength of evidence: In vitro and plant-model only; not applicable to human viral disease based on available evidence.

Two new steroid compounds, leiwansterols A and B, and three known compounds were isolated from Omphalia lapidescens. In vitro experiments showed that all five compounds had anti-tobacco mosaic virus (TMV) activity. The polysaccharide LW-1 showed protective and inactivating efficacies against TMV of 78.10% and 48.20% respectively at 100 mg/L, but had no direct effect on TMV itself, suggesting it operates via induction of plant host resistance rather than direct virucidal action.

5.5 Anti-inflammatory Activity

Strength of evidence: Preliminary (mechanistic/in vitro); no dedicated human clinical trials identified.

Anti-inflammatory properties of O. lapidescens are attributed to its protein and polysaccharide constituents, consistent with the broader properties ascribed to fungal polysaccharides, which are known to modulate inflammatory cytokine cascades. The relevant evidence is embedded within mechanistic antitumor and immunomodulatory research, not from standalone anti-inflammatory trials.

6. Body Systems and Health Areas Associated With Omphalia

Gastrointestinal / Digestive System: O. lapidescens was historically linked to the large intestine and stomach meridians and used for the treatment of parasitic infestations and the promotion of digestion. Its primary classical indication involves intestinal parasites, abdominal discomfort, and stagnation of food.
Immunological System: Beta-glucan polysaccharides (OL-2, LW-1) demonstrate immunostimulatory activity in animal models, with effects on peritoneal exudate cells, spleen cells, bone marrow cells, and colony-stimulating factors.
Oncology (Adjunctive): Omphalia has been used in clinical cancer treatment. Many studies on Omphalia have concentrated on its cytotoxicity and anticancer effects. The hematopoietic-stimulating effect observed when Omphalia capsules are combined with chemotherapy relates to its reported protective role during cytotoxic therapy.
Parasitology: This is Omphalia's primary traditional domain. It can expel various intestinal parasites such as taeniasis, ancylostomiasis, and ascariasis, especially taeniasis.
Agricultural Virology (non-human): Research into anti-TMV polysaccharides and sterols has been conducted for agricultural applications, not human health.

7. Dosage Forms and Reported Dosages

The following dosages are reported exclusively from the cited sources and should not be generalized as universal recommendations.

Powder (traditional TCM): Ground into powder and swallowed for treating taeniasis: 20 g per dose, three times daily. Tapeworm bodies are completely or partially expelled in most cases within 2–3 days.
In vitro research concentrations (pPeOp protein): MC-4 cells were cultured with 30, 60, or 90 µg/ml pPeOp, with 5-fluorouracil used as a positive control. These are experimental cell-culture concentrations, not human dosages.
Anti-TMV polysaccharide (plant model): The protective and inactivating efficacies of LW-1 at 100 mg/L against TMV were 78.10% and 48.20%. Again, these are plant-system concentrations.
Capsule and tablet forms: Tablets and capsules containing O. lapidescens as a principal component have been extensively employed in clinical tumor treatments in China, though specific standardized dosage information in mg per capsule or tablet was not extractable from the available literature.

8. Safety, Toxicity, and Notable Interactions

8.1 General Safety Profile

O. lapidescens, as a medicinal fungus, has a long history of use. Its low toxicity and favorable safety profile have made it widely applied in research on various therapeutic effects.

In classical Chinese pharmacopeia classification, the drug is described as slightly bitter, cold, and mildly toxic, entering the stomach and large intestine meridians. The designation of "mildly toxic" (wei du) in TCM is a conventional qualifier indicating the need for appropriate dosing rather than severe or acute toxicity at therapeutic doses.

8.2 Comparison With Synthetic Antiparasitic Drugs

Several antiparasitic drugs including tribendimidine, praziquantel, and artemisinin are effective in treating parasitic infections and are commonly used in clinical practice. However, these drugs are associated with toxic side effects on the heart, digestive system, liver, and kidneys. Furthermore, the prolonged use of these drugs may result in the emergence of drug resistance. Omphalia's protease-based mechanism has been highlighted as a potential advantage because the protein-degrading mechanism differs fundamentally from conventional synthetic antiparasitic agents.

8.3 Observed Advantages Over Synthetic Alternatives in Chinese Clinical Literature

A Chinese patent document for an O. lapidescens injection formulation reported that the injection showed little toxic reaction, with almost no tangible adverse reactions found in treatment, whereas albendazole and praziquantel distinctly produced dizziness, headache, fever, and liver and renal function damage, making the Omphalia-based preparation safer and more reliable in reported clinical observations. This is a patent document with associated limitations; it does not represent a peer-reviewed controlled safety trial.

8.4 Temperature Sensitivity of Active Protease

The antiparasitic protease omphalin is heat-labile. This protease demonstrates optimal activity at 37 °C and pH 7.48. Decoction-based preparations (which require boiling) may substantially inactivate the protease fraction, potentially reducing antiparasitic efficacy while leaving polysaccharide fractions relatively intact. This is why powder administration (raw, unheated) has traditionally been preferred for antiparasitic use.

8.5 Gaps in Safety Evidence

The investigation of O. lapidescens' natural metabolites remains a significant area for further research. Formal toxicology studies meeting current ICH or FDA standards — including reproductive toxicity, genotoxicity, and long-term chronic exposure studies in humans — have not been identified in the peer-reviewed literature available to this review. Interaction data with pharmaceutical drugs (beyond the clinical observation of improved chemotherapy tolerability noted above) are similarly absent from the available literature.

9. Regulatory and Pharmacopoeial Status

The Encyclopedia of Chinese Materia Medica, the Pharmacopoeia of the People's Republic of China, and the Complete Collection of Chinese Medicine frequently categorize O. lapidescens as a member of the Tricholomataceae family, with the scientific name Omphalia lapidescens. It is thus an officially recognized medicinal substance in the Chinese Pharmacopoeia. The China Food and Drug Administration has approved Lei Wan Pian and Lei Wan Jiao Nang as antitumor auxiliary drugs. No equivalent monographs by the European Medicines Agency (EMA), European Scientific Cooperative on Phytotherapy (ESCOP), or the United States Pharmacopeia (USP) were identified in the available literature, reflecting its status as a substance primarily integrated into East Asian regulatory frameworks rather than Western pharmaceutical systems.

10. Summary of Evidence Strength

Antiparasitic: Strongest evidence base among all indications; supported by traditional use, mechanistic data (protease-mediated protein digestion of worms), animal studies, and historical clinical use in China. Formal large-scale RCTs are lacking in Western peer-reviewed literature.
Antitumor / Oncology-adjuvant: Supported by in vitro cytotoxicity data, animal tumor models, and limited clinical observations from Chinese medical literature; Chinese regulatory approval as an auxiliary drug exists. Independent replication in rigorously controlled human trials is not yet available in the indexed literature.
Immunomodulatory: Animal-model evidence (mouse studies with OL-2 polysaccharide); no dedicated human trials identified.
Anti-inflammatory: Preliminary; evidence embedded in broader mechanistic and antitumor research rather than dedicated anti-inflammatory clinical trials.
Antiviral (plant systems only): In vitro and plant-model evidence for leiwansterols A and B and LW-1 against TMV; not translatable to human antiviral applications based on existing evidence.