Reading a CAM (Ayurveda) paper

With the Indian government spending big bucks on complementary and alternative medicine under the aegis of the department of AYUSH, we must question whether all these spending is justified or if the money will be better spent improving the infrastructure of conventional health delivery system. With this in mind I set out read a CAM paper to find out what the CAM practitioners are up to. The paper is titled “Clinical efficacy of herbal Padmapatradi yoga in bronchial asthma (Tamaka Swasa)”. I must say at the outset that I have no knowledge about ayurveda but I do have some knowledge regarding asthma (had to study it for 4 straight years and still studying) and research methodology that I suppose will be more than adequate in examining this paper.

Introduction – Let us look at the introduction first. The paper begins with an unwarranted attack on conventional medicine.  

“The reason for the therapeutic efficacy of herbal combinations in asthma is due to multiple blocking and homeostasis of very complex and interdependent cellular and mediator networks supporting and involved in the inflammatory process of asthma, whereas modern synthetic drug therapy aimed at blocking one mediator alone would be unlikely to have any significant effect on the disease process.”

Eh, what? Why? What relevance does it have on the study at hand? For what it’s worth, lots of asthma patients lead a perfectly healthy life free of morbidities thanks to “modern synthetic drug therapy”.

“Herbal preparations have been cited as the third most popular complementary treatment modality. Sometimes herbal remedies increase the morbidity and adherence to inhaled corticosteroids.But Padmapatradi yoga. is an experience-based polyherbal compound having five herbs i.e. Padmapatra (Inula recemosa), Bhargi (Clerodenum serratum), Malaya Vacha (Alpinia galanga), Shati (Hedychium Spicatum), and Pippali (Piper longum).”

Generally when people begin with a “But” they come up with an argument. Suffice to say that the authors begin with a “But” but never say whether their preparation decrease the morbidity to inhaled corticosteroids. That they remain silent suggests that it does not. Important point to note, herbal remedies increases the morbidity to inhaled corticosteroids and should not be used together.

Also note that it is a  polyherbal therapy and the pharmacokinetics of different components will almost certainly be different. Wonder how they managed to get the dosing schedule right.

Methods – Now let’s have a look at the most important part of the study, the methods section.

“Inclusion criteria - Patients above the age of 15 years and below the age of 65 years were included, irrespective of their sex, on the basis of clinical signs and symptoms. Bronchial asthma with a history for at least one year, nonsmokers and absence of long-term remissions of asthma (lasting more than one month) are included in the study.”

So there are no proper inclusion criteria. How do they define asthma? We don’t know. Were the patients actually suffering from asthma? We can’t say with any degree of certainty. It’s not that an objective diagnosis of asthma can’t be made. The diagnostic criteria are there for all to see (NAEPP3 guidelineSection 3). Pulmonary function tests should be done to diagnose asthma as history and physical examination alone are not sufficient. But the study botches up this vital step. We can stop reading the paper here only. Without proper inclusion criteria there is no point in going through it, we don’t even know if the subjects were truly asthmatic.

“Study design and duration - The study design was open clinical trial of over 40 cases of bronchial asthma. The study was a preliminary attempt to know the efficacy of this formulation, therefore a control group was not taken. Moreover, the trial was in an Ayurveda hospital and administration of modern control was an ethical problem. The duration of treatment was one month. “

No control group – point to be noted. The ethical problem noted is laughable. What is so special about ayurvedic hospital that placebo control could not be given? Oh wait, what is modern placebo control? Is it different from ayurvedic placebo control? Perhaps they have heard of crossover trials, that way every subject would have got their ayurvedic pills but I wonder why they didn’t do that?

Criteria for assessment – it appears that the authors made up their own criteria for improvement disregarding the available criteria. How do we know their criteria are valid?

Results - They did find a statistically significant increase in PEFR after the treatment, but they botch it up again. It’s not the absolute value of the PEFR that matters but the percentage of PEFR compared to predicted value or personal best is what’s important. PEFR values change with age and sex. No data is given in the study in this regard. Were the PEFR values actually abnormal? For example, as per EU/EN13826 scale PEF meters a 45 year old lady with height 152 cm can have a normal PEFR of up to 325 l/min but this would be classified as abnormal according to the study which is plain wrong. Also why did they leave out FEV1 despite saying they did measure it? Did it not show any significant improvement? I guess not. It’s important to note that FEV1 is better than PEFR to measure asthma severity.

In conclusion I should say it may be possible that herbal treatment may have some active ingredients in which case it would be appropriate to identify the active component and then see if it works. But studies such as this are just obfuscations. Before long some charlatan will come along and may quote this study to push more non-sense.

Panda AK, & Doddanagali SR (2011). Clinical efficacy of herbal Padmapatradi yoga in bronchial asthma (Tamaka Swasa). Journal of Ayurveda and integrative medicine, 2 (2), 85-90 PMID: 21760694