Yokukansan (Japanese / Chinese Herb) Effective and Safe in Treatment of Schizophrenia: A Randomized, Multicenter Trial

anon79999497 · May 5, 2015, 9:33am

There are multiple studies listed in the postings below - this herb seems to be helpful for people who have schizophrenia. So be sure to scroll all the way down on this page.

"Our results suggest that Yokukansan has a beneficial effect on Neuropsychiatric Inventory (NPI) and on ADL scores and that Yokukansan seems to be a well-tolerated treatment."

and in this study immediately below:

Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

Abstract

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:-0.23 ± 0.08) ; placebo:-0.03 ± 0.08, P < 0.018 , ), tension (TJ-54: -0.42 ± 0.09 ; placebo: -0.18 ± 0.09, P < 0.045 , ), and poor impulse control (TJ-54: -0.39 ± 0.10 ; placebo: -0.07 ± 0.10, P < 0.037 , ).

far_cry0 · May 5, 2015, 9:47am

Yokukansan is a versatile herbal remedy with a variety of effects … …

SzAdmin · May 5, 2015, 4:54pm

Interesting - I’d never heard of this. Thanks for posting:

SzAdmin · May 5, 2015, 7:09pm

Seems safe and possibly helpful:

CONCLUSION:

Our results suggest that Yokukansan has a beneficial effect on Neuropsychiatric Inventory (NPI) and on ADL scores and that Yokukansan seems to be a well-tolerated treatment.

ncbi.nlm.nih.gov

Yokukansan in the treatment of behavioral and psychological symptoms of dementia: a systematic review and meta-analysis of randomized controlled trials.

Y Matsuda, T Kishi, H Shibayama and N Iwata, Human psychopharmacology, Jan 2013

There is currently no meta-analysis of the efficacy and tolerability of Yokukansan in the treatment of behavioral and psychological symptoms of dementia.We used information obtained from the PubMed and Cochrane Library databases until October 2012. We conducted a systematic review and meta-analysis of individual patient data from randomized controlled trials comparing Yokukansan with usual care (UC, i.e., controls). Standardized mean difference and weighted mean difference were calculated. All studies used the Neuropsychiatric Inventory (NPI) for the evaluation of behavioral and psychological symptoms of dementia.Four relevant studies (total n = 236) were identified. Yokukansan was superior to UC in the reduction of total NPI scores (p = 0.0009, weighted mean difference = -7.20, I(2) = 0%). In addition, Yokukansan was more efficacious in reducing scores on the NPI subscale (delusions, hallucinations, and agitation/aggression) than UC (p < 0.00001-0.0009). Yokukansan treatment also improved activities of daily living scores compared with UC (p = 0.04, standardized mean difference = -0.32, I(2) = 0%). Mini-mental state examination scores did not differ between the Yokukansan and UC treatment groups. Yokukansan was not different from UC regarding discontinuation due to any cause.Our results suggest that Yokukansan has a beneficial effect on NPI and on ADL scores and that Yokukansan seems to be a well-tolerated treatment.

Other research:

Yokukansan, a traditional Japanese herbal medicine, alleviates the emotional abnormality induced by maladaptation to stress in mice

anon79999497 · May 5, 2015, 7:21pm

ncbi.nlm.nih.gov

Yokukansan and its ingredients as possible treatment options for schizophrenia.

CH Yu, R Ishii, SC Yu and M Takeda, Neuropsychiatric disease and treatment, 2014

Schizophrenia is a debilitating psychotic mental disorder that affects almost the entire range of human mental function. The devastating effect of the illness is usually long-lasting and requires lifelong treatment. Despite an evolved psychopharmacological understanding, the overall therapeutic effect of antipsychotics is still not satisfactory. The choice of proper medication presents a clinical dilemma between efficacy and safety. As a result, searching for comparable treatment options with safer profiles is very important. Yokukansan (TJ-54), also called yi-gan san in Chinese, is a traditional herbal medicine with evident therapeutic effect for neuropsychiatric disorders. There are several open-label clinical studies upholding the possibility of using yokukansan to treat schizophrenia or schizophrenia-like psychosis. Evidence from animal studies and neurobiology also sheds light on the antipsychotic implications of yokukansan and its ingredients. Nevertheless, correlations between the experimental environment and clinical settings may be complicated by a number of confounders. Clinical trials with more sophisticated designs are required to fill the gap between the experimental environment and clinical settings.

ncbi.nlm.nih.gov

Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, double-blind, placebo-controlled trial (a Positive and Negative Syndrome Scale, five-factor analysis).

T Miyaoka, M Furuya, J Horiguchi, R Wake, S Hashioka, M Tohyama, N Mori, Y Minabe, M Iyo, S Ueno, S Ezoe, K Murotani, S Hoshino and H Seno, Psychopharmacology, Jan 2015

Treating schizophrenia patients who fail to respond to antipsychotics is a major challenge, and the percentage of treatment-resistant patients is estimated to be 20-25 %. Recent studies indicate that yokukansan (YKS; D2 and 5HT1A partial agonist and 5HT2A and glutamate antagonist) to be safe and useful in treating behavioral and psychological symptoms associated with dementia and other neuropsychiatric conditions. We aimed at evaluating both the efficacy and safety of YKS in patients with treatment-resistant schizophrenia.This randomized, multicenter, double-blind, placebo-controlled study was conducted between May 2010 and August 2012. One hundred twenty antipsychotic-treated inpatients from 34 psychiatric hospitals in Japan were included. Patients were randomized to adjuvant treatment with YKS 7.5 g/day or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS) with five factors [excitement/hostility (P4, P7, G8, and G14), depression/anxiety (G1, G2, G3, G4, and G6), cognition (P2, N5, N7, G5, G10, G11, G12, G13, and G15], positive (P1, P3, P5, P6, and G9), and negative (N1, N2, N3, N4, N6, G7, and G16]]. Other assessments included, Clinical Global Impression-Severity (CGI-S), Global Assessment of Functioning (GAF), and Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). The primary efficacy outcome was the change in PANSS five-factor scores. The secondary outcomes were changes in the scores of CGI-S. The analysis was made on a modified intention to treat basis with the help of a last observation carried forward method.YKS showed a tendency of superiority to placebo in reducing total all PANSS five-factor scores in treatment-resistant schizophrenia, but the difference was not statistically significant in total, depression/anxiety, cognition, positive, and negative factors. However, compared to the placebo group, the YKS group showed statistically significant improvements in the PANSS excitement/hostility factor scores (p<0.05). No substantial side effects were recorded.The results of the present study indicate YKS to be a potential adjunctive treatment strategy for treatment-resistant schizophrenia, particularly to improve excitement/hostility symptoms.

SzAdmin · May 5, 2015, 7:46pm

You can purchase it from Japan - at this web site (I think - I haven’t tried to purchase - but it looks like they accept orders from anywhere). The dosage in the studies is 7.5 grams of granules per day.

Please post a message if you buy it, and try it.

This is from the manufacturer that I believe who’s product is used in the studies and so its probably of very high quality (from a Pharmaceutical Herbs company in Japan).:

http://www.halph.gr.jp/goods/keg380.html

There is also a company that sells it in Atlanta, Georgia (USA) - probably not as high quality, a manufacturer that is out of China I believe:

100 Grams:
http://www.acuatlanta.net/sun-ten-classics-yi-gan-san-(158)-100-grams-p-45591.html

100 Capsules (50 Grams):
http://www.acuatlanta.net/sun-ten-classics-yi-gan-san-(158)-100-capsules-p-45592.html

notmoses · May 5, 2015, 8:30pm

for SzAdmin, as well: Did anything come up on long-term trials or longitudinal studies? The reason I ask is that many of the herbal remedies (for many psychiatric disorders) work really well for a while and then fall off as the body habituates to them.

SzAdmin · May 5, 2015, 9:23pm

I have not seen any long-term studies on anything in psychiatry; I think its too expensive and hard to do given the frequency that people with psychiatric disorders move, change living status, go off the grid, etc…

NotMoses - have you ever seen any longer term studies for any psychiatry medication?

I don’t believe they do them.

Even for the released FDA approved medications the studies are only for a few months.

notmoses · May 5, 2015, 10:17pm

While it’s true that I see a lot more L/T efficacy studies on psychotherapies than I do on meds, I have seen some. The problem, of course, is that the drug manufacturers either don’t want to have the neurobiological laws of tolerance, habituation and diminishing returns stare them in the face or don’t feel compelled by the FDA (they appear to have so much influence over since the early 2000s, maybe earlier) to conduct down-line efficacy studies whether or not they are made public.

What is typical of such studies when they are done and published is that all psych meds, including the anti-Ps and mood levelers, tend to lose effectiveness in their specific corporeal environments over time. (Pts: Not to worry: There are so many of them now that something is almost bound to work if you stay in the hunt. And adding cognitive psychotherapies considerably improves the odds for many.)

I’ve seen several “time lapse bell curves” that suggest that while many have gotten the benefits of, say, Clozaril clozapine for decades, even if they have done so at the nasty price of agranulocytosis, and others that say it quit working in two or three years regardless. Most fall somewhere in between, as with the ostensibly “less effective” (by comparison to Clozaril) anti-Ps.

SzAdmin · May 5, 2015, 10:44pm

That is one problem - but the other problem - as in the case of this Herb - is that if the product isn’t patentable (i.e. nobody has an exclusive license on it for 20 years) - nobody that is going to invest the millions of dollars to do a long term study - when there is no payoff to do so.

And the government only funds very few longer term studies - and even when they do then its more like “how well do early psychosis patients do over the longer term” type of study, not the more specific question of how well they do over the long term with a single herb, supplement or medication.

The cost is just too great. For example just one part of the CATIE studies of 1400 people on antipsychotic medications ( I think the period was for 6 to 9 months, but I may be wrong) was 44 Million Dollars.

http://www.schizophrenia.com/sznews/archives/002424.html

As I said - the cost is huge and just aren’t in the budget during these fiscally constrained times for government.