On Dosage, Efficacy and Safety of Chinese Herbal Medicine

Different doses of a drug produce different clinical effects; this is an undeniable fact in modern pharmacological research. The dose-response problem exists not only for Western drugs but also for Chinese herbal medicine.

Many TCM physicians, when troubled by clinical efficacy, blame the herbs themselves. Their views fall roughly into two: first, that the quality of modern herbal slices is far inferior to the past (I reserve judgment on this, because in practice, when I write a good prescription, ordinary doses purchased from a regular pharmacy often work well, suggesting modern herbs are not of poor quality); second, that the dosages permitted by the Chinese Pharmacopoeia are too conservative, making it hard to achieve efficacy. Many clinical TCM practitioners are therefore trying high-dose regimens.

High dosing can sometimes achieve effects impossible at low doses; I have deep personal experience of this. When raising a patient's platelet count, I often use Xianhecao (Agrimoniae Herba) up to 100 g; in some patients, platelets rise within a week after this, even when Xianhecao alone is used without other herbs—but in many others it does not work well.

When I use Baiji (Bletillae Rhizoma) for hemoptysis or gastric bleeding, a daily dose of 30-90 g or more gives immediate hemostatic effect. One lung-cancer patient had been treated by a famous Beijing TCM professor for over a month, yet his hemoptysis grew worse. His family came to me; I looked at the professor's prescription and changed nothing except Baiji from 10 g to 45 g. On the day he took the medicine, hemoptysis lessened; within three days it stopped.

Another lung-cancer patient with severe hemoptysis—"filling a basin"—had been sent home by a top Xi'an hospital to arrange his final affairs. I gave him 90 g of Baiji daily, decocted into a thick broth, taken as tea at any time; he stopped bleeding that day and turned from danger to safety.

On Chinese New Year's Eve of 2011 (lunar calendar), my mother vomited blood from gastric cancer and lay weak in bed; we were very alarmed. We had planned to return to our hometown on the fifth day of the first lunar month, and I feared she would not make it. Generally hematemesis is caused by gastric bleeding, and only when blood loss exceeds 500 ml does hematemesis occur. I gave her 30 g of red ginseng (Hongshen) and 60 g of Baiji, decocted and taken for three days running. Not only did the bleeding stop and her stools turn from black to yellow, but her strength largely recovered; when she took the train to our hometown on the fifth day, she was out playing mahjong the next day.

I have also used raw Dahuang (Rhei Radix et Rhizoma) up to 30 g for intestinal obstruction, and used Guipi Tang (Spleen-Returning Decoction) with Huangqi (Astragali Radix) up to 120 g to rescue a critically ill patient who was pronounced critical four times in one day; both patients turned from danger to safety within a day.

I am therefore actually supportive of using heavy doses. But the side effects of heavy doses are also enormous. The lung-cancer patient above, whose hemoptysis filled a basin and whom I rescued with 90 g of Baiji broth, nearly suffered a heart attack as a result. When I used Dahuang up to 30 g, combined with Mangxiao (mirabilite) and other purgatives, to rescue intestinal obstruction, the patient also endured cramping abdominal pain and profuse sweating and nearly collapsed. I am therefore very cautious about high dosing.

Many scholars now argue that clinical dosages of Chinese herbs should be restored to those of Zhang Zhongjing's Han dynasty. According to Professor Xue Kefan's textual research, one Han liang equals roughly 15 g today (a rough figure, not wholly accurate); Zhang Zhongjing sometimes used Dahuang up to four liang, about 60 g. Was it effective? Undoubtedly. But were the side effects large? My own experience says they were very large; mishandling them causes medical accidents.

From the preface to the Shanghan Lun, in which Zhang Zhongjing mentions that of his clan's more than two hundred members, two-thirds died within less than ten years, we can see that medical conditions at the time were limited, and that success rates under Zhang's methods may not have been high either. By ordinary human logic we may infer that Zhang himself must have participated in treating his family members; such a high mortality rate says enough.

I therefore strongly agree with the view of the elder physician Fan Wenfu: when a high dose is needed, one should start low and gradually increase. This also matches the dosing principle advocated in the Shennong Bencao Jing. Start with a small dose; if ineffective, double; if still ineffective, keep doubling until effective. Once effective, "stop when the disease is reached"; do not over-medicate.

The Ming-dynasty physician Li Zhongzi, when treating accumulation-type diseases (many of which correspond to modern tumors) with his "Yin-Yang Attacking-Accumulation Pill," devised an especially elegant method of gradual dose escalation. He had the patient start at the minimum dose, increasing daily until loose stools appeared, then restart from the minimum and cycle through.

He also had the patient take the Yin-Yang Attacking-Accumulation Pill for a while, then stop for a period, use tonics to regulate for a while, then resume the pill, cycling until cure. This treatment philosophy is remarkably advanced, balancing efficacy and safety. Is this not also the principle behind modern Western chemotherapy for cancer?

I gradually stopped daring to use large doses casually, especially of high-toxicity herbs such as Fuzi (aconite), Wutou (monkshood) and Banmao (cantharis). Many articles now wildly exaggerate the efficacy of high-dose aconite and cantharis; this is extremely irrational.

Here I must mention the elder TCM physician Li Ke. When Dr. Li was alive, I once wanted to consult him for my mother. But unexpectedly, patients whom Dr. Li had treated came to me with severe side effects after his treatment; many worsened after taking his formulas, and some were felled by a single dose, with no improvement despite repeated later adjustments by Dr. Li, their condition remaining critical.

I first treated a patient who had rapidly deteriorated after Dr. Li's care, using Guipi Tang plus Tiangdong (Asparagi Radix) and Maidong (Ophiopogonis Radix), and it unexpectedly worked quite well. After that, many patients with severe side effects following Dr. Li's treatment came to me for care; at the time, on Tianya Forum, people who had suffered mishaps under Dr. Li even specifically sought my contact information by name, asking for help.

From this I learned that Dr. Li's high-dose aconite had indeed rescued many people (especially heart-failure patients) from danger, but it had also caused many patients to deteriorate rapidly. Through my own channels I learned that, apparently realizing his dosing approach was too one-sided, Dr. Li actually reflected on it toward the end of his life. Yet now I see many people invoking Dr. Li with views even more radical than his own. People keep sending me such articles; the senders are warm-hearted and hope I will benefit, not realizing that I am a direct witness to Dr. Li's efficacy and already understand deeply both the benefits and drawbacks of his approach.

I recognize Dr. Li's medical skill and medical ethics; mentioning this story has no ill intent. Merely as one of his contemporaries who witnessed events firsthand, I wish to leave this record to offer future TCM learners another perspective, urging them to look more cautiously at high-dose use of toxic herbs. There is a tendency in the TCM community to avoid discussing side effects of TCM treatments; this is unscientific and untrue. If everyone does this, it will mislead those who come after; young TCM physicians who do not know better can easily cause medical accidents in practice—and an accident can end a career and trigger troublesome legal disputes.

Or take the elder TCM physician Sun Bingyan, a towering figure in China's TCM anti-cancer field; many patients survived a long time under his care, including the famous anti-cancer celebrity Shengdi Mei'ya, one of his patients. Shengdi Mei'ya once wrote an article describing his own experience under Dr. Sun, mentioning that Dr. Sun's methods actually had severe side effects: a considerable number of patients developed blindness or became bedridden within days of taking the medicine, while their cancers remained uncontrolled and they died soon after. But Shengdi Mei'ya later deleted the article, so later generations can hardly know of this firsthand experience, making it hard to evaluate the pros and cons of Dr. Sun's methods.

I myself once tried Dr. Sun's formula on my mother; as Shengdi Mei'ya had described, her condition rapidly deteriorated—she was poisoned, and clinically there was no benefit. By then I had studied TCM for years, and I adjusted the regimen in time, luckily avoiding a major error. But over the years I have seen many people treating themselves or their families with Dr. Sun's leftover formulas; in nine out of ten cases, rather than achieving efficacy, the patient died of poisoning.

I have always kept these lessons in mind. In recent years I have been exploring safer and more effective TCM approaches to anti-cancer therapy and stroke sequelae. Why focus on these two diseases? No other reason: my mother suffered terribly from both before she died, and I wanted to ease her pain, so my original purpose in studying TCM was very clear. Both are hard to treat and are key areas of high-dose practice. The deeper I explore, the more I feel that, for these two diseases in particular, the pros and cons of high dosing cannot be ignored.

My current research direction is treating cancer and stroke sequelae with a "large combination formula, small dose" approach. I previously wrote an article, "An Introduction to My Practical Experience Using Large TCM Combination Formulas with Multi-Target, Broad-Spectrum Anti-Cancer Action," describing this research direction. In short, I have extended the "cocktail therapy" for HIV invented by Chinese-American scientist Professor David Ho to TCM anti-cancer treatment.

I combine multiple cancer-treating category-formulas and category-herbs, controlling each herb's dose to between 1/100 and 1/20 of its LD50 (median lethal dose). I have achieved certain results with this method. Roughly estimating, its effective rate is no lower than Dr. Sun Bingyan's, while its safety is far higher.

But I do not deny that some clinical TCM practitioners achieve effective results with high-dose small formulas for cancer; after all, I have witnessed many such facts. Over the past decade-plus, through cancer patients or their families in contact with me reporting outcomes, and through prescriptions they showed me from other doctors, I have learned the methods of many contemporary TCM cancer practitioners; some patients do indeed respond to high-dose small formulas.

It should be noted that by "effective" or "works" in this article I do not mean cure, but rather improvement in quality of life and prolongation of survival. Cancer is a disease about which one cannot lightly speak of cure; many patients relapse after a period of calm, as did the anti-cancer celebrity Shengdi Mei'ya I mentioned.

I therefore believe that both my current research path and other doctors' "small formula, large dose" approach have merits. We should embrace a hundred schools of thought contending, tolerating these two very different directions and allowing each to explore deeply for the benefit of future patients, without favoring one over the other. Moreover, the same clinician may sometimes adopt a "large formula, small dose" approach for one problem and a "small formula, large dose" approach for another; this is not strange.

But we must also squarely face the serious side effects caused by excessive dosing in practice; this concerns both patient safety and physician safety, and side effects must not be ignored. Individual differences always exist; medication is the one thing where error is least tolerable—a mistake can poison someone to death, and the responsibility is heavy, so caution is essential.

In research on the dose-effect problem in Chinese herbs, the most authoritative figure in the TCM community is probably Academician Tong Xiaolin. In 2009, a key project led by Academician Tong—the 973 Program project "Basic Research on Classical Famous Formulas Centered on the Dose-Effect Relationship"—was approved by the state, and the team conducted six years of clinical research on this topic, accumulating a large body of clinical evidence.

Academician Tong and his team have published several monographs on the results of this research, carried out with government support; the better-known ones include Zhongji Qichenke—Zhongliang Moxue Diyan Ji Qiji (Heavy Doses Cure Deep-Rooted Illness—Foundational Work on TCM Dose-Effect Research), Fangyao Liangxiaoxue (Formulary Dose-Effect Studies), Fangyao Liangxiaozhen (Seeking Truth in Formulary Dose-Effect), and Fangyao Liangxiaoxue Mingyi Huijiang (Famous Physicians Discuss Formulary Dose-Effect). Those interested may read these works; they are not only academically deep but also well written and highly readable; I myself have read them and gained much.

It should be pointed out, however, that Academician Tong's works also lack follow-up research on side effects caused by high dosing. Academician Tong himself focuses on diabetes; the high-dose herbs he commonly uses—Gegen (Puerariae Radix), Huangqin (Scutellariae Radix), Shanyao (Dioscoreae Rhizoma)—are very safe. His team has done little research on the severe side effects that arise when folk practitioners use raw Chuanwu, Fuzi, Mahuang, Pishuang (arsenic trioxide), Xionghuang (realgar) or Banmao (cantharis). Moreover, they may be exposed more to positive data; patients who were poisoned do not report to them. An academician's team is like the "spring snow sung by connoisseurs," while a humble practitioner like me has more contact with real treatment failures, so the other side I see cannot be ignored.

One view of Academician Tong's I strongly endorse: in emergencies or acute exacerbations of chronic disease, when rescuing patients, high-dose small formulas often have life-restoring power; at such times, use a high-dose small formula—single in focus, powerful in effect—but later-stage regulation should favor safer small-dose forms such as pills, powders, plasters and elixirs. This approach ensures both the efficacy of TCM in critical illness and the safety of long-term medication; it is both scientific and reasonable.

He also proposed that when using high doses, one Han liang converts to about 13.8-15 g today; medium doses, to 9 g; low doses, to 3 g. He further suggests that herbs be decocted mainly by slow simmering over low heat, rather than brought to a boil over high heat and then simmered, so that active ingredients extract more fully. The optimal herb-to-water ratio is 1:7.3, yielding the highest extraction rate. His team supports these findings with large clinical datasets; the research is very valuable, and I recommend his relevant works to anyone interested.

Medication dosage is a highly complex matter. Beginners in TCM who rashly use heavy doses may see not efficacy but side effects they cannot control. Human life is at stake; this is no game. Treating disease with heavy doses enters the deep waters of TCM; without the ability to manage risk, do not be reckless. Yet heavy doses are also an important means of rescue at critical moments, and it would be a pity for those who intend to devote a career to TCM not to study them. Try heavy doses step by step, consult the literature, maintain the caution of treading on thin ice, and observe the patient's reactions closely; only thus can efficacy and safety both be secured. When the patient is safe, the physician is safe—let us always remember this.