Chinese herbs do treat constipation

Source: Efficacy of Traditional Chinese Medicine of the Management of Constipation: A Systematic review:

Medical Condition

In the US One in three patients suffering from constipation seek medical care. Older people are more likely to have constipation than younger population particularly those older people in residential aged care. In medicine there are actually three types of constipation 1) functional 2) de-factory disorders and 3) slow transit constipation. The most common  treatments are laxatives, enemas and in serious cases manual removal of faeces. As usual the reports of Chinese herbal medicine (CHM) as effectives treatment for constipation have been mixed. This review looked extensively at available research from international and chinese databases.

Finding from Systematic Research

21 high quality trials from the period 1997 – 2007 were included in this research. 18 trials used chinese herbal medicine (CHM) and 3 used acupuncture. Today’s post will focus on the CHM trials.

Many of the high quality trials reported herbs had beneficial effects on constipation. In trials where herbs were compared to conventional medications herbs was usually higher effectives rates than the conventional medicine in the control groups.

Also, adverse effects of CHM were not common and the conclusion was that using herbs for constipation is both effective and safe.

TCM Diagnosis for constipation

This research concluded there were five patterns relating to constipation. Patterns were diagnosed using traditional diagnostic methods including tongue, pulse, and questioning about other symptoms to determine pattern.

The five patterns were:

Qi-bi (obstruction of qi and or blood)

Re-bi – obstruction of qi and blood caused by heat

QI-Xu – deficiency of Qi

Xue – Xu – deficiency of blood

Leng-bi – ?

Treatments

You will have to do  your own research to find all herbs listed in formulas mentioned below. Here are some herbs and formulas used in the CHM trials included in this study.

Bai Zhu (Rhizoma atractylodis macrocephalae ) – in one trial this was used as a single herb perscription

Runchang Pian (formula includes  Da Huang in it)

Tong Bian (formula includes  Dang Gui and Da Huang)

Heji – couldn’t find what this was referring to

Mitong – spleen activation and intestine moistening

Tongbian jiaonang  – off the shelf capsule formula includes rhubarb (Da Huang root)

Boost Qi formula  – to warm yang and nourish blood –  few variations of this formula can be purchased in capsules.

Comments

According to this study in conventional medicine there are three types of constipation compared with TCM that has five underlying patterns that can cause constipation. This study reminds us that there are many causes to constipation and getting the diagnosis wrong will result in the wrong prescription.

However in conventional medicine there are few interventions and these days most of us would immediately think of going to the chemist and buying laxatives before we would consider going to the doctor or seeking out an alternative gentler remedy. In TCM formulas and single herb prescriptions provide many more options for a patient and the great benefits of formula prescription is that you can treat the symptom of constipation and also the underlying causes.

This is a better outcome for older people  in care who are currently reliant on the medical staff’s prescriptions of drugs that address symptoms only and have side effects.

For example, Cisapride , a drug used to speed up motility in the digestive system can have these side effects:

Gastrointestinal side effects are often due the pharmacologic actions of Cisapride. These effects appear to be dose-related, as 20 mg doses are associated with an increased incidence of diarrhea, abdominal pain, and flatulence compared to 10 mg doses.

In a study of 1500 patients, approximately 2.5% discontinued cisapride therapy, usually due to abdominal pain and intolerable diarrhea.

Gastrointestinal side effects have been reported the most frequently. These have included diarrhea or loose stools (14.2%), abdominal cramping (10.2%), nausea (7.6%), flatulence (3.5%), borborygmi (rumbling bowel sounds), and dry mouth. Nervous system side effects have included headache (19.3%), dizziness, somnolence, and fatigue. (This came from drugs.com  and for more information o other side effects  go to http://www.drugs.com/sfx/cisapride-side-effects.html)

 

References

Efficacy of Traditional Chinese Medicine for the Management of Constipation: A Systematic Review. Li-Wei Lin, M.S., R.N., Yuan-Tsung Fu, M.D., Ph.D., Trisha Dunning, Ph.D., R.N.,Anthony Lin Zhang, Ph.D., M.P.H., Tien-Hui Ho, M.S., R.N., Maxine Duke, Ph.D., R.N., and Sing Kai Lo, Ph.D.

Journal of Alternative and Complementary Medicine Col 15. No 12 2009, 1335 – 1346


Chinese herbs and Supplements increase survival from lung cancer

Abstract

Complementary and alternative medicines are used by up to 48% of lung cancer patients but have seen little formal assessment of survival efficacy. In this 10-year retrospective survival study, the authors investigated Pan-Asian medicine + vitamins (PAM+V) therapy in a consecutive case series of all non-small-cell lung cancer patients (n = 239) presenting at a San Francisco Bay Area Chinese medicine center (Pine Street Clinic). They compared short-term treatment lasting the duration of chemotherapy/radiotherapy with long-term therapy continuing beyond conventional therapy. They also compared PAM+V plus conventional therapy with conventional therapy alone, using concurrent controls from the Kaiser Permanente Northern California and California Cancer Registries. They adjusted for confounding with Kaplan-Meier, Coxregression, and newer methods –propensity score and marginal structural models (MSMs), which when analyzing data from observational studies or clinical practice records can provide results comparable with randomized trials. Long-term use of PAM+V beyond completion of chemotherapy reduced stage IIIB deaths by 83% and stage IV by 72% compared with short-term use only for the duration of chemotherapy. Long-term PAM+V combined with conventional therapy reduced stage IIIA deaths by 46%, stage IIIB by 62%, and stage IV by 69% compared with conventional therapy alone. Survival rates for stage IV patients treated with PAM+V were 82% at 1 year, 68% at 2 years, and 14% at 5 years. PAM+V combined with conventional therapy improved survival in stages IIIA, IIIB, and IV, compared with conventional therapy alone. Prospective trials using PAM+V with conventional therapy for lung cancer patients are justified


Location of trial:  USA

 

 

Medical Condition

Lung cancer is leading cause of cancer death in US today. IN 1988 The median survival rate for NSC lung cancer after chemo and added 8 months of B- and y- interferons was a mere 6 months. In 1988 all conventional treatments and adjunct therapy didn’t make a significant difference in reducing risk of death (for more details see paper).

Treatment

The treatment does not replace chemotherapy instead it is designed to complement a cycle of adjunctive chemotherapy. Treatment involved diet, exercise or appropriate activities (relaxation) , supplements and chinese herbs provided in the traditional dry form which were given to the patients to decoct. All patients were encouraged to continue being active when they returned home. Supplements and herbs were provided at specific stages of the chemotherapy cycle and the supplements varied at each stage (stage 2 and 3 were very similar).

 

Herbal formulas , as always, are modified for the patient. Often starting from a base formulae for presenting pattern the formula is then modified to address specific symptoms.

 

Participants

239 people followed from beginning of their treatment and until death of up to ten years after treatment begun. ,  but also retrospective survival analysis data of NSC lung cancer patients was taken from other clinics in US for statistical comparison against the specific population of patients who had  taken complementary program of Pacific Asian Medicine and Vitamins during conventional cancer treatments including chemo/surgery/radiotherapy.

 

Outcomes Measured

Median survival rates following conventional and conventional + PAM + V for stages II, IIIA/IIIB/IV of NSC lung cancer

Results

The overall study concluded that survival rates increased in patients who had participated in the complementary program taking PAM and vitamins and this was most significant at stages IIIA/B and IV.

For more details refer to a very detailed paper which also lists all supplements, herbal formulas and single herbs.

 

Comments

This is a great study that in my opinion has attempted to do everything possible to demonstrate a valid and reliable model to measure the benefits of  using a complementary program during conventional cancer treatments.

 

References

Lung Cancer Lung Cancer Survival With Herbal Medicine and Vitamins

in a Whole-Systems Approach: Ten-Year Follow-up Data Analyzed

With Marginal Structural Models and Propensity Score Methods

 

Michael McCulloch, LAc, MPH, PhD1,2, Michael Broffman, LAc1,

Mark van der Laan, PhD2, Alan Hubbard, PhD2, Lawrence Kushi, DSc3,

Alan Kramer, MD4, Jin Gao, MD, PhD5, and John M. Colford Jr, MD, PhD2

 


Acupuncture to treat carpal tunnel syndrome

Acupuncture in Patients with Carpal Tunnel Syndrome – A RCT. 

Chun-Pai Yang, MD,*w z Ching-Liang Hsieh, MD, PhD,w y Nai-Hwei Wang, MD,Jz Tsai-Chung Li, PhD,z# Kai-Lin Hwang, MSc, ** Shin-Chieh Yu, MD,* and Ming-Hong Chang, MD w w zz  – Clinical Journal of Pain, May 2009 (4) 327 – 333

 

Overview of Trail

RCT to test efficacy of acupuncture compared with steroid treatment for patients with mild to moderate carpal tunnel syndrome (CTS).

METHODS:

A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n = 39), and (2) acupuncture administered in 8 sessions over 4 weeks (n = 38). A validated standard questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia, weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS were performed at baseline and repeated at the end of the study to assess improvement. All main analyses used intent-to-treat.

RESULTS:

A total of 77 patients who fulfilled the criteria for mild-to-moderate CTS were recruited in the study. There were 38 in the acupuncture group and 39 in the steroid group. The evaluation of GSS showed that there was a high percentage of improvement in both groups at weeks 2 and 4 (P < 0.01), though statistical significance was not demonstrated between the 2 groups (P = 0.15). Of the 5 main symptoms scores (pain, numbness, paresthesia, weakness/clumsiness, nocturnal awakening), only 1, nocturnal awakening, showed a significant decrease in acupuncture compared with the steroid group at week 4 (P = 0.03). Patients with acupuncture treatment had a significant decrease in distal motor latency compared with the steroid group at week 4 (P = 0.012). Acupuncture was well tolerated with minimal adverse effects.

CONCLUSIONS:

Short-term acupuncture treatment is as effective as short-term low-dose prednisolone for mild-to-moderate CTS. For those who do have an intolerance or contraindication for oral steroid or for those who do not opt for early surgery, acupuncture treatment provides an alternative choice.

 

More detail about treatment

The patients who received acupuncture were treated with only two points:

PC-7 (Da Liing),  PC-6 (Neiguan)

The needles were applied at standard depths for theses points. Thrusting and twirling stimulation was used after insertion and then the needles were left in for 30- minutes. This treatment was repeated twice a week for four weeks.

More Details about how results 

For full details of other measurements  see paper. Here’s a few I thought were interesting

Decrease in sleep disturbances / insomnia was measured. this is is fairly common in patients with CTS who are worken up by the pain and numbness sensations in the hand or they have trouble getting comfortable in bed to then relax into sleep. The acupuncture treatment had significantly better improvements in sleep disturbances compared with steroid treatment in week 4.

 

DML – Distal motor latancy – internal between stimulus and compound action muscle  potential (CMAP).

Acupuncture had significantly better improvement in DML compared with steroid group

 

CMAP  –  the action potential of group of muscle fibres stimulated by a motor nerve

Steriod group had significantly better CMAP of the APB muscle (Abductor Pollicis Brevis – The muscle that abducts the thumb)

 

Side effects and drop outs

Some expected side effects during acupuncture treatment including pain , paresthesia. 5% of patients reported these symptoms during treatment.

18% of patients on steroids reported side effects and 4 dropped out due to intolerance of severe epigastralgia.

 

Comments

A good study but short and as the authors conclude we need more studies into long term treatment benefits of acupuncture for CTS . This would help determine whether acupuncture is required for  long term symptom relief or after a longer period of time the acupuncture could be discontinued when CTS become asymptomatic. Perhaps after intensive treatment the patient requires less frequent treatments over a long period of time.

 

 


Using chinese herbs to treat different types of Depression

Source: The beneficial effects of the herbal medicine Free and Easy Wanderer Plus (FEWP) for mood disorders: Double-blind,placebo-controlled studies. Zhang-Jin Zhang a,*, Wan-Hu Kang b, Qiang Li b, Qing-Rong Tan c. Journal of Psychiatric Research 41 (2007) 828-836

About research

Free and Easy Wandering Pills (FEWP) is a old and well known Chinese formula used to treat premenstrual tension, depression, mood swings and stress related gastrointestinal symptoms (bloating, abdominal pain, alternating bowel habits) where there is no underlying weakness. There are have been clinical some trials to conducted determine whether FEWP has any beneficial effect on people with unipolar or bi-polar depression.

This post will summarize the two types of trials discussed from 1) to test whether FEWP was beneficial to patients on no other drug. 2) to test whether FEWP increase tolerance of CBZ and also reduced discontinuation of CBZ treatment due to its strong side effects.

 

Trials

Trial One  – 26 week random controlled double blinded: FEWP+ Placebo compared with FEWP + CBZ. 49 bi-polar depression without mania, 43 bipolar with mania).

Trial Two – 12 week random controlled double blinded weeks: FEWP compared with a Placebo group. 62 bi-polar and 87 with unipolar.

Treatment

FEWP used in trials contains these ingredients

Bupleurum (Chai Hu)

Scutellaria baicalensis Georgi (Huang Qin)

Zingiber officinale Rosc (Sheng jiang)

Angelica sinensis (Dang Gui)

Gardenia jasminoides Elles (Zhi Zi)

Paeonia suffruticosa (QIng Xian Bai)

Paeonia lactiflora (Bai Shao)

Paeonia Cocos Wolf (Fu ling)

Metha hapacalyx Briq (Bo He)

Glycrrhiza uralansis Fisch (Gan Cao)

Medical Condition

Bi-polar is a more severe type of depression with symptoms that can include: cognitive impairment, withdrawal,  mania:  hallucinations, grandiose ideas and delusions, drug and alcohol use, reckless behavior and overspending. The drug CBZ is one medication used to control bi-polar symptoms.

Uni-polar depression is another way to describe the most common types of depression that do not have more severe and psychotic symptoms but still impact people’s lives.  Symptoms’ include: poor appetite, low libdo, loss of pleasure in things, withdrawal, prolonged sadness, feelings of hopelessness and dread, low self-worth, may include use of drugs and alcohol as self-medication, more serious condition can include suicidal ideation. Major depressive disorder is diagnosed when patients have been experienced a number of symptoms for two weeks or more.

Outcomes Measured

Clinical Global Impression-Severity (CGI-S)

Clinical response of > or equal to 50% reduction in Hamilton rating scale for Depression (HAMD)

Montgomery and Asberg depression rating scale (MADRS)

Clinical response of > or equal to 50% reduction in CGI-S and YMRS

Bech-Rafaelsen Mania scale (BRMS)

Side effects were assessed at each visit

Results (for full details read article)

Trail One

Patients in adjunctive FEWP showed a significantly lower overall dis- continuation rate (31%) at endpoint compared to placebo (51%, p = 0.009), and of 15% in adjunctive FEWP discontinued due to intol- erable side effects, markedly lower than those in placebo (28%, p = 0.019). No difference in discontinuation for lack of efficacy and exacerbation was observed in the two groups. Patients receiving adjunctive FEWP had significantly fewer adverse side effects and lower serum levels of CBZ than those in placebo.

Trail Two

Both unipolar and bipolar patients assigned to FEWP displayed significantly greater improvement on the three efficacy indices and significantly higher clinical response rate (74%) than those treated with placebo (42%, p < 0.001) at endpoint.

 

Comments

FEWP does have anti-depressant effects associated with inhibition of MAO activity and modulation of monaminergic neurotransmission. Interestingly the effects of FEWP kick in late in a treatment cycle just like SSRIS, which take a few weeks to take effect. FEWP has been analyzed for other pharmaceutical actions and neuroprotective effects, for more details refer to the paper or other research.

The limitations of testing FEWP on depression is that it overlooks depression manifests with different symptoms and the formula should be adjusted to treat those symptoms. For example western diagnosed clinical depression can be presented as yin deficiency or yang deficiency or or excess patterns like liver qi stagnation caused by stress. These patterns have distinctive symptoms and pathogenesis, which a generic formula would not be suitable.

References

The beneficial effects of the herbal medicine Free and Easy Wanderer Plus (FEWP) for mood disorders: Double-blind,placebo-controlled studies: Zhang-Jin Zhang a,*, Wan-Hu Kang b, Qiang Li b, Qing-Rong Tan c. Journal of Psychiatric Research 41 (2007) 828-836


Chinese herbs for Urinary Tract Infection in women

Abstract

We assessed the effects of Chinese herbs on the uncomplicated urinary tract infections (UTIs) in women caused by fluoroquinolone-resistant strains. A total of 56 pre-menopausal women with uncomplicated UTIs caused by fluoroquinolone-resistant strains were included. Urine cultures were carried out. All organisms were proved to be fluoroquinolone-resistant at baseline. The patients were orally administrated Chinese herbal concoction for ten days. Chinese herbal concoction eradicated the primary pathogen in 71.4% of the patients at the 1-week follow-up. Among the 20 patients who had bacteriologic failures in the Day 5 of treatment, 2 developed superinfection. Of the failures in the group, Proteus mirabilis, Staphylococcus epidermidis and Providencia rettgeri were implicated in 50.0%, 50.0% and 100.0% of the failures, respectively. The clinical outcomes were also good, with cure or improvement for more than 80% of all subjects. About 14% of the study subjects reported at least one potential adverse event. The adverse events most frequently reported were nausea and diarrhea. All patients tolerated the symptoms. The adverse reactions did not prevail after discontinuation of the medication. Chinese herbal therapy may be an acceptable alternative for the treatment of uncomplicated UTIs caused by fluoroquinolone-resistant uropathogens.


 

Location of trial:  ChangChun (participants were outpatients of The First Affiliated Hospital to University  of Chines Medicine

Treatment

As an alternative therapeutic method, the patients were orally administrated Chinese herbal concoction. The prescription was as follow: Tong Cao [Stachyurus himalaicus Hook.f.et Thoms] 20g, Hua Shi [Talcum] 15g, Chi Shao [Paeonia lactiflora Pall.] 15g, Hui Xiang [Foeniculum vulgare Mill.] 15g, Guan Gui [Cinnamomum cassia Presl] 15g, Li Zhihe [Litchi chinensis Sonn] 15g, Tian Kuizi [Semiaquilegia adoxoides (DC.) makino] 15g, Zihua Diding [Viola ycdoensis Mak.] 20g, Ju Mai [Dianthus superbus L.] 15g, Ma Chixian [Portulaca oleracea L] 50g, Pu Gongying [Herba taraxaci] 30g. The concoction was prepared by mixing the crude drugs in 800ml water, getting 200ml liquor after the drugs decocted in 800ml water (100°C for 30 minutes twice). After cooling, concoction was stored with temperature 18–24°C, humidity 55%–70%. The concoction was orally administrated by 200ml/day for ten days.

Medical Condition

The target in this trial was floroquniolone resistant uncomplicated urinary tract infection (UTI). In other words bacteria infections in the urinary tract that have become resistant to a brand of anti-biotics.  UTI symptoms include painful urination with burning sensation, frequent urge to urinate and sometime pain in supra pubic region.

UTI is more common in women between 20 and 40 years of age. Over the course of just four years Bacteria Drug resistance in patient cases where the prescription of  fluoroquinolone s has doubled to 16% of cases examined in a study.

 

Participants

56 women aged between 20 – 45 years old without any significant underlying disease. All patients were ambulatory pre-menopausal.

Outcomes Measured

  1. absence of key symptoms
  2. decrease in severity of symptoms from initial assessment
  3. failure: symptoms got worse or there were complications
  4. Adverse reactions: any adverse affects from using the chinese herbal concoction.

Results

Of the 56 patients in this study, causative organisms isolated from urine cultures before treatment were (with number of strains in parentheses): Escherichia coli (35), Pseudomonas aeruginosa (10), Klebsiella pneumoniae (5), Proteus mirabilis (2), Staphylococcus epidermidis (2), and one each forStaphylococcus aureus, Proteus morganii, Enterobacter aerogenes, and Providencia rettgeri. Two patients were infected with two organisms.

More About one Treatment

7.1% patients had nausea, 3.6% had diarrhea. 1 patient had a skin rash and one patient had constipation. 

All patients completed the trial.

 

 

Cochrane Quality 

Not official information, so here are my observations

This was not a randomised controlled study and so did not involved a control and treatment gropup. All patients were aware of the type treatment given to them

Although the paper does state the bacteria present in relapse or failed cases. It is not easy to correlate the bacteria eradication to the patient outcomes. And of course the challenges remains to determine which herbal compounds in a formula of several herbs might be responsible for clearing the bacteria causing the UTI.

Comments

This type of study could  be repeated in a randomised study with fluoroquinolone or a patient specific anti-biotic prescription based on drug resistant bacteria present.

References

Fluoroquinolone-Resistant Uncomplicated Urinary Tract Infections, Chinese Herbal Medicine May Provide Help Y Tong, Y Jing, D Zhao, L Zhang, S Zeng. African Journal of Traditional, Complementary and Alternative Medicines.


Chinese herbs and Hypertension

Effect of Chinese herbal medicine for calming GAN and suppressing hyperactive hang on arterial elasticity function and circadian rhythm of blood pressure in patients with essential hypertension

Study:

Source

Institute of Integrated Traditional and Western Medicine, Xiangya Hospital, Central South University, Changsha, China. zgw7512@sina.com

Location: China

Treatment

The treatment received a modified Tian Ma Gou Teng Yin given to subjects as a granule extract formula in 200ml boiling water:

10g Rhizoma Gastrodiae (Tian Ma)

20g, Ramulus Uncariae cumuncis  (Gou Teng)

30g, Goncha Haliotidia (Shi Jue Ming)

30g Concha Ostreae (Mu Li)

10g , Radix Achyranthis Bidentatae (Niu Xi)

The control group received 10 mg of Enalapril, which was increased for patients who continued to show high blood pressure after two weeks (see paper for more details)

Medical Condition

Stage one or stage two hypertension (defined by conventional blood pressure measurements )  – this equates being in the range of SBP 140-179 and DBP 90-109. Subjects were recruited on a criteria of 24H ABPM equating to a mean waking BP of > 135/85 or an asleep mean BP of > 120/70> note:

Participants

64 patient randomly divided in a 32 subject control group and 32 subject treatment group

Outcomes Measured

  1. ABPM – 24h SBP and 24h DBP
  2. SBP and DBP were taken in morning and evening periods
  3. Trough Peak ratio
  4. hemodynamics and physical properties of Carotoid artery (including elasticity)
  5. nitric oxide and endothelin-1 levels

Results

Both medications were effective in lower blood pressure. The chinese herbal formula was not statistically different when comparing the metrics of 24ABPM with Enalapril. There was also no significant statistical difference in reducing pressure efficacy between the two groups. The chinese formula produced better results in some measurements:

Recovery of circadian rhythm of blood pressure in more patients than enalapril.

greater effect on NO and ET-1 levels

Trough/Peak was significantly better with Chinese herbs

 

More About the Treatment

Tian Ma Gou Teng Yin is a classic formula for calming liver yang and liver wind including symptoms of vertigo, insomnia and dizziness. This formula was modified by removing some herbs and adding others. the focus was on calming the liver suppressing wind and benefiting Shen.

Cochrane Quality and Risk Rating (if available)

Not available

Comments

The original formula is actually quite new – documented around 1950 by Hu Guang Ci. This formula has been used in other clinical trials including hypertension, headaches, epilepsy, ischemic stroke and vertigo. However the modification used in this trial removed 8 herbs from Tian Ma Gou Teng Yin  and added 3.

 

 

References

Effect of Chinese herbal medicine for calming GAN and suppressing hyperactive hang on arterial elasticity function and circadian rhythm of blood pressure in patients with essential hypertension,

ZHONG Guang-wei (钟广伟)1, CHEN Min-jing (陈民敬)2, LUO Yan-hong (罗艳红)1, XIANG Ling-li (相玲丽)1,XIE Qi-ying (谢启应)3, LI Yun-hui (李云辉)1, ZHANG Chen (张 臣)4, and GAO Feng (高 峰

 Chinese Journal of Integrative Medicine, June 2011 ,17(6) 414-420

Chinese herbs and Cough

Effective of Chinese Medicine preparation in the treatment of cough in uncomplicated upper respiratory tract infection


Study: Effectiveness of a Chinese herbal medicine preparation in the treatment of cough in uncomplicated upper respiratory tract infection

Location of trials: Hong Kong

Year of Trial: 2003

Type of Trial: Randomised double-blinded placebo controlled trial

Medical Condition

Acute cough is a common symptom of upper respiratory tract infections (URTI). The subjects in this trial presented the typical variations of cough symptoms including: night cough; sputum; nasal congestion, hoarseness, sore throat and other symptoms experienced with a common cold such as muscle pain, headache; running nose and sneezing.

Treatment

Tablets containing extracts granules from these herbs were given the TCM group. Placebo tablet given to the control group.

Chuan Bei Mu (Bulbus Fritillariae Cirrhosae) 27.3%, Jing Jie (Herba Schizonepetae) 10.5%,  Fang Feng (Radix Ledebouriellar )10.5%, Jie Geng (Radix Platycodi ) 10.5%,  Gan Cao (Radix Glycyrrhizae) 4.4% , Zi Wan (Radix Asteris) 10.5% Bai Bu (Radix Stemonae) 10.5% , Bai Qian (Rhizoma Cynanchi Stannotonii )10.5% Chen Pi (Pericarpium Citri Reticulatae) 5.3%.

NB: Many subjects were prescribed pharmaceutical medicine at the beginning of the trial. e.g 67 subjects were given Fexofenadine. Paracetamol was given to 44 subjects. Read study paper for full listing of pharmaceutical medications.

Dosage: The dosage was 3 tablets three times a day (each tablet was 500 mg)

Participants

Most subjects had a mean of 4 day history of cough. 81 started trial. 19 withdrew before study was completed. Reasons for withdrawing included: worsening symptoms (so had to seek other treatment) : using over the counter cough medicine; the cough improved and stopped before end of trial; conditions changed and antibiotics had to be used. In all cases none of these subjects experienced adverse effects from the formula. Participants were encouraged to withdraw if their symptoms changed or deteriorated.

Outcomes Measured

  1. Leicester Cough Questionnaire – A questionnaire to assess chronic coughs
  2. Cough Score – patient rating of cough severity
Treatment period was 5 days. Assessments and examinations were conducted on day 4 and day 7.

Results

62 patients (75.6%) had completed the trial and no adverse effects were reported. Both intervened and control groups had improved in cough score and LCQ in the follow-up period,= despite no overall statistical significance was observed in the differences of scores between the two groups. Women taking TCM had significantly fewer problems with sputum production (p = 0.03) and older subjects (>35 years of age) reported a significant improvement in hoarseness (p = 0.05) when compared to those using placebo.


Cochrane Quality 

not found

Comments

The first question that come to mind is why  allow a variety of pharmaceutical medications to be used on both the TCM and placebo groups? The paper acknowledges that his may have confounding effects on the TCM preparation, which begs the question why do it in the first place? If the primary objective of this study was to test the effectiveness of TCM preparation on cough surely you would control the variables as much as was within your power.

This trial seems to be an attempt at standardising TCM treatments across all subjects using a  common formulation (as it mentions one similar to the Pe PA Kao syrup). An approach to a single formula for all patients contradicts the principles of TCM medicine. We know that when you get a cough you usually have other symptoms and these symptoms can vary from person to person. In TCM the pattern diagnosis determines the treatment and therefore treatments are not the same for each patient. With colds you can narrow it down by reverting to base formulas commonly used for wind-cold, wind-heat attacks or wind-attached etc. However there maybe other symptoms present that warrant formula modifications and failing to address these other symptoms could result in an ineffective treatment or a worsening condition. For example it could be hypothesised that the number of drop outs may have been less if they had been prescribed a formulation based on their individual pattern.

However conducting a trial in which multiple formulations maybe possible if you had large numbers but even then  you would have to question the validity of such a trial where you are testing effectiveness of multiple remedies against the same placebo group. Valid clinical trails need simple valid hypotheses that can be retested. This trial seems an attempt at doing that. However you have to question the unusual decision of allowing subjects to use antihistamines , paracetamol and other drugs.

References

Wong WCW, Lee A, Lam AT, Li KT, Leung CYM, Leung PC, Wong ELY and Tang JL. Effectiveness of a Chinese herbal medicine preparation in the treatment of cough in uncomplicated upper respiratory tract infection: a randomised double-blinded placebo-control trial:  www.coughjournal.comn/content/2/1/5

 

TCM and Non-acute bronchial Asthma complicated with gastroesophageal reflux

A review of effectiveness and safety of TCM treatments for bronchial asthma and gastroesophageal reflux (GERD)


Study: Zhao Yu-Hao, LIU Zhao-hua, JIANG Sheng-hua, SHI Cheng-he: Systematic review of randomized controlled trials of traditional Chinese medicine treatment of non-acute bronchial asthma complicated by gastroesophageal reflux. Journal of Traditional Chinese Medicine: 32(1):12-18

Location of trials: All trials in this review were conducted in China

Treatment

This review looked at  randomized, controlled trials that compared TCM treatments to western medical treatments such as anti-inflammatory drugs, bronchodialators for asthma and drugs to inhibit gastric acid production and promote gastric peristalsis. TCM trials selected included those using various herbal formulas and one trial involving a  combined treatment of acupoint injections , cupping and ginger-separated moxibustion.

Medical Condition

Gastroesophageal reflux and bronchial asthmas are often found together in patients. The theory is that regurgitated contents of the gut during reflux can irritate or damage tissues outside the esophagus such as the bronchial tissue of the lungs. It is believed this type of irritation of bronchial may cause asthma. One study revealed that 59.2 % of asthma patients had symptoms of gastroesophageal reflux.

What is gastroesophageal reflux? Also referred to as Gastrophageal reflux disease (GERD) or acid reflux is where stomach acid breaches the barrier (a sphincter type lid)  between the stomach and the esophagus. The acid damages the esophagus wall and causes that painful feeling we call heart burn. Nausea, belching, regurgitation are other symptoms associated withGERD.

Participants

Six studies were analysed – totalling 304 patients.

Outcomes Measured

  1. Asthma Scores: Reid method was reported in two studies
  2. Gastroesophageal reflux scores: used Harper method in three studies the symptoms relieved and the bulk of signs disappeared within 5 days
  3. Pulmonary function: was reported in two studies
  4. Adverse reactions: no adverse reactions were reported in any of the selected studies.

Results

Methodological quality was low in all six RCTs. Two RCTs showed that clinical efficacy was higher in the treatment group than in the control group (RR: 1.43, 95% CI: 1.10 to 1.87 vs RR: 1.51, 95% CI: 1.09 to 2.08). One RCT showed that the asthma score was lowered more effectively in the treatment group than in the control group (MD: -1.10, 95% CI: -2.04 to -0.16). Two RCTs showed that the gastroesophageal reflux score was reduced more effectively in the treatment group than in the control group (RR: -3.70, 95% CI: -4.30 to 3.10 vs RR: -5.30, 95% CI: -6.32 to -4.28). One RCT showed that some pulmonary function values were improved more effectively in the treatment group than in the control group (P<0.05). No differences were seen in the various indexes between groups in the other RCTs. No adverse reactions, dropout rates, or follow-up rates were reported in any of the RCT

More About one Treatment

One study used these herbs to treat asthma (dosage not available in review paper)

Sha Shen (Radix Glehniae seu Adenophorae),Ban Xia (Rhizoma Pinelliae), Bai Zhu (Rhizoma Atractylodi Macrocephalae), Wu Zhu Yu (Fructus Evodiae), Huang Lian (Rhizoma Polygonati) , Zhi Shi (Fructus Aurantii Immaturus), Zhi Gan Cao (Radix Glycyrrhizae Preparata).

Commanality of herbs across the six studies were:

Ban Xia – 5/6 studies

Gan Cao – 4/6 studies

Zhi Shi – 3/6

Huang Lian/Whu Zhu Yu/Xuan fu hua/Wu Zei Gu – 2/6

Cochrane Quality 

Methodological quality was rated low in all studies selected for this review.

The quality of the selected trials was criticised for being of low quality due, what seems to be a set of common characteristics of TCM trials conducted in CHINA including inconsistent interventions (different formulas), difficulties extracted bigger numbers of trials , lack of detail around the trial methodologies  and measures that would only lead the reviewers to conclude the trials may be subject to bias.  In this case there were no details of drop-outs and follow-ups. In thew review  the authors make many more specific comments regarding trial quality.

 

Comments

This review demonstrates that at a collective level of the selected studies, and based on the information available to the reviewers, that TCM treatments for bronchial asthma and gastroesophageal reflux could be just as effective as common western medication and in one study a TCM combined with western medicine was significantly better that  using western medicine alone to treat asthma.

However in the limitations section of this paper , the authors  caution readers to jump to conclusions that TCM is definitely equally curative or better than pharma treatments. This is a small review and not a meta-analysis.

 

References

Zhao Yu-Hao, LIU Zhao-hua, JIANG Sheng-hua, SHI Cheng-he: Systematic review of randomized controlled trials of traditional Chinese medicine treatment of non-acute bronchial asthma complicated by gastroesophageal reflux. Journal of Traditional Chinese Medicine: 32(1):12-18

 

Chinese herbs and Sore Throat

A Clinical Study for herbal remedy for Sore throat (Acute Pharyngitis) 


Study: Hu SY, Ma R, Liu HP. A study for clinical efficacy of “Ertong Qingyan Jiere Koufuyie” in the treatment of acute pharyngitis.

Location: China

Treatment

Herbal formulation called Ertong Qingyan Jiere Koufuye was given to treatment group

Medical Condition

Acute Pharyngitis: Pharyngitis can result in very large tonsils that cause trouble swallowing and breathing. Pharyngitis can be accompanied by fever or cough

Participants

106 acute pharyngitis patients with “Feiwei fever” TCM signs, in hospital/out-patient = 72/34 cases. Treatment group: Ertong Qingyan Jiere Koufuye, 1 to 3 years old: 5 ml tid, 4 to 7 years old: 10 ml tid, 8 to 14 years old: 15 ml tid. Course of treatment: 5 days Control group: Fufang Shuanghua Koufuye. 1 to 3 years old: 5 ml tid, 4 to 7 years old: 10 ml tid, 8 to 14 years old: 15 ml tid. Course of treatment: 5 days. Both groups were forbidden to use antibiotics. If the temperature > 39 C, their fever was abated by physically cooling and given an antipyretic analgesic

Outcomes Measured

  1. Recovery: all the symptoms relieved within 3 days, the signs and symptoms disappeared
  2. Marked improvement: the symptoms relieved and the bulk of signs disappeared within 5 days
  3. General improvement: the symptoms relieved and some of the signs disappeared within 5 days
  4. Inefficacy: the signs and symptoms had not improved within 5 days

Results

  • 45 in 70 cases recovered in treatment group
  • 15 in 36 recovered in control group
  • 2 persons in 70 had no improvement
  • 1 person in the treatment group experienced adverse effects

More About the Treatment

Ertong Qingyan Jiere Koufuye was a specific formulation for new drug development by a Chinese manufacturer who funded this study. The formulation contains herbs used in Traditional Chinese herbal medicine and most can be found on the internet. Formula contained: Chai hu (radix bupleuri), Niu huang (Calculus Bovis), Zi hua di ding (herba violae), Qu mai cai (Herba Sonchi Arvensis), Yu xing cao (Herba Houttuyniae), Lu gen (Rhizoma Phragmitis), Chi xiao dou (Semen Phaseoli).

Cochrane Quality and Risk Rating (if available)

In Chinese Herbs for sore throat, Yang, WU, Zeng and Li (2012) made a number of observations about the quality and risks associated with this type of study and other similar ones conducted in China. Here are some of the observations

  • The need to use conventional drug terms to explain TCM terms making it more informative for both physicians and consumers.
  • The absence of placebo groups made it difficult to understand the effectiveness of the formula
  • The study was funded by a drug company, which used another drug in the control group. Yang et al rated these factors as high-risk bias.
  • The variability in formula constituents, impurities and contaminants accepted as a factor that may contribute to heterogeneity of between different study results. The preparation methods and quality of herbs should be stated in the study.
  • Chinese names for herbs are not sufficient and internationally recognized names of all plants should be recorded in studies.

Comments

I found this clinical study in Yang, WU, Zeng and Li (2012) larger study to analysis the efficacy and safety of herbal treatments for sore throats (including acute/ chronic pharyngitis, laryngitis, and tonsillitis). According to this analysis the efficacy of Chinese herbal treatments for sore throats had not previously been systemically reviewed. I chose this particular study because the tested formulation showed overall good results for treatment of a sore throat (pharyngitis); there was no significant adverse effects (only one person reported in study) and it was a formula that contained Chinese herbs that should be readily available in Australia and America. If you read the full study conducted by Yang et al (2012), it is easy to understand why they rated this study and other studies as very low in quality despite some studies reporting positive results in generally large portions of treatment groups.

 

References

Huang Y, Wu T, Zeng L, Li S. (2012) Chinese medicinal herbs for sore throat.

Hu SY, Ma R, Liu HP. A study for clinical efficacy of “Ertong Qingyan Jiere Koufuyie” in the treatment of acute pharyngitis. Journal of Chinese Medicine 2004;19(1):31–3.