There is an unmet need for more treatment options for pain and inflammmation. The dangers of the common nonsteroidal and steroidal anti-inflammatory drugs are well-known. I will not belabor that here. Instead, I present two different little-known NSAIDS that seem to have a relatively benign safety profile.
The first is ASHMI, a Chinese herbal formulation reported to be safe, and as effective as prednisone for asthma, in a randomized controlled double-blind trial. Prednisone is a premier anti-inflammatory. Given the safety profile of the ASHMI formulation, it would seem to merit a try for indications other than asthma.
It is commercially available under the brand name "Phytocort". The remainder of this discussion of ASHMI has been shamelessly copied from my earlier piece KosAbility: Alternative Medicine - Relief from Severe Asthma.
Pharmacology and immunological actions of an herbal medicine ASHMI on allergic asthma
This study was undertaken to compare the efficacy, safety, and immunomodulatory effects of ASHMI treatment in patients with moderate-severe, persistent asthma with prednisone therapy. Methods: In a double-blind trial, 91 subjects underwent randomization. Forty-five subjects received oral ASHMI capsules and prednisone placebo tablets (ASHMI group) and 46 subjects received oral prednisone tablets and ASHMI placebo capsules (prednisone group) for 4 weeks.
ASHMI is a combination of three Chinese herbs. In this study neither the patients nor the investigators knew who was getting which medication. They compared ASHMI to prednisone, the gold standard of asthma treatment. They had a sufficient number of subjects to get highly statistically significant results, as we shall see. This was published in the Journal of Allergy and Clinical Immunology:
With an impact factor of 12.047, the journal ranks 1st of 23 in the Allergy category and 7th of 135 in the Immunology category in the 2013 Journal Citation Reports
So this study was top quality by any standard. Let's see what they found:
By week 4 (the last week of treatment), symptom scores (median) were reduced in patients treated with ASHMI (5.0 to 2.0 P < .001; Fig 1, A) and patients treated with prednisone (5.0 to 2.0 ; P < .001; Fig 1, B). Improvement in symptom scores was similar between the treatment groups (P = .47; Table II). [edit: range values removed to improve readability]
P<.001 means the treatment effects were highly significant in both arms of the study. P=.47 means the differences between the two arms were insignificant. So from the patients' perspective both treatments’ benefits were similar.
FEV1 [Forced Expiratory Volume = lung capacity] values showed significant improvement after treatment with ASHMI (64.9 to 84.2 ; P < .001) and prednisone (65.2 to 88.4 ; P < .001; Fig 2, A). PEF [Peak Expiratory Flow] values in both treatment groups also showed significant increases (ASHMI, 64.6 to 84.8 P < .001; prednisone, 65.0 to 88.1 , P < .001; Fig 2, B). Increases in FEV1 and PEF were significantly greater in the prednisone group than in the ASHMI group (P = .02 and .04, respectively; Table II).[edits: here and below I removed standard deviation values to improve readability]
So the prednisone group did a bit better on this measure, but both treatments registered a highly significant improvement. Of course, there is a downside to prednisone:
In this study, pretreatment cortisol levels were slightly below normal ... in both groups... After treatment, subjects in the prednisone treatment group showed a significant reduction in serum cortisol levels after treatment (5.1to 3.7 mg/dL; P < .001). In contrast, patients in the ASHMI treatment group showed increased levels of serum cortisol (5.4 to 7.7 mg/dL; P < .001; Fig 4), which were within the normal range. The difference between groups was statistically significant (P < .001).
So ASHMI patients’ cortisol got back to normal range and prednisone patients’ cortisol declined. How about safety?
Treatment with ASHMI and prednisone was well tolerated. Neither group showed abnormal findings in hematology, serum chemistry tests, or electrocardiograms. No serious adverse effects were observed in either group. Both groups showed an increase in weight (2.8 kg for prednisone group and 0.8 kg for ASHMI group), and the difference between the groups was statistically significant (P < .001). Of patients receiving ASHMI, 5.08% (3 of 45) had gastric discomfort, whereas 15.51% (9 of 46) patients in the prednisone group reported gastric discomfort.
Note: Weight gain is a known side effect of prednisone treatment. Also, if you ever need to take prednisone, eat something first. Otherwise it tends to damage the stomach lining.
How to get this ASHMI treatment? If this were a new drug we would have to wait for completion of Phase 1, 2 and 3 trials, a new drug application, an advisory committee meeting, and an FDA decision, a process which takes many years. Then be prepared to pay the big bucks: Xolair costs $860 a vial and requires injection of a number of vials per month. However, this treatment is herbal. Nutricology sells it as "Phytocort" on Amazon for $25 for a supply which lasts 2-4 weeks depending on dosage. Any downside? Traces of lead were at one time detected in some Nutricology products prompting a prop 65 notification from the company. What the company says about this:
"We have placed those labels as a requirement of The Environmental Research Center (ERC) for foods and supplements that contain levels of naturally occurring lead in the food ingredients that compose them. We believe ERC's claims to be without merit, as our products comply with all federal Food, Drug and Cosmetic Act and California's Sherman Food and Drug Act requirements, and contain naturally occurring levels of lead in low levels, which is allowable even under California Proposition 65. We are currently resolving this matter, but until we are able to do so, we are including the prophylactic warning on some of our products. Compared with many common foods, our supplements do not contain an unusually high amount of lead. A serving contains less than 1% of the normal daily intake of lead from food in the United States (Kehoe RA, 1964). A serving of supplements contains significantly less lead than a serving of most food in North America (Schroeder and Balassa, 1961). As always, we continue to evaluate our ingredient sources toward the end of finding even purer ingredients for our complex formulas."
I took my chances with this issue an did not hesitate to start Phytocort, back in mid-January [2015]. Within a week I was off all asthma meds except for an occasional puff off albuterol. Since then, with the spring pollen there was a period of three days in early March when I needed moderate doses of prednisone. Otherwise, no prednisone, and on many days no oral meds at all. Not ideal, but manageable, versus frightening with a grim prognosis. And, back to my daily exercise routine almost every day, including running up hills.
Adverse effects:
According to the study is cited above there were no serious adverse effects from ASHMI. Three of 45 patients had gastric discomfort. A more recent review did not note any serious adverse effects.
A web search for adverse effects of Phytocort came up empty. There were 8 one-star reviews on Amazon. One person said it made their asthma worse, one person said it raised their blood sugar, one said it gave them headaches. A couple said it did not do anything but did not say how much they took or for how long. I personally did not experience any adverse effects from taking Phytocort. I am not taking any asthma medications at this time because my asthma is in remission.
NAC
Another potential anti-inflammatory to consider is an NAC, N-acetylcysteine. NAC is FDA approved in IV form as a treatment for liver toxicity due to acetaminophen overdose. It is commonly used as a mucolytic to thin pulmonary mucus. It has demonstrated protection against chemotherapy ototoxicity as an injection into the ear. In a trial using both oral and IV delivery, it was safe and effective for improving the neurological status of Parkinson's patients. NAC treatment was found to result in significant improvement in skin picking disorder.
A study using an animal model found NAC to be effective in relieving prostate inflammation. I can personally attest it works for that purpose. This is the only evidence of anti-inflammatory activity that I am aware of. However, prostatitis inflammation is very tough to treat. The efficacy of NAC for this purpose makes it worth a try for other forms of inflammation, in my opinion. Subscription site ConsumerLab tested 11 different NAC supplements and found all contained the labeled amounts of NAC.
Adverse effects:
According to ConsumerLab NAC should not be taken with nitroglycerin as it can result in undue lowering of blood pressure, and should not be taken by women who are pregnant or nursing.
There are adverse effects attributed to the very high dosages used to remedy liver toxicity, mainly anaphylaxis type reactions. As far as I know no such reactions have been reported at lower dosages. At a dose of 1200 mg per day, plus a higher dose via IV one day per week, the Parkinson's trial found “There were no patients that dropped out of the study and no significant adverse events” among a small group of 12 patients. I checked 95 reviews of NAC that were posted here. There was one negative review that alleged heart problems and referenced this study. However, that study fed mice very high dosages – drinking water spiked at a concentration of 10 g of NAC per liter. Personally I have difficulty with the high acidity of NAC. I neutralize it by mixing it with 25% by weight of calcium hydroxide and putting the mixture in capsules. A similar result could be accomplished by taking a calcium antacid along with NAC.
Of course this review is by no means complete. There are other possibilities such as turmeric/curcumin, and quercetin. Let me know in the comments if you like review of these or other herbal anti-inflammatories.