Randomised Controlled Trial Appraisal Tool

Posted on Posted in Statistics

 

Randomised Controlled Trial Appraisal Tool

 

Section A: Are the results of the review valid?

 

Screening Questions

 

  1. Did the trial address a clearly focused issue?

rYes rNo rCan’t tell

Justify your answer:yes

 

Many clinical trials on men with androgenic alopecia have shown that minoxidil treatment is effective in about of half of the cases for instance, the conclusion of a long year, randomised, doubled-blind trail involving 56 males, was that dermatologically acceptable hair growth developed in 32% of individual. In another 12-month study, minoxidil produced at least moderate cosmetic improvement in only 24% of individuals. Data derived from multiple ,double-blind ,placebo-controlled trails, involving over 2000 males between the variying ages of 18 and 50 years, showed that twice daily application of 2%minoxidil solution for a period of one year produced moderate to heavy regrowth in approximately 30 to 35%of patients. Although significant hair regrowth can occur in patients of all ages, mixoxidil treatment is more likely to be successful in individual under 40 years.furthermore,an approving response is more likely when the balding patch is recently developed less than10 years,covers a small area(diameter 10cm and contains residual,maniaturised hairs,1cm long or longer rather than long hairs at all. considering the last variable, there is a consent that the greater the density of such miniaturised hairs, the better the cosmetic outcome.importantly,the agent is more effective on the scalp vertex than on the frontal area where it is generally of little value.many researches have investigated the effect of monoxide on male scalp as a function of treatment time.one of the comparative treatment has given with the administration of Finasteride, a synthetic 4-azasteroid compound.the efficacy of regular usage of finasteride treatment for male baldness has been resently evaluated in several double-blind placebo controlled trails.Waldstreicher investigated that the effect of fnasteride in 326 individuals with mostly mid-scalp and anterior baldness.

 

 

 

HINT: An issue can be ‘focused’ In terms of

  • The population studied
  • The intervention given
  • The comparator given
  • The outcomes considered
  1. Was the assignment of patients to treatments randomised?

Yes     No       Can’t tell    

Justify your answer: yes

Randomised controlled clinical trials done on men with androgenicalopecia. The conclusion of a yearlong, randomised, double-blind trail involving 56 males, was acceptable hair growth took place in 32%of individuals.in another 12-month study, minoxidil produced at least moderate cosmetic improvement in only 24% of individuals. Data derived from multiple, double-blind, placebo-controlled trails, involving over 2000 males with the age group of 18 and 50 years, revealed that twice daily application of 2% minoxidil solution for a period of one year has shown the regrowth of moderate to heavy in about 30 to 35 % of clients.the research studies on minoxidil application showed that this treatment is mostly successful for the clients within the age of 40 years. The allocation sequence was not in concealed.

 

 

 

 

 

 

 

HINT: Consider

  • How was this carried out?
  • Was the allocation sequence concealed from
  1. Were all of the patients who entered the trial properly accounted for at its conclusion?

Yes     No       Can’t tell    

Justify your answer: yes

 

The trail had not stopped early and the conclusion of a long year randomised double -blind trail involving 56 males resulting the regrowth of hair with 32% of overall individuals.in other research study which took place for a duration of 12 months shows that 24%of the individuals got benefited with minoxidil treatment.the data which has derived from multiple doubled-blind placebo controlled trails involved about 2000 males between the age group 18 to 50 years with regular minoxidil application with a dosage 2% for one year developed average to excellent hair growth in approximately 30-35% of total group.in a recent pilot study,pierard-franchimont and co-workers found that 6 months of minoxidil 2% treatment(once a day application) produced an 11% increase in mean hair density and 7% increase in median hair shaft diameter in the effected vertex area .most of the researches have concluded that the maximal growth response is achieved after 12 months of minoxidil use.

 

HINT: Consider

  • Was the trial stopped early?
  • Were patients analysed in the groups to which they were randomised?

 

Detailed questions

 

  1. Were patients, health workers and study personnel ‘blind’ to treatment?

Yes     No       Can’t tell    

Justify your answer: no

All the participants involved with this studies were completely oriented with the description of treatment .Philpot and co-workers recently showed that the action of minoxidil is to stimulates hair regrowth in hair follicles cultures where a blood supply is absent.immunocytochemistry and autoradiographic analysis of primate scalp has indicated that minoxidil increases the number of DNA synthesising cells and with this pathophysiological action eventually terminal hairs regrowth.other researcher (De villez) reported that excessive hair growth firstly reported within 4 months in to the theraphy.by 8months these hairs became longer and pigmented while other non vellus hairs had also begun to lengthen and thickened.reseacher suggested that minoxidil application can be apllied on the scalp even after the shampowing but the particular shampoo must be non-medicated and the individual can swimmed and carry out his daily activity.

 

 

 

 

 

HINT: Think about

  • Patients?
  • Health workers?
  • Study personnel?

 

  1. Were the groups similar at the start of the trial?

Yes     No       Can ‘t tell    

Justify your answer:no

The clinical trail was started on men with androgenic alopecia with the age group of 18 and 50 years and the fortunate results were found in the patients who were below the age of 40’s.For male pattern baldness, a minoxidil concentration results and its relationship has been indicated.A concentration of 1% had achieved significant effect where as the concentration of 5% is more effective than 1% and 2 % .However the effect of application volume has not been clinically assessed, topical application experimentation larger initial volume has not been delay the time to minoxidil solution and improves its penetration.the same medicine has also been experimented on females by (Rushton and fenton)and the results showed that minoxidil solution is more effective in females than in males but researcher suggests that womens who are applying minoxidil on the scalp hairs must be aware because the medicine may develop facial hypertrichosis(hair grows on face)but disappear when treatment stops.

 

 

 

 

 

 

HINT: Look at

  • Other factors that might affect the outcome such as age,
  • sex, social class
  • researchers and patients?

 

  1. Aside from the experimental intervention were the groups treated equally?

Yes     No       Can’t tell    

Justify your answer: can’t tell

 

In these studies the different groups were experimented with varying number of participants eachgroup as well as differentages and duration of treatment course and the dosage of medicine. For instance the randomised double-blind trail involving 56 males shows cosmetically acceptable hair regrowth with 32% and in another 12 months study,minoxidil shows the improvement in only 24% of individuals.in placebo-controlled trails, involving 2000 males participants with regular minoxidil application of 2% twice daily for an year shows the result of 35 to 35%.response to the minoxidil treatment took place within the time period of 4 to 6 months for some individuals and other shown the successive results at 12 months.

 

 

 

 

Section B: What are the results?
  1. How large was the treatment effect?

Justify your answer:

A fascinating response is more likely came into exist when the baldy patch is recently developed in less then 10 years ,covers a small area of more then 10 cm in diameter and contains residual,miniaturised hairs,1 cm long and some hairs are more longer than that.significantly, the agent is more effective on scalp vertex (medial region)than on the frontal area where commonly has a little value.most of the researches have concluded that the maximal growth response is attained after 12 months of minoxidil usage.long term treatement is generally characterised slow decline in further new regrowth new years. If minoxidil treatment stops even after four years of treatment, accelerated hair loss may begins to arise after 4 to 6 months, the degree of scalp hair may return to pre-treatment stage or even below.

 

 

 

 

HINT: Consider

  • What outcomes were measured?
  • Is the primary outcome clearly specified?
  • What results were found for each outcome?

 

  1. How precise was the estimate of the treatment effect?

Justify your answer:

Minoxidil is a derived from pyrimidine derivative and interestinly it is the first which came in to existence for scalp hair loss treatment.it was originally synthesised as an anti-hypertensive medication in oral form and surprisingly found to induce hair growth in patients than later with outcomes of unexpected side effects led to the development of a topical minoxidil local application.various researches have documented that it is a stimulator of hair regrowth and with extensive trails on both men as well as women with alopecias minoxidil treatment resulted in excellent outcomes without side effects

The approximate estimate effect of minoxidil treatment varies with age and gender such as in multiple double-blind trails the result shows that the drug play a significant role in the clients under 40 years of age.Acording to Rushton and Fenton this agent is more effective in women then in men, however the overall successive outcomes can be considered in the range of 30 to 40 percentage.

 

 

 

HINT: Consider

  • What are the confidence limits?

 

Section C: Will the results help locally?

 

  1. Can the results be applied in your context? (or to the local population?)

Yes     No       Can’t tell    

Justify your answer:yes

There is no doubts with the credibility of mixoxidil treatment because,infact this was the first drug become available for treating hair loss and has been proven to be the most effective and safe(without side effects) for both men and women.the product is currently available as solution containing 2 or 5 %minoxidil, in formulation composed of 60%ethanol, 20% propylene glycol and 20% water Considering the dosage and duration of usage must be aware from   dermatological experts in order to achieve excellent results.as far as consent with the availability of this drug, it has an easy access to medical and chemist stores for both men and women,the major disadvantage of minoxidil treatment are its cost and the need for continual for long peroid, open ended usage.

 

 

 

 

HINT: Consider whether

  • Do you think that the patients covered by the trial
  • are similar enough to the patients to whom you will
  • apply this?, if not how to they differ?

 

  1. Were all clinically important outcomes considered?

Yes     No       Can’t tell    

Justify your answer:can’t tell

 

The mechanism of minoxidil agent is still not fully understood and multiple thoughts were involved one theory proposed that minoxidil, metabolised to minoxidil sulphate in the hair follicles and acts as potassium channel agonist to reduce the cytoplasmic free ca+2 concentration and thus hair growth promotes.in the given studies, the different treatment modalities were conducted in randomised controlled trails.some kind of treatment promotes oral medication and some suggest to apply topical application.but amongst all minoxidil treatment has successfully achieved an evidence with appropriate outcomes. The results may be delayed in terms of various factors such as age and gender and dosage but the outcome is definite without any side effects.

 

 

 

 

HINT: Consider

  • Is there other information you would like to have seen?
  • If not, does this affect the decision?

 

  1. Are the benefits worth the harms and costs? Yes Can’t tell No

Justify your answer:no

With the maximum number of trails conducted on different group of people with differentaged groups, the research studies shows that minoxidil application has been proved to be the the most effective option for hair loss treatment or androgenic alopecia. IN contrary the alternate medicines like Finasteride, corticosteroids, dithronol and herbal remedies contains certain side effects like irritation of scalp, severe eczema and drug toxicity. The major disadvantage of minoxidil solution is the cost and the need of continual. The lotion must be applied twice daily in seven days a week with good compliance is necessary in order to achieved a positive cosmetic response. The modality has been associated with certainly no systemic side effects if mixoxidil treatment stops even after four years of duration then after 4 to 6 months, scalp hair remains the same as pre-treatment levels or even below.

 

 

HINT: Consider: Even if this is not addressed by the review, what do you think?

 

REFERENCE:

HEALTH DATABASE LIBRARY (UTS)

Treatments for Androgen etic Alopecia and Alopecia Areata

Current Options and Future Prospects

Victor M. Meidan and Elka Touitou

Department of Pharmaceutics, School of Pharmacy, Faculty of Medicine, the Hebrew University, Jerusalem, Israel.