Protocol A

Calf's foot jelly for osteoarthritis

Scientific background
A daily oral supplement of glucosamine (a component of
cartilage) has been shown in at least one study to reduce the
loss of cartilage in the knees of patients with osteoarthritis (OA),
while patients on placebo lose 0.1 mm joint space annually.
Calf's foot jelly (CFJ) is a traditional remedy that also contains
components of cartilage. Unlike glucosamine, CFJ can be incorporated into many cooking recipes
and is used as a condiment. If it is effective it is therefore more likely to be widely adopted by
patients.
Aim of investigation
To determine the effect on the progression of OA (measured by serial x-rays) of dietary treatment
with CFJ.
Methods
Hospital outpatients age over 50 years with painful primary OA of knee, who have no
contraindications (such as potential allergy) and who have had a previous x-ray of the knees will be
invited to take this food supplement for 1 year. Power calculations based on published research
indicate that 60 patients are required with a follow-up period of 12 months. After consent baseline
radiographs are taken, and the patient is issued with one month's supply of CFJ. Subsequent
supplies are collected monthly from the hospital dispensary or, if more convenient for the patient,
from their GP's surgery. At the time of collecting new supplies the patient returns the old container,
and also brings a urine sample for analysis. The CFJ contains a tracer dose of lithium chloride that
equilibrates with total body water, so the lithium/creatinine ratio in urine reflects the compliance in
taking the treatment. Every 3 months patients attend the outpatient clinic for clinical examination
and at 12 months for x-rays of the knees. Limitation of movement and pain are recorded on
separate linear analogue scales.

Analysis and interpretation

Cartilage thickness is assessed by the width of the joint space on knee x-rays (the inter-bone
distance). Therefore, in those patients who complete the protocol (that is, take the CFJ for 1 year
and are therefore in a position to gain the benefits of treatment) joint space narrowing (change in
inter-bone distance) will be measured with a ruler and will be compared to the annual rate of joint
space narrowing calculated from the x-rays taken before the study and the study baseline x-rays.
Change in movement and pain will also be calculated. Although a reduction in the rate of joint space
narrowing is the main purpose of the treatment, improvements in movement or pain will also be
considered a successful outcome.
Protocol B
Lotion for spot reduction of subcutaneous fat

Scientific background
The deposition and remobilisation of triglyceride (fat) in adipose tissue is under
hormonal control. Release of fat is achieved mainly by the action of tissue lipases in fat cells, which
split the triglyceride and release fatty acids into the bloodstream. The hormones adrenaline and
noradrenaline activate these tissue lipases. This does not affect the total body fat, but makes it
possible to remove fat deposited locally, which will be re-synthesized elsewhere.

Aim of investigation
To test the ability of a lotion containing a synthetic noradrenaline analogue to
remove fat from a subcutaneous depot.

Methods
Following ethics committee approval, 120 women age 20 60 years, who are keen to lose fat
and/or cellulite from their thighs, will be recruited from local slimming clubs. Women who are
currently using other forms of anti-cellulite treatments are ineligible to join. Detailed trial information
will be issued and written informed consent obtained. Participants will receive two containers,
marked with code numbers only, one containing the active lotion, the other an identical-looking
placebo. Women are advised to apply one lotion to the anterior surface of one thigh, and the other
lotion in the same manner to the other thigh, daily for 6 weeks. The type of lotion applied to each
thigh (active or placebo) is chosen at random by means of computer-generated randomization
numbers, and both the women and investigators are blind as to which treatment was used on which
thigh. To demonstrate compliance, women are required to complete a brief daily treatment chart.
Photographs of both thighs in a standard position (seated with thighs horizontal, camera 1 m above
anterior surface of the thighs, lighting from the side to display skin texture) will be taken at the start
and finish of the trial period.

Analysis and interpretation

The pairs of photographs (baseline and post-trial) will be examined
independently by two judges, who do not know which thigh was treated with the hormone or the
control lotion. The picture-pairs will be rated R, L or O, if the judge considers that the right, left, or
neither thigh show a reduction in fat or cellulite. These judgements for each judge will be converted
into a score of +1 if the thigh treated with hormone was judged to be more reduced, O if neither was
reduced, or -1 if the control thigh was more reduced. The scores will be added together. If the total
score of the judges is >1 this will indicate that the lotion containing the hormone analogue was more
effective control lotion.
Protocol C

Castor oil to treat baldness

Scientific Background
It has long been known that castor oil is one of the natural cures for
baldness and works as a humectants (a substance that absorbs or
helps another substance retain moisture). All that is required is to pour
some castor oil in the palm of the hand and gently massage it on the
bald areas of the head. This will help in nourishing the hair and boost
hair growth.
Aim
This project is designed to demonstrate that regular use of castor oil improves hair growth.
Methods
Many people seek help for their problems with baldness by consulting at our natural remedies clinic.
We will use our web site to invite men between the ages of 25 and 45 (a time when men are
particularly concerned about their appearance) to volunteer to join the study, and will offer a 50%
treatment discount if they do so.
Participants will be offered our own superior brand of specially prepared castor oil to apply to the
balding areas each evening for 2 weeks, and a standard commercially available shampoo to use
each day for 2 weeks as a comparison. The products will be mailed to the participants and in order
to prevent any bias, the order in which these are to be used will be randomised.
At the end of each 2 week period participants will complete our on-line questionnaire, which asks
about their worries and concerns about hair loss, how they feel about it now, and whether they think
hair growth has improved over the previous 2 weeks.
Participants will also answer the questions, Which two week period was best for your hair? and
Would you recommend our superior brand of specially prepared castor oil to others?
Analysis
To reduce the time taken to complete the study we will keep a continuous track of the responses of
study participants. The chance of random selection of the castor oil as the preferred treatment is
less than 5% for 5 people in a row (25=1 in 32 or 3.13%) and so we will stop the study when 5
people in a row have chosen castor oil.
Protocol D
Moxibustion for Breech Presentation
Scientific Background
Breech presentation (head up) is common in the mid trimester of pregnancy. Women with a breech
presentation at 36 weeks, are frequently offered External Cephalic Version (ECV). This is
successful in 30 80 % of cases. ECV is not suitable for all, hence treatments that facilitate
spontaneous version are being explored. These include moxibustion, a type of acupuncture that
involves the application of heat to specific acupuncture points, by the burning of specific herbs
(moxa). If moxibustion can be shown to be effective, women would avoid the need for Caesarean
Section.

Aim
To determine whether moxibustion is effective in producing spontaneous version of breech
presentation in late pregnancy.

Method
The trial will take place at five London hospitals after ethics committee approval was granted.
Healthy women with a singleton pregnancy attending ante-natal clinics, who are found to have a
breech presentation on physical examination by a midwife or obstetrician at 34 35 weeks
gestation, will be invited to take part. They will receive verbal and written information about the aim
and study procedures. Exclusion criteria include pelvic abnormalities; previous uterine surgery;
foetal or uterine abnormality or other pregnancy complications.
Women who consent to take part, will be assigned to receive moxibustion or observation-only, the
group allocation being determined by computer-generated random numbers, held by a staff member
not involved in the study. Recruitment will cease after a total of 250 women are enrolled.

Midwives, trained in the administration of moxibustion, will perform the first treatment. This involves
burning sticks of the herb Artemisia vulgaris next to the acupuncture point BL 67 (tip of the fifth toe),
to induce a warming sensation. Participants will then be taught the technique and advised to carry it
out at home for 30 minutes (15 minutes per side) twice a day for seven days. All participants will
complete an AFM-count form twice a day for seven days, with the number of AFM counted in one
hour. If, after one week of treatment (or observation-only) breech presentation persists
(demonstrated on physical examination), the same treatment is to be continued for another week,
and the patients will be examined again.
Thereafter, all women who still have a breech presentation, will be offered ECV.
Primary outcome measure is the number of spontaneous versions after two weeks of treatment;
secondary end-points are AFM and compliance.

Analysis and Interpretation

Data analysis will be performed by an independent investigator, who is blinded to the treatment
groups. The proportion of spontaneous versions following treatment with moxibustion will be
compared with that in the controls.