The side effects reported during the treatment phase are as shown in table 4.10. The commonest side effect was nausea reported by 9 (16.36%) versus 12 (21.82) followed by constipation by 3 (5.55%) versus 5 (9.09%), and diarrhoea by 2 (3.64%) versus 2 (3.64 %) patients in Omeprazole and Ranitidine groups respectively. There was no incidence of vomiting or skin rash in either group.
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The CADET-HN study had reported headache as the commonest side effect reported by 7.5% of patients followed by diarrhoea in 7.0% and abdominal pain in 6.6% of study subjects and these side effects occurred equally in the two study groups. The study did not also report incidence of vomiting and skin rash as was observed in the present study. The study in Ibadan on Meprasil a brand of Omeprazole, had however reported equal incidence of diarrhoea and nausea (0.13%) with skin rash occurring in only in 0.06% of study subjects. The lower incidence of nausea observed in this study compared to the one observed for Omeprazole in the present study could have resulted from the smaller sample (20 per study arm) used for that study compared a much larger (55 per study arm) sample for the present study.
However both studies observed that, the side effects reported by the participants were minor.
This was also the case in the present study as none of reported symptoms was serious enough to warrant withdrawal from the study.
5.8 STRENGTHS AND LIMITATIONS OF THIS STUDY
5.8.1 Strengths: The strengths of this study lie in the facts that it was conducted in primary care settings where patients make their first contact with the Doctor. Most patients were therefore seen with undiluted symptoms without interventions that could have confounded the results of this study. Moreover, the drugs used for this study were registered by NAFDAC (National Agency for Food and Drug Administration and control) which guaranteed the quality of the drugs.
The Global overall symptom scale which was used for this study is a validated tool that has been used and shown to be a reliable outcome measure in clinical trials on dyspepsia. All the
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tools were also translated to Hausa language which was the common language among the study participants.
5.8.2 Limitations: This study was single blinded as only the researcher was blinded to group allocation. The patients could not be blinded due the non-availability of dummy tablets. Efforts were made however to as much as possible conceal group allocation to the participants after randomization by dispensing the medication in opaque polythene bags.
It is interesting to note however that only a few studies on this subject were double blinded (perhaps due to the technicality involved), whereas most were open label clinical trials.
Time constraints did not allow for patients to be treated and followed up for longer periods as was done in similar studies conducted elsewhere. The patients were however treated for the minimum duration of four weeks recommended by standard guidelines.
Monitoring of adherence to medication was done using pill count. This has its obvious limitations especially in the settings under which the present study was conducted. But it was observed that similar studies conducted elsewhere also used pill count and this is acceptable since those studies and the present study are primary care based clinical trials rather that may not afford the technicality involved in monitoring blood levels of the study drugs in order to confirm adherence.
5.9 IMPLICATION OF THE STUDY FOR FAMILY MEDICINE
This study had attempted to look at the treatment of dyspepsia, a common problem in primary care using two commonly prescribed drugs for dyspepsia in primary care; Omeprazole and
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Ranitidine. The two drugs, though proven by this study to be safe and useful in the treatment of un-investigated dyspepsia in primary care, were found to be associated with low symptom improvement rates at 4-weeks of treatment and high symptom relapse rates at 4-weeks after cessation of treatment.
A good number of patients in both study arms were also found to have other associated non-specific symptoms in addition to dyspepsia symptoms. This finding suggests that for a good number of patients presenting with dyspepsia in primary care there is more to it than just hyperacidity or dysmotility. In these patients, dyspepsia may just be one of a symptom complex of an underlying psychological problem rather than the presence of peptic ulcer disease.
This therefore calls for a more comprehensive approach by Family physicians to all patients presenting with dyspepsia in primary care in order to diagnose and treat such patients more appropriately. It also calls for more primary care based research, especially in relation to
“psychological” versus “acid suppression” therapies for dyspepsia in primary care.
5.10 CONCLUSIONS AND RECOMMENDATIONS
5.11 Conclusions: Based on the findings of this study, the Author concludes as follows:
1. That both Omeprazole and Ranitidine are safe and useful drugs for the treatment of un-investigated dyspepsia in adults that presented at the general out-patient department of the Jos University Teaching Hospital (JUTH).
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2. It was observed at the end of the treatment phase, that more participants achieved desired symptom improvement (relief and resolution) with Omeprazole than Ranitidine but the observed difference was not statistically significant.
3. Overall, Omeprazole was associated with better treatment out-come, higher patients’
satisfaction scores and less symptom relapse rate at 4-weeks after therapy.
4. A good number (about one-third) of participants in each group were found to have other
‘non-specific’ symptoms in addition to dyspepsia symptoms at baseline. This suggests the possibility of co-existing psychological disorders in such patients and may have negatively affected the overall treatment outcome observed in this study.
5.12: Recommendations: Based on the findings of this study, the author wishes to make the following recommendations;
1. Omeprazole should be used in preference to Ranitidine for the treatment of un-investigated dyspepsia in adults presenting at the general out-patient department of the Jos University Teaching Hospital (JUTH).
2. There is the need for more research to be conducted on the efficacy and cost effectiveness of the newer PPIs such as Rabeprazole and H2RAs such as Lafutidine in the treatment of UD in primary care.
In view of the high prevalence of H. pylori infection reported in the study environment, more research is needed in the area of “empirical triple therapy” versus “monotherapy” and the role
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of psychological interventions including the use of Anti-depressant drugs in the management of UD in primary care. At present there is dearth of literature in these areas.
3. There is also the need to develop a prototype protocol to guide Physicians in the use of Antibiotic medications in the management of adults presenting with UD at the general out-patient clinics of JUTH. This will streamline the use of Antibiotics in the management of such patients and go long way in reducing unnecessary treatment costs, risk of developing side effects and the development of drug resistance.
4. Finally, primary care physicians should adopt a more comprehensive approach to adults presenting with un-investigated dyspepsia at the GOPCs of JUTH. This will ensure early identification and proper management of those with underlying psychological symptoms.
87 REFERENCES
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Appendix I
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Appendix II
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APPENDIX III
CONSENT FORM
My name is Dr Attahiru Abubakar Kaoje;
I am conducting a research to compare the efficacy of two drugs commonly used in the treatment of heartburn in adult patients. You are being asked to participate because you complained of heartburn. If you agree to participate, you will be randomly allocated to either of the two groups of study without knowing which of these two drugs you will be taking throughout the study. If after all the explanations you finally agree to participate, I would have you sign this form.
Procedure
If you agree to participate in this study, I will ask you certain questions concerning your complaint and carry out routine clinical examination. In addition you will also help me with the following;
1. Two-weekly follow-up visits
3. Feed back on progress made during treatment.
Risk and discomfort
1. The clinical examination is not painful.
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2. I am aware that in some cases, some people could develop side effects of either of the study drugs but from our experience with the use of these drugs I can tell you that they are well tolerated by our patients and most of the side effects are mild and transient.
For example in a similar study involving 180 subjects using similar drugs only very few people reported these mild side effects and none reported any serious or life threatening side effect.
You are also free to pull out of the study if any side effects become unbearable. Some commonly described side effects of these drugs are;
Both may cause nausea, headache, constipation, diarrhea and flatulence; these are usually mild and self limiting, but if they persist however, I will treat you with Paracetamol, or an antimotility agent or liquid paraffin or encourage you to take liberal oral fluids as required.
Very rarely one of the drugs has been reported to cause hair loss, depression (mild) abnormal liver function and increased heart beat. If any of these happens, you will be advised to withdraw immediately.
Cost of the study
The treatment is entirely free of charge.
Withdrawal: Participation is completely voluntary and you may withdraw from the study at any time. Withdrawal will not attract any penalty.
Benefit: You will benefit from participating in the study because you will receive free treatment for heartburn and at the same time contribute towards the development of knowledge.
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The benefit to the society is that it will add a new dimension to the treatment of heartburn in our environment.
Question: Do you have any question to ask about this study? I will be glad to answer.
˝I willingly agree to participate in this study˝
Initials and signature/thumb print of participant………
Signature of researcher and date……….
Mobile phone no. of participant………
Signature of witness………
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APPENDIX IV
QUESTIONNAIRE ON THE COMPARISON OF OMEPRAZOLE AND RANITIDINE IN THE TREATMENT OF UNINVESTIGATED DYSPEPSIA IN PRIMARY CARE
Please kindly provide answers to the questions below;
Intials………. ID No………..
Weight (kg)……… Age (yrs)………..
Height (m)………. Hosp No………
Sex: M/F Occupation……….
Address……….. Telephone………
Date………..
Please answer’ yes’ or ‘no’
History
Heartburn [yes] [no]
Epigastric pain [yes] [no]
Abdominal Bloating [yes][no]
Others [specify]
Clinical findings
Obesity (BMI)………..
Epigastric tenderness…present/absent Others (specify)………