A  Study of the Efficacy of Adjunctive Moxibustion in the Treatment of Tuberculosis

Principle Investigator: Paul Waako (MBChB) MSc. PhD, Associate Professor and Head of Department Pharmacology and Therapeutics, College of Health Sciences, Makerere University Medical School , Kampala

Co-investigators:

Dr. Ibanda Hood MBChB, Worodria William MBchB. Mmed PhD (Makerere Uni)

Jenny Craig BSc, PhD, LicAc, MBAcC, and  Merlin Young LicAc, MTA (Moxafrica)

Abstract:

A 12 month pilot study with TB patients in Kampala has suggested that daily use of moxa can improve the recovery rate and reduce the side effects of medication. This is now being expanded into a Randomised Control Trial to investigate in more detail the effects of moxa on immune responses, recovery rates and quality of life. The study will involve 180 patients presenting as new cases of TB, either with or without HIV co-infection. All patients will receive the standard TB medication according to their condition. In each group (+/- HIV), half of the patients will be trained in self-administration of daily moxa treatment for 8 months. Regular monitoring of all patients will be carried out , with analysis of sputum and blood, radiological monitoring, clinical examinations and assessment using the Karnovsky score. Patients will be withdrawn from the study in the case of non-compliance or any adverse symptoms or disease complications.

After many hiccups, including a three month hiatus in drug supply into Uganda, this RCT finally started at the end of August 2012. It is being managed by a hand-picked young team, led by Professor Paul Waako. All are deeply committed to completing a rigorous investigation. The study is teherefore due to run from September 2012 until June 2013.

Hypotheses:

Null hypothesis:

That there is no difference in the cure rate of patients receiving standard TB therapy alone and the cure rates in patient receiving standard TB treatment plus moxibustion

Alternative hypothesis:

That the cure rate of TB patients receiving Standard therapy plus moxibustion is more than that of patient receiving only standard TB therapy.

Research questions 

a) What is the cure rate in patients receiving 2HERZ/6HE plus MOXIBUSTION compared to the cure rate in patients receiving 2HERZ/6HE?

b)  Does the addition of moxibustion to standard TB treatment, improve lives/decrease morbidity of TB patient during and after treatment?

Study objectives

General objective

The main objective of this research is to study the effect of moxibustion on the cure and morbidity rates in patient taking first line tuberculosis medication in Uganda.

Specific objectives

a) To study the bacteriological response of new patients (cases of TB) receiving moxibustion plus standard TB therapy.

b) To study the clinical response of patients receiving adjunctive moxibustion and the clinical response of patient receiving TB therapy alone

c) To compare the proportion of patients who will get cured in the study arm that will be given adjunctive moxibustion to the study arm that will not get the moxibustion

d) To compare improvement in quality of life (using the Karnofsky score) in patients receiving adjunctive moxibustion with patients receiving only Tb therapy.

Laboratory and radiological follow up

This will involve doing sputum smears to see how the patients respond to TB treatment.

Liver and renal function test will done to ensure the patient is not developing toxicity to the drugs.

WBC count, CD4 and CD8 will be also done to see the response of the patients immunity to moxibustion but also in case some may need antiretroviral therapy.

a)      Sputum smears; sputum smears will be made using Ziehl-Neelsen (ZN stain) Staining Technique and then examined under the microscope. The sputum smears will be done end of months, 0, 1, 2, 5 and 8

b)      WBC counts will be done using a coulter Act Diff 5 Auto loader machine. This will be done every two month (at months 0, 2, 4,6 and 8)

c)      CD4 and CD8 count will be done using Fasc Calibur machine. This too will be done every two month, (at month 0, 2, 4, 6, and 8)

d)     ESR will be done at the same time as the WBC

e)      Liver and renal functions tests; these will be done at the start of treatment and any time along the treatment when the patient develops signs of either liver or renal toxicity.

f)       Radiological follow up. To achieve this, we shall do a chest radiograph (since we are going to see only patients with pulmonary TB). The radiograph will be done at the start and end of treatment (month 0, and 8). A radiologist will be used to interpret the radiographs.

Follow up of Participant’s Quality of life

Each participant’s quality of life of the participants is going to be monitored during the course of the study. Using the Karnofsky performance score.

The patient’s Karnofsky score will be recorded every time he/she comes to the clinic for follow up in the study for all the above mentioned reasons of follow up.

Study justification

Due to the high HIV burden (more than 5% for most of the sub-Saharan Africa), there is a high regional incidence of TB disease in Africa, and the highest global rates of mortality. Meanwhile, an inadequate health care system, poor and mismanaged drug supply chains, poor patient follow up, and lack of counseling to ensure adherence to TB treatment, have all led to an increase in the burden of multidrug resistant (MDR) Tuberculosis infections.

The current treatment regiment for MDR –TB is expensive in terms of the high costs of the requisite second line drugs, and the culture and sensitivity tests required for their proper use, as well as the cost of liver and renal function tests required during follow up of patients. These are just some of the problems faced in the management of MDR –TB.

It makes sense, therefore, that we consider methods that have hitherto been reported to have worked in the treatment of TB in the past, in this case in Japan and other East Asian countries, but which have not yet been properly investigated using modern science.

Moxibustion therapy has the singular advantage of being cheap and easy to use by patients themselves. It might even, alongside available and affordable first line drugs prove to be a realistic alternative to second line drugs for treatment of MDR-TB when such treatment is unaffordable, and/or might be used to help reduce the increasing incidence of MDR-TB itself by improving the cure rates for new cases of TB.

The purpose of this study is therefore to investigate if the method of small-cone moxibustion used in Japan in the 1930s could help in increasing the cure rate of TB, might reduce the rates of morbidity, but most of all might help decrease the incidence of MDR-TB. 

Study design

This is a randomized controlled clinical trial phase II with two arms, one with patients taking TB treatment with moxibustion, and the other of patients taking TB treatment without moxibustion.

Study site

The study will be carried out at Kiswa Health Centre, Kampala, Uganda.

Budget

The budget is $57,000. For more information on budget breakdown see "budget"..

  

 

 

 

                                                                                                                                                                                                                                                                                                                                                                   

                                                                                                                                           

  

 

 

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